ISO 9001:2000
Documentation Requirements
Based on ISO/TC 176/SC 2
March 2001
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Two of the Most Important Objectives
in the Revision of the ISO 9000Standard
• 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
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ISO 9001:2000
• Significantly reduces documentation
requirements
• Is much less prescriptive
• Allows more flexibility in choice of
documentation system
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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
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What Is a Document?
• Communication of information
• Evidence of conformity
• Knowledge sharing
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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
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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.
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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.
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Document Mediums
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Paper
Magnetic
Electronic
Photographic
Master Sample
Other
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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
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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
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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
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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
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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
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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
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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)
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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)
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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
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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
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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
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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
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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)
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Required Records (2 of 2)
• Basis for calibration of
measuring equipment
(7.6a)
• Results of calibration (7.6)
• Internal audits (8.2.2)
• Release of product (8.2.2)
• Nonconforming product
(8.3)
• Results of corrective
action (8.5.2)
• Results of preventive
action (8.5.3)
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• Results of supplier
evaluations (7.4.1)
• To demonstrate process
validity where output
cannot be measured
(7.5.2d)
• The unique identification
of a product (7.5.3)
• Customer property (7.5.4)
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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
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Processes Include
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Management
Resources
Product realization
Measurement
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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
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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
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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
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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
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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
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Bibliography
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Guidance on the Documentation
Requirements of ISO 9001:2000
ISO/TC 176/SC 2/N525R
March 2001
Quality Management Systems –
Requirements
ISO/FDIS 9001
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