| INTRODUCTION | |
| 1 | SCOPE |
| 2 | REFERENCES |
| 3 | TERMS & DEFINITIONS |
The
introduction page of the quality manual (QM) shall introduce the reader to the organization and
provide evidence of its commitment towards QMS. Introduction may contain brief
description of the following:
·
Introduction to the organization
·
Site Address and Contact Details
·
Licenses and Approvals
·
Company Products and Services
·
Legal and Regulatory Obligations
(product, process, environment etc)
·
Why QMS is adopted by the organization,
Organizations Mission and Vision
·
Purpose of Quality manual and its
section wise makeup
·
Responsibilities: For implementation of
QMS, Review of Quality Policy, Review of Quality Objectives, review of Quality
Manual.
Scope and Exclusions
First define the scope of QMS and then give exclusions along with
justification.
Scope:
Exclusion:
Clause:
Justification:
ISO 9001:2008 standard states following requirements for Scope
and Exclusion-
ISO
9001:2008, 1.2 Application, Para 2 & 3:
Where
any requirement(s) of this International Standard cannot be applied due to
the nature of an organization and its product, this can be considered
for exclusion.
Where
exclusions are made, claims of conformity to this International Standard are
not acceptable unless these exclusions are limited to requirements
within Clause 7, and such exclusions do not affect the
organization's ability, or responsibility, to provide product that meets
customer and applicable statutory and regulatory requirements.
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),
This
means, exclusions form the ISO 9001:2008 standard are acceptable however,
these exclusions shall be limited to clause 7 (Product Realization). Entire
clause or a sub clauses can be exempted if proper justification for exclusion
is provided.
The
scope of Quality Manual shall include all the processes which are covered
under QMS. Statement of scope should be relevant, complete in all sense,
clear & unambiguous and precise. For certification purpose the
organization is audited for the processes defined in a scope.
|
References
Documents,
guidelines, regulations etc., which are referred during implementation of the
QMS and preparation of QM, shall be enlisted in this column. These can be
divided into two sub groups:
Regulatory
Requirements (if not given in introduction sub section Legal and
Regulatory Obligations)
Standards
and guidelines
Terms and Definition
Explanation of terms and
definitions used in the Quality Manual are given in this section. Standard
vocabulary terms and definitions are available in ISO 9000:2005.
References:
ISO 9001:2008 Quality
management systems — Requirements
ISO 9004:2009 Managing for the
sustained success of an organization- A quality management approach
ISO 9000:2005 Quality management
system: Fundamentals and Vocabulary
