Nonconformities and Corrective actions. Clause 10.1 ISO 9001:2015
In the 10 clause, ISO 9001 introduced determine of
nonconformities.
Nonconformity is when a certain requirement is not complied
with (in the context of ISO 9001) the requirements might be the ISO 9001
standard itself, the relevant legislation, the QMS documentation, and the
requirements of interested parties.
Nonconformities and corrective actions are important because
they enable companies to identify oversights, mistakes, errors in the manner
and deal with them effectively.
Nonconformities can be identified by anyone at any time.
During everyday operation, in the monitoring process, etc. however, most of the
nonconformities are usually identified during the internal audit.
This clause of ISO 9001 also introduce determine corrective
actions, meaning a formal way for a company to resolve nonconformity.
The ISO 9001 require companies to keep records as evidences
of nature of nonconformities, the action that will taken and results of the
implemented corrective actions. This record is usually called the corrective
action form.
It is not enough to implement the corrective actions, the
company should sure it really resolved the root cause of the non-conformity,
that is mean the results and effect should be evaluated. Keep in mind that the
correction and corrective action are not the same thing.
Correction mean removal of the consequences while corrective
action means removal of the cause of the nonconformity.
Because of the significant of corrective action for
improvement the QM, it is to be a good practice to document the procedure for
nonconformities and corrective actions. This procedure defines the steps for
analyzing the nonconformities, initiating corrective actions, assigning
responsibilities for corrective action, how to document the corrective action,
how to evaluate the effectiveness of the corrective actions, etc.
The standard requires companies to take the following
actions when the nonconformities occurs:
1- Control and correct the nonconformity and deal with the sequences.
For example, in case of the nonconformity is the internal
audit was conducted by untrained auditors, the company should train internal
auditors and deal with risks that might have happened because of
inappropriately conducted internal audit.
2- Evaluate the need to eliminate the cause of nonconformity to prevent its reoccurrence.
This by review the nonconformity, determine the cause, and
identifying if similar nonconformities exists.
Refer to the same example, because the internal audit is very important
to QMS, the company must take sure that this nonconformity does not occurs in
the future. if the cause of nonconformity for example lake of person
responsible for internal audit process, then the company must assign
responsibility to relevant person to prevent this from happing again in the
future.
3- Implemented relevant actions.
For our example, it can be by conduct new audit with newly
trained auditors.
4- Review the effectiveness of the corrective action taken.
In our example, after the certain period you should check if
the new conducted audits were performed by trained auditors.
5- Make changes to the QMS if needed.
In our example cane be document an internal audit procedure,
where the responsibilities of the person in charge of internal audit will be
explain, and the requirements for having trained internal auditor will be
clearly stated.