If ISO 9001:2015 is effectively applied, auditors will no longer use a clause-by-clause approach to auditing QMSs. Dr. Croft of TC 176 addresses this issue directly while answering a question about the difference in audit approach expected of ISO 9001:2015. Continue reading
Let’s say Pete’s company has been in business for over thirty years. Now ISO 9001:2015 comes out requiring risk-based thinking. Does that mean Pete must therefore engage in formal risk management, and that management must use a risk assessment tool to provide evidence of risk-based thinking? Continue reading
Confusion surrounding ISO 9001 has caused many organizations across the globe untold troubles. The upcoming revision of ISO 9001, due later this year, offers yet another source of confusion: the concept of risk-based thinking (RBT). Some are responding to this new requirement with suggestions for companies to use risk assessment tools to provide (easy?) evidence of risk-based thinking. Continue reading
In 1987, when the ISO 9000 family was originally released, the ISO 9000 (the document) was fairly clear about the intended use of the standards. Despite this, organizations got the idea that THEY were the end users of ISO 9001. This mindset was so prevalent that it influenced later revisions of the standard, as its authors try to be responsive to customer feedback. This mindset is still prevalent today; a change in mindset would make many organizations’ experience with ISO 9001 much better. Continue reading
No, ubiquitous RBT isn’t a new rap group. It’s a more of a reality show. While risk permeates every aspect of life, risk-based thinking (RBT) is applied anywhere good sense is needed to deal with risk. Each risk recognized offers an opportunity to apply RBT. Continue reading