Comments include:
- The new standard is very helpful in quality management system (QMS) implementation, not only in manufacturing industries but also for nonmanufacturing sectors. Above all, audits of the process-based approached 2000 standard seem to enhance the effectiveness of audited QMSs. Customers get more value-added certification services.
- The process approach of the 2000 version helps organizations eliminate complicated QMS documentation.
- The degree of top management involvement becomes clearer because senior managers' responsibilities and roles are emphasized in the QMS.
- The standard provides the opportunity to view the complete management system. It is more closely aligned to the day-to-day practice of the general manager. All the requirements in the standard are 'common sense' and very close to 'normal' business practices.
- The new standard is more generic than the previous edition and this allows organizations to be more flexible during QMS implementation. It also shifts the focus away from documentation to results and performance.
- Many organizations have problems in understanding and complying with the requirements of ISO 9001: 2000 because they see it as a quality assurance standard.
- Some difficulties were identified relating to:
- Correct interpretation of processes and controlling them through performance assessment
- Assessment of customer satisfaction
- Data analyses in small companies that are not involved in batch production.