ISO 13485:2016 is a management system for medical device. It ensures the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose.
Medical Device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:
a) Intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:
diagnosis, prevention, monitoring, treatment or alleviation of disease,
diagnosis, monitoring, treatment, alleviation of or compensation for an injury
investigation, replacement, modification or support of the anatomy or of a physiological process,
supporting or sustaining life
control of conception
disinfection of medical devices
providing information for medical or diagnostic purposes by means of in-vitro examination of specimens derived from the human body;
and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.
UKAS means the United Kingdom Accreditation Service. UKAS is the UK’s National Accreditation Body, responsible for determining, in the public interest, the technical competence and integrity of organisations such as those offering testing, calibration and certification services.
ISO 13485 certification without UKAS accreditation may mean that your organisation have a risk to lose large contracts and business opportunities due to unrecognised ISO certification.
The time to get ISO 13485 Certification depend on company size, number of locations, business nature and operation complexity.
For Company (Staff < 20), it take 4 months on average.
For Company (Staff ~50), it take 6 months on average.
For Company (Staff ~100), it take 7-9 months on average.
You may take below steps :
1) ISO 13485 Gap Analysis.
2) Establishment of ISO 13485 Documentation.
3) Attend ISO 13485 Training.
4) Implementation of ISO 13485 System.
5) Arrange an Internal Audit
6) External ISO 13485 Audit by Certification Body.
There are two major Fees.
1) ISO 13485 Certification Fee charged by Accredited Certification Body such as SGS, Lloyd’s Register,BV, BSI, ACI, DW..
2) Consultant Fee charged by us.
The Fees depend on company size, number of locations and operation complexity.
No. Because of conflict of interest. Certification Body can provide ISO 13485 Standard generic training only but cannot tell you how to implement ISO 13485 System in your company.
Absolutely Yes. In general, ISO Consultant will draft documentation, guide your company to implement ISO 13485 system until passing in ISO 13485 Certification Audit.
In general, the company can put the ISO 13485 logo in the website, name card and letterhead after receipt of corresponding ISO 13485 Certificate.
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