Quality
Manuals
The ISO 9000
Standards require that organizations have Quality Manuals, quality
procedures, and quality records. The Quality Manuals describe
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 Manuals, quality procedures describe
the steps each person, team or division must follow to meet the
policies described in the quality 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 Manuals 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 Manuals,
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 Manuals;
·
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 Manual, much of the advice it contains is obsolete! It has
been replaced by Section 4.2.2 of ISO
9001:2000.
Document your
quality system:
·
Document your quality system. Consider using
the following document hierarchy:
·
Level A: Quality
Manuals
·
Level B: Quality Procedures
·
Level C: Detailed Quality
Documents
