Auditing a QMS which has minimum documentation
It is common for an auditee to disagree with the auditor over the degree of documentation required to conform to ISO 9001. What should you do when you are only presented with a quality manual and the six documented procedures specifically required by ISO 9001 during audit? Try our quiz and find out what the Auditing Practices Group recommends.
NEW! Quiz yourself1. Which of the following conditions is the correct documentation requirement as defined in ISO 9001:2000? a) A documented quality management system b) A quality policy c) A system of documents d) All of the above. 2. Which is the correct definition of a quality manual? a) A document stating results achieved or providing evidence of activities performed |
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b) A document specifying which procedures and associated resources shall be applied by whom and when to a specific project, product, process or contract
c) A document specifying the quality management system of an organization
d) All of the above.
3. An organization must have documented procedures for which of the following activities:
a) Internal audit
b) Control of nonconforming product
c) Corrective action
d) All of the above.
4. Which of the following are needed to ensure the effective planning, operation and control of processes according to ISO 9001:2000?
a) Organization charts
b) Quality objectives
c) Documents containing internal communications
d) All of the above.
To find out how you scored, read on (answers at the end).
Disagreements often arise due to different interpretations 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:
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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."
Documentation – the main objectives:
a) Communication of Information
The type and extent of the documentation will depend on the nature of the products and processes, communication systems communication skills and organizational culture.
b) Evidence of conformity
Have planned actions been carried out.
c) Knowledge sharing
In order to disseminate and preserve the organization’s experiences.
Documents may be in any form or type of medium, and the definition of “document” in ISO 9000:2005 clause 3.7.2 gives the following examples:
- paper
- magnetic
- electronic or optical computer disc
- photograph
- master sample
ISO 9001:2000 Documentation Requirements
ISO 9001:2000 Clause 4.2.1 General explains that the quality management system documentation shall include:
a) documented statements of a quality policy and quality objectives;
b) a quality manual
c) documented procedures required by this International Standard
d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and
e) records required by this International Standard
The notes after Clause 4.2 make it clear that where the standard specifically requires a “documented procedure”, the procedure has to be established, documented, implemented and maintained.
All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO 9001:2000, or, for the particular case of records, according to clause 4.2.4.
Guidance on Clause 4.2 of ISO 9001:2000
a) Documented statements of a quality policy and objectives, Clause 5.3
The documented quality policy has to be controlled according to the requirements of clause 4.2.3. Some organizations may be revising their quality policy for the first time and will need to pay particular attention to clause 4.2.3 (c), (d) and (g). Requirements for the quality objectives are defined in clause 5.4.1 of ISO 9001:2000.
b) Quality Manual, Clause 4.2.2
The format and structure of the manual is a decision for each organization, and will depend on the organization’s size, culture and complexity. Some organizations may choose to use the quality manual for other purposes besides that of simply documenting the QMS.
c) Documented procedures
The organization must have “documented procedures” for the following six activities:
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Control of documents |
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Control of records |
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Internal audit |
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Control of nonconforming product |
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Corrective action |
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Preventive action |
d) Documents needed to ensure the effective planning, operation and control of processes:
- The only documents specifically mentioned in ISO 9001:2000 are:
- Quality policy (clause 4.2.1.a)
- Quality objectives (clause 4.2.1.a)
- Quality manual (clause 4.2.1.b)
- There are several requirements of ISO 9001:2000 where an organization could add value to its QMS and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them. Examples may include:
- Process maps, process flow charts and/or process descriptions
- Organization charts
- Specifications
- Work and/or test instructions
- Documents containing internal communications
- Production schedules
- Approved supplier lists
- Test and inspection plans
- Quality plan
Note: Requirements for the control of records are different from those for other documents, and all records have to be controlled according to those of clause 4.2.4.
Guidance on the records required to be kept according to ISO 9001 can be found in Annex B of the following document:
“ISO/TC 176/SC 2/N 525, ISO 9000 Introduction and Support Package: Guidance on the Documentation Requirements of ISO 9001:2000”
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Quiz answers: 1. (a); 2. (c); 3. (d); 4. (b)
Note for question 2:
a) defines a record
b) defines a quality plan
c) defines a quality manual
