ISO 9001:2000Documentation Requirements

Based on ISO/TC 176/SC 2 March 2001

BY: Ahmad Bassiouny

Evelean William

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 objectivesA quality manualDocumented procedures required by the international standardDocuments needed by the organization to ensure effective planning, operation and control of its processesRecords 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 Manual

Minimum content specified in Clause 4.2.2Scope of the Quality Management System, including details of and justification for any exclusionsDocumented procedures established for the QMS, or references to themDescription 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 sizeOrganization’s complexityOrganization’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 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 DocumentationProcess maps, process flow charts,and/or process descriptionsOrganization chartsSpecificationsWork and/or test instructionsProduction schedulesApproved suppliers listsTest and inspection plansQuality 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 meansDoes 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 organizationQuality 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