| Why does ISO 9000 place so much emphasis on | | | | are defined within a procedure or by a system and |
| documentation? | | | | that it exists and is controlled. |
| Think of the Document Control Procedure as | | | | Types of Records required by ISO 9001:2008 |
| 'evidence' that an established process or procedure | | | | Document Control Procedure |
| was adhered to in order to satisfy customer | | | | 5.6.1 Management reviews |
| requirements. Both Registrars and Internal Auditors will | | | | 6.2.2 e) Education, training, skills and experience |
| always focus on the quality, continuity and flow of | | | | 7.1 d) Evidence that the realization processes and |
| documentation; inconsistencies in this flow of | | | | resulting product fulfil requirements |
| information will indicate a problem and generate a | | | | 7.2.2 Results of the review of requirements related to |
| non-conformance. | | | | the product and actions arising from the review |
| It is vital that your organization implements and | | | | 7.3.2 Design and development inputs relating to product |
| maintains a robust document and record management | | | | requirements |
| system pursuant to Clause 4.2. of ISO 9001:2008. | | | | 7.3.4 Results of design and development reviews and |
| Terms and definitions | | | | any necessary actions |
| To better understand the difference between a | | | | 7.3.5 Results of design and development verification |
| document and a record, the following terms and | | | | and any necessary actions |
| definitions are taken from ISO 9000:2005: | | | | 7.3.6 Results of design and development validation and |
| Term, Clause and Definition | | | | any necessary actions |
| Document, 3.7.2, Information and its supporting medium | | | | 7.3.7 Results of the review of design and development |
| Record, 3.7.6, A document stating results achieved or | | | | changes and any actions |
| providing evidence of activities performed Control of | | | | 7.4.1 Results of supplier evaluations and any actions |
| Documents (4.2.3) | | | | arising from the evaluations |
| Implementing a quality management system might | | | | 7.5.2 d) As required by the organization to |
| mean that you will be generating new documents and | | | | demonstrate the validation of processes where the |
| keeping some records that you might not be already | | | | resulting output cannot be verified by subsequent |
| keeping. Some of this documentation may seem | | | | monitoring or measurement |
| burdensome until you become more familiar with the | | | | 7.5.3 The unique identification of the product, where |
| quality standard. In general though, the organization | | | | traceability is a requirement |
| must: | | | | 7.5.4 Customer property that is lost, damaged or |
| - Approve documents before your distribute them | | | | otherwise unsuitable for use |
| - Provide the correct version of documents at points | | | | 7.6 a) Basis used for calibration or verification of |
| of use | | | | measuring equipment where no international or national |
| - Review and re-approve documents whenever you | | | | measurement standards exist |
| update them | | | | 7.6 Validity of the previous measuring results when the |
| - Specify the current revision status of your | | | | measuring equipment is found not to conform to |
| documents | | | | requirements |
| - Monitor documents that come from external sources | | | | 7.6 Results of calibration and verification of measuring |
| - Prevent the accidental use of obsolete documents | | | | equipment |
| - Preserve the usability of your quality documents | | | | 8.2.2 Internal audit results and follow-up actions |
| In order for any organization to demonstrate the | | | | 8.2.4 Indication of the person(s) authorizing release of |
| effective implementation of its quality management | | | | product. |
| system, it may be necessary to develop documents | | | | 8.3 Nature of the product nonconformities and any |
| other than documented procedures. However, the only | | | | subsequent actions taken, including concessions |
| documents specifically required by ISO 9001:2008 are: | | | | obtained |
| - Quality policy (4.2.1.a) | | | | 8.5.2 e) Results of corrective action |
| - Quality objectives (4.2.1.a) | | | | 8.5.3 d) Results of preventive action |
| - Quality manual (4.2.1.b) | | | | Document Control Procedure Summary |
| - Control of Records (4.2.4) | | | | Remember that you are in control of the documents |
| A record is a document that provides traceability; it | | | | and records and not vice versa. Only document and |
| declares results or presents evidence that the | | | | record what is necessary - the fewer documents and |
| activities undertaken met customer requirements. It is | | | | records you keep, the fewer things that will be audited, |
| important to identify relevant quality records as you | | | | and the more time you will have to actually run your |
| progress your documentation and ensure that records | | | | business. |