ISO 9001:2000 Documentation Requirements

1
ISO 90012000Documentation Requirements

• Based on ISO/TC 176/SC 2
• March 2001

2
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

3
ISO 90012000

• Significantly reduces documentation requirements
• Is much less prescriptive
• Allows more flexibility in choice of
  documentation system

4
ISO 90012000

• 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

5
What Is a Document?

• Communication of information
• Evidence of conformity
• Knowledge sharing

6
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

7
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.

8
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.

9
Document Mediums

• 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

12
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

13
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

15
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

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Documented Procedures

• Required by ISO 90012000
• 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 90012000
• 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 90012000
  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

20
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

21
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)

• 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)

• 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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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

25
Processes Include

• 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 90012000
• Should not be the documentation that drives the
  processes

27
Demonstrating Conformity With ISO 90012000

• May not need extensive documentation
• Must be able to provide objective evidence of
  effectiveness of processes and quality management
  system

28
Objective Evidence

• Data supporting the existence or verity of
  something (Clause 3.8.1 of ISO 90002000)
• 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 90012000

29
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 90012000
• Example Internal and external audits

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Terms and Definitions

• Document - information and its supporting medium
  (ISO 90002000 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

• Guidance on the Documentation Requirements of ISO
  90012000
• ISO/TC 176/SC 2/N525R
• March 2001
• Quality Management Systems Requirements
• ISO/FDIS 9001