ISO 9001 Quality Management Systems, the world’s leading quality management standard, has recently been revised..
Why was ISO 9001 revised?
All ISO standards are reviewed every five years to establish if a revision is required to keep it current and relevant for the marketplace. TISO 9001:2015 is designed to respond to the latest trends and be compatible with other management systems such as ISO 14001.
The new version follows a new, higher level structure to make it easier to use in conjunction with other management system standards, with increased importance given to risk. More information about the changes can be found in the news area.
I am certified to ISO 9001:2008. What does this mean for me?
Organisations are granted a three-year transition period after the revision has been published to migrate their quality management system to the new edition of the standard.
The latest edition of ISO 9001, ISO’s flagship quality management systems standard, has just been published. This concludes over three years of revision work by experts from nearly 95 participating and observing countries to bring the standard up to date with modern needs.
With over 1.1 million certificates issued worldwide, ISO 9001 helps organizations demonstrate to customers that they can offer products and services of consistently good quality. It also acts as a tool to streamline their processes and make them more efficient at what they do. Acting ISO Secretary-General Kevin McKinley explains: “ISO 9001 allows organizations to adapt to a changing world. It enhances an organization’s ability to satisfy its customers and provides a coherent foundation for growth and sustained success.”
The 2015 edition features important changes, which Nigel Croft, Chair of the ISO subcommittee that developed and revised the standard, refers to as an “evolutionary rather than a revolutionary” process. “We are just bringing ISO 9001 firmly into the 21st century. The earlier versions of ISO 9001 were quite prescriptive, with many requirements for documented procedures and records. In the 2000 and 2008 editions, we focused more on managing processes, and less on documentation.
“We have now gone a step further, and ISO 9001:2015 is even less prescriptive than its predecessor, focusing instead on performance. We have achieved this by combining the process approach with risk-based thinking, and employing the Plan-Do-Check-Act cycle at all levels in the organization.
“Knowing that today’s organizations will have several management standards in place, we have designed the 2015 version to be easily integrated with other management systems. The new version also provides a solid base for sector-quality standards (automotive, aerospace, medical industries, etc.), and takes into account the needs of regulators.”
As the much anticipated standard comes into being, Kevin McKinley concludes, “The world has changed, and this revision was needed to reflect this. Technology is driving increased expectations from customers and businesses. Barriers to trade have dropped due to lower tariffs, but also because of strategic instruments like International Standards. We are seeing a trend towards more complex global supply chains that demand integrated action. So organizations need to perform in new ways, and our quality management standards need to keep up with these expectations. I am confident that the 2015 edition of ISO 9001 can help them achieve this.”
The standard was developed by ISO/TC 176/SC 2, whose secretariat is held by BSI, ISO member for the UK. “This is a very important committee for ISO,” says Kevin, “one that has led the way in terms of global relevance, impact and utilization. I thank the experts for their hard effort.”
ISO 9001:2015 replaces previous editions and certification bodies will have up to three years to migrate certificates to the new version.
ISO 9000, which lays down the concepts and language used throughout the ISO 9000 family of standards, has also been revised and a new edition is available.
Learn all about the new ISO 9001:2015 in this five minute video:
ISO 9001:2015 will replace ISO 9001:2008. The revised ISO 9001 was published on Wednesday 23rd September 2015.
The standard follows the common structure provided by Annex SL. To find out more about Annex SL click here.
The changes were managed by the ISO committee ISO/TC 176. Its role was to ensure that the standard was published fit for purpose for the foreseable future.
ISO 9001:2015 is more compatible with other management systems, such as ISO 14001, making it more effective and efficient to integrate management systems.
There are changes to the:
structure – which follows the ten section structure defined in Annex SL.
Sector specific changes:
ISO 9001 is the base standard for sector specific standards including AS 9100 (aerospace), ISO 13485 (medical devices) and TL 9000 (telecommunications).
These are likely to be revised in the near future, although each industry oversight body (e.g. IATF and IAQG) will determine the change process.
High level changes to all management system standards – The most significant changes expected in the 2015 standard are in Clauses 4, 5 and 6, i.e. Context of the organization, Leadership and Planning, but there are many others throughout the standard.
CONTEXT OF THE ORGANISATION
This is a new concept and relates to the external factors and conditions that could affect an organization and it’s ability to provide products and services to customer requirements. Examples could include governance, regulation, sector, stakeholders and shareholders to name but a few.
Tip: The context will influence the type and complexity of management system needed.
There are enhanced requirements for top management to demonstrate leadership and commitment directly with the QMS.
Tip: Top management is expected to be “hands on” and to ensure that the quality policy and quality objectives are consistent with the overall strategy and context. This is new territory for ISO 9001 audits (NOT NECESSARILY), and more audit time is expected to be devoted to discussions with the organizations leaders.
Is a new term introduced to the high level structure, with a requirement to address risks and opportunities and to carefully plan changes within the management system.
Tip: Risks and opportunities, for example, could relate to the use of electronic systems within the management system. Introducing such systems would require change and transition arrangements, which should be planned within the management system.
This new section builds upon the 2008 requirements for competence and awareness (now extended to include persons under the organization’s control, not just employees) and communication.
Tip: With the increasing use of outsourced providers, this requirement reminds organizations that this resource must be managed effectively just as internal providers are managed.
This section has similar requirements to the existing standard, but with a new emphasis on evaluation in addition to the monitoring, measuring and analyzing requirements.
Tip: Evaluation is the interpretation of results and analysis. Processes may be well defined and effective, but do they yield optimum results? This may be a new challenge for internal audits.
ISO 9001:2015 is expected to be much less rigid than previous versions, and to incorporate more business management terminology and concepts. Documentation requirements are much less prescriptive and left more to the organization to judge its own needs.
The standard is written for the benefit of organizations, not auditors. There are likely to be more challenges to auditors to understand and recognise the extent and type of evidence that would be acceptable to confirm compliance to the 2015 requirements.
ISO 9001:2015 auditors will be engaging in dialogue with business leaders, seeking understanding and explanations from them about policy, strategy and quality objectives, and ensuring these are compatible.
The audit experience from the client perspective is could be very different. Systems should be updated to benefit the user, not the author!