Without question, there is immense value for organizations to have their metrology (calibration) and testing laboratory suppliers comply with ISO/IEC 17025:2005, General Requirements for the Competence of Testing and Calibration Laboratories, especially in the medical device industry. For medical devices to be considered safe and effective, testing and inspection requires the use of calibrated measuring and monitoring equipment.

FDA demands that certain activities be performed using monitoring and measuring equipment with a high-degree of accuracy. The materials employed in the manufacture of medical devices need to be tested to ensure they are appropriate for the application. Design and process validation activities, material biocompatibility, packaging, sterilization validation, and electrical performance must be tested to a high-degree of reliability. The only way to ensure that the integrity of the testing results is through the use of an accredited ISO/IEC 17025 facility for calibration and testing.

Reasons for Compliance

There are various reasons to ensure that the testing house is accredited to ISO/IEC 17025 for calibration and testing. It is good business practice. These specific reasons to seek out accredited suppliers are as follows:¹

Beyond the business reasons to ensure accreditation 21 CFR, Part 820 section 820.72—Inspection, Measuring, and Test Equipment requires manufacturers to calibrate equipment. FDA considers it a fundamental matter of enforcement during inspections of device manufacturers. A similar requirement is mandated by ISO 13485:2003 under Clause 7.6 (Control of measuring and monitoring devices). Considering the regulatory oversight provided by FDA in the United States, and the notified bodies in support of ensuring compliance to 93/42/EEC (the Medical Device Directive), selecting a metrology supplier that is ISO/IEC 17025 accredited is the prudent path. If the device manufacturer is performing calibration activities in-house, then complying with ISO/IEC 17025 would be considered a best practice.

For testing activities, selecting qualified testing laboratories is not considered optional by FDA or notified bodies. Regulatory bodies expect testing to be performed by qualified laboratories. Additionally, a qualified testing laboratory is expected to be ISO/IEC 17025 accredited. Asking regulatory bodies such as FDA to accept test data from an unaccredited testing facility would be a challenging endeavor and would probably cost more in time and money and ultimately end in futility.

Common Deficiencies Associated with a Compliance Audit

The key for manufacturers, however is to have a strong understanding of the limitations their testing suppliers might face. Device makers have to look for deficiencies in their supply chain and take steps to correct or mitigate those problems. In a 2009 presentation made at the NCSLI Conference, held in Ann Arbor, Robert L. Knake (Accreditation Officer at A2LA) dove into the most common deficiencies noted during accreditation audits. Recognizing these deficiencies is half of the battle when it comes to organizations pursuing the appropriate steps to preclude making the same errors. Some of the most common deficiencies noted by Knake were as follows:

Conclusion

In conclusion, the demands of the medical device industry require medical devices to be designed, developed, validated, and manufactured to be safe and effective in their intended use. The integrity of the testing results and the obtainment of testing and inspection results through the use of calibrated equipment is a fundamental requirement enforced by FDA and other regulatory bodies. Similar to the medical device industry, the pharmaceutical, dietary supplement, and aerospace industries also have a significant reliance on testing and calibration. In support of achieving accurate results, the prudent path is to select and qualify calibration and testing facilities that are ISO/IEC 17025 accredited. If the calibration and testing is being performed by a manufacturer (in-house), then compliance with ISO/IEC 17025 would be considered a best practice.

Receiving ISO/IEC 17025 accreditation would be deemed best-in-class. Regardless of the approach pursued for testing and calibration, in-house versus supplier, ISO/IEC 17025 must be considered as part of the decision process. In closing, accurate test results rely on the practical application of the principles associated with ISO/IEC 17025.

More details on testing standards can be found in "Implementing ISO/IEC 17025:2005," written by Bob Mehta, available from ASQ.  

Bob Mehta is principal consultant of GMP ISO Expert Services, a Los Angeles/Orange County-based consulting firm specializing in global supplier quality management, supporting quality systems for FDA- and ISO-regulated companies. Mehta has more than 22 years of experience in the fields of quality, regulatory compliance, regulatory and notified body inspections, supply management, and risk management. Mehta holds MSQA, MBA, B.S. (Chem), and ASQ - CSSBB, CQE, CRE, CSQE, CBA, CQA, CPA certifications. He serves on the committee of the Industry Board of Advisor for Medical Device Industry Education Consortium (MDIEC). He is heavily involved in remediating and implementing the risk-based quality systems and supplier audit program for Fortune 500 clients in a variety of industries, including medical device, pharmaceutical, biotech and neutraceutical.