ISO9001 2015 Major Changes

ISO9001 2015 Major Changes

Business and technology have undergone radical changes, geographical boundaries are insignificant, supply chains have increasingly gone complex and the information available has multiplied exponentially. In order to ensure that ISO 9001 continues to serve business community and maintain its relevance in the market place, the ISO9001 2015 Major Changes have been taken in order to address the change in business world.

Here is a short summary of the that are considerably more substantial than those produced in the previous revisions.

The standard rewritten according to High Level Structure

The standard of ISO 9001:2015 has been restructured; the chapters, sub-chapters, paragraphs and clauses are completely revised. The restructuring does not affect the content. However, the change in structure is to comply with new topic sequence and composition guidelines. With the new structure, ISO aims to help organizations to easily integrate all parts of management systems. It makes easier for companies to include components of other standards deemed to be relevant like the ISO 14001:2015 parts of environmental standard, OHSAS 18001 occupational health and safety management standard.

Risk management

Risk management in the new ISO 9001:2015 is based on, ‘risk based thinking’ approach and is the fundamental in the revised standard. Quality cannot exist until the organization can provide its clients with a conforming product or service over the long haul. The ISO9001:2015 standard embraces concept of positive uncertainty. Managing risk means working towards improvement continuously. Corrective action corresponds to a wrongly qualified risk whereas preventive action is about risk of possible un-occurred noncompliance.


The commitment to quality by building strong, visible leadership is given importance and strengthened.
• Management representative idea is abolished completely.
• The stated goals and quality policy must keep up with strategic orientation.
• Business processes must be merged with QMS requirements.

Standard open to service industry

The context or background in which the establishment has evolved has been changed in the revised version of the standards taken into account in the way organizations do business. The revision, ISO9001:2015 takes change into consideration and the vocabulary, level of abstract is kept simple.

No to quality manual

Another ISO9001 2015 Major Changes is the elimination of the requirement for organizations to maintain a quality manual. However, documentation is still a part of the standard and it is important that documents are maintained and preserved with relevant, vital information. The change allows greater flexibility in organizations.

Importance to certified organization and stakeholders.

New clauses – 4.1 and 4.2 give great consideration to context surrounding the organization. They call for content analysis, stakeholder identification and understanding of their expectations.


The ISO9001 2015 Major Changes have assisted the standard to adapt to changing times and proved that knowledge is no doubt the key to successful projects. It considers knowledge as a resource to be managed, protected and made available wherever necessary.

For more information on the services provided by K&S Quality Associates click here

Leave a Reply

Your email address will not be published. Required fields are marked *