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4.2.3 Control of documents
This is one of the “Mandatory Procedure” requires by the ISO 9001. Any documents required by the ISO 9001 system must be controlled. Documents include:
- Internal documents (like Quality Policy, Quality Objective, Quality Manual, Quality Procedure, Work Instruction, BOM, Inspection Standard and etc)
- External documents (like Law Book related to organization, Customer Drawing, Customer Specification Requirement and etc).
- Records, in ISO 9001 system, Quality Records and Forms (like Inspection record, Production Record and etc) are a special type of document, and the control must follow the Clause 4.2.4 “Control of Records”
Organization must establish a documented procedure for this document control method. Control of documents Procedure is minatory requirement by ISO 9001. The control method must include:
- To ensure any controlled document must obtained approval before release and distribute to other.
- To ensure any new revision of documents have been reviewed and approved before release and distribute to other.
- To ensure the revision of document is proper identify.
- To ensure relevant version of documents are available to retrieve at point of use. (In other words, we must establish a system to ensure our documents are able to retrieve when necessary)
- To ensure documents are remain legible. (In other words, controlled documents must able to read and understand).
- To ensure all external documents determined by organization are follow the same process as mention above.
- To ensure any old version of documents are obsolete to prevent the unintended use. If organization need to keep any obsolete document, suitable identification to these documents must control. (In common practice, organization will keep for old version of document for future reference, but will stamp a RED “Obsolete” on that document).
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| Leadership |
| Customer Focus |
| Process Approach |
| System Approach To Management |
| Involvement of People |
| Factual Approach To Decision Making |
| Continual Improvement |
| Mutually Beneficial Supplier Relationships |
| Applying Principle of Leadership In ISO 9001 |
| Applying The Principle of Customer Focus In ISO 9001 |
| Applying The Principle of Process Approach In ISO 9001 |
| Applying the Principle of System Approach To Management In ISO 9001 |
| Applying The Principle of Involvement of People In ISO 9001 |
| Applying The Principle of Factual Approach To Decision Making In ISO 9001 |
| Applying The Principle of Continual Improvement In ISO 9001 |
| Applying the Principles of Mutually Beneficial Supplier Relationships In ISO 9001 |
| Section 4 Quality Management System |
| Section 5 Management Responsibility |
| Section 6 Resource Management |
| Section 7 Product Realization |
| Section 8 Measurement, Analysis and Improvement |
| 4.1 General Requirements |
| 4.2 Documentation Requirements |
| 4.2.1 General |
| 4.2.2 Quality Manual |
| 4.2.3 Control of Documents |
| 4.2.4 Control of Records |
| 5.1 Management Commitment |
| 5.2 Customer Focus |
| 5.3 Quality Policy |
| 5.4 Planning |
| 5.5 Responsibility, Authority and Communication |
| 5.6 Management Review |
| 5.4.1 Quality Objective |
| 5.4.2 Quality Management System Planning |
| 5.5.1 Responsibility and Authority |
| 5.5.2 Management Representative |
| 5.5.3 Internal Communication |
| 5.6.1 General |
| 5.6.2 Review Input |
| 5.6.3 Review Output |
| 6.1 Provision of Resource |
| 6.2 Human Resource |
| 6.3 Infrastructure |
| 6.4 Work Environment |
| 6.2.1 General |
| 6.2.2 Competence, Training and Awareness |
| 7.1 Planning of Product Realization |
| 7.2 Customer Related Processes |
| 7.3 Design And Development |
| 7.4 Purchasing |
| 7.5 Production and Serivce Provision |
| 7.6 Control of Monitoring and Measuring Equipment |
| 7.2.1 Determination of Requirements Related To the Product |
| 7.2.2 Review of Requirements Related To The Product |
| 7.2.3 Customer Communication |
| 7.4.1 Purchasing Process |
| 7.4.2 Purchasing Information |
| 7.4.3 Verification of Purchased Product |
| 8.1 General |
| 8.2 Monitoring and Measurement |
| 8.3 Control of Nonconforming Product |
| 8.4 Analysis of Data |
| 8.5 Improvement |
| 8.2.1 Customer Satisfaction |
| 8.2.2 Internal Audit |
| 8.2.3 Monitoring and Measurement of Processes |
| 8.2.4 Monitoring and Measurement of Product |
| 8.5.1 Continual Improvement |
| 8.5.2 Corrective Action |
| 8.5.3 Preventive Action |
| PDCA |
| 7 QC Tools |