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By Curt Lopez, Quality System Lead Auditor & Project Manager for Missouri Enterprise

Three years.  That’s how long we’ve been talking about the dramatic changes involved in the transition from the soon to be obsolete ISO 9001:2008 requirements to the new ISO 9001:2015 standard.  September 14, 2018 is the deadline for transition.  That’s about 90 days away.

Good news! Some of you have been paying attention. In the last 12 months, Missouri Enterprise has assisted over 50 of our state’s manufacturers with ISO upgrades and enhancements through workshops, internal audits, gap analysis and the development and implementation of full blown ISO transition plans. For those of you who got moving ahead of the curve and have fully implemented your transition plan to meet the requirements of the new ISO 9001:2015 standard: Congratulations! I’ve been in the trenches helping many of you with the upgrade, and I know how much work and effort you went through to succeed.

But before the ISO auditor knocks on your door, you really have one more thing to do, and that’s conduct your own internal audits to fine tune your system and be sure you’re ready. And remember that it’s always difficult to assess your operation from within, and many of you are running on skeleton crews with limited available resources, so you should strongly consider bringing in a specialist with “outside eyes” to help you with your internal audit.

Bad news! Some of you still haven’t prepared for the ISO 9001:2015 transition. If your company hasn’t gotten started yet, or you’ve been fumbling along with your limited available in-house resources trying to get things moving, then you’ve put yourself in the difficult position of having three months left to do 6 months work. You’ve heard the expression “you better start yesterday”? Frankly, if you haven’t begun the ISO transition process at your company at this very moment, then you better get started the day before yesterday. If this is you, then you need to speak to a professional right away, someone like the Project Managers at Missouri Enterprise, because the process of change to the new standard takes time, and it’s full of new challenges.

If the ISO auditor arrives and you’re totally unprepared, and worse yet, if you haven’t even begun the transition process in earnest, then you risk losing your hard-earned ISO registration or certification. If you’re at least in the process of change, with a documented path towards compliance and are in the process of implementation, you just may stand a better chance when the ISO auditor comes to town.

Supply Chain compliance. Are your critical suppliers, those who you count on to achieve and maintain their ISO compliance, up to snuff on their ISO 9001:2015 obligations? Yet again, the time to be checking on this is the day before yesterday. Maintaining the certifications and registrations your customers demand can also extend down your supply chain to important resources that bring you parts, components and services you need. The issue is so important that we’ve seen manufacturers pushing their suppliers to make sure they hit the September deadline for meeting the ISO 9001:2015 standard. We’ve even heard tell of a manufacturer who offered financial assistance to a critical vendor to help them meet the goal. That’s quite an illustration of how important it is to assure your supply chain partners are pulling their weight in helping you bring your customers what they require.

In summary, if you’ve completed your transition to the new ISO 9001:2015 standard, excellent! Now you just need to cross the t’s and dot the i’s with an internal audit to be fully prepared. Those who haven’t begun or are moving too slowly through their transition should consider bringing in expert help right away. And for those of you with supply chain partners who hold ISO certifications that are critical to your ability to meet customer requirements, now is the time to make sure everyone is on the same page and ready for the September 14th, 2018 deadline for compliance. Finally, some of the various industry specific ISO standards have other deadlines that are also looming large; see below for a partial listing of some of those deadlines.

Here are a few examples of how Missouri Enterprise has helped our peers in the manufacturing community make the transition to the new ISO 9001:2015 standard:
• Craftsmen Industries - Full ISO 9001:2015 implementation project
• Hanna Rubber Company - Full ISO 9001:2015 transition plan and implementation project.
• Able Manufacturing – Overview, internal auditor training and readiness review.
• Evan/Evco Company - Workshop, Gap analysis to identify specific areas of needed revisions, updates and and AS9100 transition
• ROM Corporation - Workshop overview of the critical steps for ISO transition planning and implementation, citing of the biggest areas of change.

Some important deadlines for industry specific ISO registrations and certifications include:

• Cybersecurity 27001, for defense contractors, December 31st, 2017
• Environmental Management Systems, ISO 14001:2015, September 14th, 2018
• Aviation, Space & Defense - AS9100, September 14th, 2018
• Automotive - IATF 16949 (formerly TS 16949), September 14th, 2018
• ISO 13485:2016, March 1st, 2019
• Occupational Health and Safety, ISO 45001:2018 (formerly, OHSAS 18001), December 2020
• Food Safety - FSSC 22000 - Version 4 was published in December 2016. Certification to the new version is possible from January 2017 onwards. As of January 2018, certification to Version 4 is mandatory. Transition timeline to be announced.
• Food Safety, ISO 22000, (,) is due to be released in 2018. Transition timeline to be announced.

Please feel free to contact me anytime for assistance with any of your ISO questions.