13485cert

Posts Tagged ‘Notified Body’

How do you prepare for ISO 13485 registration?

In ISO 13485, Quality Management Systems on December 6, 2012 at 2:40 am

A LinkedIn connection of mine recently asked for sources of good guidance on ISO 13485 registration. I wrote a blog recently about Quality Management Systems in General, but I had trouble finding resources specific to the ISO 13485 registration process. Therefore, I decided to write a blog to answer this question.

Here’s my favorite movie clip with a song for you.

Typically people learn the hard way by setting up a system from scratch. The better way to learn it is to take a course on it. I used to teach a 2-day course on the topic for BSI. The link for this course is: http://bit.ly/Get13485; I shortened the link to the BSI website.

Other registrars offer this course too. I suspect you can find a webinar on this through TUV SÜD, BSI, SGS, LNE/GMED, Dekra, etc. from time to time.

The only registrar I could find that described the process step-by-step was Dekra. I have copied their steps below:

Inquiry to Surveillance in 5 Steps

1. Inquiry
An initial meeting between [THE REGISTRAR] and the client can take place on site or via teleconference. At this time, the client familiarizes [THE REGISTRAR] with company specifics and its quality assurance certification requirements; [THE REGISTRAR] explains its working methods and partnering philosophy, and previews the details of the process.

Rob's 2 Cents

Rob’s 2 Cents

As a client I have completed two initial certifications personally and three transfers, but I have only once had the sales representative actually visit my company. I think this process is typically accomplished by phone and email. If any registrars are reading this, you will close on more accounts if you visit prospective clients personally. In fact, the one that actually visited my company (Robert Dostert) has been on speed dial for almost a decade and he’s received a bit of repeat business.

2. Application Form
The client chooses to move forward by filling out an online application form. Based on the information obtained during the inquiry stage, along with the application form, [THE REGISTRAR] prepares a quote, free of charge, for the entire certification process. A client-signed quotation or purchase order leads to the first stage of the certification process.

Rob's 2 Cents

Rob’s 2 Cents

For both of the Notified Body transfers I completed, I completed application forms and requested quotes from multiple Notified Bodies. During the quoting process, my friend Robert was more responsive and able to answer my questions better than the competition. Robert was also able to schedule earlier audit dates than the competition. To this day I am still amazed that Notified Bodies are not more responsive during this initial quoting process. All of the Notified Bodies are offering a certificate (a commodity). The customer service provided by each Notified Body, however, is not a commodity. Each Notified Body has it’s own culture, and every Notified Body has good and bad auditors. Therefore, you need to treat this selection process just like any other supplier selection decision. I have provided guidance on this specific selection process on more than one occasion, but I am definitely biased.

3. Phase One: Document Review and Planning Visit

LNE/GMED Flow Diagram for the process of ISO 13485 Certification

LNE/GMED Flow Diagram for the process of ISO 13485 Certification

At this stage, [THE REGISTRAR] performs a pre-certification visit, which entails verifying the documented quality systems against the applicable standard. [THE REGISTRAR] works with the client to establish a working plan to define the [THE REGISTRAR] Quality Auditing process. If the client wishes, [THE REGISTRAR] will perform a trial audit or “dress rehearsal” at this stage. This allows the client to choose business activities for auditing and to test those activities against the applicable standard. It also allows the client to learn and experience [THE REGISTRAR] ‘s Quality Auditing methods and style. The results of the trial audit can be used toward certification. Most clients elect for one or two days of trial auditing.

Rob's 2 Cents

Rob’s 2 Cents

Dekra’s statement that, “The results of the trial audit can be used toward certification,” is 100% opposite from BSI’s policy. BSI calls this a pre-assessment. The boilerplate wording used in BSI quotations is, “The pre-assessment is optional service that is an informal assessment activity intended to identify areas of concern where further attention would be beneficial and to assess the readiness of the quality management system for the initial formal assessment.” During these pre-assessments, BSI auditors explain that any findings during the pre-assessment will not used during the Stage 1 and Stage 2 certification audits, and the client will start with a “clean slate.” Most of the clients I conducted pre-assessments for were skeptical of this, but most auditors are ethical and make a every effort to avoid even the perception of biasing their sampling during the Stage 1 and Stage 2 audits. I highly recommend conducting a pre-assessment. You want an extremely thorough and tough pre-assessment so that the organization is well prepared for the certification audits. If the auditor that will be conducting the Stage 1 and Stage 2 audit is not available to conduct a pre-assessment, try to find a consultant that knows the auditors style and “hot buttons” well. FYI…You can almost always encourage me to do a little teaching when I’m auditing (I just can’t resist), and my “hot buttons” are CAPA,  Internal Auditing, and Design Controls.

4. Phase Two: Final Certification Audit 
Once the client’s documented systems have met the applicable standards, [THE REGISTRAR] will conduct an audit to determine its effective implementation.  [THE REGISTRAR] uses a professional auditing interview style instead of a simple checklist approach. This involves interviewing the authorized and responsible personnel as designated in the documented quality system.

Rob's 2 Cents

Rob’s 2 Cents

For certification audits, ISO 17021 requires a Stage 1 and Stage 2 audit to be conducted. The combined duration of the certification audits must be in accordance with the IAF MD9 guidance document–which is primarily based upon the number of employees in the company. The “interview style” that Dekra is referring to is called the “Process Approach”. This is required in section 0.2 of the ISO 13485 Standard, and this is the primary method recommended by the ISO 19011 Standard for auditing–although other methods of auditing are covered as well.

5. Surveillance 
[THE REGISTRAR] arranges for surveillance audits semi-annually or annually as requested by the client.

Rob's 2 Cents

Rob’s 2 Cents

I highly recommend annual surveillance audits, because the short duration of surveillance audits becomes unrealistically short when the auditor is asked to split their time between two semi-annual visits. A few clients have indicated that the semi-annual audits help them by maintaining pressure on the organization to be ready for audits all year-round and prevents them from procrastinating to implement corrective actions. This is really an issue of management commitment that needs to be addressed by the company. Scheduling semi-annual surveillance audits is doesn’t address the root cause. The only good argument I have for semi-annual cycles is if you have a very large facilities that would have an audit duration of at least 2 days on a semi-annual basis. The most important think to remember about scheduling surveillance audits is to make sure that you schedule the audits well before the anniversary. I recommend 11 months between audits. By doing this, you end up scheduling the re-certification audits 3 months before the certificate expires. BSI has a different policy. They want auditors to schedule the first surveillance audit 10 months after the Stage 2 audit, the second surveillance audit 12 months after the first surveillance audit, and then the re-certification audit must be scheduled at least 60 days prior to certificate expiration (i.e.  – no more than 12 months after the second surveillance audit). No matter what, schedule early.

If you have additional questions about becoming ISO 13485 registered, please post a discussion question in the following LinkedIn subgroup: Medical Device: QA/RA. For example, on Monday a new discussion question was posted asking for help with selection of a Notified Body for CE Marking. You will need to become a member of the parent group (Medical Device Group)–if you are not already one of the 140,000+ members connected with Joe Hage. George Marcel and I manage this subgroup for Joe. George is out in the Bay Area and I’m in the Green Mountains.

Who’s Afraid of the Proposed European Scrutiny Process?

In CE Mark, CE Medical, Class IIb, Class III, Medical CE, PMA, Scrutiny Process on October 12, 2012 at 2:22 am

For those of you that are not familiar with the “Scrutiny Process”, I am referring specifically to Article 44 of the proposed EU regulations for medical devices. This process is first alluded to at the end of section 3.5 in the “Explanatory Memorandum” (i.e. – the 13 pages preceding the proposal for the regulation of medical devices).

I was looking for a video that matched up with my title and when I saw this TECHNO music video.

The US already has a pre-market approval process that we fondly refer to as the PMA process. In response to the PIP scandal, the European Parliament’s ENVI Committee (Committee on the Environment, Public Health and Food Safety) proposed a pre-market approval process as part of a press release issued on April 25, 2012. In response to this political pressure, the Commission has proposed a “Scrutiny Process” that involves preparation of a Notified Body “Summary Evaluation Report” and verification that the conformity assessment was adequate by the Coordinating Competent Authority. A similar process is outlined in MEDEV 2.11/1 rev. 2, a guidance document regarding animal tissues, and the Commission Regulation (EU) No 722/2012 of 8 August 2012. The proposed scrutiny process allows competent authorities to take a “second look” and review the findings of the Notified Body that would be issuing a CE Certificate for these high risk devices. The review process is supposed to be concluded within 60 days, but the review time limit is suspended if the Competent Authorities request additional information or product samples within the first 30 days.

In section 3.5 of the Explanatory Memorandum, the Commission states that this scrutiny process “should be the exception rather than the rule and should follow clear and transparent criteria.” The criteria for invoking the scrutiny process are defined in five points 5a) through 5e) of Article 44. The five points leave room for interpretation by Competent Authorities, and the medical device industry is concerned that the review process for Class IIb and Class III devices will be delayed by at least 60 days on a regular basis. The process could easily be delayed by as much as six months when there are requests for additional information and samples.

The “Legislative Financial Statement” (i.e. – the 19 pages immediately following the proposal for the regulation of medical devices) defines a monitoring process for the scrutiny process in the “Indicator of results and impact” (Section 1.4.4). The risk of delaying access to market for innovative devices is also identified in the “Risk(s) identified” (Section 2.2.1). Therefore, the need for a control mechanism is identified in “Control method(s) envisaged” (Section 2.2.2). This will be the responsibility of the Commission to draft a guidance document to define the control method(s). Until industry has an opportunity to review such a guidance document, executives will continue to voice their concerns and apply their own political pressure to the European Parliament.

Revision of EU Medical Device Regulations – Released Yesterday

In CE Mark, CE Medical, Medical CE on September 27, 2012 at 8:34 pm

For those of you that have Google alerts, subscribe to a Notified Body email notification service (and anyone else that is addicted to European Regulations), you are already aware of the new revisions that will eventually replace 93/42/EEC as modified by 2007/47/EC (also fondly referred to as the M5 MDD).

The link for the new revision is already posted on my helpful links section of my website (RA Review). The helpful links was recently re-organized by country. The link is #1 in the European section.

I will be posting commentary on the RA Review site over the next week related to the proposed revisions.

Sorry I’m a day late folks, but it’s not recommended to work on your blog while you’re on vacation. It’s especially dangerous to do so on your wife’s birthday. So everyone, please wish my beautiful wife a Happy Birthday! (September 26th). My 4 year-old daughter Gracie picked the song this week.

Picture from Vacation in Maine

Lisa, Ivy and Andre the Seal

ISO 14971 – Buy the new 2012 version?…comment please

In CE Mark, CE Medical, International Standard, ISO, ISO 14971, Medical CE, Medical Device, Risk Analysis, Risk Management on August 2, 2012 at 8:38 pm

I’m sure that there are some that disagree with my determination that the latest revision of EN 14971, revision 2012, is unnecessary (the European Commission certainly does).

 You will have to go to my website to read my cheeky posting on this topic.

And here’s another cheeky attitude from the UK…(sorry, this is not a family channel).

Therefore, I would like to clarify why I feel this way by reviewing how risk is addressed in the MDD (93/42/EEC as modified by 2007/47/EC).

  1. The term risk is mentioned only 4 times in the Articles in the MDD
  2. The term risk is mentioned once in Annex II and III, twice in Annex VII, and three times in Annex VIII and X—for a total of 10 times.
  3. The other 41 times risk is mentioned are in the Essential Requirements (i.e. – Annex I).

When companies submit a Design Dossier for review by a Notified Body, an Essential Requirements Checklist is included. This references, in table format, how all the requirements of Annex I are being met—including those related to risks. Throughout Annex I, a similar phrase is repeated many times. For example, in the first Essential Requirement (ER1) it states: “…any risks which may be associated with [a device’s] intended use [shall] constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.” In ER2 it states: “the manufacturer must…eliminate or reduce risks as far as possible…”. There is no room in the MDD for consideration of cost or economic impact when the manufacturer is designing a device with regard to risks and benefits.

If a company’s Risk Management Procedure has been found to be acceptable by a Notified Body, and the company has addressed all the Essential Requirements (ERs) with regard to risk, then there should be no impact from these 7 deviations identified in EN 14971:2012. However, if your company has not addressed each of these ERs, then you might want to consider each of these areas:

  1. Treatment of negligible risks
  2. Discretionary power of the manufacturer as to the acceptability of risks
  3. Risk reduction “as low as possible” (ALAP) verses “as low as reasonably possible” (ALARP)
  4. Discretion as to whether as risk benefit analysis needs to take place
  5. Discretion as to the risk control option/measures
  6. Deviation as to the first risk control method
  7. Information of the users influencing the residual risk

My final advice is to review Annex I and Annex X from the perspective of risk management. You may realize that you have some gaps that nobody noticed. After all, audits are just a sample.

PS – I think it’s ironic that the origins of the ALARP principle are UK case law (see link above).

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