ISO 9001:2000 Frequently Asked Questions

Q: What are the basic differences between EN ISO 9001:2000 and the previous version, ISO/FDIS 9001:2000?

A: There are no significant changes as far as content is concerned.

Q: How long will my old certificate remain valid?

A: As of December 15, 2003, all ISO 9001/2/3:1994 certificates became invalid.

Q: What are the prerequisites for certification as per ISO 9001:2000?

A: All applicable requirements of the new standard must be taken into account, i.e. the processes prescribed for the quality management system and its implementation must be identified, defined, measured, analyzed and monitored.

Q: Is a process-oriented quality system structure a prerequisite for certification?

A: No. The process approach is a future-oriented, effective way of establishing and/or maintaining an effective quality system. With its help, your organization can achieve efficient orientation to value-added and customer-oriented aspects. With the help of appropriate, clearly structured procedures, quality-system documentation can often be made leaner, thus resulting in greater acceptance by users.

Q: Which processes may be excluded? What is to be observed in this context?

A:
1) Requirements outlined in the product realization (section 7), if the exclusion can be justified; e.g. by company structure, customer requirements, etc.

2) Design and development, for example, may only be excluded if the organization does not have and design responsibility for the products covered by the scope of application.

3) If processes are subcontracted or outsourced, they many not be completely excluded. The organization must carry out adequate monitoring with respect to relevant requirements of ISO 9001:2000 and provide evidence thereof.

4) Exclusions must be justified in the quality system documentation.

TÜV recommends discussing possible exclusions and/or relevant justifications with your auditor.

Q: Which process elements must always be audited in all surveillance audits?

A:
- 4.1 Quality management system: General requirements
- 4.2 Documentation requirements
- 5 Management responsibilities
- 8.1 Measurement, analysis and improvement: General
- 8.2.1 Customer satisfaction
- 8.2.2 Internal audit
- 8.5 Improvement
- Corrective action from the last audit
- All process elements contained in the standard must be audited in the two successive surveillance audits.

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