Editing ISO 9000 family (section)

==Evolution of ISO 9000 standards==
The ISO 9000 standard is continually being revised by standing technical committees and advisory groups, who receive feedback from those professionals who are implementing the standard.

{| width="35%" class="wikitable" font-size="95%;" background-color="transparent"
!Year
!Edition of ISO 9001
|-
| align="center" | 1987 || 1st Edition 
|-
| align="center" | 1994 || 2nd Edition 
|-
| align="center" | 2000 || 3rd Edition 
|-
| align="center" | 2008 || 4th Edition 
|-
| align="center" | 2015 || 5th Edition 
|-
|}

===1987 version===
ISO 9000:1987 had the same structure as the [[British Standard]] [[BS 5750]], with three specifications for quality management systems, the selection of which was based on the scope of activities of the organization:
* ISO 9001:1987 ''Model for quality assurance in design, development, production, installation, and servicing'' was for companies and organizations whose activities included the creation of new products.
* ISO 9002:1987 ''Model for quality assurance in production, installation, and servicing'' had basically the same material as ISO 9001 but without covering the creation of new products.
* ISO 9003:1987 ''Model for quality assurance in final inspection and test'' covered only the final inspection of finished product, with no concern for how the product was produced.
''ISO 9000:1987'' was also influenced by existing U.S. and other [[Defense Standard]]s ("MIL SPECS"), and so was well-suited to manufacturing. The emphasis tended to be placed on conformance with procedures rather than the overall process of management, which was likely the actual intent.

===1994 version===
''ISO 9000:1994'' emphasized [[quality assurance]] via preventive actions, instead of just checking final product, and continued to require evidence of compliance with documented procedures. As with the first edition, the down-side was that companies tended to implement its requirements by creating shelf-loads of procedure manuals, and becoming burdened with an ISO bureaucracy. In some companies, adapting and improving processes could actually be impeded by the quality management system.

===2000 version===
<!-- Deleted image removed: [[File:apcer.png|250px|thumb|right|The Portuguese [[ISO 9001]] certification image]] -->
''ISO 9001:2000'' replaced all three former standards of 1994 issues, ''ISO 9001'', ''ISO 9002,'' and ''ISO 9003''. Design and development procedures were required only if a company does, in fact, engage in the creation of new products. The 2000 version sought to make a radical change in thinking by actually placing front and center the concept of [[Process management (Project Management)|process management]] (the monitoring and optimization of a company's tasks and activities, instead of just inspection of the final product). The 2000 version also demanded involvement by upper executives in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Another goal was to improve effectiveness via process performance metrics: numerical measurement of the effectiveness of tasks and activities. Expectations of continual process improvement and tracking customer satisfaction were made explicit.

ISO 9000 Requirements include:
* Approve documents before distribution;
* Provide correct version of documents at points of use;
* Use your records to prove that requirements have been met; and
* Develop a procedure to control your records.

===2008 version===
ISO 9001:2008 in essence re-narrates ISO 9001:2000. The 2008 version only introduced clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with [[ISO 14000|ISO 14001:2004]]. There were no new requirements. For example, in ISO 9001:2008, a quality management system being upgraded just needs to be checked to see if it is following the clarifications introduced in the amended version.

ISO 9001 is supplemented directly by two other standards of the family:
* ISO 9000:2005 "Quality management systems. Fundamentals and vocabulary"
* ISO 9004:2009 "Managing for the sustained success of an organization. A quality management approach"
Other standards, like [[ISO 19011]] and the ISO 10000 series, may also be used for specific parts of the quality system.

===2015 version===
In 2012, ISO/TC 176 – responsible for ISO 9001 development – celebrated 25 years of implementing ISO 9001<ref>{{cite web|url=http://asq.org/blog/2012/03/25-years-of-iso-9000/|title=25 Years of ISO 9000 {{!}} A View from the Q|publisher=ASQ|access-date=20 April 2016|archive-date=25 October 2016|archive-url=https://web.archive.org/web/20161025113359/http://asq.org/blog/2012/03/25-years-of-iso-9000/|url-status=dead}}</ref> and concluded that it was necessary to create a new QMS model for the next 25 years. They subsequently commenced the official work on creating a revision of ISO 9001, starting with the new QM principles. This moment was considered by important specialists in the field as the "beginning of a new era in the development of quality management systems".<ref>{{Cite journal|url = http://www.asigurareacalitatii.ro/wp-content/uploads/83-02.pdf|title = The Standard ISO 9001:2015 – A Milestone in the Evolution of Quality Management|last = Bacivarov|first = Ioan|date = 1 October 2015|journal = Asigurarea Calitatii – Quality Assurance|access-date = 14 October 2015}}</ref> As a result of the intensive work from this technical committee, the revised standard ISO 9001:2015 was published by ISO on 23 September 2015. The scope of the standard has not changed; however, the structure and core terms were modified to allow the standard to integrate more easily with other international management systems standards.<ref>{{cite web |title=Infographic: ISO 9001:2015 vs. 2008 revision – What has changed? |date=11 August 2016 |url=https://maritimecyprus.com/2016/08/11/infographic-iso-90012015-vs-2008-revision-what-has-changed/ |publisher=Maritime Cyprus |access-date=9 October 2018}}</ref>

The new ''ISO 9001:2015'' management system standard helps ensure that consumers can secure reliable, desired quality goods and services. This further increases benefits for a business.<ref>{{cite web|url=http://www.iso.org/cms/render/live/en/sites/isoorg/home/standards/popular-standards/iso-9001.html|title=ISO 9001 Quality management|website=ISO|language=en|access-date=2018-12-18}}</ref>

The 2015 version is also less prescriptive than its predecessors and focuses on performance. This was achieved by combining the process approach with '''"risk-based thinking"''', and employing the [[Plan-Do-Check-Act]] cycle at all levels in the organization.<ref>{{cite web|url=http://www.iso.org/iso/home/news_index/news_archive/news.htm?refid=Ref2002|title=ISO 9001:2015 – Just published!|date=23 September 2015 |publisher=ISO |access-date=2 October 2015}}</ref>

Some of the key changes include:
* High-Level Structure of 10 clauses is implemented. Now all new management system standards released by ISO will have this high-level structure
* Greater emphasis on building a management system suited to each organization's particular needs
* A requirement that those at the top of an organization be involved and accountable, aligning quality with wider business strategy
* Risk-based thinking throughout the standard makes the whole management system function as a preventive tool and encourages continuous improvement
* Less prescriptive requirements for documentation: the organization can now decide, in addition to the mandatory documents and records, what documented information it needs and in what format it should be
* Alignment with other key management system standards through the use of a common structure and core text<ref>{{cite web|url=http://www.bsigroup.com/en-GB/about-bsi/media-centre/press-releases/2015/august/BSI-obtains-first-global-accreditation-for-the-new-Quality-Management-standard-ISO-90012015-from-ANAB/#.Vem-kxFVhBc|title=BSI obtains first global accreditation from ANAB to certify organizations to the new Quality Management standard ISO 9001:2015|publisher=BSI |access-date=4 September 2015}}</ref>
* Inclusion of [[knowledge management]] principles
* Quality Manuals and management representatives (MR) are no longer mandatory.

"Risk-based thinking" is seen as a development from a traditional approach to risk management, seen as the responsibility of a "risk manager", to an approach which sees risk management as "a fundamental way of thinking and decision making throughout [an] entire organization.<ref>Sato, N., [https://www.9001simplified.com/learn/risk-based-thinking-in-iso-9001.php What Is Risk-Based Thinking in ISO 9001?], ''9001Simplified.com'', published on 29 December 2019, accessed on 9 December 2024</ref> The ISO and the International Accreditation Forum (IAF) have issued joint guidance on auditing practices covering risk-based thinking.<ref>ISO and IAF, [https://committee.iso.org/files/live/sites/tc176/files/documents/ISO%209001%20Auditing%20Practices%20Group%20docs/Auditing%20to%20ISO%209001%202015/APG-RiskBasedThinking2015.pdf Auditing Practices Group Guidance on: Risk Based Thinking], accessed on 9 December 2024</ref>