I'm cold, it's raining all the time, there are these wonderful snakes everywhere. They don't taste good and are terribly aggressive, even though they are very nice to look at. I don't know how much longer I can preserve. Yesterday I cut myself on a stick, but the first aid kit I got before I arrived on the mainland is absolutely useless. When I tried to stitch the wound, the needle broke off and the scissors to cut the thread were too blunt, so I had to help with my teeth. In the process I cut my tongue, fell off my chair in shock and knocked a tooth out at the corner of my homemade table. I never thought I would say this, but I long for the rules and standards of the civilized world. How could it have come to this? I want to go home! Wait a minute, what was that hissing sound back there...
In memory of Dino Eniso
After thirty years as a lathe operator, Dino Eniso have had enough of the increasingly strict rules, regulations and rules in his profession. Born in Thun in 1976, the free spirit took all his savings and emigrated in 2016, shortly after the revised DIN/ISO 13485 came into force, to an island in the South Pacific, where he wanted to find his happiness in a norm-free environment from then on. Possessions, clothing, luxury - none of these things were important to him, but it was important that he never again had to hear about quality management or DIN regulations. Unfortunately we don't know how Dino has fared since then, because he was never seen again. An expedition of zoologists, who visited his island at the end of 2019 to study a very rare and highly poisonous snake species native to the island, only found fragments of a diary. However, one place was particularly well preserved. It almost seemed as if Dino wanted this news to reach the world. We shared Dino's diary excerpt with you at the beginning because it's the least you can do for a person who has been in our industry for three decades. However, it is pure coincidence that Dino's message has a direct connection to today's blog topic.
Deadly little things or without rules it is also not so comfortable to live
After all, Dino Eniso had a very important, though perhaps somewhat belated, insight: rules, regulations and standards are important because, in case of doubt, they can save lives. If the good Dino had remembered to bring a first-aid kit from home before he set off on his adventure, he would certainly have been better off. After all, since the revision of DIN/ISO 13456:2016, Europe has one of the strictest quality management regulations for medical products.
In essence, the goal is to improve risk management
A particularly noteworthy change in ISO 13485:2016 is the addition of more explicit requirements for risk management. Companies must consider the risk associated with a product from its conception to its use. The criteria for evaluating and selecting suppliers should therefore now be based on the following factors:
- the ability of the supplier to supply products that meet the requirements of the purchaser,
- on the performance of the supplier and
- on the impact of the purchased product on the quality of the final product.
The revised standard also stipulates that the evaluation criteria must be proportionate to the risk associated with the final product.
Implications for supplier selection
It can be a challenge to assess the risk that a supplier could potentially impact your manufacturing process. However, this is a critical consideration, as equipment manufacturers are responsible for the potential risks that suppliers bring to a manufacturing process. When evaluating potential suppliers, any supplier who is not familiar with the new standard should therefore be considered as a high risk as a precautionary measure! Some small suppliers may lack the resources to obtain certification. Nevertheless, even they cannot afford to simply ignore the revision of ISO 13485 from 2016. If a small company does not need to do the 13485 certification, it should at least be able to demonstrate on request that it has done its homework in terms of risk analysis and risk management. In addition, DIN EN ISO 13485 has not been aligned with the High Level Structure (HLS) as known from the revised ISO 9001:2015. Manufacturers of medical devices certified for both ISO 13485 and ISO 9001:2015 must be aware of the structural differences!
Meeting the new expectations of ISO 13485:2016 for supplier management
Companies throughout the medical device supply chain are now required to review their current practices and close any gaps in their compliance with DIN/ISO 13485:2016. To help manufacturing companies comply with the regulations, MySolutions Group has integrated a powerful supplier management module into its product portfolio. The MySolutions software is available on both desktop and mobile devices and includes automated workflows for supplier management, evaluation and control. Detailed supplier histories are automatically managed by the system and employees can easily find and view the relevant information for each supplier.
Are you sufficiently prepared?
Working with suppliers who understand their role in an ISO 13485 compliant quality management system reduces your risk and saves you time and money. Suppliers that meet your quality and documentation requirements reduce the need for costly additional testing and inspection. Contact the MySolutions Group to learn more about how your quality management system can be made even better with the right manufacturing software!