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ISO 9001 Clause 9.3 Management Review

wilkshireconsulting
Apr 23
3 min read

In ISO 9001 9.3 Management Review management review is a formal, periodic evaluation performed by top management to assess the overall performance of the QMS and make strategic decisions for improvement. Clause 9.3 ensures that the system remains suitable, adequate, effective and aligned with the organization’s strategic direction.

9 Performance Evaluation consists of 3 different sections:

9.3.1 General

9.3.2 Management review inputs

9.3.3 Management review outputs

International Organization for Standardization. ISO 9001:2015 Quality Management Systems – Requirements

9.3 Management review

9.3.1 General

Top management shall review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the organization.

9.3.2 Management review inputs

The management review shall be planned and carried out taking into consideration:

a) the status of actions from previous management reviews;

b) changes in external and internal issues that are relevant to the quality management system;

c) information on the performance and effectiveness of the quality management system, including

trends in:

1) customer satisfaction and feedback from relevant interested parties;

2) the extent to which quality objectives have been met;

3) process performance and conformity of products and services;

4) nonconformities and corrective actions;

5) monitoring and measurement results;

6) audit results;

7) the performance of external providers;

d) the adequacy of resources;

e) the effectiveness of actions taken to address risks and opportunities (see 6.1);

f) opportunities for improvement.

9.3.3 Management review outputs

The outputs of the management review shall include decisions and actions related to:

a) opportunities for improvement;

b) any need for changes to the quality management system;

c) resource needs.

The organization shall retain documented information as evidence of the results of management reviews.

9.3.1 General

Top management must review the organization's QMS at planned intervals to ensure:

· Its continued suitability, adequacy and effectiveness

· Its alignment with the strategic direction of the organization

This ensures the QMS remains relevant as business goals, market conditions, and risks evolve.

9.3.2 Management review inputs

The standard specifies what information must be considered during management review meetings. These inputs should include:

· Status of actions from previous management reviews

· Changes in external and internal issues relevant to the QMS – such as., market changes and regulations.

· Performance and effectiveness of the QMS, including:

o Customer satisfaction and feedback

o Process performance and product/ service conformity

o Nonconformities and corrective actions

o Monitoring and measuring results

o Audit results

· Resource adequacy

· Effectiveness of actions taken to address risks and opportunities

· Opportunities for improvement

This is to provide a comprehensive and factual bias for decision making.

9.3.3 Management review outputs

The outputs of the management review should include decisions and actions related to:

· Opportunities for improvement

· Ayn need for changes to the QMS

· Resource needs

· Actions to address risks and opportunities

Documented information (records) must be retained as evidence of the results of the management review.

This ensures that the outcomes are actionable and traceable, helping to continually refine and strengthen the QMS.

In conclusion, implementing Clause 9.3 Management Review ensures that top management regularly reviews the QMS to confirm its ongoing suitability, adequacy and effectiveness. It requires evaluating key inputs like performance data, customer feedback, and risk management to make informed decisions for improvement. In the next blog post we will be diving deeper into 10 Improvement.