Wednesday, September 29, 2010

RECORDS REQUIRED BY ISO9000

Section

Description

4.2.1 General

Reference to records required by the standard

4.2.3 Control of documents

For records are controlled according to 4.2.4

4.2.4 Control of records

Records are established and maintained to provide evidence of conformity

5.6.1 Management Review – GeneralReview

Management Review records

6.2.2 Competence, Awareness, and Training

Education, training, skills, and experience

7.1 Planning a product realization

Evidence is recorded that the realization processes and resulting product meet requirements

7.2.2 Review of requirements related to the product

Results of the review and actions are rising from the review

7.3.2 Design and development inputs

Inputs relating to product requirements

7.3.4 Design and development review

Results of the reviews and any necessary actions

7.3.5 Design and development verification

Results of the verification and any necessary actions

7.3.6 Design and development of validation

Records of the results of validation and any necessary actions

7.3.7 Control of design and development changes

Results of the review of changes in any necessary actions

7.4.1 Purchasing process

Results of supplier evaluations and any necessary actions are rising from the valuation

7.5.2 Validation of processes for production and service provision

Requirements for records as applicable

7.5.3 Identification and traceability

Where traceability is a requirement, the unique identification of the product

7.5.4 Customer property

Records of customer property that has lost, damaged, or unsuitable for use

7.6 Control of monitoring and measuring devices

  • Where no standards exist, bases used for calibration is recorded
  • Records of the results of calibration and verification are maintained

8.2.2 Internal audit

  • Records of audit results
  • Implied records for reporting verification follow up activities and results

8.2.4 Monitoring and measurement of product

Records indicates the person(s) authorizing the release of the product

8.3 Control of non-conforming product

The nature of nonconformities and any subsequent actions taken, including concessions obtained

8.5.2 Corrective action

Records for corrective action results taken

8.5.3 Preventive action

Records for preventive action results taken

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