How to Raise an ISO 9001 audit non-conformity

How to Raise an ISO 9001 audit non-conformity

How to Raise an ISO 9001 audit non-conformity

An audit is part of the ISO 9001 certification and recertification process. Your organization needs to carry out documented internal audits to ensure that the QMS is working properly. In such instances, your auditor may need to write down any non-conformities in a clear and precise manner. This will enable your company to investigate and adjust to comply. We’ve compiled some useful tips to help you write a good non-conformity for ISO 9001.

What is non-conformity?

During an internal audit, the auditor takes note of how you implement your QMS. If they notice gaps or missing processes, they will record it as a non-conformity. The purpose of an audit is to compare what the ISO standard requires against what exists.

How can you write a good non-conformity statement?

A good non-conformity statement allows the auditee to take action. Therefore, you will need to structure the statement in such a way that anyone concerned with the QMS system can understand. The first step is to ensure that it includes the following in the non-conformity statement:

  • Underscore the requirement– In cases where there is non-conformity, the auditor needs to begin by stating the requirement of the ISO 9001. The auditee will gain a clear insight into what the problem is.
  • Detail what is wrong-Remember that the purpose of the audit is to help the organization investigate and rectify any non-conformities. Detailing what is wrong in clear statements will give the auditee a proper foothold on the problem.
  • Rely on evidence- The auditor needs to document every process, so collect detailed evidence of any non-conformities. Again, the purpose is to offer the organization an opportunity to act quickly and correct the infractions.

A good audit statement should detail the non-conformity correctly as per the standard and should be written in a way that it does not lay blame on anyone or seek to give solutions to the non-conformities witnessed.

Include the following phrases in the Non-conformity statement

Should be-This statement is from the ISO 9001/2015 standard, which details the arrangements in which the QMS system should be implemented. Using ‘should be’ means that the non-conformity compares to the standard and not the personal opinion of the auditor. Not being able to write a ‘should be’ statement could mean that the non-conformity is nonexistent.

As found-“As found” is the statement that allows the auditor to provide evidence. After stating your audit finding that flouts the “should be” statement, you use ‘as found’ to include documented proof. Example:

Should be: All standard operating procedures should be approved by the Head of department.

As found: During a review of the company’s standard operating procedure, it was found that seven samples of the SOP lack the signature of the Head of Department. These samples are in doc 208,207,210, 215,218,219 and 220.

Good non-conformity statements make things easier for organizations.

There is no prescribed way of writing a non-conformity, so the auditor must be as clear as possible. Remember, we are helping the company.

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