The international standard ISO 13485:2016 for Medical Devices quality management systems was published in March 2016.
The ISO Standard has been released and manufacturers need to ensure their supplier quality-related procedures are compliant.Now, OEMs need to ensure all supplier quality-related procedures are compliant.
This article will provide the necessary information to perform a gap analysis, as well as identify areas for making existing systems more robust. It will also provide a tool that can be used to assist in the reduction of this potential risk.
ISO 13485:2016 is the most recent update to the quality system standard specifically for medical device companies.
You have until March 2019 to update your current ISO 13485 certificate to the new version. But don't panic yet.
There may be many differences between ISO 13485:2003/EN ISO 13485:2012 versions and the ISO 13485:2016 version—including an increased focus on risk management, supplier controls, and feedback mechanisms–that may seem daunting.
ISO 13485:2016 Revision—Major Changes to Supplier Quality
Fortunately, the changes made to the ISO standard are more harmonized with 21 CFR 820.50. For those companies that understand and comply with the quality system regulation (QSR), this transition should be a straightforward, easy gap analysis to complete.
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.
Types of Audits that Benefit that from an ISO 13485 Audit Checklist
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.
TAGmedica is a leading ISO 13485:2003 certified provider of final article assembly for medical device and diagnostic companies. We have complete in-house services that are compliant with ISO 13485. Our GMP audit checklist is helpful regardless of the type of audit being performed.
Is the ISO 13485 Audit Checklist Mentioned in ISO 13485:2016?
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.
TAGmedica 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.