ISO 9001:2000

Documentation Requirements
Based on ISO/TC 176/SC 2 March 2001
Two of the Most Important Objectives
in the Revision of the ISO 9000-
Standard
To develop a simplified set of standards that
will be equally applicable to small as well
as medium and large organizations
For the amount and detail of documentation
required to be more relevant to the desired
results of the organizations process
activities
 ISO 9001:2000
Significantly reduces documentation
requirements
Is much less prescriptive
Allows more flexibility in choice of
documentation system
 ISO 9001:2000
Enables each organization to develop the
minimum amount of documentation needed
in order to demonstrate the effective
planning, operation and control of its
processes and the implementation and
continual improvement of the effectiveness
of its quality management system
 What Is a Document?

Communication of information
Evidence of conformity
Knowledge sharing
Communication of Information
The type and extent of the documentation
will depend on the nature of the
organizations products and processes
The degree of formality of communication
systems
The level of communication skills
The organizational structure
 Evidence of Conformity
Provision of evidence that what was
planned has actually been done.
Say what you do, do what you say and
prove it.
 Knowledge Sharing
In order to disseminate and preserve the
organizations experiences.
Example: a technical specification, which
can be used as a base for design and
development of a new product.
 Document Mediums
Paper
Magnetic
Electronic
Photographic
Master Sample
Other
 Clause 4.1, General
Requirements
Documented statements of quality policy and
quality objectives
A quality manual
Documented procedures required by the
international standard
Documents needed by the organization to ensure
effective planning, operation and control of its
processes
Records required by the international standard
 Documented Statements of
Quality Policy (1 of 2)
Defined in Clause 5.3
Appropriate to the purpose of the organization
Includes a commitment to comply with
requirements and continually improve the
effectiveness of the Quality Management
System
A framework for establishing and quality
objectives
 Documented Statements of
Quality Policy (2 of 2)
Defined in Clause 5.3
Is communicated and understood within the
organization
Is reviewed for continuing suitability
 Documented Statements of
Quality Objectives
Defined in Clause 5.4.1
Includes those needed to meet requirements
for product [Clause 7.1]
Are established at relevant functions and
levels within the organization
Are measurable and consistent with Quality
Policy
 Quality Manual
Minimum content specified in Clause 4.2.2
Scope of the Quality Management System,
including details of and justification for any
exclusions
Documented procedures established for the
QMS, or references to them
Description of the interaction between
processes of the QMS
 Quality Manual-Structure
Structure of the manual is a decision for the
organization based on:
Organizations size
Organizations complexity
Organizations culture

Controlled in accordance with the requirements

of Clause 4.2.3
 Documented Procedures
Required by ISO 9001:2000
Control of documents (Clause 4.2.3)
Control of records (Clause 4.2.4)
Internal Audit (Clause 8.2.2)
Control of nonconforming product (Clause 8.3)
Corrective action (Clause 8.5.2)
Preventive Action (Clause 8.5.3)
 Documents Needed by the
Organization

Specifically referenced in ISO 9001:2000

Quality policy (Clause 4.2.1a)
Quality objectives (Clause 4.2.1a)
Quality Manual (Clause 4.2.1b)
 Additional Documentation

There are several requirements of ISO

9001:2000 where an organization could add
value to its Quality Management System
and demonstrate conformity by the
preparation of other documents
 Additional Documentation
Process maps, process flow charts,and/or process
descriptions
Organization charts
Specifications
Work and/or test instructions
Production schedules
Approved suppliers lists
Test and inspection plans
Quality plans
 Documented Procedures
Controlled in accordance with Clause 4.2.3
May combine the procedure for several
activities into one document
May require more than one document for a
single procedure
May require additional procedures in order
to implement an effective QMS
 Records
Requirements for control of records are different
from those for other documents
All records have to be controlled in accordance
with the requirements of Clause 4.2.4
Organization are free to develop records that may
be needed to demonstrate conformity of their
processes, products, and QMS
 Required Records (1 0f 2)
Management reviews
(5.6.1)
Education, training, skills
and experience (6.2.2e)
Evidence that the
realization processes and
resulting product fulfill
requirements (7.1d)
Design and development
inputs (7.3.2)
Results of design and
development reviews
(7.3.4)
Results of design and
development verification
Results of design and
development validation
Results of review of
design and development
changes (7.3.7)
 Required Records (2 of 2)
Results of supplier Basis for calibration of
evaluations (7.4.1) measuring equipment (7.6a)
To demonstrate process Results of calibration (7.6)
validity where output Internal audits (8.2.2)
cannot be measured Release of product (8.2.2)
(7.5.2d) Nonconforming product
(8.3)
The unique identification
Results of corrective action
of a product (7.5.3) (8.5.2)
Customer property (7.5.4) Results of preventive action
(8.5.3)
 Preparing to Implement a QMS
Process approach
Identify the processes necessary for
effective implementation
Understand interactions between these
processes
Document the processes to assure
effective operation and control
 Processes Include

Management
Resources
Product realization
Measurement
 Process Analysis
Should be driving force for defining
amount of documentation, taking into
account the requirements of ISO
9001:2000
Should not be the documentation that
drives the processes
Demonstrating Conformity With
ISO 9001:2000
May not need extensive documentation
Must be able to provide objective evidence
of effectiveness of processes and quality
management system
 Objective Evidence
Data supporting the existence or verity of
something (Clause 3.8.1 of ISO 9000:2000)
May be obtained through observation,
measurement, test or other means
Does not necessarily depend on
documented procedures, records or other
documents except where specifically
required by ISO 9001:2000
 Objective Evidence
Where the organization has no specific
procedure for a particular activity, and this
is not required by specification, it is
acceptable for this activity to be conducted
using as a basis the relevant clause of ISO
9001:2000
Example: Internal and external audits
 Terms and Definitions
Document - information and its supporting medium (ISO
9000:2000 Clause 3.7.2)
Procedure Specified way to carry out an activity (3.7.4)
Quality Manual Document specifying the quality
management system of an organization
Quality Plan document specifying which procedures and
associated resources shall be applied, by whom and when
to a specific project (3.7.5)
Record document stating results achieved or providing
evidence of activities performed (3.7.6)
Specification document stating requirements