Quality system

At Uppsala Genome Center, we are commited to providing quality assured services to our users, and have adapted to a strict quality control system that will ensure secure handling from project planning to data delivery.

Our Quality Policy

The quality policy of Uppsala Genome Center, reviewed and accepted by SWEDAC, follows:

  • NGI-UGC facility shall perform services of high international standard based on their users’ needs.
  • NGI-UGC facility shall perform services in an impartial manner free of commercial, financial and other pressure.
  • NGI-UGC facility strives to offer the most modern technologies for genomic analysis.
  • NGI-UGC facility shall work actively with education and outreach activities to promote knowledge about current state-of-the-art technologies for genomic analysis as well as technologies under development.
  • NGI-UGC facility shall perform their analyses in accordance with quality standard SS-EN ISO-IEC 17025, and the facility will continuously develop its quality, methodology and data security.
  • NGI-UGC facility personnel are aware of the quality system documentation, and carry out their work in accordance with it.
  • NGI-UGC facility contacts with its users, funders and other external bodies shall be in accordance with good professional practice.
  • NGI-UGC facility will operate in accordance with the ethical, legal and regulatory provisions at Uppsala University and in accordance with good practice in medical and scientific research.

Accreditation by SWEDAC

To secure a high quality of the offered services, Uppsala Genome Center works according to the European quality standard ISO/IEC 17025 and is accredited by SWEDAC as a testing laboratory for sequencing, with accreditation number 1239. New methods and protocols are continuously validated and added to the collection of accredited methods. The sequencing and analysis quality are monitored by regular comparison of the performance of the methods against data from other laboratories. As an accredited laboratory Uppsala Genome Center are audited on-site by SWEDAC prior to continuation of the accreditation.

Accreditation and quality assurance in practice

The foundation for the quality of the services at Uppsala Genome Center is it's highly skilled and dedicated laboratory personnel who handle thousands of samples in hundreds of projects every year. The sequence data we produce is quality controlled and processed by an equally skilled and dedicated group of bioinformaticians who secure delivery of high-quality data to the users.

The following standard services at UGC are accredited according to ISO/IEC 17025 standard:

  • PacBio amplicon libraries

  • Ion AmpliSeq Exome

  • Ion Fragment library

  • BCR-ABL1 mutation screening

This document lists the current scope of Swedac accreditation at UGC.

All other services (such as PacBio de novo assembly, Ion AmpliSeq Transcriptome, etc.) follow the same work procedures as the above listed to as far extent as possible, but deviate from this in varying degrees.

With our high throughput of samples, it is vital to manage and track the samples throughout the process. Therefore, Uppsala Genome Center uses an integrated, in-house developed laboratory information management system (LIMS) for sample and data tracking from project start to end. Currently the comprehensive MiniLIMS from BioTeam is being implemented for the sequencing processes. Further, we use AM system for keeping track of current Standard operating procedures (SOP) and other important documents. It assures that we can work in a time efficient and correct way according to the quality requirements specified by the ISO/IEC 17025 standard.

Below is a list of some of the requirements stated by the ISO/IEC 17025 standard by which the platform operates by daily:

  • All steps of the sequencing process must be validated, well-defined, fully traceable and monitored using statistical methods.
  • Each staff member’s responsibilities and tasks must be well-defined.
  • The process is constantly monitored and evaluated for identification of unnecessary or weak points and consequent actions are taken.
  • All decisions should always be evidence-based.
  • Each staff member should have the competence required for his/her tasks and participates in internal and external competence development.
  • The facility must maintain a high level of information security.
  • Complaints from users are registered and consequent actions are taken.

Further, as an accredited facility Uppsala Genome Center is subject to an audition of the sequencing process, bioinformatic analyses, data storage, customer relations, and management by SWEDAC.