ISO 9001: 2015 Quality Systems Standard - 5th edition:

Fundamental changes to structure and contents

by Dr. L.N. Senaweera

The fifth edition of ISO 9001: 2015 was published by the International Organization for Standardization (ISO) last month, in keeping with the changes taking place in the world to provide best practices to organizations while improving compatibility with other applicable ISO management system standards.

This standard focuses on changes that organizations will have to make to better comply with the spirit of the standard. ISO's rules for the development of standards need periodic review.

The ISO 9001:2015 has amended the structure and contents of ISO 9001:2008.

ISO 9001:2015 replaced the 2008 version which is implemented by private and public sector organizations in 165 countries. Although certification is not a mandatory need of the standard, as of 2013, 1.1 million organizations worldwide have been audited and certified by independent certification and registration bodies to ISO 9001:2008.

However, ISO 9001:2015 is the fifth edition of the standard which was first published in 1987. The fourth edition, published in 2008, was a thorough revision, including new needs, reducing paper work and a sharpened customer focus, reflecting developments in quality management and experience gained since the publication of the initial version.

The ISO Technical Committee (TC176) which develops the ISO 9000 series of standards has make fundamental changes to its structure and contents in the fifth edition to have a results oriented approach with minimum documentation.

The changes will affect QMS processes and documentation of currently certified organizations.

Significant impact

Thus, the new ISO 9001:2015 standard will have a significant impact on organizations already certified.

ISO 9001:2015 is not a product standard, but a Quality System Standard. It applies not to products or services, but to the process which creates them. The standard provides workable guidelines for the implementation of widely accepted best practice models, which can serve as the first step towards Total Quality Management.

The 2015 edition features important changes, which the Chair of the ISO subcommittee that developed and revised the standard, Nigel Croft refers to as "evolutionary rather than revolutionary" process.

"We are bringing the ISO 9001 firmly into the 21st century. The earlier versions of ISO 9001 were quite prescriptive, with many documented procedures and records. In the 2000 and 2008 editions, we focused more on managing processes, and less on documentation," he said.

"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," said Croft.

The new version provides a platform for organizations to perform effectively when using the standard as part of their business processes.

It is designed to be applied to virtually any product or service made by any process anywhere in the world.

The other important point is that any interested party hoping to introduce multiple management systems (eg energy, environmental, health and safety) will have less work because the structure and the core needs of these are identical.

ISO 9001:2015 has two informative annexes. Annex A provides clarification on the new structure, terminology and concepts underpinning the standard.

Annex B details the other international standards on quality management and quality management systems developed by ISO/TC 176. These are designed to provide assistance to an organization seeking to set up, implement, improve or audit its quality management system.

Some of the key changes of ISO 9001: 2015 are, Leadership - Clause 5, previously 'Management Responsibility', has now changed to 'Leadership'.

Context - Two new clauses (4.1 and 4.2) are now addressed the factors relating to the context of the organization.

Scope - More emphasis on the definition and content of the scope of the quality management system than ISO 9001:2008.

Process Approach - Clause 4.4 of ISO 9001:2015 sets out specific needs considered essential to the adoption of a process approach.

Risk-based Thinking - The much troubled clause of preventive action has disappeared. But, the core concept of identifying and addressing potential mistakes remains. It discusses in terms of risk and opportunities.

Services - The term 'product' has now been replaced by 'products and services'.

Improvement - Clause 10 addresses the improvement in a much broader manner than in ISO 9001: 2008 clause 8.5.1.

External Provision - Clause 8.4 of the new standard addresses all forms of external provisions.

Documentation - Procedures and quality records have been taken out and a new concept 'documented information' gives full authority to the organization to identify and control, maintain and retain information.

Clarity - The wording of the standard has been amended to make them more explicit.

Terminology - As in previous editions, the terms and definitions remain in the separate standard - ISO 9000:2015. What is important is that although the standards named in the 9000 series do in fact describe standardized elements of a quality system, they do not specify standardized measures or achieving quality assurance within an organization.

Neither would they be in any position to do so due to their general and versatile character. On the contrary, they are a means of helping organizations to pave their own way by using proven and best standardized principles.

Important points

Organizations that are certified ISO 9001 should contact their certification/registration bodies to agree to a program for analysis and clarifications of ISO 9001:2015 in relation to their Quality Management Systems and upgrading certificates.

When ISO 9001:2015 was published in September 2015, it was the start of a three-year transition period during which organizations wishing to move to the new version of the standard need to make changes to their existing Quality Management System.

Organizations in the process of certification to ISO 9001:2008 should change to ISO 9001: 2015 by applying for transition to the new version as it has already been published.

The Sri Lanka Standards Institution (SLSI)being the national standards body of Sri Lanka and only member body of the International Organization for Standardization (ISO), has the authority to adopt any international standard published by ISO as a national standard.

Therefore, SLSI has adopted the ISO 9001:2015 as a national standard. This standard can now be purchased from the SLSI Documentation and Information Division.

SLSI will train industry personnel on the new needs. To ensure that SLSI certified organizations migrate to the new version smoothly, SLSI will develop a sound transition plan.

The writer is the Director General and CEO of the Sri Lanka Standards Institution.