One - Clause 0.1 (General)
Three - Clause 1.1 (Scope - General)
One - Clause 1.2 (Scope - Application)
One - Clause 4.1 (QMS - General requirements)
One - Clause 5.1 (Management commitment)
One - Clause 7.2.1 (Determination of requirements related to the product)
One - Clause 7.3.2 (Design and development inputs)
Do you find anywhere the term 'statutory and regulatory requirements' in clause 8 (Measurement, analysis and improvement) requirements?
The term 'statutory and regulatory requirements' is invisible in clause 8, however internal auditors can play a significant role in meeting statutory and regulatory requirements. It will be a good idea that the auditor during the audit preparation phase obtains relevant information from internal as well as external sources with respect to the statutory and regulatory requirements that may apply to the organization and its product, such as, legal requirements related to health, safety and environment.
In case the auditor finds any noncompliance to any of the statutory and regulatory requirements, it should be reported as CAR (corrective action request) and such action will help the organization in improving the effectiveness of the organization’s quality management system.
What is your opinion?
With best wishes,
KRS
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