ISO

ISO 9001:2000
9001:2000
Documentation
Documentation
Requirements
Requirements
Based on ISO/TC 176/SC 2
March 2001

ISO 9001:2000
 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 organization’s 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 organization’s
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 organization’s 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:
• Organization’s size
• Organization’s complexity
• Organization’s 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)
• Results of calibration (7.6)
• To demonstrate process
• Internal audits (8.2.2)
validity where output • Release of product (8.2.2)
cannot be measured • Nonconforming product (8.3)
(7.5.2d) • Results of corrective action
• The unique identification (8.5.2)
of a product (7.5.3) • Results of preventive action
• Customer property (7.5.4) (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
 Bibliography
• Guidance on the Documentation
Requirements of ISO 9001:2000
ISO/TC 176/SC 2/N525R
March 2001
• Quality Management Systems –
Requirements
ISO/FDIS 9001