Compliance

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Quality Systems and Compliance

At Bio Calibration Services, we use the most modern and effective technology available for our equipment and software and follow up-to-date standards. We operate a robust system to ensure quality in all areas of operation, including training, computer system validation, change control and inventory control.

Our documented calibration service uses a computer-controlled calibration procedure, and all information, conditions, raw data and readings are captured electronically and directly stored in a computerized database. From there, we can ensure security, protect the information’s validity and analyze trends.

All of our calibrations and services are NIST traceable and ISO 17025 compliant.

Bio Calibration Company’s technicians go through rigorous training so they can meet proficiency requirements for conducting calibrations. Their performance is evaluated regularly. Our lab engages in Proficiency Testing and we provide assurance of the quality of the services provided.

Quality Policy and Objectives

To help ensure the highest quality service, we have strict standards and objectives for all of our services. Our policy is to:

  • Consistently provide quality calibration services that conform to customer and regulatory requirements
  • Ensure that all personnel are competent and qualified for the tasks they perform, and that all personnel familiarize themselves with quality system documentation in order to implement the policies and procedures in their work
  • Professionally and effectively perform calibration services in order to produce accurate and precise results
  • Consistently comply with ISO 17025:2017, ISO 8655 and ANSI/NCSL Z540.3 in order to ensure quality testing services and to continuously improve the effectiveness of the laboratory management system

Compliance Procedures

We have formulated a number of systems and procedures designed to meet the highest standards across the entire calibration process, from personnel training to proper documentation of issues and changes.

Quality Systems and Documentation Practices

We established a quality systems manual to guide management of the quality system. The detailed document is rigorously maintained to keep our calibration systems and procedures up-to-date with compliance and regulatory standards.

Our documentation practices provide established guidelines for recording information about the quality records and certificates of Bio Calibration Company and our customers.

Change Control

Our change control procedure details a system that is designed to ensure that changes to documents are implemented in a traceable and controlled manner. The purpose of our document change control system is to ensure that document changes and updates related to services, processes, materials or policies are reviewed, justified, approved, implemented and documented in ways that conform with applicable regulatory, company and quality systems requirements.

Non-Conformance Reporting (NCR)

Customer Complaints/Corrective and Preventive Actions (CAPA): If you have any issues with our calibration services, or if an issue arises that needs attention, we've established an efficient and documented procedure for the timely receipt, dissemination, evaluation, investigation and resolution of all customer complaints and instances of non-conformance.

Technician Training

Bio Calibration Company has enacted measures to determine training responsibilities for our personnel. We are dedicated to providing comprehensive training, assessing competency regularly and maintaining robust training records.

All of our technicians receive ongoing, documented training in GMP 1GLP and compliance practices in order to ensure compliance with FDA regulations.

ISO Accreditation

Bio Calibration Company holds official ISO 17025:2017 accreditation. We have a 4-year plan for accreditation and quality improvement, offering a total quality system

NIST Traceability

All equipment used for measurement within our calibration services are traceable to NIST standards. All relevant traceable information relating to this equipment is documented and included in our standard service documentation.