ISO/IEC 17025:2005 and the Benefits of Accreditation

There is immense value for medical device manufacturers in having their calibration and testing laboratory suppliers comply with the General Requirements for the Competence of Testing and Calibration Laboratories in ISO/IEC 17025:2005.

From initial design and development to the shipment of medical devices that can be characterized as safe and effective, the accuracy of the testing and inspection results depends on the use of measuring and monitoring equipment that is calibrated. In addition, the materials used in the manufacture of medical devices need to be tested to ensure the materials are appropriate. Design and process validation activities, the assessment of material biocompatibility, packaging studies, sterilization validation and electrical performance testing must be performed to a high-degree of reliability.

The FDA demands that these activities are performed using monitoring and measuring equipment with a high-degree of accuracy. 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.

Other Industries

Other regulated industries such as dietary supplements (21 CFR, Part 111), pharmaceuticals (21 CFR, Part 211), Medical Devices (21 CFR 820) and even aerospace (AS9100 – premised on ISO 9001), rely on the integrity of testing and need to employ monitoring and measuring equipment that is accurately calibrated with traceability to a national standard, for example to National Institute of Standards and Technology (NIST) or other recognizable standards. Pharmaceuticals and dietary supplements, similar to medical devices, must be safe and effective in their intended use. These industries also employ extensive verification and validation testing and subsequent inspection to ensure product safety.

Reasons for Compliance

In 2005, Hershal C. Brewer explored the reasons for the use of ISO/IEC 17025-accredited suppliers for calibration and testing. In Quality Digest Magazine, Brewer listed the following reasons:

  • Product testing to verify suitability of product for market introduction;
  • Compliance with regulatory and statutory requirements;
  • Ensure product safety and efficacy;
  • Achieve product certification from organizations such as Intertek or UL; and
  • Regulatory requirement to achieve product listing.

The need for medical device manufacturers to calibrate equipment is a fundamental requirement mandated by 21 CFR Part 111 (Subpart D – Equipment and Utensils § 111.35), 21 CFR 211 (Subpart D – Equipment Section 211.68 and Subpart I – Laboratory Controls Section 211.160), 21 CFR Part 820 (Section 820.72 Inspection, measuring, and test equipment) and enforced by FDA during their inspections of device manufacturers. A similar requirement is mandated by ISO 9001:2008/ISO 13485:2003 and AS9100 Rev. C 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 to pursue. If the device manufacturer is performing calibration activities in-house, then complying with ISO/IEC 17025 would be considered a best practice.

For the execution of testing activities, selecting qualified testing laboratories is not considered optional by the FDA. Regulatory bodies expect testing to be performed by qualified laboratories. Additionally, a qualified testing laboratory is expected to be ISO/IEC 17025 accredited. For example, if testing is being performed to IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance) the expectation is that testing be performed at an accredited testing facility such as Intertek. Asking FDA to accept test data from an unaccredited testing facility will not draw a favorable response.

In conclusion, the rigorous standards for medical devices require them to be designed, developed, validated, and manufactured to be safe and effective for their intended use. Obtaining testing and inspection results through the use of calibrated equipment is a fundamental requirement enforced by FDA and other regulatory bodies. For 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 in-house by a manufacturer, compliance with ISO/IEC 17025 would be considered a best practice. But regardless of the approach pursued for testing and calibration, in-house versus supplier, ISO/IEC 17025 must be considered.

FSMA’s Registration Mandate is the Key

The focus of media attention is currently on FDA’s proposed rules for a Foreign Supplier Verification Program and for Accreditation of Third-Party Auditors. But I would draw your attention to a FSMA provision that is already in force, which, from the agency’s viewpoint, is the most significant new authority under the new law — biennial registration of facilities.

The true significance of the registration mandate is, I believe, being overlooked in the media because of the focus on proposed rules and delays. Under FSMA, facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States must register with the agency every two years. There are some exemptions, namely farms, retail food establishments, restaurants, non-profit food establishments, and fishing vessels. But the mandatory registration requirement means that a large number of companies that were not previously very visible to the agency will now be on the radar screen.

Prior to the Bioterrorism Act of 2002, food manufacturers were not required to register with FDA so the agency had to do the best job it could to compile an inventory of food manufacturers so they could be inspected on a regular basis. This was supposed to occur at least once every five years. FDA relied on the states to identify food firms in their state based on tax records and other state requirements for licensing and registration. But this information was often inaccurate or incomplete. Compiling a list of foreign food firms that imported to the U.S. was even more problematic.

On several occasions, outbreaks of foodborne illness were traced to firms that had never been inspected by FDA either because they were considered low on FDA’s priority list or because they were not in FDA’s inventory.

The Bioterrorism Act required all food manufacturers foreign and domestic to register with the FDA thus solving the inventory problem. But the amount of information required by the law was very limited so that FDA often could not tell whether the firm was producing low-risk or high-risk foods. The greatest limitation to the Bioterrorism Act was that companies were only required to register one time. Companies were required to update their registration information if they made changes in the foods they produced and other changes, but many neglected to inform FDA. A 2009 Inspector General’s report indicated that 48 percent of registered facilities gave inaccurate information or failed to update information. Over time the inventory became less and less accurate, which contributed to the disaster that was the Peanut Corporation of America.

PCA’s Blakely, GA plant was registered with FDA as a roaster and blancher of peanuts which was considered fairly low-risk by FDA. By the time of the massive Salmonella outbreak beginning in late 2008, the plant was producing a variety of peanut products including peanut paste. These peanut products were sold to other food companies throughout the U.S. including large companies like Kellogg. When FDA traced the source of the outbreak to the PCA Blakely plant in early 2009, I believe all of the prior inspections were conducted by Georgia state officials under FDA contract. At $500 per inspection under the FDA contract, Georgia inspectors could not do a thorough job and missed many GMP violations that contributed to the establishment and spread of Salmonella throughout the plant. Had PCA bothered to update its registration to reflect its expanded product line, the FDA may have targeted the Blakely plant for an inspection ($10,000 is the cost of an FDA inspection) and prevented the outbreak.

Under FSMA, food facilities are required to reregister every other year and list any changes to the food categories they produce. Furthermore FSMA gives FDA authority to suspend registration if facilities do not comply with the registration requirements. Overall this gives FDA much greater control of its food facility inventory, increases its ability to target high-risk firms, and provides regulatory teeth to encourage compliance.