Scope of Services & Approvals

It is AMTAC's policy to provide appropriately accredited certification, where such exists. Only by this means can our clients receive the maximum commercial benefit as a result of our assessments and registration process.

The key organisations that have assessed and accredited AMTAC are:

•  UKAS - the United Kingdom Accreditation Service
•  The European Commission, via the MDA
•  SCC - Standards Council of Canada (Pending)

Where appropriate AMTAC will authorise the use of the UKAS logo and / or the EU 'CE' Marking by clients:

UKAS accreditation ( No. 0060 ) is constantly being enlarged and specific details are available, on request. Accredited certification is provided in relation to:

  •  ISO   9001 - Quality Management Systems
  •  ISO 14001 - Environmental Management Systems
  •  EN   46001 - QMS : Medical Devices
  •  ISO 13485 - QMS : Medical Devices

(Note: UKAS does not, as yet, accredit OSHAS 18001 - Occupational Health & Safety Systems )

'CE' Marking of Medical Devices

AMTAC holds one of the most comprehensive approvals for its Notified Body activities in relation to Medical Devices:

"ALL MEDICAL DEVICES
ALL CLASSES OF DEVICES
CONFORMITY ROUTES II, V & VI"

(ISO 9001, 9002, 9003 & EN 46001, 46002 type respectively)

Scope Re: EU 98/79/EC : In-Vitro Diagnostic Medical Devices

"ALL MEDICAL DEVICES "
- via Own Branding / Private Labelling Route Only

AMTAC is one of the World's longest established providers of product, material and quality system assessment and certification services.

A Serviced Designed to Excel

AMTAC provide a total service, delivering a high level of support both prior and after assessment. We want to see our client companies deriving benefits from the implementation of Business Management Systems. Our culture is one of seeking out 'opportunities for improvement' - not just filling in forms & finding non-conformities.