ISO SYSTEM POLICIES:

This policy document describes policies determined by TQCSI’s Certification Approval Panel in the interpretation of general issues regarding all management systems.

A fundamental IAF requirement for management system certification is that internal audits and management review be conducted annually.

Internal audits

A minor non-conformance is to be raised if all processes of the respective management system have not been internally audited in the last 12 months (ie those processes that are required by each clause of the respective standard). A major non-conformance is to be raised if an internal audit of the respective management system has not been conducted at all in the last 12 months.

Internal audits need not be an audit against the respective Standard. By virtue of TQCSI auditing against the Standard and the management system, clients satisfy ISO 9001:2015 Clause 9.2 (or the respective clause for other standards) by simply auditing against their management system documentation.

There is a growing tendency to require internal audits to only be audits of operational procedures. This is wrong, internal audits must be of the management system processes themselves (ie the management system documentation addressing the required clauses of the Standard). Auditing of operational procedures (ie. SOPs, work instructions, etc which facilitates ISO 9001 Clause 8.1) may be conducted simultaneously but is more often conducted at another time, providing it is scheduled and those procedures are regularly reviewed. Normally, TQCSI would require operational procedures to be reviewed at least two yearly, although reviewing processes with higher risk to the client more frequently is encouraged.

Reviewing operational procedures may only require the respective procedure to be verified as being correct.

A traditional checklist approach to internal audits is acceptable providing the checklist is reviewed and updated from time to time so that it remains current.

Sufficient evidence is to be recorded to ensure the internal audit findings can be justified.

Management Review

A minor non-conformance is to be raised if all required inputs of management review have not been conducted in the last 12 months. A major non-conformance is to be raised if management review has not been conducted at all in the last 12 months.

Management review may be conducted in whatever format the client chooses although most clients use a traditional meeting. If not through a meeting, then there must be reasonable evidence that the respective management team participated in some form of discussion – simply reading a report is not acceptable. All required inputs of ISO 9001:2015 Clause 9.3.2 (or the respective clause for other standards) must be discussed and reasonable evidence of the discussion must be recorded (normally in meeting minutes). Any other agenda items required by the management system documentation must also be discussed. Any action arising from management review must be recorded and a person nominated, preferably (but not compulsorily) with a target date.

There must also be some traceability to previous management review records to ensure proposed action was achieved or is being monitored.

TQCSI POLICIES FOR AUDITING & CERTIFICATION OF ISO 9001

This policy document describes policies determined by TQCSI’s Certification Approval Panel in the interpretation of ISO 9001 for the auditing and certification of quality management systems. It complements TQCSI Work Instructions 32 (QMS Certification) which should also be referred to by auditors when auditing clients’ quality management systems.


Minor nonconformances are to be raised where:
·         a discrepancy which has the potential to have a significant impact on the effectiveness of the quality management
          system has not been addressed since being raised at a previous audit
·         a serious discrepancy or a number of like discrepancies indicate there is a breakdown in part of the quality
          management system or the quality of end product is jeopardised
·         the objectives of the quality management system are not established and monitored
·         there is a significant breach of legislation or a regulatory requirement
·         all parts of the quality management system have not been internally audited in the last 12 months
·         all requirements for management review have not been conducted in the last 12 months.

Major nonconformances are to raised where:
·         the agreed action plan to address a minor nonconformance has not been implemented
·         a serious discrepancy or a number of like discrepancies indicate there is a total breakdown in the quality management
          system
·         there is a very significant breach of legislation or a regulatory requirement
·         an internal audit of the quality management system has not been conducted in the last 12 months
·         management review has not been conducted in the last 12 months.

General Policies:
·         Quality (business) related objectives must be identified, documented and reviewed in a plan.


 
     
 

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