With the change of time, technological options available today, there is a 180 degree shift on ISO’s approach on ISO 9001 standard with regards to documented procedures. When introduced in 1987, there was tremendous emphasis on documented procedures, all management system elements practically needed procedure, be it Purchasing, Design, Manufacturing and so on. The emphasis on procedures was so much that the intent of the standard, that is the “result” from Management system which is “good quality product and services” that customers wants to be assured of getting from a certified organization was lost in the ocean of procedures.

In my career as an auditor and trainer, I have found great degree of frustration from many senior management professionals those who run the organization and felt the documentations were indeed crippling the organization, brought in bureaucracy, started to destroy the creativity .I argue with them that the standard always did not ask for procedural steps and how an activity should be performed as the standard has never been suggestive. At many instances it was the competence and understanding of the consultants, implementers or even the auditors on the business processes of the organizations that mattered.

There is no doubt procedures are important, written or otherwise, such as a convention butcompliance to procedures itself maynot produce results and therefore the emphasis must be on “results”. This is where process approach comes in. A “process” is basically transformational activities to convert inputs into output. The process would produce desired results when activities are logical and performed under controlled condition.

As a good auditor you therefore must look at what is/are the desired result or results expected from the processes. What are the activities to be performed and their right sequence for effectiveness and efficiency? What are the required inputs and sources of inputs? Once you look at these elements and remain focused, you really do not need a procedure for auditing or performing such activities. If a documented procedure is felt necessary by the organization, let them have it. As an auditor or implementer, one needs to look at the value of a document, does it serve any purpose, and can the activities be adversely affected without a procedure? If yes-then you need to have one. This is the fundamental understanding.

Let me give an example. Say you are auditing how a tea shop makes a cup of great tea for its customers. Desired output is a “nice refreshing tea with great flavor”. What is needed? Tea leafs, water, water heater, a tea pot, milk, sugar and clean cup and plate to serve. Now look at the variables those can affect the quality of the tea. Quality of water comes first, and then the quality of tea, amount of tea leafs per cup, soaking temperature and time, amount of sugar, amount of milk etc.etc. These are the process inputs ,  parameters and activities those need absolute controls for consistent results. You may expect some kind of a procedure or guidelines or training instead of a procedure. Serving temperature is another critically important thing. The guest may otherwise burn his or her tongue while taking the first sip itself!!

If there is no procedure or no guidelines or anytraining, each time they make tea may differ in taste. Different personsare most likely to make completely different tasting tea. This is not a situation you would expect in a hotel serving you a tea! Therefore a procedure and guidelines may be needed. If the people are very well trained on this process to keep the variable under control, you really need no procedure; everyone will produce the same output. This is a management system capable of delivering consistent results. This is how you need to audit. 

ISO 9001:2015 audit transition course

As we all know that latest edition of ISO 9001 is published in September 2015 and new edition 9001:2015 replaces the previous ISO 9001:2008 edition. 9001:2015 audit transition course assist you get awareness about the significant changes occurs in the current edition. This IRCA approved courses is advantageous and those who are already working in quality management system it will helps to make transition successfully.

 

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