ISO 9001:2015 requires Top Management to review the organisations management system at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the organisations strategy.

Required inputs into management review:

Management review is required to be planned and take into consideration:

1. Previous management reviews action plans,
2. Any changes in external and internal issues (organisational context) that are relevant to the quality management system,
3. The adequacy of resources,
4. Effectiveness of actions taken to address risks and opportunities,
5. Any opportunities for improvement,

6. Data on the performance and effectiveness of the management system, including trends in:

   • Customer satisfaction and feedback from relevant interested parties (stakeholders),
   • The extent to which quality objectives have been met,
   • Process performance and conformity of products and services,
   • Nonconformities and corrective actions,
   • The results of monitoring and measurement,
   • Results of audits,
   • External providers (Suppliers / subcontractors) performance.

Outputs of management review:

Outputs must include decisions and actions related to:

1. Any opportunities for improvement,
2. Any changes required to the management system,
3. Resource requirements, Documented information (records) are required to be retained as evidence of the results of management reviews.

Comment:

Note the specific need for visible alignment between the management system and organisations strategic objectives and also any changes in organisational context (See article 4.1) relevant to the organisations management system. Lastly, the effectiveness of actions taken to address any risks and/or opportunities. Although the organisations Quality Policy is not specifically referred to this may be affected by these changes and hence would require a review and update as necessary under any changes in organisational context. (I therefore always recommend that it also be included in the Management Review agenda.)

Execution

Historically, some ISO 9001 “compliant” organisations addressed management review as a “tick the box” exercise and carried out reviews once a year in order to meet the minimum requirements of the standard. IE: The ISO 9001 compliant Management System was treated as a bolt on to normal operations. A common symptom of this lack of integration was a list of Management Review action items still outstanding at the next meeting…

Much more added value can be gained of course, if the process is integrated into normal operational and strategic business processes. Many organisations already analyse, evaluate, share and act on operational and strategic level data, on a planned and regular basis. If this is the case, better then to integrate the requirements of the standard into the normal business processes rather than hold a separate (and possibly duplicated) review.

Possible Inputs Examples

1. Previous management reviews action plans. Follow up plans derived from previous reviews may include actions to address opportunities to improve products / services, processes and the management system, but also investigations and resultant actions relating to business metrics / Key Performance Indicators not operating at planned levels.
2. Any changes in external and internal issues (Organisational Context.) Examples may include: Entering into new markets, regions or dealing with new customers. Introduction of revised product ranges / services. Introducing, modifying or outsourcing processes. Changes in regulations, legislation or customers specific requirements. A global Pandemic…
3. The adequacy of resources. Reviews of resources may include:
   Human. Training, recruitment, secondment or changes in organisational structure. Other. Purchase / replacement / refurbishment of plant, tooling, equipment and fixtures. Improvements in infrastructure and environmental conditions. (See also article 7.1 to 4.)
4. Effectiveness of actions taken to address risks and opportunities. See article 6.1 for a detailed analysis.
5. Any opportunities for improvement. Any Key Performance Indicators or Business Metrics not operating at required levels are typical key inputs, however organisations should not limit the scope to metrics alone as any aspect of the management system may present an opportunity to improve.
   (See also articles 9.1.1, 9.1.2 & 9.1.3 on monitoring, measurement, analysis and evaluation, 9.2 on Audits and 10.1,10.3 on Improvement.)
6. Management system data and trends. The revised input list is self-explanatory. Note however the specific reference to trend analysis which requires current and historical data in order to make decisions and actions based on both positive and negative trends.

Audit Check:

Auditors will expect to see reviews carried out at planned intervals with appropriate Inputs, analysis, and outputs including effective execution of planned actions.

Checks may also be carried out to verify that planned reviews ensure management system alignment with the organisation’s strategic goals. Organisational context and actions to address risks, will also be expected to be demonstrable as Management Review inputs.

Depth of content, appropriately planned frequency, timeliness of execution (no recurring late meetings), appropriate attendance and outcomes acted upon are all indicators of Top Management taking ownership of the Quality Management System. This may be established via the (required) records of management reviews, or during interviews with top management.