Quality


More than a mere play on words – it is indeed attention to quality that matters, more than almost anything else in building long-standing customer confidence
PolarSeal demonstrates an unbroken commitment to quality accreditation from the inception of the ISO 13485 Quality Standard.
 

The PolarSeal Quality Policy and Management System includes a commitment to:

  • Compliance with all applicable laws and regulations
  • The concept of continual development
  • Effective communication of quality objectives
  • Taking care of employees and visitors
  • Working closely with customers and suppliers
  • Adopting forward-looking business decisions
  • Training staff in the needs of quality management
  • Maintaining a dual site manufacturing capability
Polarseal specialise in Medical Device Contract Manufacturing, R&D prototyping and product development with an unbroken commitment to quality accreditation from the inception of the ISO 9000 Quality Standard.
Polarseal specialise in Medical Device Contract Manufacturing, R&D prototyping and product development with an unbroken commitment to quality accreditation from the inception of the ISO 9000 Quality Standard.

PolarSeal consistently upholds and maintains its fullest commitment to:

  • ISO 13485:2016
  • ISO 9001:2015
  • MDD 93/42/EEC – being replaced by regulation 2017/745 in May 2021.
  • ISO 7 Cleanrooms to 14644-1
  • FDA Registered and Audited

Dual Manufacturing Capabilities

PolarSeal can demonstrate genuine dual manufacturing capability with two stand-alone manufacturing facilities in the UK. Our two sites being based 150 miles apart from each other, ensures our clients can be rest assured that they will never be without a production facility with PolarSeal.