4.2.2 The Quality Manual

4.2.2 The Quality Manual

Establishing rules for the quality management system

by scott dawson

DEFINITION

A quality manual is a document stating the company management's intentions for operating the quality system. It includes policies for all areas of the business affecting or affected by the quality system. These policies authorize department managers to implement procedures within the boundaries specified in the quality manual. They also serve to provide a measure for procedures, processes and results.

REQUIREMENTS

The quality manual is a stated requirement of the ISO 9001 standard. Here is the relevant section:

4.2.2 Quality manual
The organization shall establish and maintain a quality manual that includes:

1. the scope of the quality management system, including details of, and justification for, any exclusions (see 1.2),
2. the documented procedures established for the quality management system, or reference to them, and
3. a description of the interaction between the processes of the quality management system.

One thing to note about this requirement is that no guidelines are given regarding the format or organization of the manual. These decisions are left to the company to determine how to structure the document to best support its objectives.

In terms of contents, as a minimum, the quality manual must include the following:

1. The company's quality policy (showing the company's commitment to quality).
2. An explanation of the company's documentation structure.
3. Policy statements demonstrating management's intention to comply with ISO 9001 requirements (less any appropriate exclusions). The policies must cover all areas of the ISO standard and be traceable (reference) to them. These policies must include:
   • How management expects company operations to function.
   • Who is responsible to implement these expectations (by function or job title).
   • Where and when the policies are applicable within the organization.
   • What interdependencies exist between functions and processes.
4. Reference to the "second tier" operating procedures of the company.
5. Assignment of one or more "management representatives" for quality in the organization.
6. A description of the company's organization (usually in the form of an organization chart, top level of the company only).

NOTE 1: The quality manual would normally contain no proprietary/confidential information and is usually made available to customers and third party auditors.
NOTE 2: A clear distinction should be made between the contents of the quality manual and operating procedures. The quality manual defines what management's intentions for operation of the quality system while the operating procedures define how these intentions are implemented within the organization.

USES

The primary uses of the quality manual are:

1. To communicate management's expectations for quality to the organization.
2. To demonstrate the company's compliance with ISO 9001 requirements.
3. To serve as a measure for compliance to management's expectations for:
   • Internal audits
   • ISO Registrar audits
   • Customer audits

DEVELOPMENT

The development of the quality manual follows several steps:

1. List policies to be written (note any ISO 9001 requirements that do not apply).
2. List second tier operating procedures, cross-referenced to policies.
3. Draft policies based on ISO 9001 requirements.
4. Circulate for input from all departments.
5. Note quality system inadequacies identified.
6. Determine format and structure of the manual.
7. Publish first draft of manual.
8. Formal review, approval and release.

EXAMPLE

As an example of how the quality manual policies should reflect the requirements of ISO 9001 see the following:

ISO 9001 Requirement 5.6 Management review 5.6.1 General Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records from management reviews shall be maintained (see 4.2.4). 5.6.2 Review input The input to management review shall include information on a) results of audits, b) customer feedback, c) process performance and product conformity, d) status of preventive and corrective actions, e) follow-up actions from previous management reviews, f) changes that could affect the quality management system, and g) recommendations for improvement. 5.6.3 Review output The output from the management review shall include any decisions and actions related to a) improvement of the effectiveness of the quality management system and its processes, b) improvement of product related to customer requirements, and c) resource needs.

Sample quality manual policy X.X Management review X.X.1 General The management of XXX company reviews the company's quality system to ensure its continuing suitability, adequacy and effectiveness. The management review includes determining opportunities for improvement and the need for changes to the quality system, including the quality policy and quality objectives. The management review convenes on at least an annual basis. Records of the management reviews are maintained in accordance with the company's quality records policy (ref. xxx). X.X.2 Agenda and Minutes The agenda of the management review is as follows: a) results of internal and external audits b) customer feedback c) process and product quality results d) follow-up actions from previous management reviews e) organizational or business changes that could affect the quality system f) action items for improvement g) other business Minutes are kept as a record of the management reviews, to include at least: a) action items to improve the effectiveness of the quality system and processes b) action items to improve product quality c) resources needed to successfully implement above action items