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October 2014

ISO 9001 2015 Changes

Quality Resource Center Update to Expected  ISO 9001 Р2015 Changes

An official draft of ISO 9001-2015 changes has been released for comment by interested parties and a final draft standard is scheduled for release by the end of November 2014. The new standard is expected to be published in September 2015 with March 2017 for the final discontinuance of the 2008 standard and September 2018 for all concerned to fully implement the new standard.

Until a new standard is published and officially released companies should start planning for a changeover but do nothing to specifically alter their quality systems toward the new standard. Certifying audit companies will follow the above schedule unless it changes.

The 2015 standard will differ in some formal ways and it will be structured differently. The basic areas of quality control will remain the same but with renewed general emphasis on planning and management accountability. A Quality Manual will not be a formal requirement. There will be 10 sections or clauses the last seven of which will be auditable. The reason for the new standard is to promote compatibility with other standards, to recognize the various ways management is capable of satisfying the basic requirements and to respond to quality control needs discovered over time.

The seven auditable clauses will be:

  1. Control of the organization
  2. Leadership
  3. Planning
  4. Support
  5. Operation
  6. Performance Evaluation
  7. Improvement

Risk will be better linked to prevention but no formal risk management process will be specifically required. Risk aversion will be considered an outcome of many areas of the QMS including planning meetings. The basic principles of control and process including effects on consistency and efficiency and customer satisfaction will not change but formal quality manuals or procedure manuals will not be required. The Management Representative will not be required. Permissible exclusions will be replaced by a non-applicable designation subject to validity checks at audits.

A larger emphasis in sections 4, 5, 6, and 7 will be put respectively on:

  1. Organizational purpose
  2. Management accountability and quality objective/QMS integration
  3. Risk and opportunity analysis and follow-up and
  4. Future resources planning. But, no major overhaul will be needed. All other standards will eventually incorporate new changes but the timing is as yet not determined.

In the interim it is suggested that companies can do a gap analysis of the ISO 9001 – 2015 changes and especially with respect to the above for areas to improve. It should also be noted that the auto industry has decided as a whole through its trade organization has decided not to implement the standard due to their heavy investment in the previous standard and TS16149.

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Next Steps in the ISO 9001:2015 Revision Process

Next Steps in the ISO 9001:2015 Revision Process

The DIS phase (Draft International Standard) is the first major step in the ISO publication process. The DIS ISO 9001 revision 2015 was officially issued for public comment in early May 2014. The next steps will be the review and discussion of changes before the issuance of the FDIS (Final Draft International Standard), expected in November 2014, and the publication of ISO 9001:2015 in September 2015.

The transition period for introducing and adopting the new requirements for organizations with ISO 9001 certification will start after the new version’s publication in September 2015 and organizations will have three years to implement these into their management systems.

While the DIS is not the final release, it does reflect changes to existing requirements. As the revision process goes forward, the later FDIS will likely have minor amendments included before the final revision is issued. Quality Resource Center recommends that all organizations start familiarizing themselves now with the actual requirements of the DIS version.

What are the main expected changes to ISO 9001?

ISO 9001:2015 will have a modernized approach to quality management, characterized by the following:

  • An increased emphasis on achieving value for organizations and customers. The new version will be more results- and improvement-oriented
  • The new version will also have a distinct emphasis on risk management and risk-based thinking
  • Increased requirements for feedback from all involved stakeholders and processes (not only from clients)
  • Greater emphasis on involvement of top management
  • A revised structure to align with all other ISO management system standards and facilitate integration with other management systems
  • The standard will be more readily applicable by service industries and organizations
  • More flexibility on the type and use of documentation; simplified requirements for documented procedures (no longer a “quality manual”)
  • What has not changed is that the customer remains the primary focus

Quality Resource Center will publish information on new developments on a regular basis. Our team is available to support you with this transition and can provide further information and assistance on this new draft standard.