质量管理

  • 服务与支持
  • 质量
  • 法规支持
  • 质量管理
质量管理
  • 监管声明
  • 提取物信息
  • 常见问题解答
  • 质量管理
  • 法规支持

文件

  • 质量方针
  • ISO 9001:2015
  • ISO 9001:2015 剑桥
  • ISO 9001:2015 剑桥
  • ISO 22301:2019
  • MDSAP 埃桑
  • ISO 13485:2016 埃桑
  • ISO 13485:2016英特芒顿
  • ISO 13485:2016 洛根
  • ISO 9001:2015 新西兰
  • ISO 13485:2016 新西兰
  • ISO 13485:2016 帕辛
  • ISO 9001:2015 新加坡
  • ISO 13485:2016 新加坡
  • ISO 13485:2016 乌普萨拉(Ficoll Paque PREMIUM)
  • ISO:13485:2016 达塞尔
  • ISO 13485:2016 桐庐
  • ISO 14001:2015
  • 质量管理体系
  • 指定产品的Cytiva变更控制过程标准
  • 指定Biacore产品的Cytiva变更控制过程标准
bp-service

ANSI-NSF Certificates

  • NSF International Recognizes Pall Corporation, Cortland, NY.


ASME Certificates

  • The National Board of Boiler & Pressure Vessel Inspectors Certification of Authorisation to Register
  • The National Board of Boiler & Pressure Vessel Inspectors Certification of Authorisation to Register
  • The National Board of Boiler & Pressure Vessel Inspectors Certification of Authorisation to Register
  • Certificate of Authorization, ASME, Pall Manufacturing UK Limited Portsmouth.
  • Certificate of Authorization, ASME, Pall Trinity Micro, Cortland, New York


ATEX Certificates

  • ATEX quality assurance notification - Pall, Portsmouth

CE EC Certificates

  • ECM21MDD015 rev. 0 CERTIFICATO CE EC Certificate.


符合性声明和EC证书(埃桑现场)

请注意,以下文件对应于最新可用版本,因此不适用于文件发布日期之前制造的产品

  • 医疗器械:
    • 欧盟医疗器械指令93/42/EEC,Biosafe S.A
    • 符合性声明1级附件医疗器械记录
    • 符合性声明FA-100.2
    • 符合性声明FB-100.x
    • 符合性声明RCA-100
    • 符合性声明Sepax RM(Sepax 2 RM)
    • 符合性声明Sepax S-100(Sepax 2)
    • Sepax一次性细胞分离工具符合性声明
    • 符合性声明Smart Max AS-310

Environmental statements

  • REACH - Cytiva
  • REACH - Kleenpak™ Presto sterile connector
  • REACH - Pall
  • SVHC affected articles - Cytiva (PDF)
  • SVHC affected articles - Cytiva (XLSX)
  • California Prop-65 substances
  • PFAS (perfluoroalkyl and polyfluoroalkyl substances) in products
  • PFAS - Pall Corporation Statement
  • General Information on RoHS Compliance


Halal Certificates

  • IFANCA HALAL Product Certificate, Pall Trinity Micro, Cortland,NY,USA.
  • IFANCA HALAL Product Certificate, Pall Trinity Micro, Cortland,NY,USA.
  • HALAL Certificate, Pall, Crailsheim,Germany.
  • HALAL Certificate, Pall Manufacturing UK Ltd ,Ilfracombe, UK.


ISO 13485 Certificates

  • Cytiva ISO:13485:2016 Dassel
  • Cytiva ISO 13485:2016 Uppsala (Ficoll-Paque PREMIUM)
  • 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
  • Cytiva ISO 13485:2016 Cambridge
  • 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 ISO 14001 Pall Manufacturing UK Ltd
  • Certificate of Approval Pall Manufacturing (UK) Ltd and its subsidiaries ISO 14001:2015
  • Certificate of Approval: Pall Aerospace Division Redruth UK ISO 14001
  • Certificate of Approval: Pall Middle East Dubai Annex
  • Certificate of Approval: Pall Medistad B.V.
  • Certificate of Approval Nihon Pall ISO 14001
  • Certificate of Approval Pall Exekia ISO 14001
  • Certificate of Quality, Pall Filter systems GmbH ISO 14001: 2015
  • Certificate of Quality, Pall Filter systems GmbH ISO 14001: 2015
  • Certificate of Approval: PALL Newquay UK ISO 14001 and 45001
  • Certificate of Approval: PALL Portsmouth UK ISO 14001
  • Certificate of Approval: Pall Aerospace Division Redruth UK ISO 14001
  • Certificate of Approval: Pall Corporation Cortland NY ISO 14001
  • Certificate of Approval: Pall Corporation Deland FL US ISO 14001
  • Certificate of Approval: Pall Corporation Port Richey FL US ISO 14001
  • Certificate of Approval: PALL Port Richey FL USA ISO 9001
  • Certificate of Approval: Cytiva Pensacola FL USA ISO 14001
  • Certificate of Approval: Pall Puerto Rico US ISO 14001
  • Certificate of Approval: Pall Putnam CT US ISO 14001
  • Certificate of Approval: Pall Putnam CT US ISO 14001
  • Certificate of Approval: Pall San Diego CA US ISO 14001
  • Certificate of Approval: Timonium MD US ISO 14001
  • PALL Arabia for Manufacturing - ISO 14001:2015


ISO 22301 certificates

  • Cytiva ISO 22301:2019
  • Certificate of Self Determination-ISO 22301
  • Certificate of Approval-ISO 22301 Nihon Pall Manufacturing Ltd.
  • 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 Nihon Pall Manufacturing
  • Certificate ISO 45001:2018
  • Certificate of Approval PALL FRANCE SAS ISO 45001:2018
  • Certificate of Approval Pall Manufacturing ISO 45001:2018
  • Certificate of Approval Pall Australia Pty Ltd ISO 45001:2018
  • Oman Inspection and Certification Services LLC Pall Arabia for Manufacturing ISO 45001:2018 Occupational Health and Safety Management System
  • Certificate of Approval PALL FRANCE SAS ISO 45001:2018
  • Certificate of Approval Pall Manufacturing ISO 45001:2018
  • Certificate of Approval Pall Australia Pty Ltd 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



ISO 50001 certificates

  • Certificate ISO 50001:2018
  • Zertifikat ISO 50001:2018
  • Certificate Standard ISO 50001:2018
  • Certificate Standard ISO 50001:2019
  • Certificate Standards 50001:2018
  • Zertifikat Prüfungsnorm ISO 50001:2018

ISO 9001 Certicates

  • Cytiva ISO 9001:2015
  • Cytiva ISO 9001:2015 Singapore
  • Cytiva ISO 9001:2015 New Zealand
  • Cytiva ISO 9001:2015 Cambridge
  • Fluid Technology and Asset Protection - ISO 9001
  • Certificate of Approval Pall Manufacturing (UK) Beijing ISO 9001 2015
  • Certificate of Approval Pall Australia Pty Ltd Somersby
  • Certificate of Approval Pall Australia Pty Ltd Cheltenham
  • Certificate of Approval Pall Australia Pty Ltd Seventeen Mile Rocks
  • Certificate of Approval Pall Manufacturing UK Ltd ISO 9001 2015 Biotech Multi site
  • Certificate of Approval Nihon Pall ISO 9001
  • Certificate of Approval, Pall China, Beijing, China - ISO 9001
  • Pall Singapore, Singapore (include Port Washington SLS - MicroE and Additive Manufacturing) - ISO 9001
  • Pall Additive Manufacturing, Singapore -ISO 9001
  • Pall France - ISO 9001 - English
  • Pall France - ISO 9001 - Francais
  • Pall Exekia Bazet France - ISO 9001
  • Pall Genedisc Technologies France - ISO 9001
  • PALL Arabia for Manufacturing - ISO 9001:2015
  • Certificate of Quality, Pall Filter systems, Bad Kreuznach, Germany GmbH ISO 9001: 2015
  • Certificate of Quality, Pall Filter systems, Pall PASS Bad Kreuznach, Germany GmbH ISO 9001: 2015
  • Certificate of Quality, Pall Filter systems, Crailsheim, Germany GmbH ISO 9001: 2015
  • Certificate of Approval Pall GmbH Dreieich Germany
  • Qualitaetszertifikat Pall GMBh ISO 9001: 2015
  • Certificate of Approval: Pall Advanced Separations Systems
  • Certificate of Approval: Pall Carrigaline Ireland - ISO 9001
  • Certificate of Approval: PALL ITALIA S.r.l. ISO 9001
  • Certificate of Approval: PALL Fribourg Switzerland ISO 9001
  • Certificate of Approval: PALL Newquay UK ISO 9001
  • Certificate of Approval: PALL Farlington UK ISO 9001
  • Certificate of Approval: PALL Portsmouth UK ISO 9001
  • Certificate of Approval: PALL Pensacola FL USA ISO 9001
  • Certificate of Approval: PALL Hauppauge NY USA ISO 9001
  • Certificate of Approval: PALL Microelectronics Port Washington NY USA ISO 9001
  • Certificate of Approval: PALL Port Richey FL USA ISO 9001
  • Certificate of Approval: PALL Exton PA USA ISO 9001
  • Certificate of Approval: PALL Westborough MA USA ISO 9001
  • Certificate of Approval: Pall Technologies SA ISO 9001
  • Certificate of Approval: Pall Arabia for Trading ISO 9001
  • Certificate of Approval: Pall Arabia for Industrial Services ISO 9001
  • Certificate of Approval "Certificate of Approval Pall Europe Limited, Pall Aerospace Division AS 9100D (technically equivalent to EN 9100:2018 and JISQ 9100:2016) | ISO 9001:2015
  • Certificate of Approval: This is to certify that the Management System of: Pall Aeropower Corporation AS9100D (technically equivalent to EN 9100:2018, JISQ 9100:2016 and KS Q 9100:2018), ISO 9001:2015

Kosher Certificates

  • KOSHER CERTIFICATE Pall Manufacturing (Ilfracombe) UK Ltd
  • KOSHER CERTIFICATE Pall Filter systems GmbH, Crailsheim,Germany
  • KOSHER CERTIFICATE Pall Corporation World Headquarters Port Washington, NY.


MDSAP Certificates

  • MDSAP Certificate Eysins.


Pressure Equipment Directive 2014/68/EU Certificates

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


我们知道质量

许多公司测试质量。 在 Cytiva,质量观念是根深蒂固的。 在整个设计和制造过程中,您的 Cytiva 产品的每个方面都必须满足严格的质量要求并达到高水平的性能。

Cytiva 的业务在生物技术行业拥有 50 多年的经验。 我们为受监管环境中使用的产品提供广泛的技术、产品、服务和知识以及监管支持文档。 我们向生物制药行业持续供应的往绩记录表明了我们的承诺和能力。

要请求客户审核,请联系您当地的 Cytiva 代表。

  • EHS 计划管理
  • 可持续性

环境,健康与安全(EHS)计划管理

Cytiva致力于制定世界一流的计划,以管理环境,健康和安全(EHS)风险。 承诺始于我们的董事会,董事会定期审查公司的环境和安全绩效。 Cytiva EHS副总裁制定了全球EHS方针,并实施EHS战略。

阅读更多有关EHS计划的信息。
Cytiva EHS方针
ISO 14001:2015证书


在 Cytiva,可持续性意味着调整我们的业务战略以满足社会需求,同时最大限度地减少对环境的影响并促进社会发展。

随着我们的业务全球化,我们的供应链也在全球化,包括环境、健康、安全、劳工、人权和其他实践可能存在问题的地方。 我们希望我们的供应商遵守法律要求,公平对待工人、提供安全和健康的工作环境并且保护环境质量。

阅读有关可持续发展工作的更多信息。

了解更多

  • 生物工艺 层析填料
  • 生物工艺设备(下游)和软件