Issue 110 – Is calibration “Not Applicable” in a Service company?
ISO 9001:2015…
Is calibration “Not Applicable” in a Service company?
I appreciate receiving emails with questions and/or comments from readers of this Newsletter… please continue to do so since it provides me with ideas on what these publications should cover. In my last Newsletter (ISO 9001:2015 Newsletter Issue 109) we discussed the topic of “Why review QMS documents if nothing has changed?”, and now in this Newsletter we will discuss “Is calibration ‘Not Applicable’ in a Service company?”.
The ISO 9001:2015 Element numbering…
Element 4 – Context of the organization
Element 5 – Leadership
Element 6 – Planning
Element 7 – Support
Element 8 – Operation
Element 9 – Performance evaluation
Element 10 – Improvement
Is calibration “Not Applicable” in a Service company? As background information, when the 2015 version of ISO 9001 was released in September of that year, one very obvious change was that every time the word “product” was used, it was replaced with “products and services”. I believe this was intended to attract more Service organizations to use ISO 9001 as a framework for their QMS. To date, Manufacturing organizations continue to be the primary users of the ISO 9001:2015 Standard. However in those instances where a Service company does implement an ISO 9001 based QMS, they find themselves confronted with “shall” requirements that are not easily addressed. A good example is “calibration”. I can tell you from first hand experience of working with a handful of my Service Clients, not to mention applying ISO 9001 within our organization, that the best way to handle these situations is to look at the “intent” of the ISO requirement.
Clause 7.1.5 Monitoring and measuring resources, that states the following: “The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements“. Service organizations also have core processes that fulfill Customer Orders (just like a Manufacturing company does)… and these core processes need to be monitored/measured in order to ensure their Output meets Customer requirements… the key difference is that the “resources or devices” used to monitor/measure are not your typical measuring instruments. So in this case, you’ll need to review how the Service organization ensures that Customers Orders are fulfilled, while at the same time implementing monitoring/measuring activities to ensure that the requirements of the Customer are met… and then decide how best to “calibrate” those monitoring/measuring activities.
Be sure to watch for our next Newsletter issue where I will be answering some of the questions that I get from Readers of my Newsletters about how to implement the requirements of ISO 9001:2015 in a specific and practical way, that will also help improve business performance…
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Need Help?
ISO 9001:2015 Internal Audit Outsourcing (we can do it for you OR with you!)
For cost effectiveness, the Internal Audit function can be outsourced to an external experienced auditor on a periodic basis. This will provide an independent and objective assessment to management, of where process issues may exist, along with identifying opportunities for improvement. It will also provide the evidence needed to satisfy the Internal Audit requirements in the ISO Standards. We have used two different approaches with this service: a) We conduct the entire audit ourselves, or b) We act as the lead auditor, and along with your Team of internal auditors, we complete the entire audit together. This latter approach allows your people to receive guidance and direction from an experienced lead auditor while at the same time maintaining significant involvement in the internal audit process.
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Internal Process Auditor Training for ISO 9001:2015
The two (2) day Internal Process Auditing for ISO 9001:2015 Training Session is focused on a process approach to auditing with the objective being not only to assess conformance of the quality management system, but also to uncover process improvements during an audit. This goes hand in hand with the process auditing requirements found within ISO 19011 and the process approach covered in ISO 9001:2015, which promotes continual process improvement throughout this Standard. An enhanced checklist is developed, and there will be workshops throughout, to reinforce learning, as well as a live, practice audit. If you are looking to meet the ISO 9001:2015 internal audit requirements and to “raise the bar” for your internal audit program then this is the course you should consider.
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Until next time…
Tim Renaud
Helping Business Professionals Reduce Risk and Remove Waste!