Nov
18

how many procedures, how many records

 quality systems


4.2.3 - control of documents,
4.2.4 - control of records,
8.2.2 - internal audits,
8.3 - nonconforming product,
8.5.2 - corrective action; and
8.5.3 - preventive action.

All other elements while they do not require documented procedures will require established processes and have records that can demonstrate effective controls.

Records

The minimum records required by the standard are;
 
4.2.3 - control of documents,
5.6.1 - management review,
6.2.2 - training,
7.1 - planning of product realisation,
7.2.2 - review of requirements related to product,
7.3 - design and development,
7.4.1 - purchasing process,
7.5.2 - validation of processes for production and service provision,
7.5.3 - identification and traceability, 
7.5.4 - customer property,
7.6 - control of monitoring and measuring devices,
8.2.2 - internal audits,
8.3 - nonconforming product,
8.5.2 - corrective action; and
8.5.3 - preventive action.

So keep an open mind when designing your system and only document what your business needs to ensure customer focus and profitability.
 
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