IKOR electromedicina
08/08/2014

ISO 13485 STANDARD, FDA

In a previous post on the Evolution of Quality, we said that with Total Quality Management, quality is no longer seen as a cost and starts to be seen as an investment to improve profits.

From this, it is easy to assume that this evolution towards Total Quality is maintained in organisations over time and Quality Management Systems in them are evolving continuously. Today, there is a great number of International Standards that address how a Quality Management System should be defined in companies.

Perhaps, the best known and most widely accepted is the standard ISO 9000 family, a set of quality and quality management standards established by the International Organization for Standardization (ISO).

This family of standards appeared in 1987 based on the British Standard BS 5750 from 1987, experiencing their greatest growth from the 1994 version. The current version dates back to 2008.

With the appearance of these standards, the leading industrial sectors saw their benefits but complained that they were too generic and needed to be adapted to their respective sectors to make them more demanding.

Among the benefits of adopting these standards as Management references were:

• Standardise the activities of staff working within the organisation through documentation.

• Increase customer satisfaction by ensuring quality products and services consistently, given the standardisation of procedures and activities.

• Measure and monitor the performance of processes.

• Increase the effectiveness and / or efficiency of the organisation in achieving its objectives.

• Continuously improve processes, products and efficiency, among other things.

• Reduce the negative impact of production or provision of services.

Taking the contents of the ISO 9000 Standards as reference, sectors such as the automotive industry published their own ISO TS16949 standard, a more demanding standard adapted to the automotive sector.

The medical sector also adopted and published its own standard ISO13485 for the same reasons.

  • ISO 13485 STANDARD

The ISO13485 international standard specifies the requirements for a quality management system that can be used by an organisation for design and development, production, installation and servicing of health products, and the design, development, and provision of related services.

So organisations such as the following may be certified:

• Manufacturers of health products

• Distributors of health products

• Technical support services for health products

• Electro-Medical Services – Hospital Clinical Engineering

• Hospital Sterilisation Centres

To be certified with this standard allows access to customers in the medical sector, who typically require this certification as a condition of guarantee to meet their initial requirements and to initially validate a supplier.

What is IKOR doing in this regard?

The IKOR Group works with clients in the medical industry and it is one of the sectors in which we wish to continue implanting ourselves. For this reason, among the plans for 2015, we aim to certify our production plant in Spain and our ITC Development Centre.

Currently, and with full focus on our customer in this sector, we are developing a plan of action to introduce the product designed by us and manufactured for them in the American market. This process is very costly and the product must pass strict audits, from its design through manufacturing and distribution by the FDA.

The FDA (U.S. Food and Drug Administration or the Food and Drug Agency) is the agency of the Government of the United States, responsible for regulating food (for both people and animals), drugs (human and veterinary), cosmetics, medical devices (human and animal), biological products and blood products.

We are engaged in a plan in collaboration with our client and an American provider, expert in the FDA requirements. This plan will take us to adapt our internal procedures in designing and manufacturing products for the medical sector so that by the end of 2014 we can obtain the approval of the FDA. This process will allow us to face with greater success the challenge of certification according to ISO13485 in 2015.

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About Ikor

We are a global company committed to innovation that provides a total service for the design and manufacture of electronic circuits (EMS), including complete supply chain solutions for world-leading industrial and technological companies.

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Electronic systems, Medical

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