Quality Assurance Manual

The Quality Assurance Manual (QAM) describes the procedures that are followed to monitor the quality of work. Routine methods are documented in organizations Standard Operating Procedures (SOP). SOP’s are reviewed annually and revised periodically as needed; revision dates and summary of changes are documented in the preface to each SOP. The date revised and approved is also documented in the preface. Original copies and computer files are kept in a secure place. Copies are controlled and kept in each staff member’s Training Manual.

The ISO 9000 Standards require that organizations have a Quality Assurance Manual, quality procedures, and quality records. The Quality Assurance Manual describes organizational structure, its approach to meeting customer needs, its documentation structure, and the policy and responsibility of management for meeting the requirements of the various clauses of the standard. Just like Quality Assurance Manual, quality procedures describe the steps each person, team or division must follow to meet the policies described in the Quality Assurance Manual. Procedures specify who does what, when it is done, and what documentation is used or produced as a result of the activity.

After understanding Quality Assurance Manual and quality procedures, there is third document called Quality Work Instructions. Quality Work Instructions differ from procedures in that they cover the instructions for tasks specified in the procedures. Work instructions can be detailed instructions in the form of written statements, diagrams, or checklists. Quality Records provide evidence that the required product or service quality was achieved or that organizations quality system was implemented correctly.

Now a very important question: How will the New Documentation System affect my job and me? How much the implementation of ISO 9000 affects you really depends on your job. You may be asked to do new things, such as helping to define and document the proper Quality Assurance Manual, quality procedures and work instructions; or, to make sure that the existing documentation system is up to date. If your job is completely documented, your job may not be affected much at all. Some of the roles that almost every employee can expect to take on as part of ISO 9000 implementation are:

·         Be familiar with organizations Quality Policy;

·         Be familiar with the Quality Assurance Manual;

·         Be familiar with your role in organizations structure and your responsibilities;

·         Be familiar with the documentation that affects you;

·         Consistently adhere to the quality system documentation once it is approved and implemented;

·         Maintain complete and accurate records when necessary;

·         Educated and guide new employees to use the ISO 9000 system;

·         Identify ways to improve organizations Quality System;

There is other system based on the ISO 10013:1995 quality standard published by the International Organization for Standardization. It presents a comprehensive interpretation of this standard using language that is clear and easy to understand. If you need to develop a manual for an ISO 9001:2000 Quality Management System, study Section 4.2.2 of ISO 9001:2000. While ISO 10013 certainly does talk about how to develop a Quality Assurance Manual, much of the advice it contains is obsolete! It has been replaced by Section 4.2.2 of ISO 9001:2000.