ISO 9001:2015, Clause 9.3

This article provides a summary of the Management Review requirements as stated in the recently published Draft International Standard (DIS) version of ISO 9001:2015. The DIS Management Review differences from ISO 9001:2008 are also described.

ISO/DIS 9001:2015 Summary

9.3 Management Review

9.3.1

Review the quality management system at planned intervals to ensure a suitable, adequate, and effective system.

Plan and carry out management review considering:

  • Status of actions from previous management reviews
  • Changes in external and internal issues relevant to QMS, including strategic direction
  • Information on quality performance, including trends and indicators for:
    • Nonconformities and corrective actions
    • Monitoring and measurement results
    • Audit results
    • Customer satisfaction
  • Issues concerning external providers and other relevant interested parties
  • Adequacy of resources required for maintaining effective QMS
  • Process improvement and conformity of products and services
  • Effectiveness of actions taken to address risks and opportunities (see 6.1)
  • New potential opportunities for continual improvement

9.3.2

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

  • Continual improvement opportunities
  • Any need for changes to QMS, including 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 of the draft standard are now stated in clause 9.3, instead of clause 5.6 as in ISO 9001:2008. The DIS has adopted the new clause structure required for all new and revised management system standards, which places Management Review under clause 9, Performance Evaluation.

The requirements for clauses 5.6.1 (General) and 5.6.2 (Review Input) are now addressed in untitled clause 9.3.1, and clause 5.6.3 (Review Output) is included in untitled clause 9.3.2.

2. Relocated Requirements

All of the clause 5.6 requirements of ISO 9001:2008 have been retained (except for the reference to preventive action). However, some 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 9.3.1 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. Policy and Objectives

Clause 5.6.1 of ISO 9001:2008 required the review of any needed changes to the quality policy and quality objectives. Policy and objectives are no longer mentioned under Management Review. However, a similar and broader requirement is stated in 9.3.2: “any need for changes to the quality management system, including resource needs.”

4. Quality Performance

Clause 5.6.2 of ISO 9001:2008 requires that “information” be included for the listed review inputs. The draft standard changes the requirement to consider “information on the quality performance, including trends and indicators”, for the listed topics.

5. Strategic Direction

The draft standard has clarified that management reviews must consider changes in external and internal issues that are relevant to the QMS, including its “strategic direction”.

The new requirement, therefore, is to plan and conduct your management reviews considering the changing business conditions and to align the reviews with your organizational strategies.

6. Nonconformity and Corrective Action

A current input in clause 5.6.2 is to review the “status of preventive and corrective actions”. The related requirement in the DIS 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 draft 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 9.3.1 to be “customer satisfaction”.

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 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. Continual Improvement

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

Note that the draft standard defines Improvement as an “activity to enhance performance’, whereas Continual Improvement is defined a “recurring activity to enhance performance.”

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 or 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 9.3.2 to be grouped with the other review output requirements.

Further management review changes may be introduced in the FDIS version, as well as, the final published version of the ISO 9001:2015 standard.