Expertise & Quality
Biolog Lab Services recognizes its responsibility as a provider of quality test services.
Our Quality Management System (QMS) has been established to align with our clients’ quality requirements and to ensure consistent delivery of quality services. We are committed to continuous improvement to ensure the effectiveness of our QMS, and ultimately your satisfaction.
Accreditations & Registrations:
ISO 17025:2017 Accredited
FDA Registered FEI #
USDA/APHIS Permit #
Memberships & Associations:
- Parenteral Drug Association (PDA)
- American Herbal Products Association (AHP)
- American Society for Microbiology (ASM)
- American Society for Quality (ASQ)
- Council for Responsible Nutrition (CRN)
- Delaware Bioscience Association
- International Probiotics Association (IPA)
- Master Brewers Association of America (MBAA)
- North Carolina Craft Brewers’ Guild
Our Quality System Includes:
Quality Policy – Adhered to by the Biolog Lab Services team.
Team Approach – A dedicated team that works to continuously monitor and improve the Quality System effectiveness using the Quality Policy, audit measures, data trend analysis, proficiency testing, corrective and preventative actions, risk analysis, and Management Review.
Detailed Procedures – Detailed Quality System and Standard Operating Procedures ensure consistent processing and accurate results of the Client’s samples.
Quality System Audits – ISO Accreditation, Client, Internal, and Regulatory audits ensure compliance with specific requirements of the ISO 17025:2017 Standard and 21 CFR Part 211 cGMP regulations.
Qualification & Validation – A stringent equipment qualification, process validation, and calibration and maintenance program to ensure that critical equipment, processes, and supplies that affect the quality and accuracy of test results meet all required specifications.
Training – cGMP and internal procedure training is provided to all employees to ensure continuous understanding and compliance with the Biolog Lab Services’ Quality System.
Our Quality Assurance Policy
Through the application of proven laboratory techniques and testing performance excellence, Biolog Lab Services is committed to consistently providing services at an exceptional value that meet or exceed our customers’ expectations. We shall achieve this through continuous improvement of our business practices, laboratory processes and systems through programs that develop the expertise, professionalism, impartiality, and integrity of our employees.
The management and employees of Biolog Lab Services are committed to these quality objectives:
- Ensuring compliance with ISO/IEC 17025:2017
- Biolog Lab Services policies and procedures, applicable sections of 21 CFR Part 211 (Subparts B, C, I and J), requirements of organization providing accreditation such as ANAB and any applicable regulatory authority requirements.
- Providing other various microbiological testing that are not included on our Scope of Accreditation.
- Ensuring impartiality in all lab activities by reviewing and eliminating or reducing potential risks to conflicts of interest.
- Consistently providing quality services and meeting commitments to our customers.
- Performing accredited testing for the activities listed below and as defined on the ANAB Scope of Accreditation which include:
- Identification of Microorganisms via DNA Sequencing for bacteria, yeast, and fungi
- Identification of Microorganisms via MALDI-TOF for bacteria
- Meeting the needs and requirements of our customers though superior Customer service.
- Ensuring that all our personnel are qualified and competent and familiarize themselves with Quality Management System documentation and implement these policies and procedures in their work.
For completion of the following documents, please contact QA@biolog.com
- Quality Agreement
- Master Service Agreement
- Confidentiality / Non-Disclosure Agreement
- Quality System / Survey Questionnaire
- Disbarment Statement (per 21 U.S.C. 335a (a) and (b))
- Supplier/Vendor Qualification form
- Contract Services form ·
- Material Transfer Agreement
Onsite Quality Audits
If you would like to schedule an onsite quality audit, please email us.