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.


The first step in this process was to interview the client to gain a complete understanding of their processes. RQMIS then conducted a system-wide baseline audit using 21 CFR 820 and EN/ISO 13485 as the reference standard. The audit results were then utilized to develop a gap analysis for all major client processes.

To address the redesign of the Design Control and CAPA process, our team laid out the overall operational processes using flowcharting methods. Once the flowcharts were finalized our consultants developed SOPS, WIs, and Forms. Special attention was given to the previous Notified Body audit in which the client's certification was called into question.

The client's Technical File reconstruction required an extensive review of existing design control documentation for their medical devices and IVDs, interviews, and audit source documentation. To manage the internal audit program RQMIS conducted four audit visits to cover all aspects of the Quality System. Corrective Actions (C/A) were identified with consultation from company management which was then monitored by RQMIS consultants to ensure completion.

RQMIS Approach:

A Sr. Quality Consultant (acting as the Project Manager) and Technical Writer were assigned to this project. RQMIS recommended a strategy of using a full baseline audit, Gap Analysis, and C/A Plan to get the Quality System in place and ensure future certification and provide a comprehensive and effective Quality System.

Our baseline audit was the foundation. Since RQMIS consultants have deep operational experience in other medical device companies they are able to provide suggestions as to how an operation can be designed more efficiently while still being compliant with the standards and regulations. 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.

Challenges And Issues:

  • We needed to obtain and decipher the client's “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? Our consultants 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 poses a challenge. In this case, 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 with our work.
  • "Nice to have" vs. "Need to have" - Where do you draw the line? This requires thorough knowledge of FDA Regulations and ISO Standards. Finding the right mix of Design Control procedures, templates, forms, and requirements can be tricky. RQMIS found that perfect balance by not overwhelming the client but still ensuring compliance. RQMIS found a good balance.

Benefits/ Results:

We're proud to say this client passed their audit! The Notified Body provided very positive feedback on the improvements and needless to say, the client was happy and retained RQMIS for future projects.

Have an upcoming audit?

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Contact RQMIS at info@rqmis.com, call us at (978) 358-7307, or just click the Contact button below.


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