Change creates new opportunities that may benefit any organization; Although there is no guarantee in the business world, changes must be made to win!
With the many challenges and changes that have taken place, the potential has grown and there may even be opportunities for small companies to diversify their operations.
Attracting new customers and different markets can be an advantage in times of uncertainty. When one market stagnates, other markets may remain stable or even grow. Creating diversity creates new opportunities that may benefit any organization. There is no guarantee in the business world, but to win it you must have an active presence.
The medical equipment industry offers a great opportunity. We know that this industry will always exist. Also, the demand in the medical equipment industry is always high. On the other hand, the amount of research in this industry has also increased. For this reason, to enter this market, obtaining a quality management system, such as ISO 13485: 2016 certification can be useful for many organizations.
Manufacturers of medical devices
Most medical equipment regulations, especially EU and UK regulations, place the level of control of medical device manufacturers based on the risk of the devices being manufactured. Low-risk devices can often be verified. However, the requirements of the regulations still need to be implemented; Including the implementation of appropriate QMS to ensure the understanding and fulfillment of these requirements.
Because product quality and patient safety are essential in the medical industry, ISO 13485 helps meet medical device standards throughout the product life cycle. Because these standards have been approved internationally, quality management systems designed to meet ISO 13485 requirements play a role in meeting regulatory needs.
ISO 13485 is the most used in the medical industry for quality management. Although it is not mandatory; But ISO 13485 provides a framework for quality management system and its processes must meet most legal and regulatory requirements.
In addition to legal requirements, ISO 13485 certification improves quality processes and shows that there is a system to meet customer needs and legislation. Many medical device customers want to see if a center confirms the existence of QMS and the device.
So having a reputable organization that conducts audits and issues ISO certification can reassure customers.
Medical Equipment Distributors
In a similar way to manufacturers, there are regulatory requirements that medical device distributors must meet. In the EU, for example, the distributor must ensure that the devices are CE marked, the conformity marks are set, and the labeling and identification is accurate. You may also need a dedicated authorized representative.
Achieving ISO 13485 certification helps you show customers that you have a quality management system that is independently verified.
Department suppliers and service providers
Due to recent problems in the medical device industry, the amount of requirements imposed on regulators by medical device manufacturers has increased. In many cases, informed institutions and regulatory bodies need manufacturers to have more oversight of their service providers and providers. Obtaining ISO 13485 can show manufacturers that a potential supplier can meet their needs.
These requirements specifically include increasing the need for traceability, identification, risk assessment, cleanliness, documentation of supplier evaluation procedures and processes. These requirements may be familiar to organizations with AS9100 or IATF 16949 when compared to ISO 9001. These standards have a higher level of quality requirements.
At a time when the aviation industry is in recession due to the Corona virus and uncertainty in the automotive industry in some parts (such as the UK), there may be good opportunities to diversify by providing parts and services to the medical equipment industry.
This does not mean that organizations with ISO 9001 alone can not obtain ISO 13485 certification; But more process may be needed.
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