ISO 13845:2016 – Aiming at involving all organizations, for an improved medical device product life cycle

In this article we will explore (the institution ISO, and in particular) the value and content of the most recently revised ISO 13845 for medical device manufacturing and quality system management. In light of our most recent Deep Dive country report on Taiwan, we will also exemplify the relevance of this standard to market entry, and draw out the presence of China within ISO.

Updated ISO 13845

The ISO 13845 Medical devices – Quality management systems – Requirements for regulatory purposes has been updated and re-released recently, March 2016. This standard was in part inspired by the more commonly known ISO 9001, related to general quality management systems.
Through various guidelines it aims at involving all organizations related to the product life cycle, and making their processes more efficient, compliant, and sustainable.

ISO 13485 certification establishes indicators for the medical devices industry on how to manage quality, uniting the perspectives from both regulators and industry.

The new ISO 13845 brings with it the following changes/emphases:

  • Maximize cohesion of regulatory requirements and quality management systems: documentation requirements
  • Its applicability has been widened to include all organizations involved at any point of the product life cycle: e.g. contract manufacturers, logistics providers, distributors, installation and servicing, importers, exporters, etc.
  • Greater attention to post-market surveillance: detailed responsibilities when handling complaints, reporting criteria of events, planning of corrective actions/ to prevent reoccurrences of an issue with a medical device without undue delay
  • More focus on the management of risk factors, and on having infrastructure appropriate for the task at hand
  • A seamless transition from design to manufacturing, in consideration of sustainability principles

The importance of a standard for medical device quality management

With economic and environmental pressures keeping the topic of sustainability and corporate responsibility inevitably ongoing and making it continuously more urgent- it is vital to embrace the management of product from creation to disposal, i.e. its product life cycle. To achieve quality throughout, the product life cycle must deploy qualitative and intelligent processes and logistics at each step.

  • An immediate example of the benefit of ISO 13845, is to be seen in Taiwan. Taiwan officially recognizes this certification for the licensing of medical devices wishing to trade on its domestic market. Accordingly, it facilitates international trade and can provide an advantage over a competitor who does not have the standard and whose market registration is longer as a consequence.

Additionally, the very design of this ISO intends to implicate all organizations that contribute to the manufacturing and distributing of the medical devices. As such, it must guide all these (non-core production) organizations on how to improve their processes also, such as maintenance practices, risk management, etc.– to seek quality in an efficient and sustainable manner, for as far as the product processes may reach.

Technical Committees and ISO’s medtech topics

ISOs are created by expert groups belonging to designated technical committees (TCs). Technical Committees address particular standardization needs that come up in industry. The TCs most relevant to healthcare, and medical devices specifically, are the following:

  • TC 76 – Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use
  • TC 84 – Devices for administration of medicinal products and catheters
  • TC 121 – Anesthetic and respiratory equipment
  • TC 150 – Implants for surgery
  • TC 168 – Prosthetics and orthotics
  • TC 170 – Surgical instruments
  • TC 194 – Biological and clinical evaluation of medical devices
  • TC 198 – Sterilization of health care products
  • TC 210 – Quality management and corresponding general aspects for medical devices
  • TC 212 – Clinical laboratory testing and in vitro diagnostic test systems
  • TC 215 – Health informatics
  • TC 229 – Nanotechnologies

Member countries and the presence of China

Each member country of the ISO institution has a local body dedicated to ISO management. This body in turn can be involved in the ISO processes (e.g. technical committees) to varying degrees, depending on the category of the member.

The total of 162 members, from most involved and influential to lesser, are spread out as follows:

  • Member bodies – 119 countries: have greatest influence over ISO standard development and strategy, vote in meetings, and are licensed to sell ISO standards nationally
  • Correspondent members – 39 countries
  • Subscriber members – 4 countries

It is interesting to look at the distribution of TC participation amongst the different categories of member countries, to lend us an impression of their influence within the institution ISO, and the importance that their country is likely to grant to ISO standards.

China is a full member body with 739 TC participations; meaning they have actively weighed in their say into 739 technical committee standard formulations.

Of the 162 member countries, there are only 3 nations that have a higher technical committee count participation than China. These are France (749), UK (745), and Germany (741). Following closely behind China is the Republic of Korea (736).

Notably, China’s ISO division, which it has named the Standardization Administration of the People’s Republic of China (SAC) includes the state of Taiwan.

For further quantitative and qualitative information on the Taiwanese healthcare system and the macroeconomic climate, or that of other national healthcare systems, please look into our Business intelligence platform or order the TforG Deep Dive report containing volumes of 984 surgical procedures in 13 specialisms.

About Laura Weynants

Performs primary and secondary market research to create country reports at TforG. Interviews KOLs and medical sector professionals to build on TforG’s healthcare market expertise and competence networks. Complementing five years of sustainability policy and CSR communication, she now focuses on grasping key medical market trends, structures and opportunities in medical sectors worldwide. Coming from an international background of living in Germany, Spain, USA, UK and Belgium, she has gained a keen insight in international organizations and language skills to perform first hand investigations. She graduated from Sussex University Brighton, UK with a BA English Literature and Sociology and achieved a Master Degree in Sustainability and Corporate Social Responsibility in EOI Business School in Madrid, Spain.