ISO 13485 Audit Checklist – ISO 13485:2016 and MDSAP

About this checklist

The ISO 13485 audit checklist supports an audit of a medical device quality management system against ISO 13485:2016. It lists the processes, documents and records to examine, and it links each question to the clause of the standard it comes from, so that an audit finding can be traced back to the requirement it breaches. It is used by quality managers to assess whether the organization's quality management system aligns with ISO 13485:2016 and to gauge readiness for a third-party ISO 13485:2016 certification audit.

Why the ISO 13485 audit checklist matters

ISO 13485:2016 is the quality management standard for medical devices. A structured checklist helps you to: - Cover every clause of the standard in a repeatable way, so that successive audits use the same criteria and findings can be compared over time. - Test the effectiveness of each process rather than confirming the existence of a document. - Identify nonconformities before an external certification body does, so that you can correct them through the CAPA process and be ready for assessment. - Produce a written record of the audit, with objective evidence and the requirements cited, that can be presented at a certification audit. - Support MDSAP oversight and MDR reporting obligations, which the checklist addresses in the CAPA and MDR sections.

What the ISO 13485 audit checklist covers

The checklist is organised into sections, each examined through a set of yes/no/not applicable questions: - **Management controls.** Quality manual and scope of the quality management system, the description of how processes interact, criteria and methods for monitoring process effectiveness, quality policy and objectives, quality planning, management review, internal audit, the management representative and resourcing. - **Design and development controls.** Design and development planning, design inputs and outputs, design review, verification, validation, transfer to production, risk management, control of design changes and the design history file. - **CAPA process.** Corrective and preventive action procedures, nonconforming product, investigation of failures and determination of root cause, trending and use of statistical techniques, and verification of the effectiveness of CAPA actions. - **Medical device reporting (MDR).** Determining the need for investigation and reporting, and the controls that prevent release of defective product. - **Production and process controls.** Process control, monitoring and measurement, and the records that show the device was made to specification. - **Sterilization process controls.** Controls over sterilization, including the validation and monitoring of the sterilization process. - **Purchasing controls.** Evaluation and control of suppliers and purchased product. - **Documentation and records.** Document and record control, including approval, revision and retention. - **Technical files.** The technical file and the evidence it must contain.

Who it is for

Quality managers, regulatory affairs and compliance professionals, internal auditors, notified body or certification body auditors, and others involved in preparing for or conducting an ISO 13485:2016 audit.

Frequently asked questions

- **Is this checklist suitable for a workplace inspection or compliance review?** Yes — it is a workplace inspection or compliance checklist that guides you through an ISO 13485:2016 internal or certification audit. You answer a set of yes/no questions across the management, design, CAPA, MDR, production, sterilization, purchasing, documentation and technical file areas, and record supporting evidence as you go. - **What areas does the checklist cover?** It reflects the requirements the checklist itself cites: quality management system scope and process interaction, management review, quality policy and objectives, internal audit, design and development controls, risk management, CAPA and nonconforming product, MDR reporting, production and process controls, sterilization, purchasing, documentation, records and technical files. - **Which standards or regulations does it refer to?** The checklist references ISO 13485:2016, the MDSAP program and MDR reporting. Each question also cites the specific ISO 13485 clause it maps to, so you can trace an answer back to the requirement. - **Can it be used to prepare for a certification audit?** Yes. It is designed to assess an organization's readiness for a third-party ISO 13485:2016 certification audit, and it can equally support internal audits and supplier or process reviews. - **What does a good ISO 13485:2016 audit checklist include?** A current ISO 13485:2016 audit checklist structured by subject area, with questions, evidence prompts and space to record findings, conformities and nonconformities.

Frequently Asked Questions

Yes — it is a workplace inspection or compliance checklist that guides you through an ISO 13485:2016 internal or certification audit. You answer a set of yes/no questions across the management, design, CAPA, MDR, production, sterilization, purchasing, documentation and technical file areas, and record supporting evidence as you go.

It reflects the requirements the checklist itself cites: quality management system scope and process interaction, management review, quality policy and objectives, internal audit, design and development controls, risk management, CAPA and nonconforming product, MDR reporting, production and process controls, sterilization, purchasing, documentation, records and technical files.

The checklist references ISO 13485:2016, the MDSAP program and MDR reporting. Each question also cites the specific ISO 13485 clause it maps to, so you can trace an answer back to the requirement.

Yes. It is designed to assess an organization's readiness for a third-party ISO 13485:2016 certification audit, and it can equally support internal audits and supplier or process reviews.

A current ISO 13485:2016 audit checklist structured by subject area, with questions, evidence prompts and space to record findings, conformities and nonconformities.

Written by

Arne Reis

Founder

Process optimizer with 25 years of expertise, focused on operational excellence in quality, maintenance, EHS, and commissioning. Emphasizes innovative solutions and top-quality standards.

View LinkedIn profile