3 Things You Need To Know About Risk, Calibration and ISO9001
Posted by Phil WisemanJun 21, 2017 10:15:44 AM
3 minutes to read
Planning. Context. Customer Focus.
Planning Section 6.1 Actions to address risks and opportunities
Context Section 4.2 Understanding the needs and expectations of interested parties
Customer Focus Section 5.1.2 b) The risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;
Calibration is typically viewed as something you have to do.
Do you want to have it calibrated or do you need to have it calibrated?
Is there really a difference?
As you delve into ISO9001:2015 the answer is both.
Calibration is inextricably weaved in Planning, Context, and Customer Focus. A well-articulated calibration program allows you to address Planning, Context, and Customer focus. This would include a clear understanding of customer tolerances and the selection of the appropriate measuring device to meet that tolerance. Likewise, you will need to take a close look at the standards used in calibration to determine if they are adequate to minimize the risk of product non-conformity. Simply having a device calibrated will no longer be adequate. You will need to understand the methods and standards used and make a fit for use determination. In legal terms, you need to exercise due diligence.
As a customer of calibration, regardless if that is an internal or external lab, you will need to specify your requirements and have ongoing conversations with all parties to ensure requirements are met.
Phil Wiseman is Chief Marketing Officer at Alliance Calibration. He earned a B.S. in Chemical Physics from Centre College. Phil is an ASQ Certified Quality Auditor and ASQ Certified Manager of Quality/Organizational Excellence.
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