Posts Tagged ‘Audit Mutu’

Auditing a QMS which has minimum documentation

January 13th, 2009 bambangkesit Comments off

There can be disagreement between an auditor and an auditee on the absence of certain documented procedures, when the auditee presents only a quality manual and the six documented procedures specifically required by ISO 9001:2000. The differences in view between the auditor and the auditee can arise from differences in the interpretation of the ISO 9001 requirements contained in Clause 4.2.1, and the related Note, which state:

“4.2.1 General

The quality management system documentation shall include:


d) documents needed by the organization to ensure the effective planning, operation and control of its processes.

NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to

a) the size of organization and type of activities,

b) the complexity of processes and their interactions, and

c) the competence of personnel.”

The auditor should requests information on the auditee’s operating processes and subsequently ask questions, record answers and observe staff at all levels (including administrative personnel, process owners and operators), to confirm that the actual working status conforms to the descriptions given.

Thereafter, the necessity for any documentation should be evaluated in the light of the observed need for consistency, and the role that any documentation could play in avoiding any significant, identified risks.

The reader is referred to the advice given in document referenced “ISO/TC 176/SC 2/N 525,

Sumber :, 12 Januari 2009

Understanding the process approach

January 12th, 2009 bambangkesit No comments

Helping an auditor to interpret the process approach

If an auditor does not understand or misunderstands the process approach, direct him or her to recognized 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 ). 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:

  1. determining the processes and responsibilities necessary to attain the quality objectives of the   organisation; 
  2. determining and providing the resources and information necessary; 
  3. establishing and applying methods to monitor and/or measure and analyse each process;
  4.  establishing and applying a process for continual improvement of the effectiveness of the QMS.

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