ISO Audit 13485 Checklist

Why use checklist to audit for ISO 13485 certification?

The quality and effectiveness of medical devices affect the safety of patients, users and others more than many other products. For this reason, national and international regulatory agencies require medical device manufacturers and providers to demonstrate that they have a quality management system (QMS) that has been audited and certified by an external body.

Certification bodies generally base their audits on the EN ISO 13485 standard "Medical devices: Quality management systems - Requirements for regulatory purposes." This addresses the requirements that medical device manufacturers and suppliers must meet in developing, implementing, and maintaining quality management systems. In addition to QMS requirements, the standard also includes customer requirements and the regulatory requirements of the European Union (EU), Canada, and other major markets worldwide.

In substance, ISO 13485 is similar to the ISO 9001 standard. However, it contains additional requirements for medical devices and reformulates some of the requirements of ISO 9001 for its own purposes.

Using an ISO 13485 checklist, external inpectors determine whether a company's QM system complies with the standard's requirements and is thus suitable for certification. However, such a checklist can also be used by internal quality management teams to prepare for the external ISO 13485 audit.

This article deals with:

1. The relevance of ISO 13485 certification

2. The preparation for an ISO 13485:2016 certification audit

3. App & software for obtaining ISO 13485:2016 certification

Why ISO 13485 certification is important

Medical devices manufactured or offered by companies that do not have a certified ISO 13485 quality management system are usually denied access to important markets. This can lead to delays in market entry and, consequently, to lost sales.

With certification to EN ISO 13485 by an independent certification body:

• companies confirm that they meet the aspects of the requirements of relevant guidelines for medical devices covered by the standard.
• communicate their high quality standards
• gain competitive advantage through independent certification

Preparing for ISO 13485 certification

With an internal ISO 13485 audit, medical device manufacturers and providers prepare for external certification of their QM system. The best way to do this is with an ISO 13485 audit checklist, which should be designed as a questionnaire for the professional conduct of an audit. The audit checklist should include all relevant standard requirements of ISO 13485 and, in the best case, additionally the provisions of the Medical Devices Regulation 2017/745/EU (MDR) and/or the Medical Devices Directive (93/42/EEC).

The template should be structured in such a way that all areas can be processed step by step without omitting important aspects. For this purpose, the checklist contains the basic audit questions for all standard requirements of the current ISO 13485:2016 and supports companies in meeting the individual requirements.

The internal 13485 audit checklist is a great support for quality management teams. It can be used to directly check and enter the following information:

• Requirements of the standard
• Provided evidence
• Evaluation

In addition, responsible personnel may take the following actions:

1. Establish a team of QMS experts to ensure compliance with the standard through regular audits
2. Identify the specific areas addressed by the ISO 13485 standard through research.
3. Identify the current status of the quality management system, as well as risks and opportunities for improvement. For this purpose, a GAP analysis or a readiness audit can be used.
4. Conduct quality audits and verify that they are compliant with the ISO 13485 standard.

The results of the internal audit are then clearly available. Thus, the ISO 13485 audit checklist serves as a guide, based on which the requirements of the standard can be checked for their implementation and thus the operational quality management system can be evaluated in the best possible way.

Software & App for ISO 13485 Audit Checklist

The certification of the QMS according to the ISO 13485 standard is complex. An extensive catalog of questions on all requirements of the standard make the external and internal audit a time-consuming task. It is all the more annoying when information is lost due to faulty documentation.

With a digital tool like Lumiform, the ever-increasing legal requirements for documentation are more easily met. Internal quality managers document digitally with the mobile app via smartphone or tablet - without any paper and pen. The system guides them through the audit and alerts them to forgotten checks. The clean, transparent documentation helps to avoid delays in market entry and thus lost sales for many ISO standards, including when using our free ISO 31000 template.

The app and desktop software offers QM teams and external auditors numerous benefits during ISO 13485 audits:

• With the flexible form builder, in-house ISO 13485 audit checklists from paper can be digitized in a matter of minutes.
• About 5,000 ready-to-use templates help to get started digitally immediately, quickly and securely.
• Using the super intuitive mobile app, working with teammates to complete any audit is a breeze.
• All audit results are automatically bundled into one report and can be sent to stakeholders.
• Comprehensive analyses help to uncover faulty areas in quality management systems for medical devices more quickly and thus to continuously improve audit processes.