Quality Policy of the SNP&SEQ Technology Platform in Uppsala

The SNP&SEQ Technology Platform recognizes that a good reputation regarding the provided services is a prerequisite for obtaining new users and continued funding for the operation. The objectives of the Quality System are defined below.

• The SNP&SEQ Technology Platform services shall be performed according to the needs of the users and be of internationally high standard.

• The SNP&SEQ Technology Platform shall use the most modern methods and equipment for SNP genotyping and DNA sequencing

• The SNP&SEQ Technology Platform shall perform analyses in accordance with the SS-ISO/IEC 17025:2005 quality standard and shall continuously develop its quality system, methods and data security

• The SNP&SEQ Technology Platform staff shall be familiar with the documentation of the quality system and apply it in their work

• The contacts between the SNP&SEQ Technology Platform and its users, funders and other external bodies shall conform with good professional practices

• The SNP&SEQ Technology Platform shall follow the ethical and legal regulations of Uppsala University and good biomedical and scientific research practices

Accreditation of the SNP genotyping process by SWEDAC

The SNP&SEQ Technology Platform is accredited by SWEDAC according to the European quality standard ISO/IEC 17025. The SNP&SEQ Technology Platform in Uppsala is one of the first European laboratories for large scale SNP genotyping to achieve accreditation. Flexible accreditation is granted for the complete genotyping and sequencing process, including the selection of SNP markers and development of new SNP assays (a list over what is accredited can be found here). In this respect the accredited SNP genotyping process differs from accredited genetic analyses in forensic and clinical genetics laboratories, where only predefined forensic markers or specified disease mutations are analyzed. The ISO/IEC 17025 quality standard requires that both the lab work and the management of the SNP&SEQ Technology Platform is performed according to documented standard operating procedures. The accreditation mark is a guarantee to other parties that the SNP genotyping is of high quality.

Accreditation and quality assurance in practice

Quality is not maintained by itself and to our help we have integrated an in-house developed laboratory information management system (LIMS), Chiasma, and Canea Framework (www.Canea.com) into our daily work, that facilitates keeping track on samples and data generated in our genotyping/sequencing pipelines, current SOPs 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 standards.

The points listed below are the most important ones that are stated by the ISO/IEC 17025 standard.  Many of the points are necessary to ensure that the results that are delivered to the customer projects are correct. The main difference than before the accreditation process started is that the steps are performed in a more standardized manner now.

• The genotyping and sequencingprocess is well defined and monitored using statistical methods.
• Evidence-based decisions on for example method development are taken.  
• Work tasks are performed according to written routines to ensure that all staff members use a unified procedure
• Full traceability is maintained for all steps of the genotyping and sequencingprocess
• Each staff member’s responsibilities and tasks are well defined
• Each staff member has the competence required for his/her tasks
• Each staff member participates in internal and external competence development
• We maintain a high level of information security
• We emphasize good relationships with reagent and instrument suppliers
• Feedback is collected from “customer” projects using questionnaires.
• Complaints from “customers” are registered and consequent actions are taken and monitored
• Annual audition of the genotypingand sequencingprocess, customer relations and management is performed.
• The genotypingand sequencingprocess is monitored to identify unnecessary or weak points.