Transition to ISO 9001: 2015 Approach to Risks, Design and Development,

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...think to start now.

We continue our articles on the new ISO 9001:2015 and how we can go transitioning. The standard has been bringing small changes occasionally, with only a major change in year 2000 (process approach) till year 2015 so it is therefore advisable to anticipate and plan a smooth transition.

Even for many cases where it has not even reached the management system remains focused on processes, effectively, this development is a support and help to end the previous evolution and focus the system towards a complete and global management that safeguards the risk for the customer and assist in the sustainability of enterprises.

The norm becomes more international, independent of the volume of business, more holistic, through the high-level structure, considering the context, and through the reduction of documentation requirements and manual, than the elements themselves required, becoming much more scalable. It is also quite remarkable that the high-level structure extends to the ISO 14001:2015 and which is to be extended to other management standards..



The approach to risks directly results in the disappearance of preventive action, as these processes and considerations are embedded in the risk assessment. It is true that the rule does not say how we should analyze and assess the risks, but also sheds tracks citing the ISO 31000. The tool you choose should be appropriate depending on the context of each company and especially for the risks posed to consumers, but there risks should be related to objectives, and whether to implement risk control measures.

Operations maintain the need for planning and customer focus as well as the elimination of the exclusions, and explicitly stating "design and development" as an ordinary part thereof, for those who have that kind of activity, which are all . Every organization, whether in services or products, develops an activity which is performed from a model, more or less elaborated, ie designed your service or product, or has commissioned the design to others, and develops later or not.

Chapters 9 and 10, are also key, because we have to evaluate the performance looking at the risks, correct first and then improve, completing the PDCA cycle. Of course there is a certain standard orientation towards innovation, because the actions and correct deviations plans to improve nonconformity, and these corrections are set on the risks and on the facts, to overcome them. 

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