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Medical Device Audit Checklist

medical device audit checklist

Ensure compliance with ISO 13485 by performing detailed internal audits that focus on compliance, quality, and efficiency

medical device audit checklist

Medical Device Audit Checklist

An audit checklist allows quality managers to document evidence of compliance based on processes, standard requirements, and process characteristics.

Medical device manufacturers adhere to ISO 13485 and are mandated to perform internal audits to ensure the safety and effectiveness objectives are established and maintained. These audits focus on improving processes and ensuring that manufacturing, development, and other related control meet current good manufacturing processes (GMP), and the requirements of ISO 13485. These audits help determine the current status and health of the QMS and processes. The standard emphasizes that manufacturers must use a risk-based approach to all quality processes, which reiterates the value of an ISO 13485 checklist

Quality managers use the ISO 13485:2016 audit checklist to determine if the implemented QMS aligns with the ISO 13485 software standard requirements. It is used for internal audits while preparing the system for a third-party ISO 13485 certification audit.

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medical devices internal audit

Are Medical Device Audit Checklists necessary for a Medical Devices Internal Audit?

The ISO 13485 audit checklist reports all the requirements of the ISO 13485 version 2016 in a tabular form. While the ISO 13485:2016 standard does not include requirements that state an internal audit checklist must be used, medical device audit checklist is beneficial and effective to conduct an audit.

  • The checklist documents the questions that make sure that the process outputs meet the planned arrangements for the process.
  • The ISO 13485 internal audit checklist is a time-saving tool that will help prevent mistakes and implement a lean-but-useful QMS.
  • Upon completion, the audit checklist helps the auditor review to reconfirm if any aspect of the evaluation process was uncovered.

Benefits of using a medical device audit checklist

  • Provides structure to the audit
  • Helps ensure audit scope is followed
  • Acts as a record that QMS was evaluated
  • Helps the auditor during the audit process
  • Works as a notes repository for future reference
medical device audit checklist benefits

A 7-Step Guide to Quality & Compliance for Medical Devices Companies

iso 13485 audit checklist audit stages

Understanding Audit Stages of ISO 13485 Audit Checklists

Clause 8 of ISO 13485 focuses on the importance of audits, detailing the need for a manufacturer to regularly plan and conduct internal audits. Essentially, the audit plan must include an ISO 13485 audit checklist that details the required tasks to be performed. The lead auditor creates and maintains the audit checklist. The checklist structure allows the auditor to document compliance evidence based on processes, methods’ characteristics, and the audit standard’s requirements. The critical requirements for the internal audit process:

  • Quality audits should be performed to ensure compliance of the quality system to the applicable regulatory requirements
  • The independence of the auditors shall be demonstrated consistently
  • The link between internal audits and the CAPA process shall be shown appropriately and documented
  • Internal audit plans and reports shall be documented.

ISO 13485:2016 mandates Stage 1 and Stage 2 audits, which vary in depth, duration, and scope. ISO 13485 audit checklists help prepare for both stages or an internal audit before certification or recertification.

  • Stage 1 audits can be performed in a day. An ISO auditor from the certifying body will provide a positive and negative findings report to determine whether the company is ready to proceed to stage 2.
  • A comprehensive evaluation of the organization’s compliance, stage 2 audits can last several days. The auditor will review documentation, internal audits, management review, controls, and all relevant processes. The auditor will produce a list of non-conformances to be corrected before certification or recertification.

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Simplifying Internal Audit Checklist for Medical Devices

The ISO standards consist of eight sections. The first three sections introduce the scope, normative references, and definitions, while the remaining sections detail the requirements. Sections four through eight consist of the main sections of the audit and questions regarding the issues.

  • The management section

    Focuses on checking various parameters that verify if the management reviews are conducted to support and maintain an effective QMS. These management reviews concentrate on the suitability and effectiveness of quality systems, list the various improvements needed to meet customer requirements, and identify resource needs. The audit also ensures that these reviews are conducted at least annually. The management section of the audit checklist also covers training, which helps break down silos and spread knowledge among employees.

  • Design and development

    Help verify that the company controls these processes aligned with the intended uses and specified requirements defined for that medical device. This is an essential component of external audits. Internal auditors can call for special audits that focus on design control, validation, and risk management to evaluate the medical device effectively.

  • The production and process controls

    Section verifies that the company has production and process controls to produce products that meet the expected specifications. The ISO 13485 internal audit will include testing processes, infrastructure, facilities, equipment, and supplier management.

  • Corrective and Preventive Actions (CAPA)

    Help verify that the QMS is self-regulated. Although not all issues found during internal audits require CAPA, this section is critical to understanding the areas that need extra attention. The CAPA section lists the areas of nonconformance that can require a specialized audit.

  • Purchasing controls

    Section of the ISO 13485 internal audit checklists focuses on the processes the company has in place to check if the products, materials, and services that the suppliers offer are effective and compliant. This section is essential to those organizations that outsource design, development, and/or production.

  • Documentation and records

    Help the auditor verify if the company can control documentation and make records available to staff and auditors.

  • Customer-related processes

    Focus on checking if the company is compliant with regulations while handling customer-related processes.

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All the QMS processes in one software, excellent choice.

We have implemented CQ in a new medical device start up. The set up and implementation went very smooth and the support from the provider has been outstanding. The system fully supports compliance with ISO 13485.

Some of the reasons why I would recommend the software are: – 100% cloud-based – Allow almost paperless Quality Management System – Excellent customer support – Simple set up and implementation – User friendly – Efficiency and security – Accessible cost for small companies.

Laura Granados,
QMS Systems Development Consultant

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create an audit checklist that checks conformance

How to Create an Audit Checklist that Checks Conformance?

An ISO 13485 audit is evidence of the outcome of a process carried out by an auditor who reviews records of employees and compares them against planned arrangements to estimate if what is being carried out is what was intended. There are two sets of planned arrangements to check

  • ISO 13485:2016 requirements
  • Company’s regulations and processes that have been put in place

An ISO 13485 audit checklist is a set of questions that the auditor refers to during the audit. The ISO 13485 audit checklist consists of a series of questions and status updates that ensure that everything matches the plans agreed in the organization’s QMS, including internal activities, supplier evaluation, and supplier audit reports. The checklist is divided into different sectors that correspond to the sections of the ISO 13845. Specifically:

  • Part 1: Quality Management System
  • Part 2: Management Responsibilities
  • Part 3: Resource Management
  • Part 4: Product Realization
  • Part 5: Measurements, Analysis, and Improvement

Internal audits can be performed on one or more specific quality system processes. Thus it is essential to have a medical device audit checklist divided into different sections so that only the part relevant to the particular audit is considered.

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Frequently Asked Questions

  • The ISO 13485 audit checklist

    • Simplifies audit planning

    • Includes corrective actions deadlines

    • Acts as a comprehensive document for third-party evaluation

    • Helps to identify process gaps

    • Aids with data consolidation

    • Reduces audit preparation time

    ComplianceQuest has prepared an audit checklist for ISO 13485 audit that helps quality leaders know the gaps, perform preventive action, and remain compliant with all regulations.

  • ComplianceQuest offers cloud-based Audit Management Software System to discover and resolve any quality and compliance issues. ComplianceQuest Audit Management Software allows collaboration between stakeholders at different stages of an audit. The software can be used to build a data-driven QMS workflow that results in Continuous Improvement (CI). CQ’s Audit Checklist feature gives quality leaders insights to “know their gaps”, take preventive action and remain compliant to all regulations.


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