Armstrong Medical’s Quality Management system is certified by SGS UK Limited to international standard EN ISO 13485:2016 and has been carefully constructed to ensure that our products are designed and manufactured to consistently meet the specific needs of our customers. Our commitment to continuous improvement is validated by regular audits by SGS UK Limited, who are widely recognised as being at the forefront of providing certification services.
All Armstrong Medical products are supplied CE marked in accordance with the Medical Devices Directive 93/42/EEC and also conform to a variety of international standards as applicable. However, Armstrong Medical’s internal commitment to product quality goes beyond adherence to internationally recognised standards and extends into the attitude of our highly trained production staff and dedicated Quality Team, who are always mindful that the products they manufacture are used to save lives in critical care applications both locally and across the world.
Environmental Management System
Armstrong Medical is certified by QMS International Ltd. to international standard ISO 14001:2015. Armstrong Medical’s commitment to sustainability strives for environmental improvements across all business functions.
Advantages of ISO 14001:2015 include:
- A greater emphasis on resource, waste and energy management
- Quantify, monitor and control the impact on the environment, now and in the future
- Ensure legislative awareness and compliance
- Improve environmental performance of supply chain
Armstrong Medical’s experienced regulatory department ensure that products are licensed and certified to allow export to our customers around the world including Australia, Canada, Japan and the U.S.A.
Armstrong Medical’s Quality Policy:
Armstrong Medical Limited is committed to achieving total customer satisfaction through product defect prevention and excellent customer care. This will be achieved through:
- Stringent assurance of product quality.
- Prompt delivery, accurate information provision and thorough follow-up on queries and complaints.
- Continual measurement and improvement of our performance.
- Ensuring that all employees are fully competent and aware of customer requirements.
- Compliance with ISO 13485, the EC Directive 93/42/EEC and the regulatory requirements of all our customer countries.
- Increasing our control over production through vertical integration.
Please see our quality certificates below.
AML ISO13485 - Issue 18 - Exp 190423
|303.12 KB||21st Sep 2020|
AML - MDD EC Cert - Issue 18 - Exp 190422
|1.09 MB||9th Oct 2019|
AML - ISO 14001_2015 Certificate - EXP 120321
|210.31 KB||22nd Apr 2020|
AML - MDSAP Certificate - Exp 210523
|3.32 MB||2nd Jun 2020|
AML CE1639 Annex II - Issue5 - Exp190422
|574.87 KB||21st Aug 2020|