9001:2008 Quality Management Systems - Contents of ISO 9001
has ISO 9001:2008 in all of our manufacturing plants in
China and Taiwan. The ISO 9000 family of standards relate
to quality management systems and are designed to help
organizations ensure they meet the needs of customers.
The standards are published by ISO, the International
Organization for Standardization and available through
National standards bodies. Xmultiple
ISO 9001:2008 Certificate
fo ISO 9001:2008
I: The pyramid is topped by the single, overarching
Quality Manual and Quality Policy that guides the
organization in all decisions.
Level II: The Quality Manual defines
general guidelines for completing particular tasks
and Documented Procedures.
Level III: Work Instructions define
precisely how to complete a specific task.
Level IV: Records and forms are the
base of the Quality Management System showing compliance
to the International standard and Customer specification.
ISO 9001:2008 Quality management systems ¡X Requirements
is a document of approximately 30 pages which is available
from the national standards organization in each country.
Outline contents are as follows:.
Page IV: Foreword
Pages V to VII: Section 0- Intro
Pages 1 to 14: Requirements
Section 1: Scope
Section 2: Normative Reference
Section 3: Terms and definitions (specific to ISO
9001, not specified in ISO 9000)
Section 4: Quality Management System, The general
requirements for a quality management system are defined
in clause 4.1 of ISO9001:2008.
Section 5: Management Responsibility
Section 6: Resource Management
Section 7: Product Realization
Section 8: Measurement, analysis and improvement
In effect, users need to address all sections 1 to
8, but only 4 to 8 need implementing within a QMS.
Pages 15 to 22: Tables of Correspondence between ISO
9001 and other standards
Page 23: Bibliography
standard specifies six compulsory documents:
Control of Documents (4.2.3)
Control of Records (4.2.4)
Internal Audits (8.2.2)
Control of Nonconforming Product / Service (8.3)
Corrective Action (8.5.2)
Preventive Action (8.5.3)
In addition to these, ISO 9001:2008 requires a quality
policy and Quality Manual (which may or may not include
the above documents).
types of auditing are required to become registered
to the standard: auditing by an external certification
body (external audit) and audits by internal staff
trained for this process (internal audits). The aim
is a continual process of review and assessment, to
verify that the system is working as it's supposed
to, find out where it can improve and to correct or
prevent problems identified.