To those companies who have dropped their ISO 9001:2008 registrations or have been putting off attaining certification, you may want to re-consider your options.
Over the last several years many companies decided to either drop or let their ISO 9001 registrations expire, because their customers were not demanding they maintain their registrations or they did want to continue paying for their certifications. Other companies are aware their customers would like to have all their suppliers certified, but have been dragging their heels until the customer finally demands registration or their contracts will be pulled.
But there is a new ISO 9001:2015 standard waiting in the wings that may change a few minds.
The new ISO9001:2015 standard has been released in draft form and is awaiting ratification by the board of directors. Once this standard has been ratified, it is presumed to take effect in January 2015.
Be aware that risk analysis is the thread that runs like a winding river throughout the new standard. While risk analysis is not a foreign element in ISO 13485:2003, TS 16949:2009, AS 9100 Rev C, etc., it is new to basic ISO 9001.
This element may leave many smaller companies not familiar with risk analysis quivering at the thought of tackling this new issue. The standard has also changed with a different numbering system, which means quality and procedures manuals will have to be re-written or amended. However, remember the ISO 9001 standard has not been significantly re-drafted since ISO 9001:2000, which has been a bonus to most certified companies.
There is an option for you to consider. You can finally decide to assemble your team together and achieve registration by December and become certified to the ISO 9001:2008 standard, which does not contain risk analysis. Then you will have 3 years to switch over to the new standard, unless the ISO board changes its mind about that, to familiarize yourself with the risk analysis requirements.
Additionally, ISO 13485:2003 is in the process of being changed, so those of you putting off registration to ISO 13485 may want to bite the bullet, and also achieve certification by December of this year. Just keep in mind that the ISO board has not written the new rules in stone yet, and may be subject to change. Additionally, do not wait to plan a registration audit in December, because there may not be enough auditors to meet demand.
Remember attaining registration is not only a great marketing tool to persuade new customers that you possess a legitimate quality management system, but will help you identify processes and areas in your company where you are losing money.
This system, if used correctly, will help you make more money, but again too many top management personnel only think of the initial cost, and not the long term benefits.
However, remember to contact accredited registrars to receive a legitimate certificate. Those accredited registrars can be identified on the ANAB.org website.
Steer clear of the unaccredited registrars, who are only interested in accessing your wallet, and provide a certificate that is not accepted by major OEM's.
Elaine Pascoe is owner and president of consultant agency Progressive Integrated Systems Inc. She can be reached at [email protected].