Documenting the Quality Management System

Section 4.2.1 of ISO 9001:2008 states that documentation of the quality management system includes:

1. Documented quality policy;
2. Documented quality objectives;
3. Quality manual;
4. Implementing procedures required by the standard; and
5. Implementing procedures/instructions required by the organization.

Quality Policy and Objectives

ISO 9000:2000 defines the quality policy as "the overall intention and direction of the organization, related to quality, as formally expressed by top management". Section 5.3 of ISO 9001:2008 states that the policy must:

1. Be appropriate to the organization;
2. Include a commitment to meet requirements and continually improve the quality management system;
3. Provide a framework to establish quality objectives;
4. Be communicated and understood within the organization; and
5. Be reviewed for continuing suitability.

Do you make heart valves or axles for little red wagons? Do you sell to a local market or globally? Do you have a large or small organization? Avoid terms like "world class" unless you really intend to measure where you stand in the world. Customer requirements are not the only requirements. There are customer requirements, contract requirements, regulatory requirements, and requirements established internally to permit processing. A simple policy meeting the requirements could be:

"ABC Company is committed to meet all requirements necessary to provide complete internal and external customer satisfaction through continual improvement of the quality management system".

Quality objectives are sought with relation to quality and measure how well the organization is meeting the quality policy. Some examples with regard to the policy above might be:

1. On time delivery
2. Product conformance
3. Conformance to FDA regulations
4. Continual improvement

Quality System Manual

There are many reasons to have a quality manual. A fundamental reason is that it communicates your company's quality policy, procedures, and requirements. If you are planning on registration to a quality management system standard such as ISO 9001:2008, a quality manual is required. A quality manual may also be needed to show compliance with quality requirements in contractual situations, so even if your company is not planning for registration a potential customer may ask for your quality system manual. It is not possible to fully implement ISO 9001:2008 without an understanding of the ISO 9000:2000 standard, which although a separate standard, is referenced in ISO 9001:2008 and the terms and definitions of ISO 9000:2000 apply as requirements in ISO 9001:2008. The way a term is defined can actually create or define requirements.
ISO 9000:2000 provides the following definitions:

1. Quality management system - management system to direct and control an organization with regard to quality.
2. Quality manual - a document specifying the quality management system of an organization.
3. Specification - document stating requirements.

If these are combined, the definition of a quality manual could be: "A document stating the requirements for a management system used to direct or control an organization with regard to quality of product or service". The quality manual is used as a tool by top management to define the requirements the various groups within the organization must meet when developing the management system. The quality manual is implemented, not the ISO 9001:2008. Audit of the system is to first evaluate if the quality manual addresses all of the requirements of the standard and then evaluate if the quality manual is implemented. The quality manual includes:

1. Scope and exclusions for the quality management system,
2. Reference to implementing procedures or the procedures themselves,
3. And a description of the interaction between the processes of the quality management system.

There are many different methods used to write a quality system manual; some are very original. Many manuals seem to be based on being paid by the word or by the hour and others by how difficult it is to understand.
There is no required format for a quality system manual, although there is a standard that provides guidelines, Guidelines for quality manuals, ISO 10013 - 1995. The manual is not written for the convenience of an auditor, but if a well qualified auditor can't understand the manual, how can anyone else? The numbering system in the manual is not required to follow the same numbering system as the standard, but it does make it easier to evaluate if they are the same. With this in mind the following is recommended:

• Section I - Introduction to company: history, location, products, etc.
• Section II - Scope and Exclusions
• Section III - Quality Policy and objectives. (Section 5.3 of the manual defines the requirements for creating and controlling the policy, not the actual policy).
• Section IV - Start here following the same numbering system as the standard.

Required Procedures and Instructions

A process is a series of activities necessary to converts inputs to outputs. The processes necessary to implement the quality manual must be defined, but not necessarily documented except for the following 6 processes:

1. Control of Documents
2. Control of Records
3. Control of Non-conforming product
4. Internal Audit
5. Corrective Action
6. Preventive Action

If a procedure is written to implement a specific requirement is should be referenced at the end of the section defining the requirement. It can be included instead, but unless it is a very simple system it should be separate. The manual is usually reviewed and approved at the top management level. Lower level procedures are reviewed and approved at an appropriate level. It is best if they are not mixed. The manual provides clear requirements for the quality management system and links to the next level.