How ISO Standards Goes Hands in Hands With Medical Industries?
The healthcare sector among all the industrial sectors is one of the sector that is highly bound by rules and regulations, regional and international laws, standards and medical guidelines. All medical staff including surgeons, doctors, and nurses with the help of standardized medical high quality precise devices do their maximum efforts to take care of their patients. With developed standards, legislation support and provided guidelines on medical quality management one is able to serve with consistent high quality results. Other emerging industries like e-health support and services, regenerative medicinal use and nanotechnology have open new horizons in medical industry. The most popular ISO standards in medical and healthcare industry is ISO 9001 (Quality Management System) and ISO 13485 (Quality Management System for Medical Industries).
Implementing ISO Standards in Medical Healthcare Sector
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Medical Devices Manufacturing ISO Standards
There are numerous ISO standards that have been specially designed for medical care devices manufacturing industries keeping in view its requirements, customers’ needs and market competition. Keep in consideration that the medical devices companies operating in and selling their products and services to the European Union and Canada have few special requirements with respect to ISO and ISO standards that are applicable worldwide to many industries and are success guaranteed too.
ISO 9001 – Quality Management Standard
ISO 9001 is more of generic i.e. industrial specific quality management system that can be successfully adopted and has been widely accepted by many manufacturing industries including healthcare and medical devices manufacturing industry also. The practical implementation of ISO 9001 not only ensures better quality control system but also comes up with other priceless benefits like cost savings by reducing rework, rejections and wastages made during manufacturing processes, improved customer care services by reduction in customer complaints making your brand’s image more reputably acceptable as compared to other marketplace robust competitors, enhanced employees’ engagement leading to success of your overall business and lastly embedment of continuous improvement cycle that will provide unbeatable results in terms of high sales and enhanced customers’ circle by opening more doors to new customers and business opportunities. Being ISO 9001 compliant can make one more harmonized with other quality control mechanisms.
ISO 13485 – Quality Management for Medical Device Manufacturers
Looking for a quality management system that is designed specifically for medical devices manufacturing industry? ISO 13485 is the answer to all the requirements of healthcare industry. Be it risk management and its controls, process and product validation or accurate product traceability ISO 13485 have it all covered. Moreover ISO 13485 has harmonized clauses with ISO 9001 in the standard keeping in view the medical sector’s requirements. Fortunately ISO 13485 follows the same process approach as of ISO 9001 so it is much easier to integrate both the systems. One of the vital requirement of ISO 13485 is having a risk management plan in documented form. The brief steps of risk management includes basic three modes which are:
- Assessment of risks existing in the system
- Analysis of the identified risks existing in the system
- Mitigation of the identified risks existing in the system to the best possible level
ISO 13485 represents all the requirements of medical industry in detail and on microscopic level to incorporate manufacturing needs according to modern market and latest design engineering. What ISO 13485 ensures to your customers is the type of medical devices you design or promote has fulfilled is free from flaws that can lead to dissatisfaction for customers, the medical products are environment friendly, the manufacturing processes are validated and the products are traceable, proper risk management activities are being carried out periodically and on need basis, employees’ safety and product safety is first priority and anything being done is properly documented.
In order to get insights about the difference between ISO 9001 and ISO 13485, get your ambiguities cleared now.
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ISO 27001 – For Cybersecurity Risks
Since industrial management systems have become more digitalized and less dependent on paper work (more environment friendly). The continuous growing healthcare sector has evolved into e-healthcare sector based on user friendly sophisticated health care and health monitoring apps and let’s not forget to mention high tech biomedical devices being widely used in operation theatres and for disease diagnosis. ISO 27001 has all the guidelines about managing cyber system risks and to minimize and substitute it with less threatening risks to the optimum levels as much as possible. In order to avoid data breach, ISO 27001 has been proved as a helping hand to many industrial sectors including medical devices manufacturing industries. Being ISO 27001 certified, one will be able to avoid threats, manage risks existing in management system and can even mitigate the potential risks along with most cost effective solutions.
Concrete Benefits of ISO Standards in Medical Healthcare Industries
ISO standards for medical healthcare industries brings along many rock solid advantages among which few are enlisted below:
- Minimization of faulty products
- Reduction in wastages and rework production
- Enhanced Customer satisfaction by lowering complaints
- Happier and more engaged staff
- Edge to Marketing team
- Skyrocketing Sales
- Optimum cost reduction
- Opening new doors to business and new potential customers