ISO 13485 consultant discuss the compliance benefits of developing an effective ISO 13485 audit checklist, we must take a closer look at the standard itself. ISO 13485 is a quality management standard designed specifically for companies that provide medical devices or related services. Published in 2003, the standard was designed to facilitate the harmonization of regulatory requirements for medical device manufacturers on an international scale. ISO 13485 was based on the standard ISO 9001, but it differs from ISO 9001 in several ways. The main difference is that ISO 13485 is focused on ensuring medical device safety and efficacy rather than enhancing customer satisfaction and continual improvement.
The importance of auditing is addressed in Clause of the international standard: A manufacturer must plan and perform regular internal audits. An ISO 13485 audit checklist, which is essentially a list of tasks that must be completed as part of an 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 document objective evidence based on: the organization’s processes, the characteristics of the process, and the requirements of the audit standard. Typically, the lead auditor creates and manages the ISO 13485 audit checklist.
The ISO 13485 audit checklist is an integrated part of the quality management system suite that enables medical device organizations to electronically streamline and manage their entire audit process, including the development of easy to use ISO 13485 audit checklist that can be customized to address a variety of audit types of external, internal, and supplier and regulatory ISO 13485 international standards and requirements. An ISO 13485 audit checklist is just one of many checklists and tools that can be leveraged in QMS 13485 systems Audit to meet your organization’s specific auditing needs. This unrivaled audit offering enables auditors to:
- Effortlessly plan and schedule audit resources. The simple drop and drag calendar is easy-to-use and allows auditors to quickly change audit dates and times, which makes staying on top of multiple audits easier. The tool’s advanced scheduling and routing capabilities not only streamline audit schedule management, but also allow audit resources to be allocated based on desired frequency and risk.
- Use familiar tools like Microsoft Word and Outlook to conduct audits and create, modify, and score a variety of checklists, including an ISO 13485 checklists. These comprehensive checklists promote audit consistency, which helps to ensure that the organization is in compliance with applicable regulations and standards.
- Create robust audit reports thanks to rich text data that is maintained all the way from auditor entry and peer review through to automated report generation.
- Utilize powerful online analytics and reporting tools to spot trends of potential systemic issues that allow management to make faster, more productive decisions. Increased management visibility can help prevent costly regulatory delays in getting products to market.
- Easily connect with other parties involved in the audit process. The Audit’s Web-based platform allows companies with global audit teams to easily access important audit summaries, findings, and QMS 13485 documentation, such as an ISO 13485 audit checklist, from virtually anywhere.
- Enjoy seamless connections that enable stress-free management, suppliers, and risk, allowing an organization to monitor its entire quality system and continuously improve it.