blue – ISO 17020 (type A) accredited inspection body for API GMP audits

Accreditation according to DIN EN ISO / IEC 17021-1

The German Accreditation Body DAkkS has granted blue an accreditation according to DIN EN ISO / IEC 17021-1 (Accreditation D-ZM-18678-01-00). This accreditation confirms that blue inspection body is competent to issue certifications according to ISO 9001. 

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blue inspection body provides certification services for clients in the pharmaceutical environment such as suppliers or service providers for the pharmaceutical industry. By way of ISO 9001 certification pharmaceutical companies document their high level of compliance to quality management standards and services.

With a certification by blue our clients benefit from a combined audit according to GMP guidelines and DIN EN ISO requirements. The active participation of certified GMP-Auditors of federal state authorities in the accreditation process of a "Type A inspection body“ links the content-based GMP guidelines with the predominantly normative DIN EN ISO requirements. This enables us to competently assess the implementation of ISO 9001 in the pharmaceutical sector.

Procedure for ISO 9001 certifications

Preparatory phase
Prior to the actual certification process, the applicant is advised to assess the suitability of all quality processes according to ISO 9001 beforehand by internal audits or similar measures. 

Check of documentation
By checking the QM documentation and internal audit reports the certification body  establishes whether the documentation meets the audit requirements.

Following the evaluation of basic requirements and documents for readiness for certification, the actual certification audit takes place: If the requirements are found to be fulfilled, the proper implementation of the quality management system documentation is verified. The auditor collects objective evidence during his visit on site. If there are any nonconformities a schedule is drawn up to carry out the corrective and preventive measures.

Obtaining the certification
As soon as all nonconformities have been eliminated within the given time frame the report and certificate are issued.

Surveillance and re-certification
To retain the certification a surveillance audit is carried out once a year. After three years a re-certification is due.


blue inspection body GmbH
Hafenweg 18-20
48155 Muenster, Germany
Phone: +49 251 9759950-100

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