Quality Management Systems

ISO Certificates & Site Quality Self-Assessments

As a leader in the Life Sciences industry, we are committed to product quality, manufacturing effectiveness and meeting customer expectations. Accordingly, the majority of our Life Science sites are certified to the ISO 9001:2015 standard.

Some sites are additionally certified to the ISO 13485 device standard (for applicable products), ISO 17034 / ISO Guide 34 and ISO/IEC 17025 (applicable to certified reference materials) or ISO 22000 Food Standard (applicable to food ingredients). Several sites have registered ISO 14001 environmental and OHSAS 18001 work safety management systems.

Our ISO 9001 Quality Self-Assessment provides in-depth information about our Life Science Quality Management System. The table of content of this document is aligned to « Contents of ISO 9001:2015 Quality Management Systems ». The company profile is aligned to « RX-360 Supplier Assessment Questionnaire, Module 1 ».

We also provide Site Quality Self-Assessments based on Rx-360 Supplier Assessment Questionnaire Module 2, Site Specific Information.

Rx-360 is an industrial consortium with initiatives covering the supply chain for drug products marketed in the word. We are an active member. For more information, please refer to the Rx-360 website.

Choose a Region:

APAC | EMEA | LATAM | NA
 

 APAC Sites

Please click on the appropriate marked field to open the certificate.
 

Region Country Location Site
Quality
Self-
Assessment
ISO 9001 ISO 13485 ISO 14001 ISO/IEC 17025
ISO 17034
ISO Guide 34
ISO 45001 FSSC 22000 ISO 50001
APAC Australia Bayswater  
IQNET
DQS
           
APAC China Hongkong  
IQNET
DQS
           
APAC China Nantong
Non-GMP PDF
GMP PDF

IQNET
DQS
           
APAC China Shanghai PDF
IQNET
DQS
           
APAC China Shanghai (SIAL) PDF
IQNET
DQS
           
APAC China Wuxi PDF
IQNET
DQS
           
APAC India Ahmedabad  
IQNET
DQS
           
APAC India Bangalore PDF
IQNET
DQS
  PDF IQNET
PDF DQS
  PDF    
APAC India Bangalore (SIAL) PDF IQNET
DQS
  PDF IQNET
PDF DQS
  PDF    
APAC India Hyderabad   IQNET
DQS
           
APAC India Kolkata   IQNET
DQS
           
APAC India Mumbai   IQNET
DQS
           
APAC India New Dehli   IQNET
DQS
           
APAC Indonesia Jakarta   IQNET
DQS
  PDF IQNET
PDF DQS
  PDF    
APAC Japan Ichikawa (Chiba)   IQNEF
DQS
           
APAC Japan Baraki Ichikawa
(Chiba)
  IQNET
DQS
  PDF IQNET
PDF DQS
       
APAC Japan Kanagawa   IQNET
DQS
  PDF   PDF    
APAC Japan Tokyo   IQNET
DQS
  PDF        
APAC Japan Yokohama   IQNET
DQS
  PDF        
APAC Japan Osaka       PDF        
APAC Philippines Makati City   IQNET
DQS
  PDF IQNET
PDF DQS
       
APAC Singapore Singapore PDF IQNET
DQS
           
APAC Korea Seoul PDF IQNET
DQS
           
APAC Taiwan Taipei PDF IQNET
DQS
           
APAC Thailand Bangkok PDF              

back to top

 EMEA Sites

Please click on the appropriate marked field to open the certificate.
 

Region Country Location Site
Quality
Self-
Assessment
ISO 9001 ISO 13485 ISO 14001 ISO/IEC 17025
ISO 17034
ISO Guide 34
ISO 45001 FSSC 22000 ISO 50001
EMEA Austria Wien   IQNET
DQS
           
EMEA Belgium Overijse   IQNET
DQS
           
EMEA Bulgaria Sofia   IQNET
DQS
           
EMEA Czech Republic Praha   IQNET
DQS
           
EMEA Czech Republic Praha (SIAL)   IQNET
DQS
           
EMEA Denmark Søborg   IQNET
DQS
           
EMEA Finland Espoo   IQNET
DQS
           
EMEA France Guyancourt   IQNET
DQS
           
EMEA France Meyzieu (Estapor) PDF IQNET
DQS
  PDF   PDF    
EMEA France Molsheim PDF IQNET
DQS
  PDF IQNET
PDF DQS
       
EMEA France Lyon - St.
Quentin-
Fallavier
PDF IQNET
DQS
           
EMEA Germany Berlin PDF IQNET
DQS
  PDF        
EMEA Germany Darmstadt GMP PDF
Non-GMP PDF
IQNET
DQS
PDF PDF IQNET
PDF DQS
17034
17025 English
17025 German
PDF   PDF
EMEA Germany Eppelheim PDF IQNET
DQS
  PDF PDF      
EMEA Germany Gernsheim PDF
IQNET
DQS
  PDF   PDF    
EMEA Germany Hamburg PDF IQNET
DQS
  PDF IQNET
PDF DQS
       
EMEA Germany Hohenbrunn PDF IQNET
DQS
  PDF IQNET
PDF DQS
       
EMEA Germany Schnelldorf PDF IQNET
DQS
      Country
specific
PDF
   
EMEA Germany Steinheim PDF IQNET
DQS
  PDF IQNET
PDF DQS
    PDF  
EMEA Germany Taufkirchen   IQNET
DQS
           
EMEA Greece Athen PDF IQNET
DQS
           
EMEA Hungary Budapest   IQNET
DQS
           
EMEA Hungary Budapest (SiAl)   IQNET
DQS
           
EMEA Ireland Arklow PDF IQNET
DQS
  PDF IQNET
PDF DQS
  PDF   PDF
EMEA Ireland Cork PDF IQNET
DQS
PDF PDF IQNET
PDF DQS
       
EMEA Israel Jerusalem PDF IQNET
DQS
PDF PDF IQNET
PDF DQS
  PDF    
EMEA Israel Rehovot PDF IQNET
DQS
PDF PDF IQNET
PDF DQS
  PDF    
EMEA Italy Milano   IQNET
DQS
           
EMEA Netherlands Amsterdam   IQNET
DQS
           
EMEA Netherlands Zwijndrecht   IQNET
DQS
           
EMEA Norway Oslo   IQNET
DQS
           
EMEA Poland Poznan   IQNET
DQS
           
EMEA Portugal Alges   IQNET
DQS
           
EMEA Romania Bucharest   IQNET
DQS
           
EMEA South Africa Modderfontein   IQNET
DQS
           
EMEA Slovakia Bratislava   IQNET
DQS
           
EMEA Spain Madrid   IQNET
DQS
           
EMEA Spain Mollet PDF IQNET
DQS
  PDF   PDF    
EMEA Sweden Stockholm   IQNET
DQS
           
EMEA Switzerland Altdorf PDF IQNET
DQS
  PDF IQNET
PDF DQS
       
EMEA Switzerland Buchs GMP PDF
Non-GMP PDF
IQNET
DQS
PDF PDF IQNET
PDF DQS
17025 PDF
17034 PDF
PDF    
EMEA Switzerland Schaffhausen PDF     PDF IQNET
PDF DQS
       
EMEA UK Gillingham PDF IQNET
DQS
           
EMEA UK Haverhill PDF IQNET
DQS
PDF PDF IQNET
PDF DQS
       
EMEA UK Irvine PDF IQNET
DQS
  PDF IQNET
PDF DQS
  PDF    
EMEA UK Livingston PDF IQNET
DQS
PDF PDF IQNET
PDF DQS
       
EMEA UK Poole   IQNET
DQS
           

back to top

dt Urkunde

 

 LATAM Sites

Please click on the appropriate marked field to open the certificate.
 

Region Country Location ISO 9001 ISO 13485 ISO 14001 ISO/IEC 17025
ISO 17034
ISO Guide 34
OHSAS
18001
FSSC 22000 ISO 50001
LATAM Argentina Buenos Aires IQNET
DQS
           
LATAM Mexico Estado de
Mexico
IQNET
DQS
  PDF        
LATAM Chile Santiago IQNET
DQS
  PDF        
LATAM Brazil Cotia

IQNET
DQS

           
LATAM Brazil Barueri IQNET
DQS
           

back to top

 NA Sites

Please click on the appropriate marked field to open the certificate.
 

Region Country Location Site
Quality
Self-
Assessment
ISO 9001 ISO 13485 ISO 14001 ISO/IEC 17025
ISO 17043
ISO 17034
ISO Guide 34
OHSAS
18001
FSSC 22000 ISO 50001
NA Canada Burlington (Natrix) PDF IQNET
DQS
           
NA Canada Oakville, Ontario   IQNET
DQS
           
NA USA Allentown, PA   IQNET
DQS
           
NA USA Bedford, MA   IQNET
DQS
           
NA USA Bellefonte, PA PDF IQNET
DQS
  PDF IQNET
PDF DQS
       
NA USA Burlington,
MA (includes Sigma-RBI)
  IQNET
DQS
           
NA USA Carlsbad, CA                
NA USA Cleveland, OH PDF IQNET
DQS
  PDF IQNET
PDF DQS
       
NA USA Danvers, MA PDF IQNET
DQS
  PDF IQNET
PDF DQS
       
NA USA Jaffrey, NH PDF IQNET
DQS
  PDF IQNET
PDF DQS
       
NA USA Kankakee, IL PDF IQNET
DQS
  PDF IQNET
PDF DQS
       
NA USA Lenexa, KS PDF IQNET
DQS
  PDF IQNET
PDF DQS
       
NA USA Laramie, WY PDF IQNET
DQS
    17025 PDF
17043 PDF
17034 PDF
ISO 17043 TNISSAS
     
NA USA Madison, WI     PDF PDF IQNET
PDF DQS
       
NA USA Miamisburg, OH GMP PDF
Non-GMP PDF
IQNET
DQS
  PDF IQNET
PDF DQS
       
NA USA Milwaukee, WI - Teutonia PDF IQNET
DQS
  PDF IQNET
PDF DQS
       
NA USA Milwaukee, WI -
Emmber
PDF IQNET
DQS
  PDF IQNET
PDF DQS
       
NA USA Natick, MA   IQNET
DQS
           
NA USA Norwood, OH PDF IQNET
DQS
  PDF IQNET
PDF DQS
       
NA USA Port Washington, WI   IQNET
DQS
           
NA USA Ramona, CA   IQNET
DQS
PDF          
NA USA Rocklin, CA     PDF          
NA USA Round Rock, TX   IQNET
DQS
PDF PDF IQNET
PDF DQS
17025 PDF
ISO 17034 PDF
     
NA USA Sheboygan Falls, WI GMP PDF
Non-GMP PDF
IQNET
DQS
  PDF IQNET
PDF DQS
    PDF  
NA USA Sinking Springs, PA   IQNET
DQS
           
NA USA St. Louis, MO - Barton PDF IQNET
DQS
PDF PDF IQNET
PDF DQS
       
NA USA St. Louis, MO - Broadway PDF
IQNET
DQS
  PDF IQNET
PDF DQS
       
NA USA St. Louis, MO - Cherokee GMP PDF
Non-GMP PDF
IQNET
DQS
  PDF IQNET
PDF DQS
       
NA USA St. Louis, MO - Dekalb PDF IQNET
DQS
PDF PDF IQNET
PDF DQS
       
NA USA St. Louis, MO - Ewing PDF IQNET
DQS
PDF PDF IQNET
PDF DQS
       
NA USA St. Louis, MO - Spruce   IQNET
DQS
PDF PDF IQNET
PDF DQS
       
NA USA St. Lous, MS - South Second   IQNET
DQS
PDF PDF IQNET
PDF DQS
       
NA USA St. Louis, MO- Laclede   IQNET
DQS
PDF PDF IQNET
PDF DQS
       
NA USA Taunton, MA PDF IQNET
DQS
           
NA USA Temecula, CA PDF IQNET
DQS
PDF PDF IQNET
PDF DQS
       
NA USA The Woodlands, TX   IQNET
DQS
PDF PDF IQNET
PDF DQS
       
NA USA Urbana, IL PDF IQNET
DQS
           
NA USA Verona, WI     PDF PDF IQNET
PDF DQS
       
NA USA Bellevue PDF              
NA USA Visalia, CA PDF IQNET
DQS
           

back to top