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08 July 2015

A brief introduction to ISO 13485 certification

In the global market of medical devices almost all manufactures are required to follow a set standard. This standard is to make sure the medicals devices are of good quality and acceptable. That is where ISO 13485 comes in. ISO 13485 is a quality standard similar to ISO 9001 that is meant for use by the design, development and production units of the medical devices. This is also that worldwide standard that is followed by many countries.

This standard is popular in Europe, Australia, etc. It is not formally recognized in USA but it does overlap theirs.

 

ISO 13485 Certification

 

ISO 13485 Certification is based on the ISO 9001 standard to some extent and was first implemented in 1996 in Europe. In fact as per the European Medical Device Directive (93/42/EEC) obtaining the ISO 13485 certification means you meet their quality system requirements.

Although ISO 13485 is an international standard it is more popular in Europe than other countries. There are benefits of obtaining a ISO 13485 certification for the international market as well since it gets you very close to being able to sell to other countries as well. However additional certification may be required to sell in other markets.

For example the other markets like Canada and Japan have additional quality management requirements. Hence further certification is required to quality to sell in that market.

 

ISO 13485 Requirements

 

In general it is required to create written policies on the following topics as a part of the ISO 13485 requirements: Internal Auditing Procedures; Document and record controls; Corrective and preventive actions; Controls for non-conformance; Accountability and tractability; Record Retention and Process and design controls

 

Although it is necessary to keep in mind that the ISO standards are usually updated regularly and ISO 13485 is no exception.

 

URS Certification's global presence can work for you

 

URS Ireland in Ireland is the official representative of URS Holdings for Ireland and USA. They offer several ISO Certifications within Ireland. They have a wide network within the multinational URS Holdings that spans more than 30 countries. Thus they are the right people to help you with your ISO 13485 certification.

 

They are accredited internationally by several bodies:UKAS(United Kingdom Accreditation Service); IATF(International Automotive Task Force); NABCB(The National Accreditation Board for Certification Bodies); and DAC(The Dubai Accreditation Centre)

Dr. Martin Knox

Dr. Martin Knox

Martin Knox is a PhD Chemist with significant experience in training and development, research, environmental management and water quality management. He is a lead assessor for the following international standards:

  1. ISO 9001
  2. OHSAS 18001
  3. ISO 13485
  4. ISO 14001

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