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9001Council  >  Articles & Editorials  > The Benefits of ISO 9001

The Benefits of ISO 9001

September 2018

Numerous surveys and academic articles have sought to quantify the benefits that companies typically gain after implementing an ISO 9001 Quality Management System. In this editorial we will examine some of the better-known research to see what conclusions can be drawn.

The appended bibliography lists some of the sources we have used; we encourage readers to refer to it and, if necessary, undertake further research by themselves.

ISO 9001 is truly a globally recognized standard, which will help your organization to continually improve your processes and manage business risks to meet the needs and expectations of your customers and other stakeholders.

Lloyd's Register of Quality Assurance, London

Most readers will be familiar with the ISO 9000 family of standards and may already have experience with ISO 9001:2008 and/or ISO 9001:2015. To start, we will examine a range of sources pertinent to this subject.

Lloyd's Register of Quality Assurance Many articles published in peer-reviewed academic journals continue to reference the well-documented surveys undertaken by Lloyd's Register of Quality Assurance in 1993 and 1996, both of which observed a strong correlation between ISO 9000 accreditation and increased sales and profit margins. The same articles refer frequently to Tord Häversjö's analysis of the financial impacts ISO 9000 registration had on Danish companies. More recent surveys proved very interesting: we were especially pleased to see studies discussing the benefits of ISO 9001 implementation in Macedonia and the Basque region in Spain, for example.

The World Bank The World Bank's 2007-publication, Quality Systems and Standards for a Competitive Edge , remains an outstanding reference work not only for its detailed analysis, but for its presentation of statistical data and examination of China's remarkable economic growth. The book also takes a close look at ISO 9001 accreditation in Latin America, observing that with notable exceptions such as Columbia (which has adopted the ISO 9001 standard wholeheartedly), low levels of education are one of the more recurring barriers to the implementation of Quality Management Systems.

The International Organization for Standardization We also looked at case studies published by the International Organization for Standardization (ISO), some of which are documented in their online periodical, ISOfocus . While little empirical data is offered in these studies, they are included in this editorial since they echo our findings (along with those of other researchers) across many nations and business sectors.

The Association of Southeast Asian Nations (ASEAN) In 2017 ASEAN published its 50 Success Stories of Internationalization of ASEAN MSMEs . This research is of great interest insofar as it offers instructional case studies in nations as diverse as Thailand, the Lao People's Democratic Republic, Malaysia and Vietnam. We recommended this survey to anyone interested in learning more about the benefits of ISO 9001 in developing nations.

China leads the way

China is the world leader in ISO 9001 certifications with almost 400,000 ISO 9001 certified companies in 2017. That's about four times as many as in second-place Italy and almost sixteen times as many as in the USA.

393008 certificates

97646 certificates

64658 certificates

45030 certificates

37478 certificates

36053 certificates

31984 certificates

25087 certificates

Summary and conclusions

Drawing conclusions from a study such as this is seldom straightforward. Grey areas persist, and care should be taken when assessing unduly positive trends in emerging markets. In our opinion, however, ISO 9001 remains the number one standard for private and public sector enterprises seeking not only to increase sales and profitability, but to develop a more robust culture within the workplace and better relationships with customers and suppliers. The key points that emerged from our study are detailed below.

Profitability: ROCE / ROA The two surveys undertaken by Lloyd's Register of Quality Assurance in the 1990s found that profit margins and ROCE of certified companies were more than twice the industry average. A more recent analysis examined certified and non-certified enterprises in Macedonia between the years 2002 and 2010, concluding that certified companies enjoyed significantly better growth and profitability. Similar conclusions were drawn from a survey of companies in Spain's Basque region between 1994 and 1998. We generally err on the side of caution when assessing profitability, but tend to agree that the average difference in ROCE between certified and non-certified companies lies between 15 and 25 percent . In terms of return on assets (ROA), our findings showed that certified companies typically outperformed their non-certified counterparts by an average of slightly over 20 percent. Worth mentioning is that ROCE for certified companies is in most cases higher than ROA.

Consistent implementation It is essential to note that adopting ISO 9001 does not guarantee enterprises will gain a de facto competitive edge over their rivals. The key to ensuring improved financial performance and customer satisfaction is consistent implementation . In other words, once the standard has been implemented internally and coordinated with suppliers and customers, it must then become a major component of the company's culture and daily practices, at which point it will be a catalyst for the changes that bring about competitive advantage. Retaining this competitive advantage requires commitment from senior management, along with other factors such as HR development, quality control, supply chain management and customer service / support. Most of the sources we reviewed were in broad agreement with these points.

Internationalization Little doubt exists that a rigorous and consistently applied ISO 9001 Quality Management System provides opportunities for internationalization and the penetration of foreign markets. In short, ISO certification not only improves processes and procedures, but enhances prestige both nationally and overseas. Welspun Corp in India exemplifies this point: the company gained rapid, global acceptance as a viable supplier of line pipes soon adopting ISO 9001, and is now a respected leader in its class. The case study below (researched by ISO) illustrates Welspun Corp's path to success.

China is another fine example of how ISO 9001 implementation has led to internationalization. Many analysts link the country's rapid emergence as a dominant global force with low labor costs. However, as the World Bank reminds us, labor costs in Bangladesh are half those of China. According to the World Bank, a key difference between these two nations is China's " determined drive to adopt quality standards ". In 2017 (the most recent year for which statistics are available), more ISO 9001 certificates were issued in China than in any other country.

ISO 9001: "the badge of quality" Some academics remain skeptical about ISO 9001, claiming that in many cases an ISO 9001 certificate is essentially a "badge of quality" and a requirement needed to satisfy the expectations of customers and suppliers. While our own findings indicate this may indeed be true, the same authors, researchers and academics concluded that the ISO "badge of quality" frequently opens doors to new customers and overseas markets that would otherwise be difficult or impossible to open, and improved sales growth and profitability are the typical outcomes.

Case study: Welspun Corp. Ltd

Mumbai-based steel pipe manufacturer Welspun Corp. Ltd. is one of the world's largest line pipe producers. The company has produced pipes for the world's deepest pipeline project (Independence Trail, Gulf of Mexico), the highest pipeline project (Peru LNG), the longest pipeline (Canada to the USA) and the heaviest pipeline (Persian Gulf). Welspun Corp's clients include most of the Fortune 100 companies operating in oil and gas.

ISO 9001 helped us establish our corporate quality management system globally throughout our facilities in India, Saudi Arabia and the USA. Within months, our state-of-the-art pipe manufacturing plant in Dahej, Gujarat, garnered the approval of many Fortune 100 oil and gas companies. We were on the road to success!

T.S. Kathayat, President, Corporate Quality & Technical Services, Welspun Corp. Ltd

Prior to the 1990s, pipelines manufactured in India were considered sub-standard in the West. Following globalization, however, the situation changed and entrepreneurs in India began to focus more on quality in order to compete in the new global market. In accordance with Welspun Corp's motto, Dare to Commit , the company is now firmly committed to state-of-the-art processes and ensuring its products offer the finest quality.

After ISO 9001:2015 was introduced, T.S. Kathayat, President, Corporate Quality & Technical Services at Welspun Corp discussed the company's strategic objectives. He observed: "From the moment we established our first line pipe manufacturing facility in the state of Gujarat, India, in 1996, ISO 9001 has offered strategic support. We formulated a combined integrated quality management system for both ISO 9001 and the American Petroleum Institute's API Specification Q1."

"Since engaging with standards, we have received a number of awards, both nationally and internationally, for the excellence of our quality system and manufacturing plants. Today, we are proud to say that all our facilities are accredited to ISO 9001, ISO 14001, ISO/TS 29001, and ISO/IEC 17025 for the testing facilities, among other standards. The ISO certifications have created the framework in which to expand our business globally, making us the biggest manufacturer of large-diameter line pipes in the world – a badge we wear with pride. ISO 9001 has helped us harness the vision that lies at the heart of our business."

"Our quest for continual improvement means that upgrading to the new ISO 9001:2015 will be easy. The revised version takes a risk-based approach, which was sorely lacking in the existing one. The new standard should help minimize our business risk although risk is already covered in our present system in two broad areas: delivery and product quality. We are already taking action to implement the new ISO 9001 requirements and, with the API audit of our Anjar facility in full swing, our existing QMS documentation is under revision."

"I feel sure that all global organizations will profit from upgrading to ISO 9001:2015. And if I may venture a suggestion, employee training should be the focus of attention for all companies transitioning to the new standard, in order to embed the benefits at the zero ground level."

ISO 9001:2015

Case study: Sénégalaise Des Eaux

Founded in Dakar in 1995, Sénégalaise Des Eaux is Senegal's largest water company and distributes potable water to more than 5 million people in 554 locations nationwide.

We have been using ISO 9001 since 2002 and it helps us anticipate and meet the needs of our customers.

Mamadou Dia, CEO, Sénégalaise Des Eaux

After implementing ISO 9001:2008, the company saw major benefits in terms of:

  • the quality and quantity of water produced;
  • maintenance (electromechanical and network);
  • more efficient billing, recovery and customer relations management;
  • performance of engineering projects as part of the company's expansion.

As CEO Mamadou Dia explained, "The customer wanted enough water. When that was satisfied, then came the quality of the service. And today, we imagine on a regular basis which ways we need to explore for quality to be maintained, for the service to be maintained and for the customer to be satisfied. That's why we are meeting with consumer associations every six months."

Improved quality Water potability increased from 91% to 99.1% after Sénégalaise Des Eaux implemented ISO 9001.

More efficient management ISO 9001 compliance facilitated better control of processes and a consequent 19% reduction in managerial staff. Cost savings over the following five years averaged roughly 4% per annum.

Streamlined workforce Staff costs at Sénégalaise Des Eaux traditionally represented 70% of expenditure. Through consistent application of ISO 9001, improvements in productivity led to an almost 10% reduction in staff.

Internal controls Rigorous implementation of ISO 9001 contributed significantly to improved monitoring and control of all the company's departments.

Sénégalaise Des Eaux is now a keen advocate of standardization and works closely with the Standards Association of Senegal to encourage broader acceptance of ISO 9001 across the nation.

Sénégalaise Des Eaux

Selected bibliography

Books: ASEAN and the World Bank

Guasch, J. Luis; Racine, Jean-Louis; Sánchez, Isabel; Diop, Makhtar (2007), "Quality Systems and Standards for a Competitive Edge" , Washington, DC: World Bank Publications , ISBN 0-8213-6894-X

"Future of ASEAN: 50 Success Stories of Internationalization of ASEAN MSMEs" , 2017, Jakarta: The Association of Southeast Asian Nations (ASEAN) , ISBN 978-602-6392-81-7

International Organization for Standardization

Bondois, Flavie (2010), "ISO 9001 Test: Top Marks for French Exam Centre", ISOfocus , 1 (5): 40-41, ISSN 1729-8709

Gasiorowski-Denis, Elizabeth (2015), "India Puts Quality in the Pipeline with ISO 9001" , ISOfocus , 113 : 14-19, ISSN 2226-1095

Tranchard, Sandrine (2015), "African Water Benefits from Standards" , International Standards Organization

Academic journals

Castello Dalmau, Jordi; Gimenez, Gerusa; De Castro, Rodolfo (2016), "ISO 9001 Aspects Related to Performance and Their Level of Implementation", Journal of Industrial Engineering and Management , 9 (5): 73-89, doi:10.3926/jiem.2072, ISSN 2013-0953

Ferati, Rametulla; Bytyqi, Njazi; Aqifi, Elsana (2012), "Effects of Application of Standard ISO 9001 in Profitability of SME in the Republic of Macedonia", International Journal of Scientific & Engineering Research , 3 (10): 1-5, ISSN 2229-5518

Häversjö, Tord (2000), "The Financial Effects of ISO 9000 Registration for Danish Companies", Managerial Auditing Journal , 15 (1/2): 47-52, doi:10.1108/02686900010304632, ISSN: 0268-6902

Heras, Iñaki; Dick, Gavin P.M.; Casadesús, Martí (2002), "ISO 9000 Certification and the Bottom Line: a Comparative Study of the Profitability of Basque Region Companies", Managerial Auditing Journal , 1/2 : 72-78, doi:10.1108/02686900210412270, ISSN 0268-6902

Texeira-Quirós, Joaquín; Almaça, José A.; Fernandes-Justino, Maria do Rosário (2010), "How Quality Affects the Bottom Line?", Intangible Capital , 6 (2): 258-271, doi:10.3926/ic.2010.v6n2.p258-271, ISSN 1697-9818

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  • Research article
  • Open access
  • Published: 19 July 2017

Why adopt ISO 9001 certification in hospitals? A case study of external triggers and sensemaking in an emergency department in Norway

  • Dag Tomas Sagen Johannesen   ORCID: 1 , 2 &
  • Siri Wiig 3  

Safety in Health volume  3 , Article number:  7 ( 2017 ) Cite this article

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Certification and accreditation are widely used to achieve quality and safety in health care but are also questioned regarding their assumed effects. This is a challenge for policymakers and managers, since adoption of these regimes can have a circumstantial impact upon organizations. This study’s aim was to explore how external conditions catalyzed and triggered organizational change and internal sensemaking processes as part of an ISO 9001 certification process.

The study applied an explanatory single-case design, using a narrative approach, to retrospectively follow a sensemaking process in an emergency department in a Norwegian hospital undergoing ISO 9001 certification. The certification process was a pilot initiated by a Regional Health Authority, which ran from autumn 2008 until spring 2012. Nine semi-structured, qualitative interviews were conducted, and documents in the form of minutes and reports were collected. The data was analyzed according to an organized sensemaking framework.

The adoption of the ISO 9001 certification did not follow a comprehensive decision-making process. Our study shows two external situational triggers that initiated adoption. First, a countrywide supervision conducted by the Norwegian Board of Health Supervision concluded that inadequate management and leadership negatively affected the day-to-day running of Norwegian emergency departments. This external disruption visualized longstanding organizational challenges that threatened the managers’ shared identity. A search for meaning became prominent. Second, an occasional, externally initiated certification project was a plausible solution that would lead to an immediate action that would reduce uncertainty. Institutional requirements and concepts in the international ISO 9001 standard and in the national health regulations were unfamiliar and ambiguous for the project group involved in the certification. These issues became the institutional external triggers for intra-organizational sensemaking processes that made ISO certification possible. External assessments were acknowledged as useful for making improvements.


By combining institutional theory with sensemaking theory, this case study contributes to a better understanding of how external pressure meets micro-level change processes. These understandings are important because environments give rise to adoption of different management tools, such as certification, but organizations adopting new management tools seldom abandon others. This can lead to even more complex health care.

Accreditation and certification programs in health care are used internationally to ensure, regulate and drive quality improvement and safety initiatives. Starting as a professional self-regulatory standardization and control initiative in the early years of the twenty-first century, the number of programs globally has grown tremendously in the last 25 years. In Norway such programs have no clear history other than some small ad hoc initiatives. At a national level, nationwide certification and accreditation programs have been debated [ 1 , 2 ] and were recommended by the Government in 2015 [ 3 ]. Claims about a limited evidence base and rigorous study designs of the effects upon recognized quality measures have been put forward in several international publications, especially in relation to how many resources are allocated to accreditation and certification systems internationally [ 4 , 5 , 6 ]. Recently, two updated systematic reviews about the effects of certification and accreditation [ 5 ] or external inspections [ 7 ] upon process or clinical outcomes only found respectively one and two studies that met their inclusion criteria. The authors found no strong evidence to conclude about the effectiveness of certification or accreditation. Earlier reviews, with broader inclusion criteria report in general inconsistent findings on the relationships between certification and accreditation programs and clinical performance and outcomes, a positive trend about the programs ability to stimulate improvement work and promote organizational and cultural change and change in professional practice concerned with quality of care, and contrasting views among professionals towards accreditation [ 8 , 9 , 10 ]. Studies of 89 European hospitals indicate that accreditation and International Organization for Standardization (ISO) 9001 certification are positively associated with some quality and safety structures and hospital outputs such as hospital management, clinical practice, safety, patient-centeredness and cross-border patient-centeredness. These studies demonstrated that accreditation has slightly more impact than ISO certification, but either system is better than no external assessment [ 11 , 12 ]. The recent EU project DUQUE with data from 73 European hospitals studied the relationship between ISO 9000 certification, healthcare accreditation, and quality management. The researchers concluded that accreditation and certification were positively associated with clinical leadership, systems for patient safety, and clinical review, but not with clinical practice [ 13 ]. In a Danish nationwide population-based study the researchers reported a lower 30-day mortality risk for admissions at fully accredited hospitals compared to admissions at partially accredited hospitals [ 14 ]. Using an interrupted times series analysis following one hospital in Abu Dhabi over 3 years, the researchers showed that the positive impact of healthcare accreditation on hospital quality measures to some degree was maintained during the 3 years accreditation cycle, but concluded that more focus on continuous improvement methods to sustain the positive impact form accreditation was needed, for instance, frequently self-assessment or unannounced external reviews [ 15 ]. The use of unannounced external reviews was recently studied in a nationwide cluster-randomized controlled trial [ 16 ]. No difference between announced and unannounced surveys in detecting non-compliance with accreditation standards in hospitals was found.

The uncertain relationship between adaption of different accreditation or certification programs and quality and safety objectives poses a challenge for policymakers and managers. Despite these challenges, hospital certification and accreditation are widely used and differ extensively in their purpose and organization [ 10 , 17 ]. Certification and accreditation can therefore be considered as a legitimate and institutionalized means of regulation of quality and safety in hospitals, and in complex organizations they reflect contemporary tendencies of means – ends decoupling [ 18 ]. In means–ends decoupling, we see that the adoption of new policies or formal structures has a real impact upon change of organizational activities and cultures, but there is limited evidence linking these changes to organizational effectiveness and outcomes (see Fig.  1 ).

Possible means–ends decoupling for ISO 9001 certification in hospitals. The figure is adopted and modified from Bromley & Powell [ 18 ]

Figure  1 presents the questions about why complex organizations allocate resources to practices that have a scarce or diffuse known relationship to organizational objectives. In hospitals, such objectives are most often linked to better outcomes of patient care. This case study takes these questions into a hospital context in Norway, and investigates why and how an emergency department (ED) adopted and was certified in the ISO 9001:2008 Quality management systems – Requirements standard.

ISO 9001 certification—what is it?

ISO 9001 certification can be seen as an external conformity assessment or control mechanism to assure and regulate quality and safety in health care. It is often compared to or described interchangeably within the “family” of external assessment strategies for health care organizations, and especially accreditation [ 19 , 20 ]. The common purpose of these external assessment programs is to provide information and evidence that the organizational system and performance conform to a specific standard, and both certification and accreditation programs award the assessed organization with a certificate on successful conformity. Certification bodies and auditors should strive to build confidence and trust through a practice rooted in impartiality, competent assessments, and decisions based on objective evidence [ 21 ]. The ISO 9001 standard does not prescribe performance requirements. Rather, it proposes generic requirements for structures and systems that enable organizations to formalize production or service processes into a series of procedures, and to continuously monitor, document and improve its efficiency upon customer (patients) requirements and legal regulations [ 22 , 23 ]. An audit program has a 3-year audit cycle: the initial certification process, two shorter “surveillance audits” over the next 2 years, and then re-certification in the third year.

Aim and research question

The aim of this case study is to explore external conditions that may catalyze and trigger organizational change [ 24 , 25 , 26 , 27 ], and internal sensemaking processes in the local ED management [ 24 ] that led to the continuity and change in favor of ISO 9001 certification. The following research questions guided the study:

How do external environments contribute to an adoption of ISO 9001 certification in an emergency department?

How does the local management make sense of the certification process?

This paper reports on the sensemaking processes in an emergency department in a Norwegian hospital undergoing ISO certification. By combining institutional theory with sensemaking theory, the paper contributes to a better understanding of how external pressure meets a local conceptualization of quality management processes in ISO certification.

Theoretical approach

The rise in certification and accreditation practices in healthcare [ 17 ] reflects the shifting mode in regulation (often a reduction in “hard laws” and directives), spread and diffusion of modern management tools, and demands for accountability and transparency in our contemporary society. In this case study, we treat the interplay between the enforced internal control regulations and voluntary ISO certification from the perspective of re-regulation [ 28 ] or decentered or plural regulation [ 29 ]. Typical of such regulation is the transformation into modes of governance Footnote 1 ; with or without governments, often transnational in structure, and represented by non-binding “soft” rules and regulations. Such soft regulations are often diffuse and lead organizations to search for other means and control mechanism [ 28 , 30 ].

To study the interplay between mandatory regulatory demands in healthcare and the voluntary adoption of ISO certification in a Norwegian hospital context, we draw on the contributions of institutional and sensemaking theory.

Institutional trigger

The present study emphasizes how macro institutional elements shape, trigger, or become situated by organizations and individuals, but with less influence over the continuing intra-organizational sensemaking processes [ 25 , 27 , 31 ]. People act and then use institutional structures to give meaning to their actions. This perspective breaks with more traditional perspectives where institutional environments place cognitive constraints upon organizations and intra-organizational processes by preclusion of other alternatives. According to Weber and Glynn [ 25 ], there are three mechanisms in addition to traditional cognitive constrains whereby institutional context affects sensemaking: priming , editing and triggering. Institutional contexts, in their view, refer to both the external institutional environment and institutionalized structures or scripts within organizations. People acting in situations extract cues to activate sensemaking processes. In this case study, we follow the triggering mechanisms [ 25 ] which relate to how contradictions, ambiguities, and gaps inherent in stable institutional structures create puzzles that require people to search for meaning. For example, the Norwegian healthcare regulation and the international ISO 9001 certification system represent different institutional structures that when adopted are supposed to constrain action. They also carry different legitimacy mechanisms that when adopted in different organizational contexts have the potential to be ambiguous, diffuse, or incomprehensible.

Sensemaking, turbulence, and change

The sensemaking perspective [ 24 , 31 , 32 ] helps to see the micro processes that enfold when managers adopt popular quality and safety programs, such as total quality management, six sigma, and LEAN management. Adoption processes do not follow rational, instrumental decision-making processes, rather they are filled with constantly changing sensemaking processes in order to give meaning to changing situations and outcomes [ 31 , 33 ]. Sensemaking is most evident when the world is perceived to be different from its expected state or when there are surprises [ 31 ]. Such diversity is described as triggers or a discrepant set of “cues” [ 24 ] enacted by individuals. Cues can be small bits of information, events or simple familiar structures, and people turn to earlier scripts, schemes, or frames to ascribe meaning to cues and decipher the situation. In other words, people are guided by institutional constraints, organizational premises, plans, expectations, acceptable justification, and traditions inherited from predecessors [ 31 ]. Weick [ 24 ] explains the sensemaking mechanisms that foster these organizational processes as thoughts, feelings, and intentions, the “intrasubjective meanings”, being merged into “intersubjective meanings” through conversations. In times of stability, individuals draw on common scripts and frames to make sense of situations. But, in times of turbulence and change, these “old” scripts no longer work. A gap needs to be filled and an intersubjective or collective sensemaking process again becomes prominent. People look for reasons to continue or resume their work. In the search for reasons, sensemaking is about the interplay of action and interpretation rather than the influence of evaluation on choice [ 31 ]. It is not about accuracy and truth, but about plausibility. People continually redraft their stories in their search for meaning, so the stories become more comprehensive and resilient to criticism, and richer in data. Important in our case study was how a local project group constructed a story that we regard as collective shared meanings. Shared meanings is a core theme for both crisis sensemaking and change sensemaking [ 26 ].

In this section we will describe the regulatory context of Norwegian hospitals. Then we continue with design and data collection and present our analytical framework.

Context and internal control regulation in Norway

The Ministry of Health and Care Services has the overall responsibility for the specialized health care services in Norway. Public hospitals are owned by the Government and organized in four Regional Health Authorities (RHA).

The regulation of quality and safety for health service providers in Norway is based on a functional legislation, outlined as enforced self-regulation [ 34 ], where different regulatory requirements are based on an internal control system [ 35 ]. Hospitals have in this perspective a great deal of latitude to make decisions and set priorities about their organization and services [ 36 ].

All hospitals, their service and health personnel, are subject to supervision by the Norwegian Board of Health Supervision (NBHS), through the 18 Offices of the County Governors. The main supervision of hospitals is performed as system audits, whose aim is to ensure and control whether health services are complying with national acts and regulations. In practice it involves auditing the health service’s internal control system.

In 2005, a RHA voluntarily adopted the ISO 9001 as a guide for all its hospitals, in order to operationalize the internal control system requirements [ 37 ]. It was argued that an identified lack of follow-up on the internal control system could be connected with difficult conceptualizations, vague demands, and uncertainties about overall quality management systems and its advantages [ 38 ].

The present study is designed as an explanatory single-case study [ 39 ]. For explanation building, we used a narrative approach [ 40 , 41 , 42 , 43 , 44 , 45 ] and storytelling [ 46 ] to retrospectively follow sensemaking during the local ISO 9001 certification process of an ED in a hospital trust in Norway. The process ran from autumn 2008 until spring 2012.

An overall story or narrative was produced during the research process. It illustrates how those involved in a local project group collectively made sense of the practices and experiences that unfolded during the certification process. The stories and meanings that the informants provide about past experiences can in itself be seen as a sensemaking process, as the nature of sensemaking builds upon frames that continuously change as the informant act and acquires experience [ 24 ]. The narrative can as such be seen as a co-construction between the informants and the author (the researcher), in addition to stories from documents (artefacts), and are constructs through which events are made sense of rather than just representations of these processes [ 40 ].

Sample and data collection

The case study relies on data produced from qualitative interviews and documents [ 39 , 47 ]. An initial exploratory interview was conducted in June 2011. Then documents and informants were selected for further study. Data derived from documents took the form of minutes of meetings and reports that were made available by informants and official websites (Table  1 ). The main data collection was performed during spring and autumn 2012.

Twelve informants were firstly purposefully selected. All were managers and key personnel in the ED, head of clinical and service departments, key personnel in the certification process, and the project management in the Regional Health Authority. After conducting eight interviews (Table  2 ), a distinct picture of the key local project management for the certification process could be drawn. The eight interviews revealed a distinct local organizing and sensemaking process, especially that of the local project management (and the local ED management, since managers were represented in the project management).

Semi-structured interviews were conducted in June and August 2012, according to an interview guide and centered upon three themes: (1) the subjects’ role, the organization, and aspects concerning quality and safety work; (2) the certification process and its results; and (3) how ISO 9001 standard and certification was understood in relation to formal quality and safety regulations and management tools. Open questions were generally used, often followed by either preplanned or ad hoc probing questions, in order to help subjects to recall and tell more detailed stories about the ISO certification process and their experiences.

Analytical framework and process

Organized sensemaking is primarily a process theory. When conceptualized organized sensemaking can be treated as a sequence of “ecological change—enactment—selection [and]—retention [ 31 ]”. Ecological changes in this context are treated as both intra- and inter-organizational environments. In the organizing process of enactment , people are shaped by environments and sense anomalies that are “…triggered by discrepancies and equivocality in ongoing projects, [and] begin to change the flux of circumstances into the orderliness of situations” [ 31 ]. S election is a process of narrative reduction where possible meanings are reduced and generate a tentative and plausible story. In retention the plausible story is connected to past experience and fit with identity, and such makes a new script or cognitive frame that feeds back to the prior processes. In this case study we have applied the following analytical categories, modified, and adopted from Steyer et al. [ 48 ], that aims to emphasize the key elements in organized sensemaking processes [ 24 , 31 , 49 ] (See Fig.  2 ):

Analytical categories. The analytical categories (shown in callouts) are used in this case study to emphasize the key elements in the conceptual relationship among enactment, selection, and retention [ 31 ]. The figure is adapted from Jennings & Greenwood [ 66 ] and Weick 1979 [ 31 ]. Examples from the present case study are put in parenthesis in each callout

Frame (retention): Involves cognitive frames (retained plausible stories, such as acquired from work, training or life experiences) and formal frames (e.g., categories, plans, procedures, organizational structures, and artefacts). Frames are sources of guidance for interpretation and action.

Cue: Information or event extracted from the environment by actors. People ascribe meaning to cues by relating them to frames.

Discrepancy: Equivocality and discrepancies between cues, and between cues and frames. It gives an occasion to search for and reconsider a meaning. It is related to the question “same or different” [ 31 ]. When a situation feels different, it activates a search for meaning.

Concern: A tentative plausible story (e.g., an opportunity, problem, perceived uncertainty, issue, or controversy) that the individual or group pay attention to.

Action: Through action, people produce parts of their environment and are “making” what is sensed [ 24 ]. People also enact what has been made sense of back into the world. In this study the main actions are identified, while acknowledging the challenge of simultaneously identifying both action and cognition [ 48 ].

Our analytical process follows the principle of “narrative analysis” proposed by Polkinghorne [ 50 ], incorporating analytical features from Boje’s [ 45 ] causality analysis in an antenarrative perspective. Our narrative follows the characteristics of a narrated plot [ 42 , 45 , 50 ], where beginning, middle, and ends of the story come into being. Such retrospective reconstruction often starts with the outcome as a starting point for how this event came about. In this case study the guiding outcome was the ED’s adoption of ISO 9001 certification. Our first analytical step was to arrange the data elements chronologically and construct a baseline story. The baseline story was modified in an ongoing process along with a repeated reading of the interviews. In our next step we identified elements that are contributors to action and outcome [ 50 ]. Here the baseline story was categories into our analytical framework (Fig.  2 ). Our final analytical step was an ongoing construction (writing, categorizing, and rewriting) of the narrative into a temporally patterned whole [ 50 ]. We have visualized in brackets the categorization in the final narrative presented in this paper, to make the analytical process more transparent. To ensure trustworthiness, the narrative, with its analytical categories, was sent by e-mail to six of the informants, who confirmed the narrative. Only slight changes in the narrative were done after the informants’ responses.

The story of change

The following story is presented in two stages. The first outlines the initial establishment of the external project that initiated the pilot process in the ED. The second narrates the intra-organizational sensemaking that contributed to continuity and change in favor of ISO 9001 certification.

Following up on unacceptable conditions in emergency departments

In 2007 the Norwegian Board of Health Supervision (NBHS) carried out a countrywide supervision of 27 out of 54 hospital emergency departments in Norway, and concluded that in general, there was a lack of management responsibility for ensuring that daily tasks were planned, organized, carried out, and improved in accordance with legislative requirements [ 51 ]. The NBHS described the situation as unacceptable and required the management to take action.

As a direct follow-up of this report the Norwegian Accreditation (NA) Footnote 2 and one Regional Health Authority (RHA) initiated a collaborative project. Its objective was to set a standard that EDs could use to ensure and improve internal control and management systems, and for accreditation or certification purposes [ 52 ]. A sector committee Footnote 3 including an administrative project organization, the regional project group (RPG), was established in the spring of 2008.

The sector committee was composed of representatives from all the RHA, NBHS, and other professional experts, and their work took place from August 2008 until March 2010. The new accreditation standard for EDs was supposed to concretize the generic requirements in the legal internal control regulation. The committee considered different management standards to build upon or implement, and decided on the ISO 9001:2008 Quality Management System - requirements standard, with its additional guidelines for use in health services [ 23 ]. The main reason was that the ISO 9001 was in compliance with the current Norwegian internal control regulation. Two ED was chosen as pilots for the project, in order to (1) identify core processes and risk areas to specify new requirements for EDs and (2) become ISO 9001 certified and meet the new requirements. One of the EDs ended the process before becoming certified, and the other, whose story is told in the next section, became certified in 2010 [ 53 ].

The initial phase

The ED had struggled for years with a heavy and challenging patient flow, and worked to improve the system without acceptable results [frame]. During this time there had been a change towards more attention to quality improvement and control, both through central, regional, and local initiatives. The RHA had become more explicit on requirements about, among others, waiting time for patients, patient safety, and prevention of infections [frame]. The ED was also in the middle of a rebuilding and merging process to take over the emergency functions from another hospital. The volume of patients was high, they were kept waiting, and there was not enough beds [concern].

The ED got two nonconformities from the countrywide supervision that required managerial follow-up. The first nonconformity pertained to the accumulation of patients that could lead to failure of treatment; the second was related to the examination conditions in the ED, which did not ensure adequate protection of confidentiality, patient integrity, and information exchange [cue]. The challenges in the ED were once again highlighted [cue] and the hospital top management became more involved in resolving these challenges [discrepancy]. The ED once again started to look for solutions and make efforts to improve patient flow [action].

Some months after the report from the NBHS, the hospital trusts in the RHA were asked to participate in the pilot project. The ED was then asked by their hospital CEO [cue]. The Head of Department had a quick consultation with middle managers in the ED, and the response was “Yes, let us jump on it” (Informant Y). They immediately decided to participate in the pilot [action]. Their expectation was to get the assistance to work systematically to resolve the challenges in the ED [concern].

The process in the ED started in autumn 2008. The first meeting was represented by people from the hospital who delivered services to the ED (e.g., physicians and the X-ray department) in addition to people from the regional project group. The intention was to anchor the project with concern to those departments that delivered services to the ED, and not just the ED in isolation [concern]. Especially, the integration of physicians was considered important [concern]. The head of department was the hospitals representative in the RPG and was highly involved in the development of the new requirement for EDs during spring 2009. She also became a key actor and a primer for the local pilot throughout the project.

During spring 2009, the ED established a local project group (LPG) led by the head of department and three middle managers [action]. At that time they did not know what to expect, other than they would be assessing and describing processes, identification of system vulnerabilities, and implementation of relevant actions in the ED [discrepancy]. In any case, they immediately threw themselves into the work, starting to describe processes and identify vulnerabilities [action]. After a while they were made aware of [cue] that the pilot project would involve the use of the ISO 9001 standard [discrepancy]. Then they realized their need for local assistance about developing quality management systems [concern]. A quality adviser from the Quality and Research Department integrated in the LPG [action]. The main work on ISO 9001 certification began in the summer of 2009.

The standardization and certification phase: summer–autumn 2009

The LPG worked enthusiastically and intensively, especially in July and August 2009. Most of the group members worked extra to complete the work [action]. The rest of the employees in the ED were less involved, limiting their participation to some ad hoc working groups, such as those to establish and revise procedures. Even though the LPG had agreed that the main intention for the ED was to review their management systems [frame], there seemed to be a clear awareness among the LPG members that the hard work on standardization consisted of taking steps towards certification [concern]. They had an opportunity for external help with improvement work, and this extra focus [cue] seemed to generate actions and a desire to demonstrate that they now were able to succeed [concern].

[I]t was a combination of several things. […] When the crisis is big, it’s even more important to get things done. It’s a motivation in itself to do something—that was important. We were selected from the Regional Health Authority to accomplish this—that was an important element. […] It turned out just like a competitive element, just like: ‘This is something we can master’. Clearly, much was done before the certification body came in. We had been working very much; however, they did the last part in order to push us all the way to the end. (Informant Z)

None of the LPG members had experiences [frame] with ISO 9001 standardization and certification processes [discrepancy], except for one member of the quality department, who became an important “translator” [cue] of the ISO standard during the pilot project. The standard needed contextual adaptations to be legitimated in the ED [concern]. Terms like risk assessments, measuring, monitoring, and recording are obvious concepts and parts of an ISO quality management systems, but it was an unfamiliar terminology for the LPG [discrepancy]. The additional ED requirements developed during the project became important concretizations of the ISO 9001 standard and the internal control regulations. It generated a contextual translation [cue] of rather general requirements [discrepancy] and so ordinated a meaningful operationalization in the ED [action]. As “newcomers” [frame], the LPG needed concretization [concern].

The LPG referred favorably to the certification body. In the first phase of preparing the ED for the initial onsite document review, there was a large amount of e-mail between the ED and the certification body. The hospital received much advice and help on how to improve the organization [cue]. The auditors were considered very detailed, sometimes almost too much [discrepancy], especially during document reviews and the certification audit. At the same time the auditors created confidence with their detailed knowledge and ability to identify salient points and ask questions about the documents and systems [cue]. They also transferred experiences from other organizations and brought expert knowledge on systems and change processes. The LPG experienced the certification process more as guidance than as control [discrepancy].

It was a turning point for the LPG when they received feedback from the certification body and gained experience from the standardization process itself [cue] that changed their understanding of systems that they had considered well-functioning: “things that we took for granted” (Informant Y), but were not good enough [discrepancy]. They started working differently with their systems [action] which generated an improved overview of their organization and tasks [cue], the number of procedures was reduced considerably [cue], and explicit objectives for improvement was created [cue]. The latter was a shift from describing objectives in general concerns, like “we should be better at…” to develop measurable objectives that could be monitored. The entire improvement and certification process [action] was considered as an important help [frame].

The initial countrywide supervision pinpointed the responsibility of other professions, especially physicians, to hold them accountable for the challenges in the ED [cue]. The emphasis on creating descriptions and visualization of core processes in the ED [action] made the department more visible and the process was considered a key to the shared understanding and commitment among leaders in other departments [cue]. The certification body drove this accountability concern further, and mutual contracts with “service” departments (including physicians) was a requirement for certification [cue]. “A milestone could be seen when agreements with other heads of departments became evident” (Informant X).

There were some worries among the employees in the ED about the perceived absence of management [cue], but the LPG did not enact any significant opposition either inside or outside the ED [cue]. The fact that the ED was a part of the pilot project and was supposed to [frame] organize for and deliver a service that was certifiable [discrepancy] was regarded as an important driver, not just for the LPG but also for other professions outside the ED that participated in working groups. It seemed that “no one” would contribute to the failure of a certification status, especially since it was decided at the top of the organization and as a direct follow-up of the external supervision [concern].

[T]he symbolic perspective of certification is just as prominent as the rational. I believe that, and that’s my conclusion. Much of the things that we initiate are like that. Symbolic perspectives should not be underestimated (Informant Z).

After following up on the nonconformities that were given during the certification audit, the ED finally received its first ISO 9001 certificate in January 2010.

The time after: winter 2010–summer 2012

According to the managers and the LPG, the ISO certification process generated improvement of the management system; however, a direct impact on patient treatment was hard to demonstrate [frame]. ISO 9001 was considered as a managerial tool [frame]. When the revised management system was contrasted with the situation before certification, it illustrated both positive practical implications and improved daily organizing of the ED [frame]. The ED management started talking differently about quality improvement, and used terms and explanations that had originated from the standardization and certification process [action]. They were proud of their achievement and gladly shared their material and experiences. The ISO standard and the additional requirements for EDs were not considered the optimum way of organizing, but it was treated as one way, among many others, that generated system improvement [frame]:

[T]he fact that we are ISO-certified—as I say: We have put some things in place; it is easier to find, easier to breathe, you don’t need to doubt, you don’t have to look; it is helping to create those secure frames. So that those who work within these frames are given the opportunity to flourish in the face of the patient. (Informant W)

Even though the LPG considered the certification process to imply system improvement [frame], they did not expect that the employees would perceive quality improvements, or associate system changes with the ISO certification [concern], since the certification process did not really affect the daily operations and patient treatment. At least two other quality improvement initiatives (triage and nurses’ continuing education) were initiated in parallel with the certification process, and these were considered to have more positive association with improved treatment quality compared to the ISO certification [cue].

The ED underwent two yearly surveillance audits Footnote 4 conducted by the certification body after the initial certification audit. These external assessments were considered important for sustainability of quality improvement [cue], even though the management understood that quality improvement should be part of everyday practice [discrepancy]. Whether these audits needed to be performed by a third-party certification body was not considered of major importance, and neither was the importance of the certificate in itself [Frame].

The ED management started to question the need for further use of an external certification body [concern]. These concerns were based on (1) negative experiences from the latest surveillance audit, where a new team from the certification body conducted the audit [discrepancy], (2) the costs and resources spent [frame], and (3) having brought their quality management system to an acceptable level. The ED management had generated knowledge that enabled the ED to perform ongoing system improvements on its own [frame]. However, some sort of external audit was considered necessary [concern]. Internal audits performed by the quality department in the hospital was in theory considered equal with external audits, but in practice the external audits (e.g., by a certification body, NBHS, or the RHA) had stronger impact and triggered more managerial action than internal audits [discrepancy]. Managers from the LPG changed their perspective on audits, from seeing them as a way of controlling organizations to something useful for sustainable improvement [frame]. They started asking for internal audits and acknowledged the possibility of letting someone outside the department assess their systems and give feedback [action]. Nonconformities were used as means for further improvement [frame].

[F]or the last couple of years we have requested audits, when there are things we are questioning. […] It’s not so frightening anymore, and we see that it’s very useful for us. That I think is a result of the process. We are not so afraid of getting nonconformities, and see that these [nonconformities] are things that we can work on. (Informant V)

As a result of the countrywide supervision, the Norwegian EDs were turned inside out in ways that made it obvious to ask whether it was safe to be a patient there. The turbulence did not lead to additional formal national inquiries or major policy changes that we have seen from turbulence or health care crises in other countries [ 54 ], but it was thoughtless disruption or turbulence that was a powerful occasion for organizational change [ 26 ]. The story of the adoption of an unfamiliar set of organizational requirements (ISO 9001), that had a quite circumstantial influence on the local ED management, fits at first glance into the picture of sensemaking, where action and interpretation rather than evaluation on choice were present in the first face of the adoption process. A quick decision to become part of the pilot project was taken in the face of longstanding challenges in the ED related to patient flow and management systems. These challenges had become a frame of reference for the management, and different initiatives to resolve them had become discrepancies between what had been expected and the reality. It was not a surprise or a shock that prompted sensemaking, but ongoing discrepancies as circumstances great enough to expect people to ask for what is going on, and what should they do next. This situation challenged the management’s social and shared identity [ 24 , 26 , 31 ], as they were responsible for the quality and safe running of the ED. Such an internal turbulent environment can in itself be treated as a trigger for managers’ engagement in sensemaking towards that specific challenge or threat [ 55 ]. The importance here is how the external environment triggered sensemaking processes that initiated the adoption, continuation, and change in favor of ISO 9001 certification and additional standards. Four external triggers are identified. The first two external triggers (nonconformities and regional certification project participation) were situational-specific and present initially in the process. The last two triggers are institutional in nature [ 25 ], derived from perceived ambiguities in relative stable institutional structures (the current internal control regulation and the ISO 9001 certification). These ambiguities triggered sensemaking processes around continuity and change (the organizing processes) towards internal control systems and certification.

Situational triggers

The first trigger relates to the nonconformities from the countrywide ED supervision. For the ED management, the nonconformities did not cause disruption, but rather verification of known challenges. What they now perceived as different from earlier (a discrepancy), was the increased focus upon these known challenges and turbulence from the hospital’s top management. Treated institutionally, such an increased focus can be explained by demands to follow up on nonconformities through institutional coercion [ 56 , 57 ] or regulatory enforcement [ 58 ]. But in the sense that these onsite supervisions are ad hoc initiatives, most often with years in between, they also have the potential to cause careless disruption or surprises for organizations that can offer strong occasions for sensemaking. Basically, it can be an interruption produced by new and unexpected circumstances [ 24 ]. This seems to be true in this case study, where the received nonconformities made known challenges “visible” [ 59 ] for other parts of the organization and especially the top management, and so triggered further actions for control and accountability.

The second trigger relates to the way in which external possibilities for assistance and support led to “quick” action and interpretation. The ED management’s uncertainty about proper solutions threatened their social identity. The external possibilities for support prompted almost immediate action. Organizational uncertainty can be seen as a form of ignorance or an inability to extrapolate current actions and therefore foresee future consequences [ 24 ]. Such occasions lead people to construct processes of sensemaking to reduce that ignorance. Plausibility and belief about current action, rather than accuracy about the future, are salient in such sensemaking processes. Early available sources and information that gave some sort of plausible directions for the ED, replaced uncertainty about the future, with more certainty about the present, and as such made it possible to continue. The shared belief among the ED management prompt action, rather than change resistance, that often are seen in organizational change when identity is challenged due to identity replacement, updating, or transformation [ 26 , 55 ].

Institutional triggers

The third trigger relates to institutional structures in the current internal control regulation. Adoption of internal control system has shown to be a challenging task in health care [ 60 ], and the ED did not have a system that was clearly built up around a fulfillment of these regulatory requirements. Finding solutions to operationalize these requirements was inherent in the pilot project. The LPG’s work on concretizing the requirements and developing additional requirements for EDs set in motion important sensemaking processes about the internal control regulation. The internal control system is founded in a functional legislation [ 34 , 61 ] with a wide scope and possibilities for organizations to choose among a variety of tools for quality and safety work [ 62 ]. It is a form of soft regulation that can be (too) diffuse and therefore trigger organizations’ search for control [ 28 , 30 ]. It becomes a question of transparency and accountability [ 59 ], not just in the eyes of external actors, but for the organizations themselves. Because making things transparent is not just about documenting and open the “curtains” for direct insight, it is also about adopting new technologies that make organizational performance visible [ 59 ]. The process of concretizing the requirements in the internal control regulation that the LPG performed was such a necessary visualization that gave meaning to their own system and processes [ 32 ]. When analyzed from the perspective of Weber and Glynn’s [ 25 ] institutional trigger mechanism, we see that the stable institutional structure inherent in the regulatory system became ambiguous for the LPG and trigged further sensemaking that made organizing possible. These findings support other research arguing that a lack of competence on developing internal control systems makes it difficult to adapt to the internal control regulation in Norway [ 60 ].

The fourth trigger relates to the institution of ISO 9001 certification. The present case study shows that the ISO 9001 standard consisted of general and unfamiliar concepts and systems that triggered the LPG to find ways to translate and contextualize these ambiguities, in their efforts to make sense of the standard. Seeing the ISO standard as a trigger relates to the same institutional triggering mechanism as for the third trigger. What is different about the institution of ISO 9001 certification is that it involves auditing process performed by external auditors, and therefore integrates direct feedback mechanisms that are interlinked with sensegiving perspectives [ 31 , 63 ] or mechanisms on how institutions edit sensemaking [ 25 ]. Auditors control, negotiate, and guide during their interactions with the organizations, and those tasks give auditors room for different interpretations and conducts of their same auditing role. Concerns about interaction are important, because research on accreditation shows that when health professionals are given the opportunity to participate in assessment contexts that are collaborative and supportive, it can self-reinforce a collaborative quality and safety culture [ 64 ]. These considerations on the auditor–auditee encounter may also underpin our present findings where there was a perceived discrepancy between the conduct of the first audit team (performing both the initial certification audit and the first surveillance audit the first year) and the conduct of the last surveillance audit team the second year. The first team was perceived by the LPG to have real impact upon the standardization and improvement work in the ED. The conduct of the second team was so different that it made the ED management question the reliability of the certification process and the meaning of renewing their certificate.

A recent study [ 65 ] on stakeholder perspectives identified four factors that seemed important to increase the likelihood of a successful implementation of accreditation: (1) the program is collaborative and valid and uses relevant standards; (2) that accreditation is favorably received by health professionals; (3) that healthcare organizations are capable of embracing accreditation; (4) and that accreditation is appropriately aligned with other regulatory initiatives and supported by incentives. These findings highlight external regulatory structures and intra-organizational factors that seem to be in line with findings on triggers and organizing perspectives related to certification in our study.


This single-case study is limited to meaning making processes within a single emergency department in a single hospital in Norway. The small sample is a clear limitation of generalization from this study.

Certification and accreditation are widely used for quality and safety in health care but also questioned in respect to their assumed effects. This is a challenge for policymakers since these regimes can have a circumstantial impact upon different parts of the organization. The present case study shows that the adoption of the ISO 9001 certification in an emergency department was not led by a comprehensive decision-making process. It shows that an exogenous disruption visualized longstanding organizational challenges that threatened the managements shared identity. Again a search for meaning became prominent. The occasional possibility for help through an external standardization and certification project was a plausible solution that led to immediate action, and reduced uncertainty. Further, the case study shows that the relative stable institutional requirements that are inherent in the internal control regulation and the certification standard were unfamiliar and ambiguous and therefore triggered local sensemaking processes for a contextualization of these regulations and standards, which made the continuation and change possible. It also led to the acknowledgment of external assessments or audits in general as useful for improvement work.

When considering implications for further theory development, we see that the institutional trigger mechanism in Weber and Glyns’ [ 25 ] framework contributes to explaining the occasion for sensemaking. There is a need for more research that can refine this institutional mechanism (in addition to institutional constraints) and inform explanations of why some regulatory institutions give rise to (trigger) adoption of different modern management tools (e.g., certification or accreditation). These considerations are important, because when organizations adopt new management tools, they seldom abandon others. This can lead to even more complex health care.

Governance in this perspective refers more to the neoliberal approaches inspired by rational choice theories and governance as networks within the institutional tradition, than to a decentered theory of governance underpinned by postfoundational philosophy and democratic stands [ 67 ].

Norwegian Accreditation (NA) is the Norwegian body for accreditation of laboratories and sampling organizations, certification bodies, inspection bodies, and environmental verifiers. NA represents Norway on three European and international bodies—the European cooperation for Accreditation, the International Laboratory Accreditation Cooperation and the International Accreditation Forum. NA is also the Norwegian monitoring body for Good Laboratory Practice (GLP) inspections, according to OECD’s GLP principles ( , accessed 12. February 2014).

Norwegian Accreditation establishes different sector committees, often broadly represented, when the aim is to establish a new standard on a new domain or sector.

Surveillance audit is a yearly onsite audit so that the certification body can maintain confidence that the certified management system continues to fulfill requirements between (re-)certification and re-certification [ 21 ].


Emergency department

International Organization for Standardization

Local project group

Norwegian Board of Health Supervision

Regional Health Authorities

Regional project group

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The authors would like to thank the hospital for the access to the field and also thanks so much to all informants for taking part in the study and for giving feedback on the narratives to the authors. We would like to thank the Ministry of Education and Research for the funding of the PhD project.

This article is part of a PhD project funded by the Ministry of Education and Research in Norway.

Availability of data and materials

The data generated and analyzed during this study are not publicly available due to concerns about confidentiality regarding a small sample size and the sensitive nature of the interviews. Instead, quotations and analytical categories are included in the text. We are happy to discuss the findings or the analysis if any questions should arise.

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Department of Media, Culture and Social Sciences, University of Stavanger, 4036, Stavanger, Norway

Dag Tomas Sagen Johannesen

Department of Health and Nursing Science, University of Agder, 4604, Kristiansand, Norway

Department of Health Studies, University of Stavanger, 4036, Stavanger, Norway

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DTSJ was responsible for the conception and design of the study and undertook acquisition of data as well as analysis and interpretation of data. SW was consulted during the analysis, and interpretation process. DTSJ led the drafting of the manuscript. DTSJ and SW were both involved in critically revising the manuscript for important intellectual content and both read and approved the final manuscript.

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Correspondence to Dag Tomas Sagen Johannesen .

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The research was performed with the ethical approval of the Norwegian Social Science Data Services (December 16, 2011, Ref. 27543). A clearance for staff interviews was obtained from the hospital prior to data collection. Informants first got a written invitation to participate at its inception and then a written and oral invitation prior to the commencement of recording. The invitation explained that the interview was part of a research project, that the results would be used anonymously for analysis and publication, and that participation was voluntary and could be terminated at any time. All informants provided oral consent.

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Johannesen, D.T.S., Wiig, S. Why adopt ISO 9001 certification in hospitals? A case study of external triggers and sensemaking in an emergency department in Norway. Saf Health 3 , 7 (2017).

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Published : 19 July 2017


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HOME / case studies / ISO 9001 at AirportCreators

ISO 9001 at AirportCreators – A Case Study

Based at Schipol Airport in the the Netherlands, AirportCreators is a consulting, project management and engineering company in the field of airport development. With the help of 9001Simplified the company implemented an ISO 9001 quality management system and achieved certification in March 2021.


AirportCreators builds airports. Not simply airports. As a young and creative airport development company with a skilled and experienced team, AirportCreators is implementing non-traditional solutions to simplify the complexity of airports, reduce costs and create long-term value. Some of the company's most recent projects include:

Strategic investment planning at Dublin Airport

Development of a new terminal and pier at Schiphol Airport

Turn-key completion and system integration of the terminal building at Lelystad Airport

Development of new airport charges and cost management model at Luxembourg Airport

AirportCreators' vision of creating future-proof airports and sustainable travel is particularly visible in their recent study that led to the Hardt Hyperloop / Schiphol Airport joint venture to develop a European hyperloop network.

AirportCreators took five months to develop their quality management system

The certification audit took place at the company's Schipol office over two days

Zero findings were identified in the certification audit performed by TUV Rheinland

The Road to ISO 9001

AirportCreator's initial interest in ISO 9001 was driven by necessity as participation in tenders for big projects around the world requires a certified quality system. Prior to pursuing its own certification, AirportCreators was forced to team up with external partners that were ISO accredited, but this approach turned out to be counterproductive as both the project and AirportCreators were negatively affected by partners that didn't meet deadlines.

Realizing that ISO 9001 certification was the way forward, the company set additional objectives. For example, they wanted an efficient document control process for their paperless office. Other goals included more effective communication among team members, increased productivity, more structured methods to monitor progress, and a systematic improvement process that incorporates lessons learned.

We decided to do it ourselves because involving the team will make it easier to utilize ISO in our operations long-term.

Gé Smit Director AirportCreators

Once the decision to get certified was made, top management engaged the team in discussions to choose the ideal implementation approach. The consultancy and Do-It-Yourself options were presented and discussed, before the unanimous conclusion was reached to do it in-house. Though cost was a consideration, the main reason was the desire to get everybody familiarized with the ISO principles in order to make it easier to adopt the quality system, maintain it, and pass future surveillance audits.

Among several providers of DIY implementation kits, 9001Simplified was selected for its thorough instructions and focus on efficiency. Particularly, the 'simplified' approach resonated with AirportCreators, itself a company that drives innovation with a stated focus on simplifying the business.

The Implementation Phase

AirportCreators chose 9001Simplified's ISO 9001 Certification Toolkit and began the implementation project in April 2020. At the time the company didn't have a formal quality management system in place. What they did have was a personnel handbook and project management software called ExactOnline that proved to be helpful in meeting some of the ISO 9001 requirements.

Maria Tsagali, who led the implementation, involved all employees of AirportCreators by allocating each a clause of the standard and providing access to the implementation kit. The task was to come up with a process, and develop a procedure and form based on the provided templates and instructions. Maria supervised the process. Upon completion the entire team reviewed the outcome and decided whether it was sufficient or needed alterations.

It was very easy. The materials were very helpful and to the point. We just followed the instructions of the tool kit.

Maria Tsagali Project Manager and Strategy Consultant AirportCreators

Management were supportive from the beginning and invested in both time and budget. Though initially it was just for marketing opportunities, they soon became quite interested as the project progressed, and at the end were "really fond of their QMS". Initially for staff, the implementation of the ISO QMS seemed a very boring task. However, since all employees were actively involved in the project, they all showed a positive attitude and did their best. Soon they grew into it, they spotted their mistakes, and they came up with improvement ideas.

Adopting the new paperless ISO 9001 system and utilizing it in daily operations proved to be a natural consequence of setting up the processes. In the words of a staff member, "we had no difficulties". Maria Tsagali further explains that the entire staff had worked on the processes since April and therefore the “on-the-job testing” was easy.

The Certification Audit

By fall 2020, AirportCreators had completed the development of their quality management system. They had set up new, efficient work processes, and management and staff had made ISO part of their work routine. Before calling in the registrar for the certification audit, though, the company chose to run the ISO system for another five months, fine-tune it, and accumulate records.

The last internal audit showed that the QMS was well implemented, so not much additional preparation was needed for the certification audit. A newsletter and a couple of emails with updates and instructions were enough.

AirportCreators had selected TUV Rheinland as their registrar. The audit was conducted remotely over a two-day period and completed on March 23rd, 2021. There were zero findings. AirportCreators passed right away, no follow-up was needed.

We would follow the same approach with the 9001Simplified Do-It-Yourself tool. I think the steps we followed were successful and the guidance helpful. The Do-It-Yourself kit is effective and it works.

Maria Tsagali Strategy Consultant and Quality Manager AirportCreators

Tips and Lessons Learned

We asked Maria Tsagali, the implementation lead, if she had any tips for other companies at the beginning of the ISO 9001 project. For her the key lies in tailoring the materials to the needs of the individual company. In her own words, "the ISO QMS should reflect the personality of the company." So, the quality of the template and the customization instructions are important.

Another tip concerns the documentation structure. AirportCreators streamlined their quality processes by adopting a model that reflects their business operations (the "Process Structure", a configuration option of the Certification Toolkit). According to Maria Tsagali, this choice was even validated by the certification auditor who "was really impressed that we didn't follow the numbering of the ISO standard but our efficient process structure."

At the time of writing, AirportCreators has been certified for a week but is already reaping several benefits from their ISO 9001 system. These benefits became increasingly evident as implementation progressed and include improvements to efficiency, document control, internal communications, and project management. It's noteworthy that these early internal improvements coincide with the objectives set for their quality system.

AirportCreators also noticed improvements in the overall quality of services. Given that they implemented processes that allow them to spot mistakes early, along with a formal system to recognize and adopt lessons learnt, AirportCreators expects the improvement trend to continue.

It was worth doing it. I thought we were doing well before we started with ISO but we have improved many aspects since. Our clients will benefit from more efficient and cost-effective services.

Rogier Doffegnies Director AirportCreators

Last but not least there is the initial motivator: the marketing benefits brought along by certification. While it's too early to see an increase in sales, the company has already witnessed additional interest in its services since announcing ISO 9001 accreditation.

Are you, too, a service provider requiring ISO 9001 certification? Take the same approach as AirportCreators, implement the quality system in-house and increase your operations and efficiency.

Get Started Like AirportCreators


AirportCreators B.V. Tupolevlaan 93, 1119 PA Schiphol-Rijk, The Netherlands

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Who: Holbrook Tool & Molding: What do you know about ISO 13485:2016 What: Holbrook Tool & Molding certified their quality management system intending to demonstrate compliance with applicable FDA requirements and ISO 13485:2016. Problem: In their quest for growth in the medical device industry, Holbrook Tool & Molding decided to leverage their ISO 9001:2015 certification and gain an ISO 13485:2016 certification. However, ISO 13485:2016 clauses were not updated to ISO 9001:2015 version. Solution: Since ISO 13485:2016 follows ISO 9001:2008 clauses, it was decided to update this version which was already updated for the release of ISO 9001:2015. A quality manual was developed with less than five work instructions and training was given to different levels of the organization. Since then, internal audits have been conducted and continue today. Result: Fourteen years later, the Quality Manager can successfully maintain and improve a combined ISO 9001 and ISO 13485 quality system. Ownership and commitment have been enabled throughout the organization as the system is now easier to understand. 

Who: Holbrook Tool & Molding: A one-size quality manual does not fit all What: A quality management system was developed to enable the client to quickly respond to customers, solve problems faster and support their initiative to eliminate quality-based problems. Problem: In their quest for QS-9000 certification, a previous consulting company handed them an off-the-shelf, 100-page quality manual and 20 procedures – which the client could not possibly maintain. Solution: A  policy and procedure quality manual was developed with less than five work instructions. Appropriate training and guidance training were provided to different levels of the organization. Result: Fourteen years later, the Quality Manager was able to successfully maintain and improve the quality management system. Ownership and commitment were enabled throughout the organization as the system is now easier to understand. Holbrook Tool & Molding can maintain their ISO 9001 certification with no findings and no customer requested corrective actions for repetitive years. 

Who: Bra-Vor: One good turn deserves another What: A quality management system was developed to enable the client to quickly respond to customers, solve problems faster and support their initiative to eliminate quality-based problems. Problem: Based on a referral from Holbrook Tool & Molding, Bra-Vor also enlisted IQPS to pursue QS-9000 certification and then ISO-9000 certification. Solution: A policy and procedure quality manual was developed with less than five work instructions. Appropriate training was provided to different levels of the organization. Guidance was also provided on effective management reviews. Internal audits were conducted and continue today. Result: Fifteen years later, the Quality Manager was able to successfully maintain and improve the quality management system. Bra-Vor can maintain its ISO 9001 certification with no findings and no customer requested corrective actions for repetitive years. 

Who: Baxter Machine Product: There are two kinds of people – complexifiers and simplifiers What: A quality management system was developed to enable the client to quickly respond to customers, solve problems faster and support their initiative to eliminate quality-based problems. Problem: A former employee developed a 100-page quality manual and 20 procedures – which was impossible to maintain. Solution: A policy and procedure quality manual was developed with less than five work instructions. Appropriate training and guidance were provided to different levels of the organization.  Subsequently, an environmental management system (ISO 14001) was integrated into the quality management system (ISO 9001) and morphed into a business management system. 

Result: Ownership and commitment were enabled throughout the organization as it is now easier to understand. Baxter Machine Product can maintain both ISO certifications with no findings and no customer requested corrective actions or incidents for many years.

Who: Blair Strip Steel: If you can’t beat us, join us What: Blair Strip had an established quality system and needed someone to perform its internal audits. After an accredited surveillance audit, Blair Strip Stell hired IQPS to perform internal audits based on QS-9000. Problem: Blair Strip had one person in their quality department performing many tasks, which made it hard to maintain independence and expertise. Solution: The Quality System was upgraded to TS-16949 and integrated with ISO 14001, and internal audits continued to be conducted. Result: Eighteen years later, the Quality Manager can still maintain and improve the quality management system. Blair Strip can maintain its TS-16949 certification with minimal to no findings, and no customers requested corrective actions.

Who: Belleflex: Join us too! What: A new startup company owned by Blair Strip needed to implement a quality management system and obtain ISO-9001 certification as soon as possible. Problem: The Bellflex Quality Manager needed guidance in machine shop implementation. Solution: IQPS provided guidance through discussions regarding best practices, reviews of the system documentation, and appropriate training for all levels of Bellflex.

Result: After six months of startup, Belleflex successfully obtained an ISO-9001 certification. Their quality system and performance were recognized by NASA as an approved supplier to produce parts for the International Space Station. 

Who Blind and Vision Rehabilitation Services of Pittsburgh: We need another consultant What: A quality management system was developed to allow them to quickly respond to customers, solve problems, and eliminate quality-based problems. Problem A previous consultant left them an unfinished quality manual with 20 procedures- which was impossible to maintain. They also needed an ISO-9001 certification to fulfill a Pennsylvania Department of Transportation (PennDOT) supplier requirement.

Solution A policy and procedure quality manual was developed with only one work instruction for office staff. Appropriate training and guidance were provided to different levels of the organization. Internal audits were conducted and continue today. Result Seven years later, the quality system is easily maintained by staff members and the Operations Manager. Blind and Vision Rehabilitation Services of Pittsburgh was recognized as one of the top three non-profit organizations for 2013.

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What Does ISO 9001 Have to Do With Climate Change?

The answer might surprise you.

Published: Tuesday, February 6, 2024 - 12:03

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S uperficially, ISO 9001 and climate change sound different: ISO 9001 is about how to do things well so your organization satisfies its customers; climate change is about physical and chemical interactions in the atmosphere, and the consequences for our lives in the future.

But ISO is adding climate language to ISO 9001 . Let me explain how that came to pass.

First, some background. In September 2021, the International Organization for Standardization (ISO) issued its “ London Declaration”  on climate change. Among other things, this document committed ISO to “foster the active consideration of climate science and associated transitions in the development of all new and revised International Standards and publications.”

Note the language. This declaration commits ISO to take climate science into account “in the development of all new and revised International Standards.” This means that when the organization issues (or updates) a standard specifying the size and composition of ball bearings, or of the cover glasses on microscopes, it has to consider climate science. That rule applies all the more to ISO 9001.

Furthermore, ISO followed up on Sept. 27, 2023, with a further explanation on proposed revisions to the Harmonized Structure (Annex SL, Appendix 2 of the ISO/IEC Directives) that include climate language. Annex SL is a body of text which is incorporated directly into multiple management system standards, including ISO 9001 and many others. So an approved change to Annex SL is automatically a change to ISO 9001, ISO 14001, and the rest. The only question then becomes when a new printing will be made available, or an amendment that includes the specific ISO standard number in the header.

The arguments

Advocates have pointed out the relevance of the climate to ISO 9001 in many ways. One argument is that climate change is an important topic worldwide, and ISO 9001 is a standard with global reach. So, even if there is no direct connection, why not use it as a lever to push global activity?

case studies for iso 9001

A second argument says that the design and development of products and services worldwide is sure to affect the climate for good or ill. So why not add requirements to the sections on design and development that nudge us to act in a more helpful direction?

A third argument reminds us that the most recent edition of the standard (ISO 9001:2015) requires each organization to understand its context, including the risks, opportunities, and issues that face it. But climate change affects every organization, and therefore it’s a relevant part of everyone’s context.

To be sure, there have been arguments in the other direction as well. While climate change might affect all organizations, not all organizations can do anything about it. In particular, very small companies with narrow profit margins may have neither the size nor the flexibility to make meaningful changes to their operations in support of climate targets. Because ISO 9001 is supposed to apply to organizations of all sizes and in all industries, it shouldn’t adopt rules that some companies can’t meet.

That’s true, reply the advocates. But even if you can’t make your operations more climate-friendly, a changing climate will bring new risks that you must mitigate. So the topic remains relevant.

Another objection is that all requirements in ISO 9001 must be checked by auditors. Today there are no rules requiring quality auditors to understand climate science. But if climate requirements are added to ISO 9001, then ISO will have to issue guidance about auditor competency. Will today’s auditors still qualify, or will they all need emergency retraining? This concern has led some stakeholders to suggest moving all discussion of climate change into ISO 9000, a standard that defines the essential terminology and conceptual structure behind any formal quality management system, but which is not itself auditable.

Amid all this controversy, it’s only fair for me to explain my own view. My personal opinion is that we would all be better off if ISO 9001 could stay in its lane and avoid discussing the climate.

In the first place, as above, customer satisfaction is simply a topic different from climate change. In any complex operation, specialization brings clarity and increases effectiveness. For this reason, I think we can achieve more if we let ISO 9001 focus on customer satisfaction while a different standard focuses on climate action. 

In the second place, what kinds of climate requirements do we want to see added to ISO 9001? Either they’ll be heavy, or they’ll be light.

But if they’re heavy, then some organizations will find them too heavy and won’t be able to comply. If the rules are part of ISO 9001, those organizations will drop ISO 9001.

And if the rules we add are light, then some organizations will get cynical. “We get credit for fighting climate change without having to do any work.”

Neither of these outcomes—the heavy one or the light one—will be good for ISO 9001’s overall brand.

The ISO view

That said, my personal opinion doesn’t rule the day. I mentioned above that there’s a proposal relating to climate language before the ISO Central Secretariat. If it’s approved, then ISO could soon issue an amendment to ISO 9001. That amendment would add two sentences to the standard.

To clause 4.1 (“Understanding the organization and its context”), the proposal would add one requirement: The organization shall determine whether climate change is a relevant issue.

To clause 4.2 (“Understanding the needs and expectations of interested parties”), the proposal would add a clarification: Note: Relevant interested parties can have requirements related to climate change.

What would these additions mean?

The first is a requirement. It means organizations have to do something, and they can be audited. Now, what the organization has to do is simply to make a decision. Strictly speaking, there’s no explicit requirement even to document the decision in meeting minutes. (All the same, I advise every organization to minute this decision anyway to forestall long conversations with your auditor.) Note that if your organization decides, yes, climate change is a relevant issue, then you have to do a lot more. At that point, you have to account for climate change somehow in your QMS, the same way you account for all your other relevant issues.

The second proposed addition is just a note. It adds no new requirements, and it can’t be audited. Consider it a reminder that one or more of your interested parties might care about climate change—enough to have requirements on the subject. And although notes are formally not auditable, I can imagine some auditors wanting to discuss whether you ever asked your interested parties for their views on climate change. So be aware of the topic in any event, and think of how you want that discussion to go.

Thinking back to my discussion above, I think these requirements can’t be easily classified either as “heavy” or “light.” In practice it will have to depend on the organization—and that’s how it should be. 

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About The Author

Michael mills.

Michael Mills writes for  isoTracker QMS software  and has managed quality systems in large and small companies for close to 30 years. He is a member of ASQ and ISO TC 76 and has audited to ISO 9001 since 1996. He blogs regularly at .


What a farce.  The central aspect of Quality should be to THINK and INVESTIGATE.  Good Quality practitioners use control charts to identify when something is amiss.  They then look for the cause.  Investigation is at the heart of quality.

Instead, most quality practitioners follow the herd.  The Asch Effect takes control.  Quality practitioners jump into utter nonsense like Six Sigma, despite its own creator admitting "Six Sigma is a snow job"."Climate change" has been taking place for 4 bllion years.  The world has been COOLING for the past 10,000 years.  The world was warmer than currently, during the Medieval Warm Period, the Roman Wam Period, and the Minoan Warm Period.  There is no evidence that man's CO2 has had anything to do with climate changes.  The IPCC has stated "No study to date has positively attributed all or part of the climate change observed to man-made causes".There is a huge need for quality practitioners to start practising quality.

Greenland was once green

To put this in perspective, Greenland, which is now mostly ice, was once green enough for Vikings to settle there. There was also a time when the polar ice caps covered what is now Canada and most of New England, and as far down as Pennsylvania. While I believe that CO2 does contribute to climate change, there are far too many indulgence peddlars (or modern equivalents) who claim that, if only we send enough money their way, they can stop the climate from changing. Senator Kirsten Gillibrand cited Goldman Sachs and J.P. Morgan Chase as explicit beneficiaries of cap and trade mandates.

I have seen articles in Chemical & Engineering News that talk about atmospheric carbon capture plants whose apparent sole purpose is to remove carbon dioxide from the air that cost several hundred million dollars plus ongoing operating costs. If you want to remove CO2 from the atmosphere, the US Forest Service will plant a tree for every dollar you donate (minimum ten dollars, they will plant ten trees) which do the same thing, cost nothing to maintain or operate, expand their capacity every year, and eventually make more of themselves.

(Does not constitute engineering advice.)

Excellent article

I will share a link to this on LinkedIn. I agree with the author that ISO 9001 should stay in its lane, and here is my informal opinion on how ISO users should deal with the new requirements.

"The organization shall determine whether climate change is a relevant issue." "No" (except with regard to supply chain risks and risks to continuity of operations that could be impacted by climate-related events, in which case the organization should indeed account for these risks to avoid unpleasant surprises)." Note also that construction projects must now account for climate-related events that make supposedly hundred-year floods or storms far more common than was expected. This sort of thing is indeed relevant. 

"To clause 4.2 (“Understanding the needs and expectations of interested parties”), the proposal would add a clarification: Note: Relevant interested parties can have requirements related to climate change." My position is that, if these interested parties want reports on carbon dioxide emissions, they need to pay the costs of the full-time employees and other resources necessary to get this information because I would consider it a breach of fiduciary duty (my opinion, not legal advice) to pass these costs on to customers in the form of higher prices, workers as lower wages, or investors as lower profits. On the other hand, ISO 50001, which seeks to remove all forms of energy waste from operations, helps reduce prices, increase profits, and increase wages regardless of whether the energy is from carbon sources.

I would also consider it a breach of fiduciary duty to squander supply chain resources on carbon offsets, carbon credits, or cost-ineffective renewable energy. Note however that renewables that might be cost-ineffective in one place (e.g. solar in northern climates) might well be effective in others (the Southwest US), and that the organization does have a duty to keep abreast of new developments. For example, the price of solar panels has come down enough in the past five or ten years that I might now consider buying them for my house. I also replaced all my incandescent light bulbs with light-emitting diode bulbs when these became widely available because they pay for themselves quickly through electricity savings. 

(Does not constitute engineering advice)

Most important sentence

The most important sentence in the article, in my view: "...we would all be better off if ISO 9001 could stay in its lane and avoid discussing the climate". --Contributed by Steve65

Climate Change and ISO Standards

Of the primary ISO management system standards, the one that deals directly with climate change issues is ISO 14001.  Clauses 4.1 and 4.2 in ISO 9001 might be peripherally related, but the importance of climate change and potential man-made effects are part of environmental aspects and impacts which are key to ISO 14001, beginning with its earliest versions.  Of course, the standards that deal with greenhouse gases are even more specialized.

WHile I am an unabashed tree hugger, and an advocate to combat climate change, I agree that ISO-900X is not an appropriate forum for the topic. Is there a way I could post this to my LinkedIn page? Thanks!

Link to article

Feel to grab a small excerpt (whatever seems relevant) and/or link back to article. --QD Editors

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The implementation of the ISO 9001-2000 Quality Program has further established Burton Metal Finishing, Inc. as an industry leader, providing quality parts that meet or exceed industry standards.

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Hanlock-Causeway Company manufactures a wide range of refractory anchorage hardware products for very high-temperature construction applications that exceed 2000 degrees Fahrenheit. Soon after obtaining ISO 9001 certification for its Tulsa facility (Houston will be certified at a later date), work started to become more standardized and errors and wasted materials reduced.

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Some topics you might be interested in, fire testing services expand with new iso/iec 17025 scope.

SGS has expanded its fire safety, resistance, and flammability testing services at its laboratory in Farmingdale, New York, USA.

The laboratory’s team of experts has been successful in enhancing the scope, within the framework of its ISO/IEC 17025:2017 accreditation, to incorporate testing for:

  • Aviation and automotive:
  • Aerospace – power plant flame penetration – test methods BSS 7338
  • Airplane interiors – FAA Part 25 Chapter 12, AITM 2.0056, BSS 7387, FAA Part 25 Appendix F Part Vll
  • Building materials:
  • Test methods ASTM E2768, CAN/ULC-S102 and CAN/ULC S102.2, NFPA 262
  • Furnishings, carpets, and textiles:
  • Drapery/decorative materials – test method BS 5867-2, ISO 15025, ISO 6941
  • Wire and cables:
  • Product development – UL 1581 Section 1080 VW-1
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  • Test methods ASTM D92, ISO 2592, ASTM D93, IP 34, ISO 2719, ISO 15267

Bobby Brown, Director of Operations and Business Development, SGS said: “This welcome expansion of our scope is testament to our commitment to providing exceptional services to our clients. Our team of experts has worked diligently to incorporate the new tests, enhance existing methodologies, and leverage innovative technologies.

“The broader capability builds on our expertise and SGS’s 2017 acquisition of Govmark Testing Services to ensure that our clients, from the aviation to textile sectors, receive the highest level of service. In the end, it’s only trusted because it’s tested.”

The laboratory is recognized by various US Code agencies, state authorities, international organizations, and industry leaders, including the Federal Aviation Administration (FAA), Federal Railroad Administration (FRA), and International Maritime Organization (IMO).

The expanded scope, live from January 2024, will ensure SGS is best placed to support its domestic and international clients to meet national and international regulations and requirements.

Learn more about SGS’s Fire Safety Services

For further information, please contact:

Bobby Brown Director of Operations and Business Development SGS Connectivity & Products t: +1 631 293 8944 x 24320

We are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.

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Case study: design and development in the software industry.

Advisera Strahinja Stojanovic

The software industry is one of the fastest-growing industries in the last few decades and although software production is regulated by its own rules, very often there is a requirement for establishing a Quality Management System according to ISO 9001 . Due to the specificity of the software development industry, implementation of ISO 9001 can be even more challenging than in some other industries. One of the first questions to arise is: “Are we a production or a service delivery company?” And, although this question doesn’t change much in terms of requirements to be met, it indicates future doubts that will emerge in the implementation project.

A small start-up software company developed some accounting software and sells the software together with support. The accounting software is the main and most lucrative product they developed, and requires constant updating to meet changes in legislation, but they also develop other software solutions according to the requirements of their customers. In this case study we will discuss the process of developing new software for individual clients.

Is it production or design and development?

This question may come as a surprise in other industries, but here it is hard to make a distinction. Once the product is designed, it no longer requires production as in the manufacturing industry, so the design and development is the production and the process needs to meet the requirements of both clauses 8.3 and 8.5 at the same time.

Planning software development

Let’s assume that the requirements for the product are identified during the sales process. Because all employees in the company had little experience with project management, one of the challenges was to define the planning step in the design process. After consideration of the requirements of the standard, the company developed a planning stage that included:

  • the nature and complexity of the software production activities
  • the required stages, including applicable reviews
  • the required verification and validation activities
  • the internal and external resources needed for software production
  • the need to control interfaces between persons involved in the design and development process
  • the requirement for subsequent provision of products and services
  • roles and responsibilities within the design project, including the project team
  • inputs for design and development, including functional and performance requirements, statutory and regulatory requirements, etc.

Based on all of this information, the company later developed the project plan with defined phases, inputs, outputs, relevant documents, roles, etc. This typically involves a preliminary or high-level design of the main modules with an overall picture (such as a block diagram) of how the parts fit together. Information about the language, operating system, and hardware components are also defined at this time. Then, a detailed or low-level design is created, sometimes with prototyping as proof-of-concept or to firm up requirements.

Executing software development, testing and documenting

Once the project  stages are defined, the people involved in the design start with programming the code for the project. Software testing is an integral and important phase of the software development process. Their estimate was that 50% of the whole software development process should be tested. The purpose of the testing, which includes both validation and verification, is to ensure that defects are recognized as soon as possible. (For more information, see: ISO 9001 Design Verification vs. Design Validation .) The company adopted the test-driven development process, meaning that the tests are developed just before implementation and serve as a guide for the implementation’s correctness. Early discovery of errors and their remedy is the key to reliable software.

Deployment and maintenance

Deployment starts directly after the code is appropriately tested, approved for release, and sold or otherwise distributed into a production environment. This may involve installation, customization (such as by setting parameters according to the customer’s values), testing, and possibly an extended period of evaluation.

In some cases, maintaining and enhancing software to cope with newly discovered problems or new requirements can take far more time than the initial development of the software. Not only might it be necessary to add code that does not fit the original design , but just determining how software works at some point after it is completed may require significant effort by a software engineer. About 60% of all software engineering work is maintenance, but this statistic can be misleading. A small part of that is fixing bugs. Most maintenance is extending systems to do new things, which in many ways can be considered new work.

To prevent problems, go by the book

Many small software development companies have problems because they perceive planning the projects and structuring the process to be redundant and time-consuming, but development of the procedure with clear steps and responsibilities does a great deal in preventing problems and avoiding rework of the code. ISO 9001 is rarely a customer requirement for software companies, but the requirements of the standard – and especially clause 8.3 – can help a lot in defining the software development process, and improving the performance of the company by cutting time spent on rework due to misunderstanding of product requirements, and other challenges that emerge in the design process.

 Click here to download the free    ISO 9001 Implementation Diagram to help with understanding the steps in the ISO 9001 implementation.

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ISO 9001:2015 Implementation Diagram

Free diagram that outlines the steps for your ISO 9001 implementation

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Strahinja Stojanovic is certified as a lead auditor for the ISO 13485, ISO 9001, ISO 14001, and OHSAS 18001 standards by RABQSA. He participated in the implementation of these standards in more than 100 SMEs, through the creation of documentation and performing in-house training for maintaining management systems, internal audits, and management reviews.

Advisera Carlos Pereira da Cruz

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