ISO 9001:2015, 9.3

This article provides a summary of the Management Review requirements of ISO 9001:2015. After the summary, the Management Review differences from ISO 9001:2008 are described.

ISO 9001:2015 Summary

9.3 Management Review

9.3.1 General

Review the quality management system (QMS) at planned intervals to ensure a suitable, adequate, and effective QMS and alignment with the strategic direction of the organization.

9.3.2 Management Review Inputs

Plan and carry out the management review considering:

  • Status of actions from previous management reviews
  • Changes in external and internal issues relevant to QMS
  • Information on performance and effectiveness of the QMS, including trends in:
    • Customer satisfaction and feedback from relevant interested parties
    • Extent to which quality objectives have been met
    • Process performance and product and service conformity
    • Nonconformities and corrective actions
    • Monitoring and measurement results
    • Audit results
    • Performance of external providers
  • Adequacy of resources
  • Effectiveness of actions taken to address risks and opportunities (see 6.1)
  • Opportunities for improvement

9.3.3 Management Review Outputs

Outputs from the management review must include decisions and actions related to:

  • Opportunities for improvement
  • Any need for changes to the QMS
  • Resource needs

Retain documented information as evidence of the results of management reviews.

Changes from ISO 9001:2008

1. Clause Numbers

The Management Review requirements are now stated in clause 9.3, instead of clause 5.6 as in ISO 9001:2008. The new standard has adopted the new clause structure of Annex SL that is required for all new and revised management system standards, which places Management Review under clause 9, Performance Evaluation.

2. Relocated Requirements

All of the clause 5.6 requirements of ISO 9001:2008 have been retained (except for references to policy and preventive action). However, some of the requirements have been reworded and relocated in a different sequence.

For example, “follow-up actions from previous management reviews” was the fifth entry in 5.6.2 review inputs, and is now listed as the first consideration in 9.3.2 when planning and carrying out the management review: “status of actions from previous management reviews”. It makes sense to have “old” business covered first and then followed by “new” business.

3. Quality Objectives

Clause 5.6.1 of ISO 9001:2008 required the review of any needed changes to the quality objectives. New clause 9.3.2 adds a specific review input on the extent to which the quality objectives have been met.

4. Performance of External Providers

The list of management review inputs for the new standard has added the performance of external providers, i.e., suppliers, associate companies, and outsourced processes.

5. Strategic Direction

The new standard has added in clause 9.3.1 that the management review must ensure alignment of the QMS with the strategic direction of the organization.

6. Nonconformity and Corrective Action

An input in clause 5.6.2 is to review the “status of preventive and corrective actions”. The related requirement in the new standard is to review “nonconformities and corrective actions”.

Corrective action is a form of problem management, and preventive action is a form of risk management. Since the new standard has added requirements on “risks and opportunities”, and it listed as a review topic, the reference to preventive action is no longer needed.

7. Customer Satisfaction

Clause 5.6.1 of ISO 9001:2008 included “customer feedback” as a review input. This requirement has been revised in clause 9.3.2 to be “customer satisfaction and feedback from relevant interested parties”.

8. Risks and Opportunities

A new requirement has been added as a review consideration, “The effectiveness of actions taken to address risks and opportunities.” It refers the reader to new clause 6.1, Actions to Address Risks and Opportunities, for more information. Clause 6.1 (and related clauses) replaces the need for the old clause 8.5.3 on preventive action.

9. Conformity of Products and Services Clause 5.6.1 of ISO 9001:2008 included “process performance and product conformity” as a review input. This requirement has been clarified as “process performance and conformity of products and services.”

10. Improvement

Clause 5.6.2 of ISO 9001:2008 identified “recommendations for improvement” as a review input. The new standard has revised the review consideration to be “opportunities for improvement.”

11. Review Evidence

Clause 5.6.1 of ISO 9001:2008 requires records from management reviews to be maintained. The word “records” has been replaced by “documented information”, the new term used to refer to documents and records.

It also adds that documented information must be retained as “evidence” of the results of management reviews. This reworded requirement has been moved from the old 5.6.1 section to new clause 9.3.3 to be grouped with the other review output requirements.