Don’t be put off by the large number of procedures in ISO 9001, not all of them will be relevant to your company and not all of them are mandatory. In the 2008 standard there were 6 mandatory procedures required to become certified. This is no longer the case. The 2015 standard is much more flexible around the documentation requirements. We discuss the types of documents outlined in the standard, and which are mandatory in order for your organisation to become certified.
The information required for ISO 9001 can be split into two types:
Documents: these include policies or objectives that you have set that can be amended at a later date.
Records: these are evidence of the results achieved. Records should not be changed or revised as they are proof of an outcome.
There are mandatory documents that you need to produce to become ISO 9001 certified. These include:
Scope of the Quality Management System (clause 4.3)
Quality policy (clause 5.2.2)
Quality objectives and how these will be achieved (clause 6.2)
The mandatory records needed for ISO 9001 include:
Monitoring and measuring resources (7.1.5.1)
Monitoring and measuring equipment calibration records* (clause 7.1.5.2)
Records of competency in staff (clause 7.2)
Product/service requirements review records (clause 8.2.3.2)
Design and development inputs record (clause 8.3.3)
Records of design and development controls (clause 8.3.4)
Records of design and development outputs(clause 8.3.5)
Record of design and development changes (clause 8.3.6)
Criteria for evaluation and selection of suppliers (clause 8.4.1)
Characteristics of product or service to be provided (clause 8.5.1)
Identification and Traceability records (8.5.2)
Records about customer property including any changes (clause 8.5.3)
Production/service provision change control records (clause 8.5.6)
Release of products and services (clause 8.6)
Control of nonconforming outputs (clause 8.7.2)
Monitoring and measurement results (clause 9.1.1)
Internal Audit results (9.2.2)
Results of the management review (clause 9.3.3)
Results of corrective actions including opportunities for improvement (clause 10.2.2)
These are the mandatory clauses that you need to provide documents and reports for in order to become ISO 9001 certified. Your documents and records will take a variety of forms, such as spreadsheets, diagrams, videos and written content. ISO 9001 requires you have some system in place that controls your documents. Note that retention policies will need to be in place establishing the length of time that records will be kept.
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