Following the articles we were able to share with our customers from DQS Argentina and DQS Taiwan, we are now proud to present an article by Soong KV from DQS Malaysia.
Changes of this latest version of ISO 9001 compare to its previous version of year 2008 are significant and accommodate to current management system trends. Previous focus in identifying core processes and ensuring effectiveness of these processes so as to achieve customer satisfaction, are now talking about the assessing and evaluating the risks and also opportunities of key processes in the context of each organization. The organization is now required to determine those interested parties who are relevant to the management system and identify the needs and expectations of these interested parties.
Top management in any organization is always the key factor to drive to success. This new version therefore emphasizes active involvement and participation of top management to ensure effective implementation & maintenance of quality management system. This is clearly described in clause 5 Leadership in the new Standard. Also significant change from previous clause of 5 Management commitment and responsibility, the position of Management representative has been removed from this revised Standard. The roles & responsibilities of MR are now part of clause 5.3 of the revised Standard.
In clause 6 Planning, Risk based thinking or Risk analysis is introduced in year 2015 version. This may not be new for some organizations especially those ISO 13485, ISO/TS 16949, AS 9100, etc. certified organizations who has implemented risk management using FMEA, ISO 14971 etc. tool. But it is definitely a very significant change in the development of ISO 9001:2015. There is no requirement to have a specific tool nor method to determine the risks. However, the organization is expected to demonstrate how the risks and opportunities in all identified processes are analyzed and evaluated. In association with these identified risks and opportunities, the management shall plan relevant actions to address these risks and opportunities as well as how to integrate and implement these actions into the processes and evaluate effectiveness of these actions. As per previous versions, quality objective remains as it is and now the 4W1H approach is introduced to plan the achievement of set quality objectives.
Previous clause of 6.1, 6.2, 6.3, 6.4 & 4.2 are now restructured and rephrased in clause 7 Support. Document and record are now redefined as Documented Information. Clause 7.6 Calibration of 2008 version is now addressed in Clause 7.1.5 Monitoring & Measuring Resources.
Previous clauses of 7.1, 7.2, 7.3, 7.4 & 7.5 are now addressed in Clause 8 Operation. The revision of this 2015 Standard does not allowed any of the requirements/clauses to be excluded. Nevertheless, some of the elements in clause 8 may be not applicable to certain organization business nature.
Clauses 9 & 10 of this revised ISO 9001 are basically clause 8.1, 8.2, 8.3, 8.4 & 5.6 of 2008 version. Management Review is now under clause 9 Performance Evaluation which reflects the nature of this requirement as CHECK activity in PDCA cycle. The review inputs have been expanded to ensure items to measure effectiveness of quality management system, such as achievement of quality objectives, performance of external providers, customer satisfaction & feedback from interested parties etc., will be reviewed effectively.
With all these changes, thorough an in-depth readiness review for our existing certified clients towards smooth transition of ISO 9001:2015 is deemed necessary. Explaining to the client about this onsite readiness review will be a challenge ahead considering other certification bodies are basically reluctant to practice so. Nevertheless, as a preferred certification partner, DQS’s approach towards upgrading to this ISO 9001:2015 shall be valued. This is very much similar to patient and doctor kind of scenario. Doctors will never diagnose nor prescribe “Offsite”. He/she for sure will see the patient face-to-face (“Onsite”) to ensure clear and unambiguous information obtained to support his diagnosis and prescription. Hence DQS’s on-site readiness review for our certified clients towards the transition of revised ISO 9001 serves the same purpose.