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.
Are Medical Device Audit Checklists necessary for a Medical Devices Internal Audit?
Benefits of using a medical device audit checklist
A 7-Step Guide to Quality & Compliance
for Medical Devices Companies
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Understanding Audit Stages of ISO 13485 Audit Checklists
- 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.
- 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.
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How to Create an Audit Checklist that Checks Conformance?
- ISO 13485:2016 requirements
- Company’s regulations and processes that have been put in place
- Part 1: Quality Management System
- Part 2: Management Responsibilities
- Part 3: Resource Management
- Part 4: Product Realization
- Part 5: Measurements, Analysis, and Improvement
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Frequently Asked Questions
What are the Various Uses of 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