Monday, March 21, 2011

GUIDELINES FOR AUDITING QUALITY SYSTEMS

Qualification criteria for quality systems auditors

1. Scope
This part of ISO 10011 gives guidance on qualification criteria for auditors
It is applicable in the selection of auditosr to perform quality sytems aidits recommended in ISO 10011-1.

2. Normative references
The following standards contain provisions which, through reference is this text. constitute provisions of this part of ISO 10011. At the time of publication,the editions indicated were valid.All standard are subject to revision and parties toagreements based on this part of ISO 10011 are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards.

3. DEfinitions
For t the purposes of this part of ISO 10011, the definitions given in ISO 8402 and ISO10011-1 apply.

4. Education
Auditor candidates should have completed at least secondary education. that is, that part of the national educational system that comes after the primary or elementary stage but prior to that which qualifies for a degree, or as otherwise determined by the evaluation panel describet in annex A. Candidates should have demonstrated competence in clearly and fluently expressing concepts and ideas orally and in writing in their officially recognised language.

5. Training
Auditor candidates should have undergone training to the extent necessary to ensure their competence in the skills required for carrying out audits, and for managing audits. Training in the following areas shold be regarded as particularl relevant:
- knowledge and understanding of the standards against which quality systems audits may beperformed;
- assessment techniques of examining, questioning, evaluating and reporting;
- additional skils required for managing and audit, such as planning, organizing, comunicating and directing.
Such competence should be demonstrated through writen or oral examination, or other acceptable means

6. Experience
Auditor candidates should have a minimum of four years' full-time appropriate practical workplace experience (not including training), at least two years of which should have been in quality assurance activities.
Prior to assuming responsibility for performing audits as auditor, the candidate should have gained experience in the entire audit process as described in ISO 10011-1. This experience should have been gained by participating in a minimum of four audits, for a total of at least 20 days. including documentation review, actual audit activities and audit reporting.
All relevant experience should be reasonably current.

7. Personal attributes
auditor candidates should be open-minded and mature; have the ability to perceive situations in a realistic way, to understand complex operations from a broad perspective, and to understand the role of individual units within the overall organization.
The auditor should be able to apply these attributes in order to
- obtain and assess objective evidence fairly;
- remain true to the purpose of the audit without fear or favour.
- evaluate constantly the effects of audit observation and personal interactions during an audit;
- treat concerned personal in a way that will best achieve the audit purpose;
- react with sensitivity to the national conventions of the country in which the audit is performed
- perform the audit process without deviating due to distractions;
- commit full attention and support to the audit process;
- react effectively in stressful situations;
- arrive at generally acceptable conclusions based on audit observations;
-remain true to a conclusion despite pressure to change that is notbassed on evidence.

8. Management Capabilities
Auditor candidates should demonstrate through suitable means their knowledge of, capability of using, the necessary management skills required in the execution of an audit as recommended in ISO 10011-1

9. Maintenance of competence
Auditors should maintain their competence by
- ensuring that their knowledge of quality systems standards and requirements is current;
- ensuring that their knowledge of auditing procedures and methods is current;
- participating in refresher training where necessary;
- having their performence reviewed at least every three years by an evaluation panel (see annex A). http://evaluatingauditor.blogspot.com/
These measures should ensure that the auditor continues to meet all the requirements of this part of ISO 10011. Auditor reviews should take into account any additional information, positive or negative, developed subsequent to the previous review.

10. Language
No audit personal should participate in unsupported audits where they are not fluent in the agreed language of the audit. Support in these terms means the audit personnel have at all times available to them a person with the necessary technical language skills, who is not subject to pressures that would affect the performance of the audit.

11. Selection of lead auditor
The lead auditor for a specific audit should be selected by audit programme management from qualified auditors using the factors described in ISO 10011-3, taking into account the following additional criteria :
- the candidates should have acted as qualified auditors in at least three complete audits performed in accordance with the recommenations given in ISO 10011-1;
- the candidates should have demonstrated the capability to communicate affectively both orally and in writing in the agreed language of the audit.

by EDY

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