ISO 13485 Audit Checklist for Medical Device Manufacturers

No matter whether you sell percutaneous catheters in the US or are planning on expanding to Europe, ISO 13485 compliance is a necessity for doing business. An independent auditor must complete an in-depth audit of your company’s quality management systems in order to meet this standard.

Get familiar with this checklist to prepare yourself for an ISO 13485 audit. It includes questions that might arise during an auditor’s inspection.

1. Documentation
Documentation is an essential element of ISO 13485 supplier audits, helping auditors gain a thorough understanding of your company and identify any nonconformances during an audit.

The 2016 version of this standard adds a requirement that organizations document their processes for managing documentation, providing resources and product realization. Furthermore, it emphasizes the need to follow documented procedures when outsourcing processes that impact quality or regulatory compliance.

Qualio offers this template with extensive preparation fields that can help you prepare for an audit with ease. A comprehensive checklist, this resource ensures all requirements of ISO 13485 standard are met, making for minimal recommendations from auditors on passing your audit.

2. Training
Training is key to minimizing human error and quality issues in medical device manufacturers. ISO 13485 encourages manufacturers of these devices to ensure employees receive training on any relevant policies or procedures for their roles within their organizations.

Companies should conduct training evaluations for each policy, procedure and task to evaluate its effectiveness in order to avoid wasting both time and resources by providing training that does not lead to increased performance. This step can prevent unnecessary training costs by saving both resources and time from unnecessary resources spent providing ineffective training courses.

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3. Quality Control
Quality control refers to the practice of assuring products meet regulations and standards, through inspections, tests, and record keeping.

Medical device manufacturing processes must abide by rigorous quality controls in order to produce products of high quality and safety, particularly when working with outside suppliers. When outsourcing percutaneous catheter production for example, companies must ensure their provider follows appropriate quality control measures.

Acing third-party audits for medical device companies requires having an ISO 13485 checklist, and Qualio offers one for free that covers every aspect of a quality management system from initial documentation through third-party audit preparation and passing them easily. Get your free ISO 13485 audit checklist now!

4. Documentation Review
ISO 13485 audit checklist can help identify areas requiring further review. For example, if your company plans on providing materials for its best-selling percutaneous catheter and you want to make sure it can meet quality standards, conducting a supplier audit may be a must.

At the start of an audit meeting, auditors will seek confirmation regarding which areas and processes of client organization fall under ISO 13485’s scope, as well as any reporting of adverse events or incidents to appropriate authorities.

An organization that is adequately prepared will find it easier to navigate the audit process, which typically includes extensive evaluation of their QMS including documentation, internal audits and management review. Passing with minimal recommendations will also make life simpler for everyone involved.

5. Risk Management
Failure to adequately address risks poses a substantial threat for medical device companies, leaving themselves open to problems that could cost money, reputation damage and legal battles; delaying or derailing business goals and project plans in the process.

Risk identification and mitigation is a core part of ISO 13485’s process. Risks can be identified through several steps, including assessing their impact and probability. Common parameters used for prioritizing risks include likelihood, consequence and acceptable threshold levels.

There are various approaches to mitigating risks, including risk avoidance (eliminating actions that might create unwanted change), transfer (buying insurance policies to cover financial damage), and reduction (introducing controls such as additional management approvals or multi-factor authentication to limit unapproved access). ISO audits require you to demonstrate your ability to manage risks effectively.