ISO 13485 Audit Checklist for Medical Device Companies

Medical device companies must demonstrate compliance with ISO 13485 to avoid delays in market entry and lost sales. An audit checklist can ensure internal quality teams document processes efficiently.

Lumiform can make ISO 13485 audits simpler for medical device quality managers. Utilize its free template to document your internal quality management system and easily prepare for external inspections.

Production and Service Controls

ISO 13485 standards place high demands on medical device companies, requiring them to implement an effective quality management system with detailed documentation that must be centrally stored in order to satisfy audits and remain certified. Without such documentation in place, companies could fail to meet audit requirements and potentially forfeit their certification.

An internal audit checklist for ISO 13485 can assist in making sure your team remains compliant. This document covers all the areas an auditor would investigate during a formal on-site inspection; such as documentation, internal audits and processes.

CAPA, complaint handling and acceptance activities are also crucial parts of quality management systems. Their primary objective is to quickly access information during audits and identify potential issues; this allows your business to remain ISO compliant year-after-year. Qualio’s cloud-based Quality Management System makes internal audits simpler while increasing visibility – helping ensure continual compliance!

Quality Management System (QMS)

Consider your Quality Management System (QMS) not as an inanimate document that simply sits on a shelf, but as something alive that ensures that drugs and medical devices meet high quality and patient safety standards. Your QMS forms the backbone for your organization’s processes to help meet customer demands effectively.

Your team must participate actively in the implementation of your quality management system for it to succeed, including both laboratory staff and product engineers who should have input into how their lab procedures are documented and run.

Your top management team must also ensure that responsibilities and authorities are clearly communicated to all employees, providing resources necessary for maintaining and improving your quality management system. Furthermore, they should promote customer awareness as well as ensure corrective action (CAPA) is implemented and records kept of management reviews.

Risk Management

Medical device manufacturers must implement risk-based approaches into their processes, with particular consideration to protecting people and property while fulfilling regulatory requirements. You should document and keep records of risk management processes during product realization as well as any records created from these efforts.

If you find a minor nonconformity, corrective actions might suffice; otherwise if it impacts patient safety or performance of medical devices significantly, further measures might need to be taken.

Your stage 2 audit auditor will examine many different aspects of your business. To make sure you’re ready, conduct a gap analysis or readiness audit prior to the audit using an effective template (such as Lumiform for automating internal documentation and real-time data analysis).

Supplier Management

Procurement is an integral component of medical device manufacturing companies. A thorough ISO 13485 audit checklist must cover procurement practices that could affect compliance with this standard – such as creating efficient procurement processes, reviewing supplier selection procedures and contracts, conducting regular supplier audits and ensuring efficient communication between procurement and other departments such as quality assurance and regulatory affairs.

On an ISO 13485 audit checklist, one area to look out for is whether a firm has established a process for tracking and investigating non-conformities during production. This includes verifying whether they have the resources available to respond effectively to issues as they arise and have in place a system for managing major non-conformance investigations.

Quality managers may find it challenging to keep track of all these requirements, especially when it comes to documentation. A digital tool like Lumiform can make documenting internal audits, CAPAs, complaint handling activity and acceptance activity much simpler.