Kerri Williams of Platinum Registration was recently asked to make a presentation about upgrading an existing ISO 9001 management System to ISO 13485.

She kindly allows us to display her presentation.  With her agreement we have modified the content to remove background and benefit information about Platinum Registration. The presentation covers many of the differences between ISO 13485 and ISO 9001  but read below for more information about some of the issues which have to be considered.  You can see the presentation here: Upgrading to ISO 13485.

Organizations who are already registered to ISO 9001 are often interested in migrating to industry specific versions of the standard.  These include TS16949 (for the Automotive Industry), AS9100 (for the Aerospace Industry) and ISO 13485 (for the Medical Device Manufacturing Industry).  In some instances, customers are insisting on conformance and in others, organizations want the marketing advantage to break into or extend their involvement in the industry.

These versions enhance the requirements of ISO 9001 by adding additional requirements that must be built into the management system and implemented – with evidence, to demonstrate conformance to an auditor.

This presentation looks at the differences that exist between ISO 9001 and ISO 13485 but the principle is the same with the other standards.

With ISO 13485 the scope of the management system is very important.  ISO 13485 is used by the medical device regulatory agencies in Europe, Canada, Australia and Japan (among others) and has been accepted by a global harmonization task force which is supported by the US.  At this time, the FDA does not use ISO 13485 and thus steps must be taken to address their requirements (CFR 21 Pt 820) if it is also applicable.  For many higher risk devices, agencies require that this standard is implemented before they will allow the marketing of the medical device.

But these rules typically only apply to the device manufacturer.  Many contractors seeking ISO 13485 do not manufacture the actual device.  And even if they did manufacture a complete device, they would only have a secondary responsibility for meeting the regulatory requirements (including ISO 13485) unless it was their name on the label as the owner of the device.  More frequently a contractor is producing parts for the medical device company who might finally assemble and sell the device.  It is they who are subject to the regulatory requirements and they want an easy life justifying how some of their parts are made to their regulators.  Thus they are keen on the contractor registering to ISO 13485.

ISO 13485 contains a number of requirements that are applicable only to the device manufacturer.  For instance, the collection of post-market intelligence.  Being registered to ISO 13485 implies that you have the ability to collect post market intelligence about the medical device.  However, a contractor might not even know what device their part is used in.  In some situations the contractor cannot exclude these requirements (like for instance they might be able to exclude the requirement for the control of sterilization) and must be able to demonstrate an ability to do something that they will never have any use to do.

The contractor needs to think carefully about what they want their management system to cover (i.e. the scope) and make this clear to the chosen registrar and their auditor so that no surprises occur.  These things are not always spelled out in the standards and highlight the reason why experienced help is essential in order to achieve success.

Other differences and additions to the standard are much clearer and simply require updating or new documented procedures and the implementation of simple processes or training.  So long as the interpretation is understood (and it is not always clear) then this is a straight forward process that just takes time and resources.

All management systems require internal auditing.  Done well internal audits bring benefits by protecting against issues before they are found by the registrar, highlighting opportunities (and waste) and giving confidence in the effectiveness of the management system.  When upgrading to a new standard an internal audit needs to be conducted.  This will ensure you haven’t missed anything and show conformance to the new standard has been achieved.  Technically it is possible to audit only the changes but if this not done well, a registrar should reject the audit as ineffective.  Bearing in mind that an internal audit would be necessary anyway, a slightly enhanced audit for the new standard is just a little more effort than normal.

Cavendish Scott, Inc. has been consulting, training and auditing on the implementation of ISO 9001 and industry specific standards for 25 years.  Upgrading an existing ISO system to meet an additional standard is something we are frequently asked to assist with.  Typically we review documentation, make adjustments to existing documents and write new procedures, support with the training, understanding and implementation of new processes and changes.  We then conduct internal audits (which usually have to be completed anyway) at a slightly enhanced level to prove conformance with the additional standard – and guarantee successful registration.  For more information tell us a little about what you want to achieve by clicking here.

Click here for the presentation

http://www.cavendishscott.com/articles-info/articles/wp-content/uploads/2010/06/ISO-13485-v-ISO-9001-060310.pdf

Official AS Training Announced

The IAQG mandated training was announced on May 1.  The training mandatory for any professional auditor to upgrade from Rev B to Rev C.  Before they can conduct registrar audits they must take and pass the training.  Then they must reapply to the RABQSA to upgrade their registration status so they can be formally recognized as Rev C auditors.  For new auditors, the content of this training will have to be integrated into the “normal” lead auditor training.

This training is also important for organizations upgrading to Rev C.  Not that they should attend the training but they should be aware of what auditors are being told.  It is likely this training will tell them where to focus, and how aggressive to be.  It is essential that you don’t upgrade your system to Rev C without knowing how and what will be audited.  Unfortunately the training content is still not available.  While some training courses have been presented, there is still no public information on content at this time.  We’ll bring you this final piece of the puzzle as soon as more information is available.

The training is substantial.  There is an 8 our on-line module (which can be avoided if you pass the exam at the beginning) and then 4 days in class training.  Also the training is very expensive – about $4000 for the training itself, then add travel and accommodation, loss of work revenue and re-registration fees.  For most auditors this will represent about $10,000.  There is a good chance that some auditors simply wont do this and thus availability of Rev C auditors will become even more difficult.

Cavendish Scott, Inc. has analyzed the changes from Rev B to Rev C and identified the best solutions for different situations.  We have also designed solutions to address the issues introduced in AS9101D.  While these changes are simple in some area, it is likely to be the most rigorously audited and if you have not fully addressed everything there is a significant chance of you losing your registration for a year.   With our approach Cavendish Scott, Inc. guarantees that you will maintain your registration. Here are more details or contact us if you have any specific questions.

The final published version of AS9101D has been released.  This is a supporting standard to AS9100C that describes a mandatory auditing approach.  It also contains the auditing checklist and the report format.  This document is incredibly important because it will affect how your system is going to be audited and surreptitiously adds extra requirements that have to be met.  Key elements of this document are:

Process approach. Many organizations wanted ISO for cheap.  They implemented a documented system that basically copied the standard.  It was quick.  It was easy.  But it wasn’t particularly useful.  It didn’t describe what actually went on in the organization and never helped with understanding how the organization worked.  It didn’t help with improvement but it did take maintenance to make sure it was working.  It was often bureaucratic, difficult to follow and was managed separately to how the organization was actually run.  Finally someone is pushing the process approach.  If your documents were written around the structure of the ISO standard then you are not demonstrating a process approach.  Ideally you should re-write you system in a process based manner.  If you don’t then you need a good way to demonstrate that you fully understand and use your system in a process based manner.  This should be a tangible response to be able to demonstrate it to an auditor.

Process Based Auditing. Registrars are mandated to audit in a process based manner.  Six audit approaches have been included in the standard are although registrars are free to audit in any manner they want, it is likely that they will opt to simply follow these approaches.  While it might not change the way you design your system, you should at least ensure you change the way you conduct audits to fully prepare for your AS auditor.

PEAR. The Process Effectiveness Assessment Report.  Auditors are required to assess the effectiveness of your systems.  A low score results in a nonconformity including a major nonconformity.  Although this is not a “requirement” contained in the AS standard, you are just as likely to lose your certificate (and new rules mean you could lose it for a year minimum) for missing this.  The scoring is applicable to key production and service provision processes.  The first thing you need Is a process (with supporting evidence) to identify which processes you are going to score and to justify those that you are not.  Although this is not your choice and your auditor may require a score for processes you have tried to exclude, you are likely to be more successful if you have a formal process with tangible evidence.  This is going to be a controversial area.  It is not difficult to perceive many organizations missing the issue (it is not in AS), complaining, appealing and even asking their customers to intervene.  It is going to be interesting.  By implementing a solution in advance, there is a good chance that your auditor will simply accept it.

AS9100C Checklist. While rumored that it would be cut out of the Rev D standard, it is still there.  This is a good thing for auditing as it ensures a thorough audit is completed.  Fundamentally nothing changed here but continue to expect a thorough and complete audit.

This standard provides us much more to think about than AS alone.  How its actually implemented is yet to be seen.  The IAQG mandatory training, which might resolve this is reviewed here.

Cavendish Scott, Inc. has analyzed the changes from Rev B to Rev C and identified the best solutions for different situations.  We have also designed solutions to address the issues introduced in AS9101D.  While these changes are simple in some area, it is likely to be the most rigorously audited and if you have not fully addressed everything there is a significant chance of you losing your registration for a year.  With our approach Cavendish Scott, Inc. guarantees that you will maintain your registration.  Here are more details or contact us if you have any specific questions.

The IAQG recently released the latest on timing for upgrading to AS9100C.

Their original schedule still remains intact.  Key milestones for this schedule are:

• Release of sanctioned (mandatory) auditor training – End of April 2010
• Once re-accredited for AS91ooC with trained auditors for AS9100C Certification Bodies are free to start updating clients to AS9100C.
• Until July 1, 2011 Certification Bodies can audit to either AS9100B or C.
• After July1, 2011 all audits must be to the AS9100C version of the standard.

As mentioned this schedule that was published in 2009 is still approximately accurate.  The additional information provided gives specific deadlines to accreditation agencies, auditor oversight bodies and training organization oversight bodies.   For example it requires the auditor oversight bodies to come up with a transition path for their auditor members to upgrade.

The auditor training material will be available at the end of April and it might take the training organizations say a month to train their trainers, incorporate the material and get themselves organized to be able to present the courses.  These training organizations must then be formally reviewed by the training oversight organizations.  Perhaps allow another month for this to take place.  Now auditors can formally access the training courses, pass the exam and submit their information to be included on the OASIS database (recognizing them as fully qualified AS auditors).  This might take another month.  Thus it may take until the end of July until auditors are trained and available.

Certification Bodies also need to be accredited to perform AS9100C audits.  This will involve them updating their management system and using trained auditors.  They can then be subject to an accreditation audit as the final step.  If then had been planning the upgrade well, their management system will already be modified and they will be attempting book their accreditation as soon as they have qualified auditors.  Lets allow just another month to do this.  In this scenario it might be the end of August 2010 before AS9100C upgrade audits can take place.

Obviously there are possible scenarios that might allow upgrades to take place sooner.  If the auditor training can be managed in May (and some may be)  and the Certification Body accreditation audit can take place in June, for instance.  However, there is a limited number of both training oversight auditors and accreditation auditors.   And whether it is booking a training class or and oversight/accreditation audit, flights are preferred with 2-3 weeks notice and these things just take time.

It is almost certain that Certification Bodies wont be able to upgrade ALL of their auditors for some time – perhaps until after the end of the year.  This will have an impact on your choice of when you upgrade.

If your audit (surveillance or reassessment) is after August 2011 (or even by the end of the year) you are unlikely to be allowed to upgrade until 2011 (and then you wont have a choice to not upgrade it being after July 2011).

You best choice is to contact your Certification Body and attempt to firm up your upgrade audit date.  They are unlikely to know until more experience of the training is gained but your persistence is important.  Similarly you MUST plan your system upgrade.  It is essential you account for the changes that AS9100D will bring (in particular the PEAR effectiveness review process) and unless you are certain of your upgrade timing you might consider adding the AS9100C changes without removing AS9100B aspects – yet!  This will mean you are ready for any date that your Certification Body might give you and you will be certain of passing.

Cavendish Scott is providing upgrade consulting including document modification, new procedures, widespread integration of new elements (e.g., risk), PEAR, training and addressing AS9100B and C.  We are also providing AS9100C internal audits so that a successful upgrade can be guaranteed. Click here to find out more: AS9100C Upgrade

AS auditors are currently in great demand.  Its about to get much more so.

IAQG has stipulated that to upgrade an existing AS9100B management system to AS9100C can be conducted during a normal surveillance or reassessment audit.  Upgrades during surveillance will require an audit at reassessment levels (twice as long as a surveillance audit) and upgrade during reassessment will require an audit at initial assessment levels (33% more).

Further, while the audit duration tables for AS9100C remain basically the same as they are currently, the rules have been changed to state that the table only covers ON-SITE time.  In other words each audit is likely to grow by a day or so as certification bodies used to include off-site time in this calculation.

What this means is that as soon as AS9100C starts to become audited, AS auditors are going to have twice their normal workload.  It is extremely unlikely that certification bodies will have the capacity to take on any new AS audits as their customers push to upgrade as soon as they can so they can distinguish themselves to their customers.

If you are trying to obtain AS certification during 2010 you need to go for the B version and book your audit for no later than June/July.  If you can convince a Certification Body you will be ready for the C version then book your audit later in the year (more auditors will be qualified and it will be more likely) and get a very firm commitment from the Certification Body.  Good luck with that.

If you are currently AS9100B then make sure you contact your Certification Body and confirm your surveillance/reassessment audit.  Make sure you confirm this very strongly with your certification body.  Perhaps contact your auditor directly and confirm it.  Get their personal buy-in (making it more difficult for them to change it).  Maybe pay in advance.

Customers rarely inform you about their plans and Certification customers are no different.  If you were a Certification Body and a large, important customer phoned requesting an upgrade with a month or two notice you are unlikely to turn them down.  Auditors will be pulled off of other jobs to be able to get that job done.  Smaller organizations might be made to suffer – it is even possible that the Certification Body might simply drop smaller customers if they don”t have resources.

All of this will start about July/August/September time frame as auditors and Certification Bodies become qualified to conduct audits to AS9100C and its going to last a couple of years  (More on timing…).  Auditors might be tempted to switch Certification Bodies with promises of bigger fees.  Audit costs to clients will rise.

Of course there is really no way of telling how this will play out in the end.   The Certification Bodies don”t really know because nobody knows when everyone will want to upgrade and who else will want AS9100C audits.  The IAQG has allowed a couple of years to upgrade but that only reduces the increased workload to one and a half times as busy rather than twice as busy.

We can all hope that there are no scheduling problems but there is no downside to taking charge of this situation, informing your Certification Body of your upgrade plans, your expected upgrade audit date and firming up your audit for this year.

Cavendish Scott, Inc. is providing a standard upgrade consulting package including all modifications to all documents, integration of new requirements, new procedures and importantly a thorough pre-assessment/internal audit to make sure you will pass.  Guaranteed Success for a fixed price!  And your audits for 2010 are taken care of! Click here to find out more: AS9100C upgrade