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Excluding "Design" from the ISO audit

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Guest user Created:   Sep 24, 2020 Last commented:   Sep 24, 2020

Excluding "Design" from the ISO audit

Can a company XX exclude 'Design' form ISO audit and still be certified? if, yes should the Certs address this exclusion (i.e. to be noted on the certificate)?

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ISO 9001 INTERNAL AUDIT CHECKLIST

List of questions to ask during the ISO 9001 audit.

ISO 9001 INTERNAL AUDIT CHECKLIST

List of questions to ask during the ISO 9001 audit.

Expert
Carlos Pereira da Cruz Sep 24, 2020

Let us consider three situations:

a) Company does not perform design activities
b) Company performs design activities, but they are performed outside the scope of the quality management system
c) Company performs design activities, and they are performed within the scope of the quality management system and the company decides to exclude design from the certification process

Situations a) and b) are allowed, but the organization has to explain why design was excluded. These are common, pacific situations.
Situation c) is not allowed. If design is performed within the management system scope it must be included. Not including design is a major non-conformity.
The following material will provide you more information about exclusions:

 

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Sep 24, 2020

Sep 24, 2020

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