Quality Management

Quality Management

IMGM is a testing laboratory specialized in genetic analyses. We work according to international standards including Good Laboratory Practice (GLP) and the General requirements for the competence of testing and calibration laboratories (ISO°17025). To comply with Good Clinical (Laboratory) Practice (GC(L)P) IMGM follows ICH guidelines, EMA guidelines, FDA guidances and relevant legislation related to the analysis of clinical trial samples.

 

Our accreditation & certifications

 

Following an on-site inspection, the Bavarian Health and Food Safety Authority certified that IMGM is able to conduct DNA/RNA quantification and sequencing for safety testing of medicinal products in compliance with the Principles of GLP. IMGM is included in the national GLP Compliance Programme and inspected on a regular basis.

Since 2004, IMGM holds an accreditation according to ISO 17025 awarded by the Deutsche Akkreditierungsstelle. The accreditation includes Sanger sequencing as well as gene expression and SNP genotyping both using real-time PCR and microarray technologies. Triannual re-certifications and interim surveillance audits ensure continuing compliance.

illumina-propel-certified

Illumina Inc. has awarded IMGM as a Propel-Certified provider for sequencing services on the Illumina NextSeq device, ensuring the delivery of the highest-quality data available for genetic analysis applications. Illumina Propel-Certified labs undergo a rigorous two-phase certification process that include data generation, data certification and on-site audit of the facility and processes. Recertification is an annual process and is accompanied by an audit.


Agilent Technologies has appointed IMGM as "Certified Service Provider (CSP) for Gene Expression Microarrays".


Affymetrix has appointed IMGM as "Authorized Service Provider (ASP) for GeneChip Technology Microarrays and for the DMET Plus Array Platform".


As the first German laboratory, IMGM has been appointed as "Certified Service Provider (CSP) for the Ion Torrent PGM platform" by Life Technologies.

Quality systems at IMGM

 

IMGM regularly hosts audits by customers, regulatory authorities and the accreditation body. We also kindly invite you to audit our facility and processes.

Proficiency testing

IMGM participates in external quality control programs (proficiency testing).

Most recent certificates:

Note that we change schemes on purpose as to analyze different targets in consecutive proficiency testing rounds so as to cover many targets cumulatively over time.

For areas accredited proficiency testing is not offered for, we are eager to work with other laboratories and set up inter-laboratory comparisons. Please contact us!

Customer satisfaction

In addition to the above mentioned certifications we conduct regular customer satisfaction surveys to further help us to identify opportunities for improvement. The high satisfaction status confirms our quality strategy. Here, you can read some of our customers' testimonials.