Professional Documents
Culture Documents
ISO 9001:2000
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
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 organizations 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 organizations 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
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
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
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)
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)
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
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
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