Time to Transition to ISO 9001:2015

Transition now from ISO 9001:2008 to ISO 9001:2015

ISO 9001:2015 was published on 15th September 2015 and is the replacement for ISO 9001:2008.  For organisations currently using ISO 9001:2008 there will be a three year transition period to switch over to the new standard ISO 9001:2015.  Certificates to ISO 9001:2008 will not be valid after the 14th September 2018.

Structure of 1SO 9001:2015

ISO 9001:2015 is based on the high level structure (Annex SL Framework) being applied to all new and revised ISO management system standards:

  1. Scope
  2. Normative References
  3. Terms and Definitions
  4. Context of the Organisation
  5. Leadership
  6. Planning
  7. Support
  8. Operation
  9. Performance Evaluation
  10. Improvement

KEY CONCEPTS

4.0 Context of the Organisation

The standard introduces a new requirement to identify the internal and external factors which are relevant to purpose and strategic direction and that will affect the ability to achieve the required outcomes in terms of quality.

5.0 Leadership

There is more of a requirement in this new standard for top management to demonstrate leadership and management direction with the system. Top management will have to be able to demonstrate leadership and commitment and detail the areas where this occurs.  Applicable legal and regulatory requirements have to be determined, understood and the organisation clearly meeting these requirements.

6.0 Planning

This is a new term added to the high level structure with a requirement to address risks and opportunities and to carefully plan changes within the management system. The company will have to demonstrate that they have assessed the risks and opportunities for the organisation.  Objectives have been enhanced with the company having to establish objectives at ‘Relevant’ functions, levels and processes including what will be done, what resources are required, who is responsible for each of the objectives, when they are expected to be completed by and how evaluation of the objectives will occur.

7.0 Support

This new term builds upon the ISO 9001:2008 requirements for competence and awareness and is now extended to include persons under the organisation’s control and not just employees.

Document control and records is now referred to as Documented Information. There is no longer a requirement for a quality manual and the six procedures.

All employees will need to demonstrate that they are aware of the current Quality Policy, Relevant Quality Objectives, their own contribution to the effectiveness of the quality management system, and the implications of not conforming to the QMS requirements.

8.0 Operation

This includes many of the old requirements from clause 7 and the basic principles of controlling operations have not changed.

9.0 Performance evaluation

This has similar themes to the existing standard, but with a new emphasis on evaluation in addition to the current requirement to measure and analyse. The requirement to monitor customer perception still exists.

10.0 Improvement

This section includes non-conformity, corrective action and continual improvement. The requirement for preventive action has been removed and replaced by the risk based thing earlier in the standard.

Resource Link: https://en.wikipedia.org/wiki/ISO_9000

PRACTICAL STEPS TO TRANSITION

ISO 9001:2015 was published 15th September 2015 and is the replacement for ISO 9001:2008. For organisations currently using ISO 9001:2008 there will be a three-year transition period to switch to ISO 9001:2015. ISO QA Isle of Man can help your business transition to the new standard, contact us today for a free consultation.

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