Quality management

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

We know quality

Many companies test for quality. At Cytiva, quality is simply ingrained into who we are. Throughout the design and manufacturing process, every aspect of your Cytiva product must meet stringent quality requirements and achieve a high level of performance.

Cytiva’s business has more than 50 years of experience in the biotechnology industry. We offer a wide range of technologies, products, services, and knowledge as well as regulatory support documentation for products used in regulated environments. Our track record of continued supply to the biopharmaceutical industry shows our commitment and capability.

To request a customer audit, contact your local Cytiva representative.

Quality Management

  • Cytiva Rx-360 General Quality Systems - Questionnaire responses
  • Quality policy
  • Quality management system
  • Standard for Cytiva Change Control and Notification process for Designated products
  • Cytiva change control and notification process for Pall Medical products

Global site certificates


ANSI-NSF Certificates


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
  • ECM21MDD015 rev. 0 CERTIFICATO CE EC Certificate


Declaration of conformity and EC Certificate (Eysins site)

Please note that the below documents correspond to the last available version, and thus it will not apply to products manufactured before the issue date of the document

  • Medical devices:
    • EC Certificate, Directive 93/42/EEC on Medical Devices, Biosafe S.A
    • Declaration of Conformity Class 1 Accessories MDR
    • Declaration of Conformity FA-100.2
    • Declaration of Conformity FB-100.x
    • Declaration of Conformity RCA-100
    • Declaration of Conformity Sepax RM (Sepax 2 RM)
    • Declaration of Conformity Sepax S-100 (Sepax 2)
    • Declaration of Conformity Sepax disposable cell separation kits
    • Declaration of Conformity Smart-Max AS-310

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 Eysins
  • 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
  • Cytiva ISO 14001:2015
  • Certificate of Approval: Pall Medistad B.V.
  • Certificate of Approval: PALL Newquay UK ISO 14001 and 45001
  • Certificate of Approval: Cytiva Pensacola FL USA ISO 14001
  • Certificate of Approval: Pall Life Sciences Belgium BVBA ISO 14001
  • Certificate of Approval: Cytiva US LLC Hauppauge ISO 14001
  • Certificate of Approval: Pall Corporation Hauppauge NY US ISO 14001
  • Certificate of Approval: Pall Life Science Belgium BVBA BL ISO 14001
  • Certificate of Approval: Pall Manufacturing UK Ltd Ilfracombe ISO 14001
  • Certificate of Approval: Pall Manufacturing UK Ltd Portsmouth ISO 14001
  • Certificate of Approval: Pall Puerto Rico US ISO 14001


ISO 22301 certificates
  • Cytiva ISO 22301:2019
  • Certificate of Approval ISO 22301 Pall Manufacturing,  Portsmouth UK Ltd
  • Certificate of Approval ISO 22301 Pall Manufacturing, Ilfracombe UK Ltd
  • Certificate of Approval ISO 22301 Pall Manufacturing, Newquay UK Ltd


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



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 Pall Manufacturing (UK) Beijing ISO 9001 2015
  • Certificate of Approval Pall Manufacturing UK Ltd ISO 9001 2015 Biotech Multi site
  • Certificate of Approval for Pall Manufacturing UK Ltd ISO 9001:2015 Walton Road site
  • Certificate of Approval: PALL Fribourg Switzerland ISO 9001
  • Certificate of Approval: PALL Westborough MA USA ISO 9001

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


MDSAP Certificates
  • MDSAP Certificate Eysins.
  • 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


  • 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.
Cytiva 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