Clause 9.0 “Checked”
Clause 9.0 of the new ISO 9001:2015 quality management system talks about performance evaluation. Performance evaluation is a key step in the PDCA cycle. Without checkpoints, we will never know if we are on the right track. Clause 9.0 provides the checkpoint mechanisms in ensuring that the quality management system is adequate, compliant and effective.
The three sub-clauses under Clause 9.0 Performance Evaluation are the following:
9.1 – Monitoring, measurement, analysis, and evaluation
9.2 – Internal audit
9.3 – Management review
9.1.1 CUSTOMER SATISFACTION
Customer satisfaction is one of the key indicators that must be monitored, measured, analysed and evaluated. A happy and satisfied customer is the true test of an effective quality management system.
A company wishing to comply with the requirements of this clause must establish a robust process of obtaining customer feedback. Gather data pertaining to the performance of the QMS and analyse these data for improvement.
9.2 INTERNAL AUDIT
The organisation shall conduct internal audits at planned intervals to provide information on whether the quality management system conforms:
1.) The organization’s own requirements for its quality management system;
2.) The requirements of this international standard;
is effectively implemented and maintained.
The organisation shall plan, establish, implement and maintain an audit programme including the frequency, methods, responsibilities, planning requirements and reporting, which shall take into consideration the importance of the processes concerned, changes affecting the organisation, and the results of the previous audits.
Define the audit criteria and scope for each audit; select auditors and conduct audits to ensure objectivity and the impartiality of the audit process; ensure that the results of the audits are reported to relevant management and take appropriate correction and corrective actions without undue delay.
9.3 MANAGEMENT REVIEW
Top management shall review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the company.
9.3.2 MANAGEMENT REVIEW INPUTS
In conducting management review, ensure that the following are included in the discussion:
A) the status of actions from previous management reviews
B) changes in external and internal issues that are relevant to the quality management system;
C) Information on the performance and effectiveness of the quality management system, including trends in:
1) Customer satisfaction and feedback from relevant interested parties;
2) The extent to which quality objectives have been met;
3) Process performance and conformity of products and services;
4) Non conformities and corrective actions;
5) Monitoring and measurement of results;
6) Audits results;
7) The performance of external providers.
D) The adequacy of resources
E) The effectiveness of actions taken to address the risks and opportunities
F) and finally, Opportunities for improvement.
9.3.3 MANAGEMENT REVIEW OUTPUTS
The outputs of management review shall include decisions and actions related to:
A) Opportunities for improvement
B) Any need for changes to the quality management system
C) Resource needs.
Make sure to retain documented information as evidence of the results of management reviews.
For information on how you too can easily be ISO-certified. Visit our website at www.agfconsultinggroup.com