ISO 9001:2000 Documentation Requirements

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Transcript ISO 9001:2000 Documentation Requirements

ISO 9001:2000
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
• 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
• 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
• 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
Master Sample
Clause 4.1, General
• 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
Documented Statements
of Quality Policy (1 of 2)
Defined in Clause 5.3
• Appropriate to the purpose of the
• Includes a commitment to comply with
requirements and continually improve the
effectiveness of the Quality Management
• A framework for establishing and quality
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
• 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
• Corrective action (Clause 8.5.2)
• Preventive Action (Clause 8.5.3)
Documents Needed by the
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
• 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
• 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
• 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
• Education, training,
skills and experience
• Evidence that the
realization processes
and resulting product
fulfill requirements
• Design and
development inputs
• Results of design and
development reviews
• Results of design and
• Results of design and
development validation
• Results of review of
design and
development changes
Required Records (2 of 2)
• 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
• Basis for calibration of
measuring equipment
• Results of calibration
• Internal audits (8.2.2)
• Release of product
• Nonconforming product
• Results of corrective
action (8.5.2)
• Results of preventive
action (8.5.3)
Preparing to Implement a
Process approach
• Identify the processes necessary for
effective implementation
• Understand interactions between these
• Document the processes to assure
effective operation and control
Processes Include
Product realization
Process Analysis
• Should be driving force for defining
amount of documentation, taking into
account the requirements of ISO
• 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
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
• 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
• Record – document stating results achieved or
providing evidence of activities performed (3.7.6)
• Specification – document stating requirements
Guidance on the Documentation
Requirements of ISO 9001:2000
ISO/TC 176/SC 2/N525R
March 2001
Quality Management Systems –