Understanding the process approach to quality systems
The process approach concept must be so well understood by auditors that they are not limited by the terminology in the standard; however, auditees may use their own “in-house” terminology.
Helping an auditor to interpret the process approach
If an auditor does not understand or misunderstands
the process
approach, direct him or her to recognised information sources,
such as the standard ISO 9000:2000 Quality management
systems – Fundamentals
and Vocabulary and the ISO 9000 Introduction
and Support Package: Guidance on the Concept and Use
of the Process Approach for management systems (document ISO/TC176/
SC2/N544, available from http://www.bsi.org.uk/iso-tc176-sc2).
A certification body/ registrar should ensure that all its auditors have received sufficient training regarding the new requirements in ISO 9001:2000, particularly those on the process approach. Thus, an auditor should realise that several steps are needed, including the following:
- determining the processes and responsibilities necessary to attain the quality objectives of the organisation;
- determining and providing the resources and information necessary;
- establishing and applying methods to monitor and/or measure and analyse each process;
- establishing and applying a process for continual improvement of the effectiveness of the QMS.
The process approach concept must be so well understood
by auditors that they are not
limited by the terminology in the standard; however, auditees
may use their own “in-house” terminology. Auditors
must be aware that the application of the process approach will be different from organisation to organisation,
depending on the size and
complexity of the organisation and its activities. Special
consideration should be given to the situation in small and
medium enterprises (SMEs), so that auditors should not expect
so many processes in quality management systems.
Helping an auditee to interpret the process approach
If an auditor is faced with a complete misunderstanding by an auditee, this situation should normally be identified at the first stage audit. The auditor should refer the auditee to recognized information sources, such as those indicated in the section above. (In particular, the referenced ISO/TC 176/SC 2/N544 document sets out different steps in the process approach and provides useful guidance with examples.)
The auditee should also pay sufficient consideration to:
- the establishment of process objectives;
- process planning; and
- the availability of records.
Auditees frequently identify too many processes; some or all of them are activities that do not fulfil the requirements of a process, in the sense that ISO 9001:2000 uses the concept. In this situation, an auditor should (in the first stage audit) propose that the auditee performs a redefinition of its processes, based, say, on criticality of the activities. This might be particularly relevant for SMEs.