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Nonconformance Finding (ISO9001 Audit)

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Lalaplus Created:   Oct 27, 2021 Last commented:   Oct 27, 2021

Nonconformance Finding (ISO9001 Audit)

During ISO 9001 Audit, if Purchase department have no procedure for purchasing, Sale department also have no sale procedure (documented procedure), so it will be considered a nonconformance finding (Major or Minor)? If not, how Auditor assess their compliance with ISO9001 requirement?
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ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Carlos Pereira da Cruz Oct 27, 2021

First, ISO 9001:2015 promotes the process approach. So, I will use the auditor’s shoes focusing my attention only on processes and clauses.

There are no mandatory requirements for procedures (please check this article - List of mandatory documents required by ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/list-of-mandatory-documents-required-by-iso-90012015/ ). So, the non-existence of procedures is not in itself a reason to issue a non-compliance). The auditor may expect that, but it is not in the standard, period.

Compliance with ISO 9001 will be assessed by translating ISO 9001 clauses 4.4.1, 8.2, and 8.4, for example, into a set of requirements. For example, which processes cross the sales and purchasing departments? Are those processes effective? What indicators are used to assess effectiveness? Are they measured, are they evaluated, are decisions made? For example, about clause 8.2 I as an auditor would start with orders received from clients and would ask for evidence of what ISO 9001 requires, same for clause 8.4 for deliveries from suppliers. For example, about clause 8.4.1 the audit can ask for:

  • Which controls are applied?
  • Which criteria are applied?
  • Which records from suppliers qualification, selection, and performance monitorization
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Oct 27, 2021

Oct 27, 2021

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