Quality Manual

The Quality Manual is a foundational document within an organization's Quality Management System (QMS), traditionally serving as the top-level document that outlines the system's structure and the organization's commitment to quality.

A Quality Manual is a document that provides a comprehensive overview of an organization's Quality Management System (QMS). It outlines the system's structure and scope, references relevant documents, and describes how the organization commits to quality and meets the requirements of a chosen quality standard, such as ISO 9001.

In the traditional QMS documentation hierarchy, the Quality Manual is positioned directly beneath the Quality Policy.

Teaching You About the Quality Manual

The status and mandatory nature of the Quality Manual have evolved with international standards, particularly with the transition to ISO 9001:2015.

Traditional Role and Structure

Historically, and in many practical implementations, the Quality Manual is the cornerstone document of the QMS.

Top-Level Documentation: The Quality Manual is the second-highest level in the traditional QMS documentation hierarchy, sitting beneath the Quality Policy. It is a top-level document that contains the most fundamental policies and procedures for the organization.

Content: The Quality Manual provides information about the organization’s commitment to quality. It typically includes, or refers to, the following elements:

Quality Policy and Objectives: The Quality Policy and objectives can be part of the manual. The Quality Policy is the overall intentions and direction of the organization with respect to quality, as established by management with executive responsibility.

QMS Scope and Description: It outlines the structure of the QMS, references to relevant documents, the business process model of the organization, and the QMS scope.

Responsibilities: It defines the responsibilities for all personnel involved.

Exclusions: It lists any exclusions from the standard.

Flexibility: The structure and content of the Quality Manual can vary based on the size and complexity of the organization and the competence of its personnel. For example, a small organization might document the entire QMS in a single manual.

Reference Document: The Quality Manual often refers to lower-level documentation, such as departmental procedures and engineering standards, which provide detailed working instructions.

Status under ISO 9001:2015 and QMSR

The necessity of a formal, standalone Quality Manual has changed under the current version of the ISO 9001 standard.

No Longer Mandatory (ISO 9001:2015): The ISO 9001:2015 standard no longer requires compliant organizations to issue a formal Quality Manual. It is considered one of the less prescriptive requirements for documentation.

Continued Use: Despite not being mandatory, many companies still choose to create a Quality Manual, often in response to a customer requirement or as a way to compile the mandatory core QMS documents (Scope, Quality Policy, Quality Objectives, and supplier selection criteria) into one document.

Documentation Structure: The ISO 9001 standard allows flexibility; some small companies may integrate their procedures and work instructions within a Quality Manual.

QMSR Context: The new Quality Management System Regulation (QMSR), which incorporates ISO 13485:2016 by reference, does not explicitly mandate a Quality Manual, but ISO 13485 requires the scope of the QMS to be documented, a requirement often satisfied by the Quality Manual, according to the EU MDR.

Management and Control

The Quality Manual, along with other QMS documents, must be managed under strict control procedures.

Controlled Document: The Quality Manual must be considered a controlled document. This means the issuer automatically updates it, is not given to anyone at any time, and cannot be revised or removed at random. The QMS cannot succeed if its controlled documentation is not followed.

Accessibility and Communication: The Quality Manual needs to be readily available to all levels of management in the organization. This allows management to verify that their lower-level procedures align with the overall organization’s policy and objectives.

Document Control System: The control system must ensure that the proper documentation, at the proper revision level, is available to the proper members of the organization. Obsolete documents should be removed or otherwise prevented from unintended use.

Analogy for Understanding the Quality Manual

If the Quality Policy is the organization's motto or constitutional statement (e.g., "We will build the safest cars"), the Quality Manual is the Pledge of Allegiance and the Table of Contents of the entire legislative code. It doesn't contain the thousands of detailed laws (procedures and work instructions), but it clearly defines the organization's governing structure, states the high-level commitment to quality, outlines what areas are covered by the system (scope), and directs personnel to the precise sections of the procedural laws where specific compliance requirements can be found. It is the high-level roadmap to the entire QMS library.

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