Quality management

Quality Management
  • Bioprocess Regulatory Statements
  • Extractables information
  • FAQ
  • Quality Management
  • Regulatory Support

Documents

  • Quality policy
  • ISO 9001:2015
  • ISO 9001:2015 Cambridge
  • ISO 13485:2016 Cambridge
  • ISO 22301:2019
  • MDSAP Certificate Eysins
  • ISO 13485:2016 Eysins
  • ISO 13485:2016 Intermountain
  • ISO 13485:2016 Logan
  • ISO 9001:2015 New Zealand
  • ISO 13485:2016 New Zealand
  • ISO 13485:2016 Pasching
  • ISO 9001:2015 Singapore
  • ISO 13485:2016 Singapore
  • ISO 13485:2016 Uppsala (Ficoll-Paque PREMIUM)
  • ISO:13485:2016 Dassel
  • ISO 13485:2016 Tonglu
  • ISO 13485:2016 Cardiff
  • ISO 14001:2015
  • Quality management system
  • Standard for Cytiva Change Control Process for Designated Products.
bp-service

ASME Certificates

  • Certificate of Authorization, ASME, Pall Manufacturing UK Limited Portsmouth.
  • Certificate of Authorization, ASME, Umeå
  • Certificate of Authorization, Cytiva Sweden National board certification


ATEX Certificates

  • ATEX quality assurance notification - Pall, Portsmouth

CE EC Certificates

  • Pall International, MDR EC Certificate


Halal Certificates

  • HALAL Certificate, Pall Manufacturing UK Ltd, Ilfracombe, UK.


ISO 13485 Certificates

  • Cytiva ISO:13485:2016 Dassel
  • Cytiva ISO 13485:2016 Sweden AB
  • Cytiva ISO 13485:2016 Tonglu
  • Cytiva ISO 13485:2016 Singapore
  • Cytiva ISO 13485:2016 Pasching
  • Cytiva ISO 13485:2016 New Zealand
  • Cytiva ISO 13485:2016 Logan
  • Cytiva ISO 13485:2016 Intermountain
  • Cytiva ISO 13485:2016 Cardiff
  • Certificate of Approval: Fribourg, Switzerland
  • Certificate of Approval: Pall Newquay , Pall Manufacturing UK Limited
  • Certificate of Approval: Pall Puerto Rico

ISO 14001 Certificates

  • Certificate of Approval: Cytiva ISO 14001:2015
  • Certificate of Approval: Pall Medistad B.V.
  • Certificate of Approval: Pall Life Sciences Belgium BVBA ISO 14001
  • Certificate of Approval: Pall Puerto Rico US ISO 14001


ISO 22301 certificates

  • Cytiva ISO 22301:2019

ISO 3834 CERTIFICATES

  • Cytiva ISO 3834 Part 2 Portsmouth

ISO 45001 certificates

  • Certificate of Approval Cytiva ISO 45001:2018
  • Certificate of Approval PALL FRANCE SAS ISO 45001:2018
  • Certificate of Approval Pall Newquay Pall Manufacturing UK Ltd ISO 45001:2018




ISO 50001 certificates

  • Certificate Standards 50001:2018
  • Zertifikat Prüfungsnorm ISO 50001:2018

ISO 9001 Certificates

  • Cytiva Global ISO9001:2015 Multi-site Certificate
  • Cytiva ISO 9001:2015 Cambridge
  • Cytiva ISO 9001:2015 Vancouver
  • Certificate of Approval for Pall Manufacturing UK Ltd ISO 9001:2015 Walton Road site

Kosher Certificates

  • KOSHER CERTIFICATE Pall Manufacturing (Ilfracombe) UK Ltd
  • Kosher Pall Manufacturing, (Portsmouth)UK Ltd


MDSAP Certificates

  • MDSAP Certificate, Pall Medical

Pressure Equipment Directive 2014/68/EU Certificates

  • EU Certificate of Conformity, Pressure Equipment Directive 2014/68/EU, Module H
  • EU Certificate of Conformity, Pressure Equipment Directive 2014/68/EU, Module H1


PRESSURE EQUIPMENT SAFETY REGULATIONS, UK STATUTORY INSTRUMENTS No 1106

  • Pressure Equipment Safety Regulations, UK Statutory Instruments No 1106, Module H1


  • EHS program management
  • Sustainability

Environmental, health, and safety (EHS) program management

Cytiva is committed to having a world-class program for managing environmental, health, and safety (EHS) risks. The commitment begins with our Board of Directors, which regularly reviews the company’s environmental and safety performance. Cytiva's vice president for EHS sets the global EHS policy and implements the EHS strategy.

Read more about the EHS program.
Danaher EHS Policy
ISO 14001:2015 Certification


At Cytiva, sustainability means aligning our business strategy to meet social needs, while minimizing environmental impact and advancing social development.

As our business has globalized, so has our supply chain, including locations where environment, health, safety, labour, human rights, and other practices can be problematic. We expect our suppliers to obey the laws that require them to treat workers fairly, provide a safe and healthy work environment, and protect environmental quality.

Read more about our sustainability work.

Learn more

  • BioProcess chromatography resins
  • BioProcess equipment (downstream) and software