What is ISO 13485:2016?
ISO 13485:2016 is a standalone guideline for developing a quality management system in a regulated industry. ISO 13485:2016 is a voluntary certification, not a regulatory requirement. It is used by the manufacturers of medical devices and related service organizations. Typical medical devices are diagnostic equipment and reagents, treatment pumps, surgical and life support equipment, and implants. It is not used by pharmaceutical companies.
ISO 13485:2016 can be implemented even if the company does not currently produce or service a medical device. This is a difference from IATF 16949 the Automotive Quality Management System.
A History lesson on ISO 13485:2016
ISO 13485 is derived from a European standard EN 46001. EN 46001 was issued in 1993 and titled “Quality Systems. Medical Devices. Particular requirements for the application of EN ISO 9001.” EN 46001 had to be used in conjunction with ISO 9001.
ISO 13485 was released in 1996 as a stand alone document. It was no longer necessary to refer back to ISO 9001. It is important to note that even after two more major edition releases, there are strong similarities to ISO 9001 and companies can implement both standards simultaneously.
In 2000 ISO 13485 was adopted and unified the European version and EN 46001 was withdrawn. The next significant change was the issuing of the 2003 edition of ISO 13485.
In 2016 the third edition of ISO 13485 was released. It is built around the numbering structure of ISO 9001:2008 instead of Annex SL. ISO 9001 and the other major standards have restructured to follow Annex SL. This does lead to some confusion. While ISO 13485:2016 remains structured according to ISO 9001:2008 and still requires documentation and records, ISO 13485:2016 expects leadership and internal audits to function similarly to ISO 9001:2015.
ISO 13485:2016 and Risk
Risk has been a key element of ISO 13485 from the very start. When dealing with health and safety there can be no compromises. Where ISO 9001:2015 and IATF 16949 have a section on actions to address risk, ISO 13485:2016 weaves risk analysis throughout the document and into every process, especially design and development.
ISO 13485:2016 and Improvement
ISO 13485:2016 does have a section on improvement however the subsections are Corrective Action and Preventive Action. A typical issue found when auditing a company to ISO 13485:2016 is preventive actions are a derivative of corrective actions – applying a lesson learned to similar products. The expectation of applying that lesson learned should be part of corrective action. Preventive actions should be changes to the management systems to prevent systemic problems which is an improvement. In addition, in regulated industries changes to product and processes may require revising submissions of approval documents for medical devices.
ISO 13485:2016 and MDSAP/ Regulatory
ISO13485:2016 is a voluntary certification where regulatory requirements are legal requirements. ISO 13485:2016 is used in multiple countries as such it is written generically rather than the specifics of the US FDA cGMP 21 CFR 820, Australia’s Therapeutic Goods Administration, Health Canada, etc. MDSAP is being used by Australia, Brazil, Canada, Japan, and the United States to provide a single audit for compliance with regulatory requirements to all five countries and ISO 13485:2016. Only Canada is making MDSAP mandatory for class II, III, and IV medical devices.
Moving forward with ISO 13485:2016
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