Six Documented Procedures as per clauses 1) 2) 3) 4) 5) 6) 4.2.3 4.2.4 8.2.2 8.3 8.5.2 8.5.

3 Control of Documents Control of Quality records Internal Audit Control of Non-Conformity Corrective Action Preventive Action

List of Records to maintained

1) 2)

5.6.1 6.2.2 (e)

Management Review records of

Maintain appropriate education, training, skills and experience

3)

7.1 (d) Evidence that the realization processes and

resulting product meet requirements

4)

7.2.2.

Review of requirements related product and actions arising from the review

to

the

5)

7.4.1

Results of the supplier evaluations and any necessary actions arising from the evaluation

6)

7.5.2 (d)

Demonstrate the validation of any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement

7)

7.5.3 7.5.4

The unique identification of the product where traceability is required Any customer property is lost, damaged or otherwise found to be unsuitable for use

8)

9)

7.6 (a) Measurement standards used for calibration

or verification of measuring equipment; national or international standards exist where no

10)

Validity of the previous measuring results when the equipment is found not to conform to requirements

7.6

11)

7.6 Results of calibration and verification of 8.2.2. Internal audits results 8.2.4 Evidence of product conformity with the

measuring equipment
12) 13)

acceptance criteria and indication of the person(s) authorizing release of product for delivery to the customer

14)

8.3 Nature of product nonconformities and any

actions taken, including concessions

subsequent obtained
15) 16)

8.5.2 8.5.3

Results of corrective action Results of Preventive action

If Clause 7.3 Design & Development is applicable 17) 7.3.2 Inputs relating to product requirements. 18) 7.3.4 Results of reviews and necessary actions. 19) 7.3.5 Results of verification & necessary actions. 20) 7.3.6 Results of validation & necessary actions. 21) 7.3.7 Results of review of changes & necessary actions.

Definitions

Document Guideline

Information & its Support medium Document stating recommendations or suggestions Procedure Specified way to carry out an activity or a process Quality Manual Document specifying the QMS Quality Plan Document specifying which procedures and associated resources shall be applied by whom and when to, a specific project, process or contract Record Document stating results achieved or providing evidence of activities performed Specification Document stating requirements