ISO 9001 – Lessons from the Trenches

Date: September 7, 2022

Time: 9:00 AM-10:30 AM PDT

Speaker: Daniel Clark, Clark Health and Safety Ltd.

Webinar Details

Themes

– ISO 9001 is so widely implemented that, by design, it applies to any kind of organization. This means that it is broad and general, and not prescriptive of methods. Figuring out how to achieve the requirements is an entire subdiscipline with its own best practices.

– Auditors will give away the nature of their industry experience by where they focus. Some have process or engineering experience, others were managers, or some with quality control backgrounds that may focus on the technical compliance like defect rates, calibration, etc.

– Infinite recursion is implied by some requirements, such as calibration. Items must be certified by a qualified certification body, which itself must be certified by a certification body that must be itself qualified. Judgement comes into play because at some point we have to accept that an organization at some level must qualify itself. An auditor should be prepared to justify that, because it gets asked all the time.

– Auditors have vastly different methods of doing audits. I have sat in with senior auditors and observed, and had the chance to do many myself or be involved with other auditors doing externals. Styles vary wildly, but it seems consistent that writing up reams of paperwork isn’t a worthwhile effort because it bloats costs, increases time and produces an onerous tome of reading that probably nobody will actually take the time to go through. There’s nothing to prove by being wordy – be concise.

– Collecting feedback is tough, but we have to do it. Surveys are used often, but are of such low quality that one wonders if they serve any purpose at all. They will solicit blasé, half-hearted feedback or overstated anger – one needs only to browse reviews on a site like Amazon to see how these systems become a game. Reviewers offer mostly 1 or 5 stars with the intent of pulling the average one way or another, which isn’t in the spirit of the practice.

– An auditor doesn’t make assessments on the quality of practices like monitoring, measuring and risk assessment, instead trying to assess if a company has done the activities to make the assessment. It’s an important distinction with a seriously blurry line.

Cases:

– Company whose founder (and holder of basically all organizational knowledge) passed away unexpectedly. Company had used the same internal auditor for a long period of time who did little in the way of actual consulting/coaching/training and relied on the owner’s knowledge base. The loss of their senior manager meant the company had to scramble to reassemble all parts of the QMS.

– Companies, by and large, are confused about what a quality manual is supposed to be. Saw more than one with manuals that copied the ISO standard verbatim, but adjusted the verbiage from “organizations must” to “we will”. This works alright for policy but less so for procedures and guidelines, because ISO doesn’t really tell you how to do anything.

– Auditing an engineering firm (as many working internationally require ISO certification) is difficult because everything applies, but indirectly or in unusual ways. Trying to come up with ways to assess monitoring and measurement, or rate of defects, or training is difficult when much of the actual “work” is performed by subcontractors and not even supervised by the audited firm.

– Manufacturing outfit with long term, specialized workers and their resistance to change. Coaching workers to participate by, for example, reporting non-conformance is a tough sell because many are dug in on the idea that this results in disciplinary action.

About the Speaker

Daniel Clark is the founder and President of Clark Health and Safety Ltd., providing safety and quality consultation and auditing services across various industries in Calgary, Alberta starting in 2018. Prior to that, Daniel worked on implementing safety and quality management systems at various companies pursuing ISO or COR certification.

Daniel has a Bachelor of Science degree, certification in health and safety, certificates in both CAD design and CNC operation, ISO 9001:2015 and 45001:2018 auditing certifications as well as certification to train other lead auditors in those frameworks through PECB. Additionally, Daniel has earned the professional designations of Canadian Registered Safety Professional (CRSP) and National Construction Safety Officer (NCSO) for his work in the safety industry, and is a Certified Quality Improvement Associate (CQIA) through the ASQ.

Being raised and practicing in Calgary, the heart of Canada’s energy industry, most of Daniel’s career has been connected to the safety and quality in the energy industry. He has performed safety and quality roles from field supervision to office-based administration and management. Daniel’s consulting business has worked with organizations offering engineering services, restoration, industrial trades, recreation, pipeline, environmental, manufacturing and food processing.