The essential focus of Quality Systems Management is to ensure the quality of SHL's scientific, consultative, training and research obligations. The unit plays a key role in meeting the needs of customers by continuously evaluating and improving processes, reducing waste, lowering costs, facilitating and identifying training opportunities, engaging staff and setting organization-wide direction.
The Quality System managers help coordinate and direct activities to meet customer and regulatory requirements, and improve effectiveness and efficiency on a continuous basis with input from the following:
- ISO/IEC 17025:2005 – The SHL Management Principal
- Clinical Laboratory Improvement Amendments (CLIA)
- Health Insurance Portability and Accountability Act (HIPAA)
- Environmental Protection Agency
- National Environmental Laboratory Accreditation Program (NELAP)
- American Industrial Hygiene Association (AIHA)
- Food and Drug Administration
- Food Emergency Response Network (FERN)
HIGHLIGHTS
- Established a Quality Advisory Committee of laboratory executive leadership.
- Completed HIPAA risk assessment/audit and improved HIPAA breach notification policy and process.
- Coordinated equipment certification and calibration lab-wide for pipettes, balances and microscopes.
- Collaborated with FDA and APHL to write training content for laboratories seeking ISO/ IEC 17025:2005 accreditation for FDA Food and Feed Testing.
- Coordinated on-site inspections by National Environmental Laboratory Accreditation Program (NELAP).
- Received ISO/IEC 17025:2005 accreditation for food testing at Ankeny and Coralville labs.
- Co-authored APHL’s Quality Management Training System.
- Oversaw successful CLIA audits at all lab locations and a successful NELAP assessment for Coralville Environmental Health Division.
- Collaborated with IDPH to establish rules for laboratory testing of medical cannabidiol.
