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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