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

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 organization’s process activities

3. ISO 9001:2000 Significantly reduces documentation requirements
Is much less prescriptive
Allows more flexibility in choice of documentation system
It is stressed that ISO 9001 requires (and has always required) a “Documented quality management system”, and not a “system of documents”.

4. 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

5. What Is a Document? Communication of information
Evidence of conformity
Knowledge sharing
Main objectives of an organization’s documentation, independent of whether or not it has implemented a formal QMS.

6. 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

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 organization’s 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
Users are also referred to ISO/TR “Guidelines for quality management systems documentation” for further guidance.

10. 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
The notes after Clause 4.2 make it clear that where the standard specifically requires a “documented procedure” the procedure has to be established, documented, implemented and maintained.

11. 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
Quality Policy must be measurable

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

14. 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:
Organization’s size
Organization’s complexity
Organization’s culture
Controlled in accordance with the requirements of Clause 4.2.3

16. 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)

17. 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)

18. 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

19. 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

22. 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)

23. 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)

24. 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

26. 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

27. 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

28. Objective Evidence
Data supporting the existence or verity of something (Clause 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

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 9001:2000
Example: Internal and external audits

30. 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

31. 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