ISO 9001 quality system under section 4.2

ISO 9001, section 4.2 provides that the “supplier shall create, document and keeps quality system which means of confirming that the product meets to particular needs. It can be seen that this documentation consists of several tiers of documents, each successive tier becoming more detailed. At the apex is the quality manual, this briefly describes all the elements of a quality system that the enterprise requires to meet the quality requirements stipulated or implied by the customer. ISO 9001 quality system contains some specified needs of their procedures.

The manual is supported by several other documents describing standardized procedures for all departmental activities with a bearing on product quality. Guidance at the working level is provided by detailed plans and work instructions. These include standard forms or check sheets in which the results of activities are recorded to provide objective evidence of quality control and which serve as a base for analysis and corrective action where required.

The quality manual

Why a quality is manual required?

• The quality manual is the main document describing the organizations quality system. It is used for the following purposes:
• To communicate the company’s quality policy and procedures to staff, suppliers and customers.
• To serve as the authorized standard of reference for implementing the quality system.
• To define the organizational structure and responsibilities of various functional groups as well as to delineate horizontal and vertical channels of communication on all matters relating to quality ISO certification.
• To project a favorable quality image of the company among customers and to meet contractual needs where specified.
• To serve as a basis for quality audits.

Preparation

The quality manual should be prepared with the utmost care and should cover all groups and persons directly concerned with quality-related activities. In an attempt to expedite the implementation of quality systems, companies may be tempted to use the quality manual of another company with a reputation for quality. No two companies are alike even when they manufacture the same product.

Structure

The main components of a quality manual are described below:

The title, scope, and introduction

 The introductory pages of the manual would normally include the title of the manual, its scope, a table of contents, and a brief introduction to the company.

Quality policy and organization.

This part of the quality manual should cover the quality policy of the company and its organizational structure, showing the responsibilities and the authority of various functional groups as explained in the previous chapter.

This is the principal part of the quality manual. It describes the elements of the ISO 9000 quality system which are applicable to the company. It also provides references to the detailed procedures and instructions for the quality-related activities carried out by different departments. It is usual to have separate sections or chapters are addressing the needs of each of the applicable sub-clauses under clause 4 of ISO 9001, ISO 9002 or ISO 9003.

As the ISO 9000 standard does not specify any format the manual, each organization is free to devise its own format. A section of a typical quality manual for manufacturing enterprises is provided in Annex I to this chapter. For further guidance of the preparation of the quality manual, the reader is referred to ISO 10013.

Distribution

Copies of the complete quality manual or the appropriate section of the manual should be manual should be distributed to all departments and functional groups who need to use them. The quality manual should be controlled document and all copies should be serially numbered and a proper record of recipients should be maintained. Certain copies of the quality manual may be required for the issue to customers and other organizations for general information, for which future control of the currency of the documents is not necessary ISO certification. Such copies should be clearly marked “uncontrolled copy. Will not be updated” or with some other suitable indication which shows that particular copy of the manual is not the final version and should not be used for contractual or other similar purposes.

Incorporating changes

Any document is subject to change for different reasons. A method of controlling and incorporating changes should be provided. This task should be assigned to an appropriate document control function.

Quality system procedures

The standard requires the preparation of documented procedures consistent with the requirements of the quality system. In the 1994 version of the ISO 9000 standards, procedures and work instructions have been merged and all are now termed “procedures”. There is no basic difference between procedures and work instructions, except that work instructions are operating instructions for performing specific jobs and give detailed guidance on how a job is to be carried out and what standard or quality level is to be achieved.

In manufacturing enterprises, all departments or functional groups engaged in activities affecting the quality of the end-product tent to carry out certain tasks according to established practices or traditions. The activities may be of a widely varying nature such as receipt and confirmation of an order from customers, verification of purchased material, assembly of mechanical devices, assessment of a manufacturing document or issue of tools and gauges. The ISO certification is mandatory for all industries who can market their product. The standard procedure for each type of activity needs to be documented in the departmental procedures manual. Documented procedures help in the effective implementation of quality because of they:

• Cause people to work in a uniform way, minimize variability and make processes predictable.
• Reduce reliance on particular persons for carrying out important operations.
• Make responsibilities clear and create conditions of internal control.

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