Business Case Studies

QMS Standards In Medical Industry

Are you one of those individuals with life saving mentality while expanding your Horizons as well as your brand name in the field of business?

If it is so, then you must be investing in the medical industry in order to create organisation which creates medical instruments and equipments. But to make your organisation Picture Perfect you need to abide by some standardization rules for quality control so that it is a Win-Win situation for you as well as your customers.

Today we will be talking about the quality management system in the medical industry, and how it has been able to change the system for good.

A brief overview

Did you know that the internal organisation for standardization had published its quality management system standards be back in 2003 so that there could be equality in the medical industry regarding the regulation of the same?

The standardization has been based on the management system of ISO 9001:2000, and it has covered all the aspects of the medical industry and how quality control can be done.

Source- https://www.orielstat.com/blog/medical-device-qms-overview/

Key objective of the QMS standardization

There were a number of mottos in order to get the QMS done for every medical facility. It has the objective of defining a quality management system show that every medical road is clear achievable and measurable. The goal is to make every problem solved and also to reduce the load of work on the laboratory workers. Let us now sneak a peek at some of the best Laboratory QMS standardization goals.

  • Improving the quality of work

If you have a laboratory then your priority will definitely be to keep the quality up to the mark so that there are no loopholes for complaint on behalf of the customers. The enterprise quality management system of the medical world checks the quality of every product and services that are being delivered to the clients so that each and every component can be measured and improvements can be achieved. The products are tested and measured with accuracy with regards to the compliance with the standards to show that the customers expectations are being met.

  • Influencing the culture

In the medical culture if one unit is perfect and Street supervision is done on quality then it is for sure that every other aspect will be taken care of. Therefore quality control standardization in the medical world is absolutely essential in order to make the working mechanism smooth. After all the medical industry is all for saving lives and it is a world that cannot afford to go wrong at any cost. Even a trivial mistake can prove to be fatal to a patient and that is why the possible mistakes should be rectified so that they do not occur again in the future. Orientation is undoubtedly a key factor to improve the test results for quality measurement.

  • Focusing on the training needs

In case of the quality management system, the help in retailing the training and professional skills of an individual so that they are absolutely efficient in order to carry out the medical tests. In some individuals, additional training might be required and that is what the quality management system determines. it keeps a clear check on the incidences when the employees are not being able to achieve the quality goals and they find out the source of the problems. There a specific goal sheets of the medical Industry that every individual participating in it needs to fulfil and the main focus of quality management system is to ensure that every individual has the prerequisite knowledge to do the same.

What is ISO 13485? Why is its existence so essential?

The ISO 13485 is a single QMS standard that has been launched by the globally accredited and accepted ISO 9000 quality management standard series. It has been written in order to support the manufacturers of the medical device and equipment so that they can enhance their designing quality and maintain the effectiveness of the same. It covers the quality control on all the aspects like design consistency, development, installation, production, delivery, as well as maintenance of the medical devices for long periods of time so that their safety can be insured.

What are the benefits of being certified by the ISO 13485?

In the medical industry in different of whether you are in an individual business venture or you want to be globally spread out this is one of the major certifications that will help you in Holistic development. All the companies which have been able to give the certification have been improved in the following aspects:

  • Increasing Global networking with the help of this certification
  • Improving the working process of the organization as well as the product quantity and quality
  • Checking the supply chain and increasing efficiency while decreasing the cost
  • Improving ways to provide safer and efficient medical devices.
  • Meet the customer expectations in accordance with the requirements.

The backdrop of the enterprise quality management system in the medical industry

The existence of ISO 13485 can be traced back to the year 1996 when it was made necessary for all the medical equipment producing companies to abide by a specific set of standards. It has been tailored to the quality system of the medical industry so that it can work according to the Expectations and requirements of the organisation while balancing the supply and demand chain.

To date, it remains to be a standalone platform and it has been able to implement the following things

  • Awareness in the promotion of regulatory requirements for management responsibility
  • Regulation on the work environment to enhance product safety
  • Risk management witty focus has been enhanced and design control activities have been developed
  • Documentation and validation of the sterile medical devices in accordance with the requirements
  • Documentation and inspection of the implantable devices
  • Verification of the efficiency of Preventive and corrective measures taken by the company.

After 1996 the QMS has been able to bring about numerous changes in the medical world and has definitely made it a better place to survive in.