Section 5.6 Management Review

Section 5.6 Management review

The QMS shall be regularly reviewed to ensure its continued suitability, effectiveness and adequacy

Opportunities for improvement shall be assessed and records of all reviews shall be maintained.

Proof How Top Management reviews the QMS.

Likely documentation Procedures concerning:

 Process and product performance;

 Audits of process, product and service;

 Customer feedback;

 Corrective and preventive actions;

 Supplier performance;

 Record keeping.

Although, when first written, an organisation’s QMS is assumed to cover all eventualities, doubtless there are parts of the system that will need further definition.

ISO 9001:2008 has recognised this possibility and has made it a mandatory requirement for Top Management to complete a review of their organisation’s QMS (for continued suitability and effectiveness) on a bi-annual basis. Records of these reviews should be retained and details of all actions agreed, allocated and minuted.

The objective of these management reviews is to establish that the QMS:

 Is achieving the expected results;

 Meets the organisation’s requirements;

 Conforms to the requirements of ISO 9001:2008;

 Continues to satisfy the customers’ needs and expectations;

 Is functioning in accordance with the established operating procedures;

 Is capable of identifying irregularities, defects and/or weaknesses in the system (and to evaluate possible improvements).

During the review, management will also review:

 The effectiveness of previous corrective actions;

 The adequacy and suitability of the QMS for current and future operations of the organisation;

 Any complaints received, identify the cause and recommend corrective action if required;

 Previous internal and external audits and identify any areas of recurring problems or potential improvements;

 Reports of non-conforming items and trend information to identify possible improvements.

5.5.6.1 Evaluation and Auditing

When evaluating a QMS, there are four basic questions that should be asked in relation to every process being evaluated.

 Is the process identified and appropriately described?

 Are responsibilities assigned?

 Are the procedures implemented and maintained?

 Is the process effective in providing the required results?

There are three basic types of audit to choose from:

 First-party audits – conducted by, or on behalf of, the organisation itself for internal purposes and which can form the basis for an organisation’s self-declaration of conformity.

 Second-party audits – conducted by customers of the organisation or by other persons on behalf of the customer (i.e. an external audit).

 Third-party audits – conducted by external independent audit service organi-sations. Such organisations, usually accredited, provide certification or regis-tration of conformity with requirements such as those of ISO 9001:2008.

5.5.6.2 Section 5.6.1 General

Section 5.6.1 General

Top Management shall review the organisation’s QMS, at planned intervals, to evaluate the:

 Need for changes;

 Effectiveness of the organisation’s quality policies;

 Effectiveness of the organisation’s quality objectives.

Proof How Top Management reviews the QMS to ensure its continued suitability, adequacy and effectiveness, in the context of an organisation’s strategic planning cycle.

Likely documentation  Management review;

 QMS audit procedures.

Management needs to establish a process for periodically reviewing the organisation’s QMS to ensure that it continues to meet the requirements of ISO 9001:2008, agrees with the organisation’s policies and objectives and continues to provide customer satisfaction. Current performance, client feedback and opportunities for improvement all need to be evaluated and possible alterations have to be made to the relevant quality documentation analysed.

It is essential that records are retained of all these management reviews and that any change that might have an effect on existing work practices is sub-jected to a change control procedure.

5.5.6.3 Section 5.6.2 Review Input

Section 5.6.2 Review input

The input to management reviews shall include results from:

 Earlier management reviews (e.g. follow-up actions);

 Previous internal, third-party and external audits;

 Customer feedback;

 Process performance;

 Product conformance;

 Preventive and corrective actions;

 Changes that could affect the QMS and recommendations for improvement.

Proof How a Top Management review of the QMS is completed.

Likely documentation  Results of audits, customer feedback, analysis of product conformance with process and procedural rules, correc-tive and prevencorrec-tive action reports and supplier perfor-mance records.

For completeness, inputs to management reviews should include everything concerned with the performance, conformance and improvement of the product. The review body should evaluate new technologies, statutory condi-tions, regulatory changes and environmental conditions for their affect on their product. Inputs would include, but are not restricted to:

 Results from previous internal, customer and third-party audits;

 Analysis of customer feedback;

 Analysis of process performance;

 Analysis of product conformance;

 The current status of corrective and preventive actions;

 The results of self-assessment of the organisation;

 Supplier performance.

5.5.6.4 Section 5.6.3 Review Output

Section 5.6.3 Review output

Management reviews shall be aimed at:

 Improving the organisation’s overall QMS and its processes;

 Improving the product;

 Enhancing customer satisfaction;

 Confirming the resources required.

Proof How the results of management reviews of the QMS are documented.

Likely documentation  Minutes of the meetings where the overall running of the company is discussed.

The aim of completing management reviews is to provide a continuing record of the organisation’s capability to produce quality products that meet the quality objectives, policies and requirements (contained in their QMS) and which continue to provide customer satisfaction.

Review output should be centred on:

 Improved product and process performance;

 Conformation of resource requirements and organisational structure;

 Meeting market needs;

 Risk management;

 Change control;

 Continued compliance with relevant statutory and regulatory requirements.

The actual management review process should also be evaluated to confirm its continued effectiveness, and a complete record of all reviews must be retained for future use.