ISO 9001:2000

ISO 9001:2000ISO 9001:2000Documentation Documentation RequirementsRequirements

ISO 9001:2000ISO 9001:2000Documentation Documentation RequirementsRequirements

Based on ISO/TC 176/SC 2Based on ISO/TC 176/SC 2

March 2001March 2001

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 ManualMinimum 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-StructureStructure 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 ProceduresRequired 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

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)

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 –

RequirementsISO/FDIS 9001