ISO 9001-2015 Is Upon Us

By Bob Jenkins, MMTC Plymouth, Mich.Bob Jenkins, MMTC

Last September, ISO released the much anticipated upgrade to the ISO 9001 Quality Management System standard that is the backbone of much of the world’s commerce. Though the changes were subtle, they are significant. If you have a certificate under the ISO 9001-2008 standard, you have until September, 2018 to migrate to the 2015 revision. Your certificate expires at that point no matter where you fall in the recertification cycle. If you are about to sign up for a new 3 year cycle with your registrar, you would do well to include the details of how the conversion will affect the 3 year cycle.

Now, before we continue to consider the end of the 2008 version of the standard, let’s focus on the most important parts of the ISO 9001-2015 upgrade. I’ll organize the approach into two classifications of change — clerical and skills based:

Clerical changes — The most significant portion of the clerical changes is the implementation of what is called Annex SL (the high level structure). There are now 10 sections rather than 8. The brilliance in this move is that the same structure will now apply to almost all other ISO standards. Now, if your firm is certified to ISO 14001 (environmental), OHSAS 18001 (safety, soon to become ISO 45001) or you have multiple industry customers (such as automotive and aerospace, TS 16949 or AS 9100), all standards will have the same structure. That should streamline the process in any business that adheres to more than one standard.

There were 7 terms redefined, but those are not “Major differences” despite the phrasing used in the standard. They are more like slight redefines. For example, “Supplier” is now deemed to be “External provider”. The other six are similar.

Skills based changes — There is now a much greater focus on mainstreaming the quality management process and placing the focus of responsibility on top level management. Now, quality objectives move to the business plan in a greater way. “Interested parties” must be defined and considered. The major question is “risk management”.

“Risk management” is where skills changes come into play. Many may not be familiar with the practice of SWOT analysis (Strengths, Weaknesses, Opportunities and Threats), so this is a learned skill that all organizations will need to visit. Although a SWOT analysis is not specifically required, it is a good way to meet the standard. We see FMEA (Failure Mode and Effects Analysis) as a key component of risk management, also providing a path to a skill improvement.

The last of the significant changes are things that are no longer required. The requirement for a management representative is gone. However, someone will still need to complete those tasks.

There is no longer a requirement of mandated procedures. However, using controlled documents and documenting results are still required, so we would suggest that if you have a system in place with procedures that are working for you, dropping them may not be the right choice for your organization.

All three of us at MMTC Quality are ExemplarGlobal Certified to the new standard. If we can help with your implementation in any way, please contact us. Further description of the changed standard is available from Sub-Committee 176 — the folks who created the changes: https://committee.iso.org/tc176sc2.

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