Tuesday, September 20, 2016

ISO 9001:2015 Transition Made Easy and Fun and Profitable




Once every 10 or 15 years, Quality Professionals are given the opportunity to make significant contributions to their company, their profession, and their career.   This is one of these times! This is a game changer!

ISO 9001:2015 is the first major revision of the standard since 2000, and it has been written with today’s business challenges in mind. The changes make it flexible enough to offer multiple benefits to organizations not just as a quality management tool, but a significant framework for business improvement, delivering efficiencies and improving customer satisfaction

Two big things – the QA manual is no longer required and the highest ranking executive at the facility is responsible for quality with emphasis on leadership engagement – not the QA Manger, not the ISO management rep.

Skeptics have argued against Quality Manuals for decades by asking where is your Engineering Manual? HR Manual? Marketing Manual? Every organization now gets a chance to create business driven process maps and process flows. This is a great way to apply all sorts of good business practices instead of just updating an old quality manual based on a new ISO standard that no one reads except during an audit.

Every quality professional gets to actively engage leadership with business driven conversations instead of “You have to for ISO.” The addition of risk based thinking appeals to every executive that has been frustrated by what has been perceived as a costly and non-value add QA/QC stuff done for ISO compliance – the plaque on the wall.   For an example, please review “Bridging the Gap between Quality and Finance”- https://www.slideshare.net/slideshow/embed_code/21171045

Transition steps
  • Find an external resource to help that speaks in business talk and understands traditional QMS, in that order. Do not engage a resources that only speaks ISO standards and ISO paragraphs and what auditors will look for – we are leaving that behind and going into a new and powerful business approach.
  • Provide appropriate training and awareness for all parties
  • Learn and rapidly adopt a process map / process workflow approach. Key business metrics will come from these processes – make sure you are collecting data and have a reporting engine.
  • Apply the process modeling across the entire organization – this is a business system, not just a quality management system. Get the executive team involved – they own the process, they should create, approve, and audit the new process definitions.
  • Check the registration timeline and plan for it – it you do not get re-certified and your certification expires, you have to start over with the registrar.   This is an expensive mistake you want to avoid.
  • Decide if any manual, labor intensive, time consuming process should be automated. Make sure data is being collected, reported, and actions taken.
Summary
ISO 9001:2015 is less rigid than previous versions and incorporates more business management terminology and concepts. Documentation requirements are left to the organization to judge its own needs. The standard is written for the benefit of organizations, not auditors.

How Can I Help You?
I am providing half day Executive Overviews, and 5 day, 10 day, and 20 day engagement plans that are customized to meet your specific needs. Send me an email to learn more at jmc@peproso.com
I am working with ISO9001, ISO13485, AS9100 and TS16949 sectors

http://peproso.com/recomendations/