Looking back on ISO history, we can see that the first standards, particularly ISO 9001:1994 placed specific emphasis on product assurance using preventive actions, instead of just checking the final product. It also required companies to comply with documented procedures – recognizing the trend to manage quality by control rather than assurance.

ISO 9001:2000 placed quality and process management at its core, changing the previous versions radically. It aimed to first understand the client’s requirements before designing processes that would help them to deliver on these. The standard also looked at how to continuously improve processes and track customer satisfaction. Where previous versions focused on quality control, ISO 9001:2000 was built on quality management. 

ISO 9001:2008 only made the existing requirements of the 2000 version specification clearer. It also incorporated some changes to make it more consistent with ISO 14001:2004, the environmental management system standard. Later in 2009, ISO 9004 (which accompanied ISO 9001:2000 for the first time) was revised to promote a sustainable business approach. This version focused on all stakeholders and not just customers and social conditions.

ISO 9001:s requirements are generic and must be carefully interpreted to make sense within specific organizations. Manufacturing is not like the service industry and over time the various industry sectors will want to (and actually did) standardize their interpretations of the guidelines specifically for their marketplace.

These include:

Information technology: TickIT interprets ISO 9000 for the software development industry.

Aviation: AS 9100 is an Aerospace Basic Quality System Standard that was developed by major manufacturers, including Boeing, Lockheed-Martin, McDonnell Douglas and Pratt & Whitney.

Automotive: ISO/TS 16949 is an interpretation that was developed by the IATF, a group of motor manufacturers including GM, Ford and Chrysler.

Telecommunications: TL 9000, the Telecom Quality Management and Measurement System Standard, was developed by the telecom consortium, QuEST Forum. Unlike ISO 9001 and other sector-specific standards, TL 9000 sets out standardized product and process measurements that allow companies to benchmark their performance in key process areas against peer organizations.

Medical: ISO 13485:2012 is the medical industry’s equivalent of ISO 9001:2008 Unlike the standards it replaces, ISO 13485:2003 is a stand-alone specification. That means compliance with ISO 13485 doesn’t necessarily mean compliance with ISO 9001:2008 and vice versa.

Oil and gas: ISO/TS 29001 looks at the design, development, production, installation and service of products for the petroleum, petrochemical and natural gas industries.

All ISO standards are reviewed every five years to make sure they are still current and relevant in the marketplace. It undergoes several stages the first being the Committee Draft stage. This is the first consultation in the development of an ISO standard where members who have chosen to take part in the revision, will form a national position on the draft and comment on it. This normally takes between two to four months. Once the national positions have been submitted, experts – all nominated by the ISO members of the participating countries – meet regularly to discuss issues or answer questions that have been raised. These meetings will continue until a Draft International Standard is published and goes out for public comment. Once the new draft has been finalized and accepted, it is published with a new date following the standard’s number. In this case, the revised ISO 9001 standard was published in 2015.

All ISO management systems share common elements. But despite this, these systems come in many different shapes and structures which can lead to confusion and difficulties when they are implemented. ISO has provided an identical structure (HLS), text and common terms and definitions for all management system standards of the future. This means that both future and revised management system standards will be consistent and simpler to integrate. The revised structure will also make the standards easier to read – leading to a better understanding for those tasked with implementing them.

This new high-level structure (HLS) is referred to as Annex SL and all ISO technical committees who develop management system standards in future use this as their blueprint. The high level structure is designed to align format, text, terms and definitions, while still giving standards developers all the flexibility they need to integrate their technical topics and requirements. The new HLS uses 10 Clauses as follows:

Clause 1: Scope

Clause 2: Normative references

Clause 3: Terms and definitions

Clause 4: Context of the organization

Clause 5: Leadership

Clause 6: Planning

Clause 7: Support

Clause 8: Operation

Clause 9: Performance evaluation

Clause 10: Improvement

So in summary, because of the new design structure, all standards will provide a stable, core set of requirements for the next ten years or more. These will stay generic, but be relevant to organizations of all types and sizes operating in any sector. While maintaining its current focus on effective process management, the standard will also reflect the changes in quality management system practices and technology since the last major revision in 2000. By applying Annex SL, the standard will improve compatibility and alignment with other ISO management system standards.

ISO 9001:2015 will also improve implementation and conformity assessments for first, second and third parties. Using simplified language and writing styles, the standard will help all stakeholders to understand and interpret key areas better.