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ISO 9001: 2000 - CLAUSE 4.2.4 CONTROL OF RECORDS

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DEFINITIONS

registration document stating results achieved or providing evidence of activities performed
NOTE 1 records can be used, for example, to document traceability and to provide evidence of verification, preventive and corrective actions.
NOTE 2 Generally records need not be subject to control review state. 3.7.6, ISO 9000:2005

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REQUIREMENT ANALYSIS - PROCESS CONTROL OF RECORDS

OBJECT

An organization must maintain records to show them that its QMS operates effectively. The records must document the SGC to demonstrate compliance with codes and was to be maintained, remain legible and properly identified, must also be indexed to be easily retrievable, stored so as to prevent deterioration, damage or loss, and ultimately must be retained for an appropriate period.

DATA ENTRY

* Training Results

* Reviews customer requirimientos

* Product design and development results

* Results of the evaluation of suppliers

* Results from process validation

* Loss and damage to customer products

* Results of process and product

* Identification of the product (if required)

* Authority to release the product

* Reports of the calibration of equipment

measurement

* Reports nonconforming products

* Results of remedial actions

* Results of preventive actions

ACTIVITIES

The type and extent of records saved depends on the processes and products involved, but must be designed to demonstrate compliance with the requirements. Should include records pertaining to suppliers

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An organization requires that its records are complete, legible and properly identified. The records must be stored in a safe place where are easily accessible and protected from damage. The records must be protected properly.

should be established (I) procedure (s) documented (s) to define the controls needed for the records. In addition to the above one organziación should consider:

- the authority to remove records

- confidentiality of records

- regulatory requirements, statutory and contractual retention records, and

- related issues use of electronic records

OUTPUTS

may include:

-Procedures for the control of the records (identification, distribution, maintenance and disposal of records)
- Hosted records properly and easily recoverable

OTHER CONSIDERATIONS

records required by ISO 9001:2000

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