Throughout the world, medical device manufacturers and their suppliers are required to satisfy the highest quality assurance regulations and standards such as ISO 13485. Established by the International Organization for Standardization (ISO), ISO 13485 is the global regulatory standard for organizations that design and manufacture medical products, devices and components. Conformance with this important standard is confirmed through a complex auditing and certification process. While meeting the many requirements contained in the standard is challenging, an ISO 13485 audit checklist can simplify the process.
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Before we discuss the 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 providers of medical devices or related services. Originally published in 1996, the standard was intended to facilitate the harmonization of regulatory requirements for medical device manufacturers on an international scale. Major revisions to the standard were published in 2003 and 2016. Just as ISO 13485:2003 rendered ISO 13485:1996 obsolete, ISO 13485:2016 replaces ISO 13485:2003.
The 2016 revision differs from the 2003 version in several ways. First, the latest version was designed to be relevant to suppliers of device components and services, as well as manufacturers. ISO 13485:2016 also reflects an increased focus regarding feedback mechanisms. The third and perhaps biggest change is that manufacturers are expected to apply a risk-based approach to all quality management processes, including auditing, which is why developing an ISO 13485 audit checklist is so important.
There are different types of ISO audits. Internal audits are generally conducted within the organization by employees (internal auditors) or consultants hired by the company. An internal audit can be carried out on a product or service, process or an entire system. External audits are performed by independent third-party audit organizations and normally result in the issuance of a certificate stating that the organization complies with a regulation or conforms to the requirements of a pertinent standard such as ISO 13485. These types of audits are often referred to as registration audits. Supplier audits are external audits performed on a supplier by a customer or contracted organization on behalf of the customer.
External recertification audits take place every three years. Internal and supplier audits occur more frequently to ensure that the company maintains the same level of quality demonstrated during the certification process. An ISO 13485 audit checklist is helpful regardless of the type of audit being performed.
The importance of auditing is addressed in Clause 8 of ISO 13485: A manufacturer must plan and perform regular internal audits. An ISO 13485 audit checklist, a list of tasks that must be completed as part of a 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.
MasterControl Audit is an integrated part of the MasterControl quality management software suite that enables medical device organizations to streamline and manage their entire audit process, including the development of easy-to-use checklists that can be customized to address a variety of audit types (external, internal, and supplier) and regulatory standards and requirements. An ISO 13485 audit checklist is just one of tools that can be leveraged in MasterControl Audit to meet your organization’s specific auditing needs. This unrivaled audit offering enables auditors to:
To learn more about ISO 13485, MasterControl Audit, or developing your own ISO 13485 audit checklist, please contact a MasterControl representative.