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Quality Assurance Documentation and Training for ISO 17025

What is ISO / IEC 17025?

ISO/IEC 17025 is the main standard used by testing and calibration laboratories. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by the ISO in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 adds in the concept of competence to the equation. ISO/IEC 17025 applies to testing and calibration laboratories, and is designed for both commercial laboratories (they perform work for other companies) and captive laboratories (as part of an organization).

Who should implement ISO/IEC Standard 17025?

• Analytical testing laboratories of organizations who are registered to an ISO 9000 based standard, if laboratories are subject to an audit
• Direct suppliers to organizations that require 17025 certification such as TS 16949
• Laboratories getting official accreditation status by an accreditation body such as A2lA or ASCLD Lab
• All regulated laboratories can use ISO 17025 as a basis for their operations since the US FDA is implementing it in their labs, and recognize it when they conduct their FDA audits

The Business Benefits of ISO/IEC 17025? 

Being compliant / accredited to ISO 17025 gives you confidence in the calibration decisions you make. It provides:

• * Additional information about the quality of each measurement made during the calibration process,
• * As a means of assessing the relative quality and capability of different calibration laboratories and suppliers world-wide
• * Eliminates the need for supplier auditing - calibration suppliers are independently verified through the accreditation process
• A* ln regulated laboratories can use ISO 17025 as a basis for their operations since the US FDA is implementing it in their labs, and recognize it when they conduct their FDA audits

For more information about the ISO 17025 standard please review the following document:  PBSI What is new in 17025.pdf

Scope of Services

PBSI can provide a Gap Analysis that identifies the gaps your organization needs to achieve accreditation to a quality management system. Other benefits of understanding what your organization requires through the Gap Analysis include:

• Identifying non-value processes
• Identifying inefficient systems
• Understanding the impact of certification requirements on your organization
• Measuring process performance and effectiveness
• Identifying opportunities for continuous process improvement

PBSI can also

• * Act as the liaison between the Client and the Third Party Certifier. It is not ethical for third party certifiers to provide consulting or technical services to certification applicants.
• * Provide consultancy advice to achieve a suitable quality management system
• * Provide program management services during your quality management system implementation
• * Prepare (or edit existing) documentation as required - Quality Documentation, Policy Manual, Standards Operating Procedures.  PBSI can help you prepare, format, and print the policies, procedures, methods and quality assurance manuals that are required by forensic laboratories for efficient operation as well as accreditation through the American Society of Crime Laboratory Directors Laboratory Accreditation Board (ASCLD/LAB) or the International Standards Organization (ISO) provide providing.
• * Assist in the development of an RFP to select or provide consulting services for the implementation of the firm's quality management system software
• * Carry out an initial Internal Audit and Management Review.
• * Provide training and mentorship for staff including ISO 17025 overview and training for internal auditors.