Now that we have the final version of ISO 9001:2015, it’s time to see if there are any implications for our organizations on the auditing side. Well, there are! The disappearance of specific required documents should not be any surprise. We went from 20 required procedures in the 1987 and 1994 versions down to 6 in the 2000 and 2008 versions. Now we are at ‘0’ but I’m sure we’ll all have plenty of documentation around for some time to come.
For many, it’s just like Linus’ blanket in the Charlie Brown world. And like the blanket, documented procedures serve very little practical purpose from the standpoint of day-to-day activities. People in your organizations know how to carry out their processes. For orientation or refreshing, some documented procedures could be helpful, but nothing replaces training. And remember that the Milleniums do not read.
So if you or some of your regulatory bodies insist on documented procedures, at least make your documenting investment pay dividends by avoid the fatal ‘wall of text’ and get creative with videos, pictograms (like WHMIS), flow charts or anything that tells the story, but gets used.
So now we come to auditing. If procedures are not going to be as plentiful, how will auditors determine conformance? According to an IRCA article, Next Generation Auditing, the steps to carry out an effective audit of our processes and activities are unique to every organization – audit activities are relative to the context. But some basics are consistent across the board and across Standards.
Overall, Green suggests that simply hauling out a procedure and walking the auditee through the requirements asking for evidence of conformance will not add value. Especially if it’s a poorly written procedure, out-dated or irrelevant because of contextual changes in the organization. In fact, forcing an employee to follow a procedure that doesn’t work is not only a profit killer, it is demoralizing.
Instead, auditors will have to start looking for process effectiveness, shown by developing new links with Management – into the boardroom, if you will. Auditors will have to assess whether the evident ‘results’ are supporting the organization’s strategic direction. Management has to make sure that they integrate QMS requirements into their business processes. Auditors will have to learn how to interview people to see if this is happening, not just whether people are ‘following the procedure’!
Results, results, results. Are they being achieved? Do people know what this looks like, and how they are contributing to the objectives of their organization? More interviews!! So the days of ticking of boxes (except for a few specific situations) are pretty much behind us. Thank goodness! Let’s get some payback from our audits and focus on ways to improve processes to give us better results. This payback goes straight to the bottom line, too.
Jim Moran
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Jim Moran, MA Ed., President of SimpifyISO.com, has worked with all 5 versions of ISO 9001 – 1987, 1994, 2000, 2008 and now 2105. He has been implementing, auditing and training in the ISO world since 1992. Jim has been doing ISO 9001:2015 presentations since November of 2013 and has done a number of webinars, ½ day presentations and full day trainings on ISO 9001:2015 for the British Standards Institute, BSI. He currently sits on ISO PC 280, an ISO committee formed to participate in the development of a new ISO Standard for Management Consulting.e-mail: jim@simplifyISO.com
website: http://simplifyiso.com/