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The importance of the document known as the Quality Manual cannot be underestimated. It contains the top management’s intentions for operating the quality system of the organisation. The Quality Manual encompasses policies concerning the quality system, including all areas affected by, or affecting, the mentioned quality system. Department managers within the organisation make use of the Quality Manual once procedures need to be implemented. Quality Manuals also provide a measure for procedures, processes, and results.

Requirements of a Quality Manual

The Quality Manual of an organisation should include the following:

  • The scope of the quality management system, including details of, and justification for, any exclusions;
  • The documented procedures established for the quality management system, or reference to them; and
  • A description of the interaction between the processes of the quality management system.

Quality Manual Format and Content

It should be noted that the format of the quality manual has no specific guidelines. It is left to your organisation to decide on the structure of the document to best support your organisation’s objectives.

Below is the content that makes up the Quality Manual:

  • The quality policy of the organisation;
  • An explanation concerning the documentation structure of the organisation;
  • Policy statements to demonstrate the intention of management to comply with ISO 9001 requirements. All areas of the ISO 9001 standard should be covered by these policy statements. It should thus include:

* How management is expecting company operations to function?

* Who is responsible for implementing these expectations?

* Where and when the policies are applicable within the organisation?

* What interdependencies exist between functions and processes?

  • Reference should be made to the company’s “second tier” operating procedures;
  • Management representatives should be assigned who are responsible for quality in the organisation; and
  • A description of the set-up of the organisation.

The quality manual does not contain any confidential/proprietary information and is therefore made available to third party auditors and customers.

You should ensure that a clear distinction is made between the contents of the quality manual and the operating procedures. The quality manual defines the intention of management for operation of the quality system, while the operating procedures define how these intentions are implemented within the organisation.

Primary Uses of the Quality Manual

The primary uses of the quality manual include:

  • Communicating management’s expectations for quality to the organisation;
  • Demonstrating the organisation’s compliance with ISO 9001 requirements; and
  • Serving as a measure for compliance to management’s expectations for:

* Customer Audits;

* Internal Audits;

* ISO Registrar Audits.

Development of the Quality Manual

Several steps are involved during the development stage of the Quality Manual:

  • Listing policies that are to be written;
  • Listing second-tier operating procedures that are cross-referenced to policies;
  • Drafting policies based on ISO 9001 requirements;
  • Input from all departments is necessary;
  • Identifying quality system inadequacies;
  • Determining the structure and the format of the of the manual;
  • Publishing the first draft of the manual; and
  • Formal review, approval, and release.
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