ISO 13485 Audit Checklist and Its Requirements for Certification

Across the world, medical equipment manufactures and their suppliers are required to meet the highest quality assurance standards and regulations such as ISO 13485. Established by the International Organization for Standardization (ISO), ISO 13485 is the worldwide legal standard for organizations the design and manufacture medical products, equipment and parts. Compliance with this important standard is confirmed through a complex auditing and certification process. While meeting the many requirements contained in ISO 13485 is challenging, an ISO 13485 audit checklist can greatly simplify the process.

ISO 13485 Audit Checklist for organizations that need to assess and control of Quality Management Systems based on the international standard ISO 13485-2003 policy and procedure requirements. This audit checklist covers every standard requirement, and includes sample audits, mark sheet for the rating of the results. A team of experienced Manufacturing and Quality Engineers effort with input and suggestions with this set of audit checklist that is easy to use and time and error saving tool for every Medical Device Organization.

The audit checklist addresses all main and sub clauses and requirements of the ISO 13485 -2003 Standard. A simple rating system is included that enables the user to record compliance measurement based on the audit findings. The Set of ISO 13485 Audit Checklist and Guide contains Introduction Description how to apply and use the audit checklist, Short introduction into audit requirements, discerning minor verses major or critical nonconformities, and how to tally respective findings and rate the overall performance. The set of ISO 13485 Audit Checklist with questions addressing each requirement stated in the Standard contains all the documentation.

Medical manufacturer Device to plan and carry out regular internal audits, for this purpose ISO 13485 audit checklists is required, which is essentially a list of tasks that must be completed during implementation. The ISO 13485 audit is an integral part of the evaluation process for the internal audit plan. The format of this checklist encourages the auditor to objective evidence on the basis of the document: the processes of the organization, the characteristics of the process and the requirements of the audit standard. Typically, the lead auditor creates and manages the ISO 13485 audit checklist.

ISO 13485 Document Procedures

ISO 13485 is often compared to ISO 9001 and is a type of quality standard. It is an international standard that has to do with the quality management system for medical devices. This is a standard that meets the requirements of the regulatory effect and ensure that medical devices are manufactured in a correct manner and are out of good quality.

ISO 13485:2003 specifies requirements of 15 additional documented ISO 13485 procedures as listed bellow for use in the planning, operation, control and monitoring:

• Procedures for Maintaining facilities and equipment that affect the quality of medical devices.
• Procedure for Managing risk in the realization of medical devices (including their distribution, installation and servicing).
• Procedure for Designing and developing medical devices and associated installation, maintenance and disposal or recycling information.
• Procedure for Purchasing goods and services for the design, manufacture and distribution of medical devices.
• Procedure for validating the use of computer software.
• Procedure for validating sterilization processes.
• Procedure for Identifying and controlling medical devices according to their status.
• Procedure for maintaining the traceability of medical devices and their components.
• Procedure for Preserving medical devices and constituent parts.
• Procedure for controlling products requiring special storage conditions.
• Procedure for Using and calibrating monitoring and measuring equipment for manufacture, installation, use and servicing of medical devices.
• Procedure for Gathering and using medical device customer feedback.
• Procedure for Inspecting and testing medical devices and their components.
• Procedure for Determining, collecting and analyzing medical device QMS data.
• Procedure for Issuing and implementing Advisory Notices.