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Quality Assurance
Quality Control
ISO & ISO 9001
1. Customer focus
2. Leadership
3. Involvement of people
4. Process approach
5. System approach to management
6. Continual improvement
7. Factual approach to decision making
8. Mutually beneficial supplier relationship
Process Approach
(main theme)
7.4 Purchasing
Supplier evaluation and selection
Relevant purchasing information
Verification of purchased product
7.5 Production and service provision
Controlled conditions including product
characteristics, work instructions, suitable
equipment, measuring devices, and system
Release, delivery and post delivery activities
Validation of processes when no other method
Identification and traceability of product and
it’s status
Care of customer property
Preservation of product
Includes constituent parts
7 Product Realization
It shall include;
Scope of the QMS
Documented procedures established for the QMS
Description of the interaction between the
processes of the QMS
Control of documents
Documents shall be controlled
A documented procedure shall be
established to define the controls
needed;
Approve documents for adequacy prior to issue
Review and update as necessary and re-approve
Ensure that changes and the current revision
status of documents are identified
Ensure that relevant versions of applicable
documents are available at points of use
Ensure that documents remain legible and readily
identifiable
Ensure that documents of external origin are
identified and their distribution controlled
Prevent the unintended use of obsolete documents,
and to apply suitable identification to them if they
are retained for any purpose
Control of records
Shall be established & maintained to provide
evidence of conformity to requirements
For effective operation of the QMS
Shall remain legible, readily identifiable and
retrievable
A documented procedure shall be established
to define the controls needed for;
Identification
Storage
Protection
Retrieval
Retention time
Disposition of records
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