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EN/ISO Recertification Audits

The Situation

U.S. Based In-vitro diagnostic and medical device manufacturer lacks the staff to conduct a internal audit in anticipation of both an FDA Quality System Regulation (QSR) audit and the next ISO recertification audit.

The Solution

RQMIS supplemented the manufacturer's staff, conducted a baseline audit, and reconstructed the manufacturer's Technical Files. The manufacturer passed its Notified Body (NB) audit. The NB auditor provided very positive feedback on the improvements.

RQMIS Helps Biotech Company Fill Interim Resource Gap and Assures Success of EN/ISO 13485 Recertification Audit


After interviewing customer, RQMIS conducted a system wide baseline audit using 21 CFR 820 and EN/ISO 13485 as the reference regulation/ standard. The audit results were utilized to develop a gap analysis for all major processes.

To address the redesign of the Design Control and CAPA process flowcharting was used to layout the overall operational processes. Once the flowcharts were finalized we developed the documents to complement the flowcharts. These included the SOPS, WIs and Forms. All forms were pdf based forms for ease of use. Special attention was given to the previous NB audit in which the company’s certification was called into question.

Technical File reconstruction required extensive review of existing design control documentation for a medical device and IVD. In addition, interviews and audit source documentation were utilized.

In managing the internal audit program, RQMIS conducted four audit visits to address all aspects of the Quality System. Corrective Actions were identified with consultation from company management. These corrective actions were monitored for completion.

RQMIS Approach:

A Senior Quality Consultant and Technical Writer were assigned to the project. The Sr. Quality Consultant managed the project. Frequent teleconferences and several visits onsite were utilized.

RQMIS recommended a strategy of using a full base-line audit, Gap Analysis, and C/A Plan to get the Quality System in place and help assure future certification and to provide a comprehensive, effective Quality System.

Our base-line audit was the foundation. Continued auditing via management of the internal audit program provided ongoing oversight into the improvements being made to the Quality System. All audits were accompanied by agendas, audit reports and corrective actions. The NB provided very positive feedback on this process and the reconstructed Technical Files.

Since RQMIS consultants have deep operational experience in other medical device companies they are able to provide suggestions on how an operation can be designed more efficiently while still being compliant with the standards/regulations.

Challenges And Issues:

  • To start – we needed to obtain and decipher the client “Source Documents” and for some companies this can be challenging. For example, is there a true DHF? Is there supporting data? Should certain documents be removed? Does the DHF need to be rebuilt? RQMIS resources know what to look for, and can help the client work through this sometimes challenging and messy task.
  • If a Notified Body (NB) Auditor is expecting a comprehensive “Technical File” to be available, and it’s currently a mixture of assorted and sometimes non-applicable or outdated information – this can also be an issue and challenge. So – we apply our proven, Standard Technical File (STF) template to walk through necessary inclusions and assemble the file accordingly. RQMIS executed this and actually received feedback that the NB Auditor was impressed.
  • Nice to have vs. Need to have? Where do you draw the line? This requires thorough knowledge of the FDA Regulations and ISO Standards. Finding the right mix of Design Control procedures, templates, forms, and requirements can be tricky. RQMIS did not overwhelm the client, but assured compliance. RQMIS found a good balance.

Benefits/ Results:

The client passed its NB audit. NB provided very positive feedback on the improvements.

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