Issue 118 – Why can’t calibration Vendors just do their job?
ISO 9001:2015…
Why can’t calibration Vendors just do their job?
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 117) we discussed the topic of “Should I use the ISO logo?”, and now in this Newsletter we will discuss “Why can’t calibration Vendors just do their job?”.
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
Why can’t calibration Vendors just do their job?… I have asked this question many times while in the middle of conducting an audit. The reason why it is so frustrating is because my Clients end up receiving a non-conformance for a poorly performed calibration service, that they have paid good money for someone else to do! I realize that the organization is responsible for any of their “outsourced” processes, as stated in the last sentence of Clause 4.1 of the ISO 9001:2015 Standard, however most companies have an expectation that calibration Vendors should know what they are doing, right?
Some of the calibration problems I’ve seen with Vendors… I can tell you from first hand experience, during multiple audits, I have discovered all sorts of problems caused by Vendors such as: a) calibration stickers missing; b) forgetting to calibrate ALL of the devices at the site; c) not placing an updated calibration sticker on a device; d) putting the wrong information on the calibration sticker; e) not using unique identification numbers for a device; f) not entering the correct information on the supporting calibration paperwork/record so it can be matched to the sticker… etc, etc, etc.
There are a lot of good reasons to perform calibration on any devices used to verify that your products/services meet specs. At the most basic level, the idea of placing calibration stickers on those devices is to let the person know, who is about to use it, that it’s clearly in good working order…. and if the sticker falls off or becomes unreadable, then there is supporting calibration paperwork available that directly connects to that device, in order to verify that this specific device is okay to use. As a final comment, my advice is to check that your PO clearly states what you expect from your calibration Vendor… and don’t pay their bill until you confirm that they’ve done what they are supposed to do.
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…
To view all of our past Newsletters or to sign up to receive them… click here
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
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.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
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.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Until next time…
Tim Renaud
Helping Business Professionals Reduce Risk and Remove Waste!