ISO 9001:2015 Transition
This email will be the first of more, hopefully, informational emails regarding your ISO 9001:2015 transition efforts. First, we appreciate the relationship we have with each of you and want you to feel very welcome to contact us regarding business and auditing aspects. As each of you know, we cannot consult, however I can give you information regarding these transitions.
I don’t know about all of you but I have actually lost sleep thinking about this transition. It just doesn’t seem flowy and intuitive. But when I finally stopped whining and kicking, I realized this standard is probably easier than any one we have gone through. But it is different; the rhythm, the layout, and the structure. Before I get into the “point”, here are a few tidbits of information about the ISO 9001:2015 standard:
[li-row]Released September 23, 2015[/li-row]
[li-row]Existing certified companies have three (3) years to transition to the new standard. (September 15, 2018)[/li-row]
[li-row]All newly revised management system standards will now be approximately 30% the same. 30% the same vocabulary, 30% the same requirements. And 100% the same structure. The idea is that you can implement a more integrated management system.[/li-row]
[li-row]There are no requirements for a Quality Manual……..slow down now….if you have one…you might want to keep it..but it is not a requirement. ( I’m going to miss y’alls Quality Manuals, that regurgitates the standard word for word EXCEPT for the scope statement : )[/li-row]
[li-row]There are no procedure requirements…..sort of. The standard now calls our old documents, “documented information”. So that means you can have your management system information in any form. Such as electronic, paper, video, stone and so on.[/li-row]
[li-row]Records are now called “documented information”!!! What?!!!! The difference between the two is “maintained” vs “retained”. Your procedures etc. are MAINTAINED (so you can use them over and over). Your records are RETAINED for posterity sake or some such.[/li-row]
[li-row]There is no specific requirement for a Management Representative….for all you MRs out there..you know you will still not be released from the depths of management system purgatory. But just as with the Quality Manual extinction, it seems most companies will keep a MR.[/li-row]
[li-row]Oh….PREVENTATIVE ACTIONS! What are those? Exactly….y’all know who you are….well you lucked out…requirement removed. But wait there’s more, instead of preventive actions…we all get to….implement throughout the entire management system—–RISK BASED THINKING. (I’m shaking my finger at all of you that have had no preventive actions…now look what the International Organization went and did…) So that is my segway:[/li-row]
I want to cover ‘risk based thinking’. The ISO 9001:2015 standard does not require your company to have a formal risk management program but it does require that the steps you take in the realization of your product and services….you think about risk, potential impact and steps that need to be taken to mitigate those possibilities. But not every potential risk needs to be addressed….YOU GET TO DECIDE based on potential impact…that’s where the risk based thinking comes in. This risk based thinking can be a very useful tool in your company. Also, not every risk you identify and mitigate means the risks must disappear. Maybe you can only do a certain level of mitigation and then the time, cost, and/resources become too much. Think PRIORITIZATION. Today I can almost bet each of you already work in a risk based thinking manner. Let me offer some examples:
[li-row]The inventory levels you maintain so you will not run out of product- you are minimizing the possibility (reducing the risk). Think about this on the front end (purchasing) and back end (finished goods).[/li-row]
[li-row]The frequency you apply to calibrated measuring equipment- I’m guessing here, but most of you determine frequency dependent upon use, criticality of the characteristic, etc. (Risk based thinking)[/li-row]
[li-row]Depth of corrective actions. Ok so let’s think about this…every corrective action that is issued does not get the same level of attention and depth applied. Why? Because you are weighing the potential impact.[/li-row]
[li-row]Let’s think about training- would the same level of training be given to an employee that applies the appropriate labels to packaging as an employee that works in a cleanroom? Both are very important processes but one may be more “risky” than others and need more detailed/length of training. (Potential Impact).[/li-row]
[li-row]In everyday life: SPEEDING….you make a decision based on risk and the threshold of potential impact you can withstand if caught.[/li-row]
Those are a few examples to hopefully help you to start “risk based thinking”
Start looking at your processes and considering how you approach risk based thinking. You do it, now become aware of it.
That’s it for today.
Along with Carol Tillman, I am always available to answer questions or assist you – so give either of us a shout! You can also visit our Website www.QSR.com and our LinkedIn Company Page to find this and other information.
Director Registration Services
Quality Systems Registrars, Inc.
QSR® is an accredited third party certification body encompassing ISO 9001, ISO 14001, OHSAS 18000, RC 14001, RCMS, AS 9100 and ISO 13485 standards.
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