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The ISO 9001:2015 standard may still be in draft form, not quite set to replace the existing standard until the end of 2015, but it’s important to keep apprised of these changes and what they will mean for you when complying with the new standard. So what changes lie ahead? In this article we’ll look into how the new version of ISO 9001 represents not necessarily a change in the actual requirements, rather, the difference in the approach. In other words, it’s the mind-set that’s changing.
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Quality is everyone’s responsibility
That mindset has become one in which no single person has the primary responsibility for an organization’s quality. Instead, we get a broad look in which everyone is committed to quality, to customers, and beyond. So, if there isn’t one core person who “owns” quality, where does quality live, and how does the entire company become engaged?
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Meeting Process-approach requirements in ISO 9001:2015
Hi Timothy,
The intent of ISO DIS 9001:2014 and we expect the final standard in September was and is as you wrote, to estbalis a “... process-based quality management system".
That word 'system' can mean any manual, soft or computer 'system' that suits the organization's "context" as the Standard requires. So it does require an electronic document management system per se, albeit, it certainly helps and affords many benefits as you and other contend.
The 'process-approach' is for some organizations, conflicting as they have documented their Quality and unfortunately, other ISO management systems by copying the headings of the clauses into their policy manual headings. The new Standard requires under 0.6 "organizations are not required to follow an identical clause-by-clause sequence when defining their QMS and are encouraged to use the process Approach as described in 0.3 to 0.5".
There are many process frameworks available for organizations to utilise and re-engineer their clause based QMS's to a process-based one like APQC PCF, IDEFO, and industry ones like ITIL III and IDEFO and so on. ERP and BPM's require that process modelling (BPMN) as does TQM CI, BPR, Lean and Six Sigma programs - they are based upon processes as we know.
What better place to source processes for improvement and then sustaining their project and process improvements reposited into these stabilised, controled and capable processes within a process-based QMS and Integrated MS.
Having process transparency and process layered audits will provide organizations and their customers and other stakeholders / interested parties, greater confidence and assurance of compliance if they can see (hard or soft copies) these processes and how they are better controlled, and meet the various Standard requirements of the clauses, that are overlaid onto their processes.
We all look forward to ISO 9001:2015 release that such process management principles and documentation, hard or soft, provides a profitable process to deliver their goods and services to their customers, with confidence.
As we move into a more distributed and mobile 'App' workplaces and access, electronic document systems are crucial as you say but hard or manual systems will for many, suffice.
Michael
Accepting
Hello Mr. Timothy,
I am in the aerospace industry for almost 30 years since this AS9100 stated I seen a lot of obstacles and problems about leadership, your comments and observations are all correct but one this as of my point of view it is important one that most of the companies they don’t believing to the system all they want is certification on the wall, that’s all there is no leader ship or “Let’s work together for better Industry” another word Leader ship exists but no action from Leaders, most of the time I am hearing, “YOU CAN NOT TEACH AN OLD DOG NEW TRICKS”
Respectfully
Victor Khosrowian
FAA A&P
NADCAP & AS9100 Lead
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