ISO Accreditation

At STERIS Instrument Management Services, we take pride in ensuring that all our instruments are manufactured and inspected to the highest possible standards so that our Customers can have confidence in every purchase.

The manufacture of our instruments and our repair service are controlled by our Quality Management System which is ISO 13485:2016 & EN ISO 13485:2016 certified and MDD 93/42/EEC compliant.

The stainless steels we use for our instruments are all as defined by BS EN ISO 7153-1 and our instruments meet the specifications, where appropriate, as follows:

  • BS 5194 – 2 Surgical instruments — Part 2: Specification for instruments with pivot joints (excluding cutting instruments)
  • BS 5194 – 3 Surgical instruments — Part 3: Specification dissecting forceps
  • BS 5194 – 4 Surgical instruments — Part 4: Specification for scissors, shears and other jointed cutting instruments

We take the principles of ethical trade seriously and have been successfully assessed to LSAS Level 3 ensuring the fair treatment of workers and safe working conditions throughout our supply chain.

ISO 13485:2016