| Documentation Requirements of ISO 9001:2000 |
4.1 The General Requirements of clause 4.1 are met if the specific requirements of clauses 5-8 are met ( i.e. have you established a system that meets the requirements of ISO 9001:2000 ); these requirements could be audited as follows:
A. Review the quality manual to determine if a systematic approach is defined for:
1) identifying and managing QMS processes (or elements) in accordance with the "process approach" defined in clause 0.2 and Figure 1 of ISO 9001:2000 identifying and showing the relationship between the following QMS processes (or elements) and their related sub-processes:
- Clause 5. Management Responsibility
- Clause 6. Resource Management
- Clause 7. Product Realization
- Clause 8. Measurement, Analysis and Improvement
2) ensuring the criteria, methods, information and responsibilities for managing QMS processes are in place.
3) ensuring that data is collected, analyzed and used to assess QMS process effectiveness and to identify needed actions or improvements.
4.2 The Documentation Requirements of clause 4.2 could be audited as follows:
A. Review quality manual to ensure required procedures are included or referenced (per clause 4.2.2).
B. Review QMS documentation to determine if documented procedures are appropriate for the size and type of the organization, the complexity and interaction of processes, and competence of personnel.
C. Review QMS processes to ensure they are adequately defined in procedures, process or job descriptions, work instructions, or other appropriate system documentation.
1) Note: there are only six "required" procedures:
- Control of Documents (clause 4.2.3)
- Control of Quality Records (clause 4.2.4)
- Internal Audit (clause 8.2.2)
- Control of Nonconforming Product (clause 8.3)
- Corrective Action (clause 8.5.2)
- Preventive Action (clause 8.5.3)
2) If/as appropriate, procedures may also be "needed" for:
- Planning (5.4, 7.1, 8.1, 8.5.1)
- Internal Communications (5.5.3)
- Management Review (5.6)
- Resource Management (6)
- Competence, Awareness, and Training (6.2.2)
- Customer-Related Processes (7.2)
- Design and Development (7.3)
- Purchasing (7.4)
- Production and Service Operation Control (7.5.1)
- Validation of Special Processes (7.5.2)
- Product ID/Traceability (7.5.3)
- Customer Property (7.5.4)
- Preservation of Product (7.5.5)
- Control of Monitoring and Measuring Devices (7.6)
- Customer Satisfaction (8.2.1)
- Process Measurement/Monitoring (8.2.3)
- Product Measurement/Monitoring (8.2.4)
- Analysis / Improvement (8.4, 8.5)
D. Review applicable standards and statutory/regulatory documents to determine if the QMS identifies required documentation and records.
E. Review other external or internal documents to ensure QMS identifies documentation and records needed to effectively manage the organization's products, processes and activities.
Note: Clause 4.2 requires that documentation be defined here - QMS document and record controls must be per clauses 4.2.3 and 4.2.4).
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