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Certification AuditThe certification audit is a though exercise and a major step for Medical Device Manufacturers looking to access a targeted market. 

If you are looking to launch your company and your products or simply step into the world of the medical device industry, then be sure to thoughtfully plan and prepare your initial certification audit.

LNE/G-MED in this edition of the February newsletter, is discussing the most common pitfalls observed during a company’s first audit, pitfalls which may delay or simply prevent the company’s access to market.

Based on our experience with ISO 13485 and CE marking audits, most of these topics lead to major non-conformities ( NCs ) which need to be fixed prior to obtaining Certificates and that could therefore impact the certification timeframe. 

Major non-conformities during an initial audit

We have prepared below a non-exhaustive list of the key items often subjects to major non-conformities during initial audits. It is important for companies to define very early on their audit plan internally and work towards reducing the level of discrepancies which could delay or prevent them from their initial goal: obtain certification.




Applicable references

ISO 13485






Quality Management System Definition

-missing some mandatory documented procedures


4.1.1, 4.2.1


-lack of process approach




-Quality Objectives not yet defined

5.1, 5.4.1

5.1, 5.4.1


-Scope not including requirements of all applicable standards/regulations





-critical suppliers/sub-contractors not identified (or not all)




-No control criteria defined




-No evidence of control (no record)




Management Responsibilities

-Management Representative not appointed




-no management review performed

5.1, 5.6

5.1, 5.6


Internal Audit

-no internal audit performed




Product Realization

-no implementation of manufacturing process

7.1, 7.2.2

7.1, 7.2.2


-Manufacturing processes not yet validated




-device design not completed or not advanced enough to show evidence of implementation




“Device File”

-Conformity to Essential requirements / not fully demonstrated yet

4.2.1, 7.3.2



-Device file not available/incomplete


4.2.3, 7.3.10



Initial certification audit steps

ISO 13485 initial audits are performed in two distinct steps. The first audit is commonly referred to as “Step 1 audit” and is performed off-site. The second step or “Step 2” is the actual on-site audit, performed at the company’s facility.

The first step’s goal is to evaluate the level of readiness of the company to be audited. This step should allow for the identification of some of the missing items but not all, especially the one linked to the lack of implementation. Step 1 audits are performed several weeks prior to Step 2 audits to allow companies address any observations or potential non-conformities prior to the actual on-site audit. Please note that the step 1 audit is not applicable to CE marking audits, only step 2 does.

In evaluating its readiness, it is important for the Medical Device Manufacturers and Companies not only to have a documented Quality Management System but also to make sure that the QMS is in fact implemented to a point that will allow 3rd party auditors to conclude on its conformity. Personnel and Management’s involvement will also be evaluated.
If you are in the process to prepare your initial certification audit, and want to know more about the common pitfalls that could be easily avoided, we invite you to join us for our upcoming free webinar on February 22nd, 2017.

To be prepared is half of the success for an audit and to ensure that the planning the initial one is properly scheduled, remains a key element. Please note that while preparing for your audit, communicate with your Certification Organization or your Notified Body to arrange with him the audit planning and make sure that the dates chosen for the audit match with your plan.


Webinar Announcement February 22

Topic: Initial Certification Audit – Common Pitfalls for Medical Device Manufacturers
Date: Wednesday, February 22nd, 2017
Time: 2:00 - 2:30 PM Eastern Standard Time
Presenter: Florianne Torset-Bonfillou, Director of Regulatory, Education and Quality – Lead Auditor at LNE/G-MED North America, Inc.

Click here to Register!


About the Writer
Florianne Torset Bonfillou LNE Gmed

Florianne Torset-Bonfillou
Director of Regulatory, Education and Quality – Lead Auditor at LNE/G-MED North America, Inc.
Florianne Torset-Bonfillou is the Director of Regulatory , Education and Quality at LNE/G-MED North America. She received her Bachelor’s Degree in Biology from the University of Burgundy and her Master’s Degree in Chemistry from University of Paris 12. She holds a professional certificate in Quality, Safety and Environmental Management. Prior to joining LNE/G-MED, Florianne worked in the Pharmaceutical and Medical Device industry as a Quality Assurance Project Manager.  At LNE/G-MED, Florianne is a Senior Design Dossier Reviewer and Lead auditor. She is also a trainer on the European Regulation, Quality Management, Risk Management, and other regulatory and quality topics.


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