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 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.

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 17025
ISO 17034
ISO Guide 34
OHSAS
18001
FSSC 22000 ISO 50001
APAC Australia Bayswater   PDF            
APAC China Hongkong   PDF            
APAC China Shanghai PDF PDF            
APAC China Shanghai (SIAL) PDF PDF            
APAC China Wuxi PDF PDF            
APAC India Ahmedabad   PDF            
APAC India Bangalore PDF PDF   PDF        
APAC India Bangalore (SIAL) PDF PDF   PDF        
APAC India Hyderabad   PDF            
APAC India Kolkata   PDF            
APAC India Mumbai   PDF            
APAC India New Dehli   PDF            
APAC Indonesia Jakarta   PDF   PDF   PDF    
APAC Japan Ichikawa (Chiba)   PDF            
APAC Japan Baraki Ichikawa
(Chiba)
  PDF   PDF        
APAC Japan Kanagawa   PDF   PDF        
APAC Japan Tokyo   PDF   PDF        
APAC Japan Yokohama   PDF   PDF        
APAC Japan Osaka       PDF        
APAC Philippines Makati City   PDF   PDF        
APAC Singapore Singapore PDF PDF            
APAC Korea Seoul   PDF            

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 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 17025
ISO 17034
ISO Guide 34
OHSAS
18001
FSSC 22000 ISO 50001
EMEA Austria Wien   PDF            
EMEA Belgium Overijse   PDF            
EMEA Bulgaria Sofia   PDF            
EMEA Czech Republic Praha   PDF            
EMEA Czech Republic Praha (SIAL)   PDF            
EMEA Denmark Søborg   PDF            
EMEA Finland Espoo   PDF            
EMEA France Guyancourt   PDF            
EMEA France Molsheim PDF PDF   PDF        
EMEA France Lyon - St.
Quentin-
Fallavier
PDF PDF            
EMEA Germany Berlin PDF PDF   PDF        
EMEA Germany Darmstadt GMP PDF
Non-GMP PDF
PDF PDF PDF 17034 German
17034 English
Annex to 17034 English
    PDF
EMEA Germany Eppelheim PDF PDF   PDF        
EMEA Germany Gernsheim PDF PDF   PDF        
EMEA Germany Hamburg   PDF   PDF        
EMEA Germany Hohenbrunn PDF PDF   PDF        
EMEA Germany Schnelldorf PDF PDF       Country
specific
PDF
   
EMEA Germany Steinheim PDF PDF   PDF     PDF  
EMEA Germany Taufkirchen   PDF            
EMEA Greece Athen   PDF            
EMEA Hungary Budapest   PDF            
EMEA Hungary Budapest (SiAl)   PDF            
EMEA Ireland Arklow PDF PDF   PDF        
EMEA Ireland Cork PDF PDF PDF PDF        
EMEA Israel Jerusalem Non-GMP PDF PDF PDF PDF        
EMEA Israel Rehovot PDF PDF PDF PDF        
EMEA Italy Milano   PDF            
EMEA Netherlands Amsterdam   PDF            
EMEA Netherlands Zwijndrecht   PDF            
EMEA Norway Oslo   PDF            
EMEA Poland Poznan   PDF            
EMEA Portugal Alges   PDF            
EMEA Romania Bucharest   PDF            
EMEA South Africa Modderfontein   PDF            
EMEA Slovakia Bratislava   PDF            
EMEA Spain Madrid   PDF            
EMEA Spain Mollet PDF PDF   PDF        
EMEA Sweden Stockholm   PDF            
EMEA Switzerland Altdorf PDF     PDF        
EMEA Switzerland Buchs   PDF PDF PDF 17025 PDF
17034 PDF
     
EMEA Switzerland Schaffhausen PDF     PDF        
EMEA UK Gillingham PDF PDF            
EMEA UK Haverhill PDF PDF PDF PDF        
EMEA UK Irvine PDF PDF   PDF        
EMEA UK Livingston PDF PDF PDF PDF        
EMEA UK Nottingham   PDF   PDF        
EMEA UK Poole   PDF            

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 LATAM Sites

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

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

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 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 17025
ISO 17043
ISO 17034
ISO Guide 34
OHSAS
18001
FSSC 22000 ISO 50001
NA Canada Oakville, Ontario   PDF            
NA USA Allentown, PA   PDF            
NA USA Bedford, MA   PDF            
NA USA Bellefonte, PA PDF PDF   PDF        
NA USA Burlington, MA   PDF            
NA USA Carlsbad, CA PDF              
NA USA Cleveland, OH PDF PDF   PDF        
NA USA Danvers, MA PDF PDF   PDF        
NA USA Hayward, CA                
NA USA Jaffrey, NH PDF PDF   PDF        
NA USA Kankakee, IL PDF PDF   PDF        
NA USA Lenexa, KS PDF PDF   PDF        
NA USA Laramie, WY PDF PDF     17025 PDF
17043 PDF
17034 PDF
ISO 17043 TNISSAS
     
NA USA Madison, WI     PDF PDF        
NA USA Miamisburg, OH GMP PDF
Non-GMP PDF
PDF   PDF        
NA USA Milwaukee, WI - Teutonia PDF PDF            
NA USA Milwaukee, WI -
Emmber
GMP PDF
Non-GMP PDF
PDF         PDF  
NA USA Natick, MA   PDF            
NA USA Norwood, OH PDF PDF   PDF        
NA USA Port Washington, WI   PDF            
NA USA Ramona, CA PDF PDF PDF          
NA USA Rocklin, CA     PDF          
NA USA Round Rock, TX   PDF PDF PDF 17025 PDF
ISO 17034 PDF
     
NA USA Sheboygan Falls, WI PDF PDF   PDF        
NA USA Sinking Springs, PA   PDF            
NA USA St. Louis, MO - Barton PDF PDF PDF          
NA USA St. Louis, MO - Broadway
and associated
organisation in Cherokee
PDF

GMP PDF
Non-GMP PDF

PDF   PDF        
NA USA St. Louis, MO - Dekalb PDF PDF PDF PDF        
NA USA St. Louis, MO - Ewing PDF PDF PDF PDF        
NA USA St. Louis, MO - Spruce   PDF PDF PDF        
NA USA St. Lous, MS - South Second   PDF PDF PDF        
NA USA St. Louis, MO- Laclede   PDF PDF PDF        
NA USA Taunton, MA PDF PDF            
NA USA Temecula, CA PDF PDF PDF PDF        
NA USA The Woodlands, TX   PDF PDF PDF        
NA USA Urbana, IL PDF PDF            
NA USA Verona, WI     PDF PDF        

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