As part of our quality and process improvement programs, each year TTE Laboratories participates in and hosts many site audits, where assessments of our physical plant, our laboratory and our quality management system are conducted internally by our quality staff, by our regulated clients and by our ISO/IEC 17025 accreditation body, PJLA, Inc.. The objectives are simple:
- Compliance to the industry standards of GMP, ISO/IEC 17025, ANSI/NCSL Z540.3. and ISO 8655.
- Continuous improvement to our quality management systems and Standard Operating Procedures
- Compliance to changing regulatory requirements of the market
Here’s a brief outline detailing the various internal audits we undergo to maintain our quality of workmanship and our industry leadership:
Annual Internal Audit
- Performed by an independent, unbiased, TTE-approved site auditor
- Assesses our quality and management systems, and conformance to the ISO/IEC 17025:2017 and the ISO 8655 standards
Annual ISO/IEC 17025:2017 Accreditation and Surveillance Audits
- Performed annually by PJLA, Inc. – a TTE Laboratories approved accreditation provider and MRA signatory to the International Laboratory Accreditation Cooperation (ILAC) via the Asia Pacific Laboratory Accreditation Cooperation (APLAC) for both testing and calibration
- Assesses TTE Laboratories’ quality and management systems, along with our ongoing conformance to the ISO/IEC 17025:2017
- Successfully passing this Audit is required to maintain accreditation status
- TTE Laboratories accommodates requests for client audits and hosts several each year
- Performed by representative(s) of a client or prospective client
Client representative(s) assess various factors important to them, including our ability to meet their regulatory requirements, and also our quality and management systems.