Effective Transition of QMS from ISO 9001:2008 to ISO 9001:2015 needs clear understanding of the new standard requirements, particularly what has changed and how these changes can influence your organization and how you would audit the new requirements effectively.
Many of the requirements are new and going to make life easy for the organizations implementing integrated management system, or implemented multiple standards for managing their management systems such as Quality management system as per ISO 9001. Environmental management system as per ISO 14001,OH&S as per OHSAS 18001(going to be ISO 45001), BCMS as per ISO 22301, Food Safety as per ISO 22000,Energy Management system as per ISO 50000 and so on. The new high level structure and common terminologies would make the integration very systematic using 10 element structure. There would be a similar look and feel.
Many of the requirements are new and explicitly mentioned in their own rights however most of them were to an extent hidden in earlier version, ISO 9001:2008 had been a fantastic standard and would remain relevant. However with change of technology, business environment, and overall maturity , the new standard needs to keep it relevant with the constantly changing world. There are significant changes in Documentation requirement and top management leadership. By removal of MR’s position the standard demanding more visible engagement of top management, this reminds me of Dr Deming’s famous quote. “Adopt the new philosophy. We are in a new economic age. … Management must awaken to the challenge, must learn their responsibilities, and take on leadership for change”. He advocated to “Institute leadership”.
However an organization can still keep this position. For certain QMS functions however as an auditor you need more matured approach to audit the top management to assess their role, engagement and participation. This is why the standard requires Top management to develop Quality Policy with their stated direction and communicate to the people within the organization, take active part in management review and improvement initiative. Quality Objectives now needs to be integrated with the strategic direction of business, in other words, Quality objectives should be integrated with organization’s objectives. This makes great business sense!
The standard does no longer require quality manual and mandatory procedures for 6 clauses as was needed by ISO 9001:2008 standard. how the organization can then document their management system then? Well you can continue with a Quality or integrated system manual if the organization desires so or develop procedures as they need and feel important to effective control of processes. The organization can even map identified processes with necessary inputs and desired output/s with defined controls and link them with records maintained or retained to provide evidence of conformity. The standard in fact now require more matured understanding and implementation with focus , thus has become subjective ,and demands more maturity and dexterity on part of the auditor.
Risk based thinking is a major highlight of the standard. Organization does requirement determination of risk affecting quality of product and services; however do the organizations need a formal risk assessment? The answer is no, however if an organization want to do it, they can of course do, in fact the progressive organization may do it to even quantify the risk and make an informed judgment and decision to the level of risk they want to leave with. This is in fact is similar to risk appetite in Business Continuity management system.
Upcoming topics would be-How to audit Documentation requirement as per ISO 9001:2015
We have developed ISO 9001:2015 implementation and transition course for the participants to gain updated knowledge and competence and remain ahead of curve. You may find the two days of transition training worth if you are an auditor of quality management system and want to contribute to organizations you work for, consult or audit quality management system as per the new standard. For maintaining IRCA registration, 2 days transition auditor training is a must and you have to gain this competence .TCB offers IRCA Approved ISO 9001:2015 Auditor/Lead Auditor transition course. Join us to retool yourself .Join us for an enjoyable leaning experience