McGuff Compounding Pharmacy Services, Inc. Receives the First Pharmacy ISO 9001:2000 Certification in the United States
and
What It Means For You

The International Standards Organization, (ISO) Geneva, Switzerland, through independent auditors, has certified that McGuff Compounding Pharmacy Services, Inc., (McGuff CPS) meets all requirements of the American National Standard ISO 9001:2000 Quality Systems-Model for Quality Assurance in:

• Product Design

• Product Development

• Production

• Installation and Servicing

McGuff CPS is the first compounding pharmacy in the United States to receive such certification.

ISO Standards are documented agreements containing technical specifications or other precise criteria to be used consistently as rules, guidelines, or definitions of characteristics, to ensure that materials, products, processes and services are fit for their purpose.  International Standards thus contribute to making life simpler, and to increasing the reliability and effectiveness of the goods and services we use.

For Physicians, ISO standards assure that a multitude of products work together or in a similar manner, worldwide.  ISO standards assure that a Japanese IV catheter (Terumo) will fit on a U.S. syringe (Becton-Dickinson) or on a German IV administration set (Codan) and that all single-use containers for venous blood specimen collection are the same.

For the general public, ISO standards assure a VISA card will work the same in Berlin, Germany as it does in Omaha, Nebraska or when you buy film in a local store in Budapest, the film speed rating will match trusty old Kodak from the U.S.A.  ISO sets worldwide standards for thousands of products, processes and services.

ISO certifies Quality Management Systems and this is the core value of an ISO 9000 series certification.   A compounding pharmacy that has achieved an ISO 9001:2000 certification (such as McGuff CPS) has achieved the highest-level Quality Management System Certification.  A simple ISO 9000 certification does not include the all-important Product Design portion of the Quality System.

Physicians and their patients benefit from ISO 9001:2000 standards by assuring, through independent auditors, that McGuff compounding pharmacy is compliant to a proven Quality Systems Model.   The ability of a compounding pharmacy to consistently provide quality products to physicians and patients is defined by their ability to manage themselves and their processes.  ISO certification assures physicians and patients the pharmacy can meet the their needs again and again.

McGuff CPS would like to challenge all compounding pharmacies to be at least ISO 9000 certified.   This would improve the level of confidence physicians, patients, federal and state governments have in compounding pharmacy and the products they provide.

For more information:

International Standards Organization Main Page

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