Quality Manual

Quality Manual is Level I document in a documentation system. The extent of documentation in any organization depends upon customer requirement, nature of the organization, its size and organizational structure, nature of product/ services provided, processes employed, statutory and regulatory requirements etc. The six mandatory procedures required by the standard may be part of the quality manual or may have a separate entity. 

These procedures are:

4.2.3- Control of Documents

4.2.4- Control of Records

8.2.2- Internal Audit

8.3-    Control of Non Conforming Product

8.5.2- Corrective Action

8.5.3- Preventive action

Based on the organization structure Quality Manual may be the only document providing details of the processes, there interaction and six mandatory quality procedures.

In the Quality Manual template, introduction and principle of the above procedures is given. These procedures are discussed in details later.

Quality policy and quality objectives are the part of quality manual. The requirements of quality manual, quality policy and quality objective are as follows:

ISO 9001:2008

4.2.2 Quality manual The organization shall establish and maintain a quality manual that includes            a)    the scope of the quality management system, including details of and justification for any exclusions (see 1.2), b)   the documented procedures established for the quality management system, or reference to them, and c)    a description of the interaction between the processes of the quality management system.

5.3 Quality policy Top management shall ensure that the quality policy a)    is appropriate to the purpose of the organization, b)   includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system, c)    provides a framework for establishing and reviewing quality objectives,      d)   is communicated and understood within the organization, and e)    is reviewed for continuing suitability.

5.4.1 Quality objectives Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy.

Preparation of Quality Manual and implementation ensures establishment of QMS as the requirements of QMS are committed in a quality manual. This is the first document requested for review by any QMS auditor during audit.

The standard promotes process based approach to Quality Management System.

The process is defined in ISO 9000:2005 as, 'set of interrelated or interacting activities which transforms input into outputs'.

Following are the requirements of the QMS as per ISO 900:2008.

The organization shall a)    determine the processes needed for the quality management system and their application throughout the organization (see 1.2), b)   determine the sequence and interaction of these processes, c)    determine criteria and methods needed to ensure that both the operation and control of these processes are effective, d)   ensure the availability of resources and information necessary to support the operation and monitoring of these processes, e)    monitor, measure where applicable, and analyse these processes, and   f)     implement actions necessary to achieve planned results and continual improvement of these processes. These processes shall be managed by the organization in accordance with the requirements of this International Standard.