The quality system is explained by the ISO standard needs the supplier to start and keep procedures for the identification, collection, indexing, filing, storage, maintenance and disposition of quality records. Quality records. The control of quality records provide the objective evidence that the requisite product quality has been attained and that the various elements of the quality system have been effectively implemented.
What are control of quality records?
Throughout the text of the ISO 9001 standard, various clauses stipulating the maintenance of records on activities covered by them refer to clause 4.6. These clauses and the quality records required are listed below:
- Contract review records (clause 4.1.3)
- Calibration records (clause 4.11.2)
- Design review records (clause 4.4.6)
- Inspection and test records (clause 4.10.5)
- Management review records (clause 4.1.3)
- Non-conformance records (clause 4.11.2)
- Positive recall records (clause 22.214.171.124)
- Records of design verification measures (clause 4.4.7)
- Records of acceptable subcontractors (clause 4.6.2)
- Records of qualified processes (clause 4.9)
- Records of qualified equipment (clause 4.9)
- Records of qualified personnel (clause 4.9)
- Training records (clause 4.18)
These are the minimum records that need to be maintained. The ISO certification is more important for every business startups. In a manufacturing enterprise, the following additional records have to be kept to demonstrate that an effective quality system is being operated.
- Records of the distribution of the quality manual, quality plan and related documents.
- Details of documents available in the organization, dates of issue, identification numbers.
- Modifications and amendments to documents issued.
- Records of assessments of subcontractors and their performance review.
- List of products supplied by customers for specific orders.
- Records of process capability studies.
- Records of observation and consequent decisions affecting process control.
- Records of corrective action taken to keep processes under control and results obtained.
- Records of preventive maintenance of process equipment.
- Records of deviations and concessions.
- Records of reworked products and repaired work.
- Records of customer complaints and warranty claims.
- Records of preventive actions taken and results obtained.
- Details of qualifications and training of personnel engaged in functions affecting quality.
- Records of major nonconformities noted during the servicing operation and corrective actions.
- Records of statistical techniques used.
The above list of quality records is for illustrative proposes only. The actual records to be maintained should be clearly specified in the procedures and work instructions of various departments of the enterprise. There are various ISO certifications are ISO 9000, ISO 9001, ISO 13485, ISO 14001, OHSAS 18001, ISO 26000, etc.
Indexing, filing, storage and retrieval
The standard calls for proper indexing and filing of quality records so that these can be easily retrieved. A simple means of indexing quality records is to maintain a register in the functional groups or departments concerned. The register should list the quality records in numeral order and these should be filed in sequence and kept in specified locations under the responsibility of designated persons. The storage of quality records should be such that they can be easily retrieved when required. Since these records may have to be kept for considerable periods, they should be stored in facilities providing an environment that will prevent damage and deterioration.
Retention of quality records
The standard requires the retention times of quality records to be established and recorded. These should cover reasonable periods during which the records may be required for study or verification. Each ISO certification is different on their industries standards. The main factors determining the retention period of quality records are as follows:
- Duration of contract
- Warranty period
- Life of the product (this applies particularly to major equipment supplied to the defence sector, power plants or the aviation industry.
- Period between quality system assessments.
- Stipulation in the contract about the retention period.
Quality records Retention period in years
management review records 3
contract view records 5
design view and verification 10
work orders 5
process control data 2
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