Successful Audit by Medical Device Manufacturer to 17025 Requirements
August 22, 2013—Integrated Service Solutions, Inc. Successfully Completes Audit by Medical Device Manufacturer to 17025 Requirements— Integrated Service Solutions, Inc. announced today the successful completion of their first 17025 customer audit. The audit was conducted at the corporate office of Integrated Service Solutions by a customer who is an international medical device manufacturer.
In July, 2007, Integrated Service Solutions earned the A2LA 17025 accreditation. Since that time, the Company undergoes annual assessment audits by A2LA which is the accrediting organization.
“Typically, we host twelve to sixteen customer audits annually at our facility,” said Catherine Peetros, Director of Business Development. “However, this is the first time that a customer conducted their audit to the rigorous requirements of 17025.”
Audits conducted to 17025 requirements focus on the competence of calibration laboratories and a quality system that demonstrates the ability to consistently produce valid results. In addition, the auditor looks for proof that there are continuous improvements to the quality system itself and, in particular, communication to the customer.
Noteworthy comments from the auditor include feedback such as:
- Very impressed with the facility and the Metrology Lab
- Your electronic documentation is the first I’ve seen of its kind. Typically, an audit consists of reams and reams of paper. Having everything electronic is impressive and a first of its kind.
- Your quality system is mature and everything is well documented including your training records
- There is clear evidence that dollars are reinvested in the company
“Customer satisfaction is a key component of our service business and ties directly to our 17025 accreditation as well as our ISO registration. So we regularly survey our client base to get their feedback, insight and suggestions. Our client satisfaction program is a mature system with traceable results and is a vital differentiator when customers are choosing their service provider,” added Peetros.
About Integrated Service Solutions, Inc.
Integrated Service Solutions, Inc. is a privately-owned ISO 9001:2008 registered and an ISO/IEC 17025 accredited company with a demonstrated ability to perform specific calibrations.
The company, founded in 1998, specializes in providing equipment services to more
than 500 regulated businesses nationwide. The Company, has a staff of nearly sixty full-time employees to provide single source service solutions across multiple technologies including:
- On-site Equipment Calibrations
- Metrology Laboratory Calibrations
- Equipment Preventive and Corrective maintenance
- Certifications for biosafety cabinets, hoods and cleanrooms
- Analytical Services for HPLC, GC, and Dissolution
- Validation Services (IQ/OQ/PQ)
- Standard Operating Procedure (SOP) Development and Implementation
- Project Management
- Technical Staffing, Training and Quality Engineering Consulting Services
Located in Eastern Montgomery County, Lansdale, Pennsylvania, USA in a 20,000 sq. ft. facility, the Company has Geothermal heated and cooled Metrology, Physical Dimensional, Total Organic Carbon (TOC) Analysis, Pipette and Mass (weight) Laboratories for precision calibrations.
Posted in: Company NewsLeave a Comment (0) ↓