A couple of thoughts concerning your overall ISO 9001:2015 transition strategy can be found below:

For 2015 actions:

1.  For the organization’s ISO team and / or leadership team, conduct a detailed overview of all the significant changes to the standard so that you better understand the implications for your organization (Sept – Dec).

2.  Obtain the funding for 2016 for an overview of ISO 31000, Risk Management Principles and Guidelines, to conduct a gap assessment against the new standard, and to have hours allotted for developing your implementation plan (Sept – Dec).

For 2016 actions:

1.  Conduct a gap assessment to evaluate status of your organization against the ISO 9001:2015 requirements (Feb – May).

2.  Conduct overview course to ISO 31000, Risk Management Principles and Guidelines (Feb – May).

3.  Develop your detailed transition plan, based on results of your gap assessment (Jun – Nov).

4.  Obtain the funding for 2017 / 2018 to work your transition plan.

5.  Don’t make significant changes to your QMS during the first year that the new standard is out.  Give the standard a year of “run time” and churn.  During this year there will be lots of discussion on various ways to meet this or that requirement especially in the area of risk-based thinking.  The various ISO technical groups will publish a handful of guidance / interpretation documents.  Let the standard work out some of the wrinkles.  This will save you rework, angst, and money in the long run.

For 2017 / 2018 actions:

1.  Start working your transition plan early 2017.  Make your transition timeline 12 to 16 months long so you are working it at a pace that is easily integrated with your operations schedule and budget (Jan 2017 – Mar 2018).

2.  Obtain the funding for your registration audit to occur in 2018 (May – Jul).

3.  This strategy will bring you into full compliance to the new standard, with a QMS that is the best reflection of your business processes, with about 6 months left before ISO 9001:2008 is no longer applicable.

The new ISO 9001:2015 brings some significant changes for your QMS and your business.  Transition to the new standard does NOT have to be complicated or expensive.  Make sure you understand the changes and their implication to your organization and help you develop a transition plan that will align and integrate risk-based thinking within your key business processes.

Bio:

Tom Bacus has more than thirty years of experience building, operating, and auditing quality management systems.  He was the Management Representative and the project lead for implementation of an ISO 9001 quality management system that aligned with and supported the risk framework and business strategy for a $75M division of a $1.5B company.  This resulted in successful certification of the quality system.

Tom also managed a staff of 105 people – planning, monitoring, and executing all aspects of the Navy nuclear submarine Quality Assurance and Submarine Safety Programs at a major maintenance and repair facility.

He is an ASQ Certified Quality Auditor (CQA), Certified Enterprise Risk Manager (CERM), and Senior Examiner for the Virginia State Quality Award.  He was awarded the NASA Astronaut’s Silver Snoopy award in 2008 for professional excellence and for being instrumental in identifying significant hardware issues and development of new assurance processes and raising the bar in quality assurance auditing.  In 2011 he received a NASA Group Achievement Award for his outstanding contribution to the development and execution of improvements to their audit processes.

Tom Bacus is the owner and Chief Executive Manager of Bacus & Associates, LLC; a certified Service Disabled Veteran Owned Small Business (SDVOSB).  You can reach Tom at bacus.associates@verizon.net.