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Volume 8 · Issue 5 · May 2003


Standards Update: Measurements, Medical Devices and Auditing
ISO 19011 and ISO/FDIS 13485 Balloted as US Standards

Three standards completed the balloting or publication process recently on the international and/or US level. Once published, these measurements, medical devices and auditing standards will have an impact on quality management system (QMS) and/or environmental management system (EMS) usage. However, the process forward for some still involves additional steps.

On April 15, 2003, ISO 10012, Measurement management systems—Requirements for measurement processes and measuring equipment, was published as an International Standard. Balloting of the Final Draft International Standard (FDIS) concluded in March 2003, and it was earlier reported that the US vote was to approve the ISO/FDIS 10012. ISO 10012:2003, which represents for some QMS standards experts the last standard to be completed in the core ISO 9000:2000 family, replaces two standards:

  • ISO 10012-1:1992, Quality assurance requirements for measuring equipment—Part 1: Metrological confirmation system for measuring equipment
  • ISO 10012-2:1997, Quality assurance for measuring equipment—Part 2: Guidelines for control of measurement processes.

ISO 10012:2003 will be available for purchase from ASQ for $56.00 by June 1, 2003. Although there are plans to ballot the measurement process and measuring equipment requirements document as an American National Standard, it was not known at press time whether the balloting process has been completed and what the results are. THE OUTLOOK will provide additional information on ISO 10012:2003’s US adoption and an overview of the standard in a future issue.

On May 13, 2003, ISO Technical Committee (TC) 210, Quality Management and Corresponding General Aspects for Medical Devices, concluded international balloting of ISO/FDIS 13485, Medical devices—Quality management systems—Requirements for regulatory purposes, although the results were not known immediately. "Once balloting closes, it takes some time for the Subcommittee Secretariat to compile and forward the results of voting to me," explained Hillary Woehrle of the Association for the Advancement of Medical Instrumentation (AAMI), which holds the TC 210 Secretariat. "If approved, we expect publication in June or July 2003."

Considering that the Draft International Standard (DIS) of ISO 13485 received an 81% vote of approval, it is expected that the FDIS will receive the two-third’s majority approval and less than 25% disapproval that are required for publication as an International Standard.

According to Woehrle, ISO/FDIS 13485 was also balloted for US adoption in parallel with the international balloting and was approved by the US Technical Advisory Group (TAG) to TC 210. "However, US adoption has not yet been approved by the AAMI Standards Board or by ANSI [the American National Standards Institution, which is the US representative to ISO]," noted Woehrle. The AAMI Standards Board must review the voting results and ISO/FDIS 13485 and indicate its approval, after which ANSI will approve its adoption as an American National Standard. Once approved, it will be announced in the AAMI Standards Monitor.

If approved, ISO 13485:200X will replace the following two standards that contained Section 4, Quality System Requirements, in ISO 9001/2:1994:

  • ISO 13485:1996, Quality systems—Medical devices—Particular requirements for the application of ISO 9001
  • ISO 13488:1996, Quality systems—Medical devices—Particular requirements for the application of ISO 9002.

One difference is that ISO 13485:200X will not be fully aligned with ISO 9001:2000, as ISO 13485/88:1996 were with ISO 9001/2:1994. Because of concerns with the regulatory nature of the medical devices sector, requirements in ISO 9001:2000 involving continual improvement of the effectiveness of the QMS and customer satisfaction are not included in ISO 13485:200X. In some instances, segments of the text in ISO 9001:1994 have been retained when they were deemed more suitable by TC 210’s Working Group 1, which drafted the revision to ISO 13485. It is not yet clear how closely ISO 13485:200X will conform with ISO 9001:2000 and if an organization that manufactures medical devices could maintain a single QMS and achieve conformity with both ISO 9001:2000 and ISO 13485:200X, if ISO 9001:2000 was desired.

It is expected that regulatory agencies in Europe and in countries in other regions will accept and/or require registration to ISO 13485:200X, while the US Food and Drug Administration (FDA) will adhere to its Current Good Manufacturing Practices (CGMPs). The CGMPs does not contain the verbatim text of the 1994 or 2000 version of ISO 9001, but instead it contains its own language that is equivalent to the requirements in ISO 9001:1994. It is likely that many medical devices manufacturers presently registered to ISO 9001/2:1994 and ISO 13485/88:1996 will transition only to ISO 13485:200X in coming months. Coverage of ISO 13485:200X will be provided in an upcoming issue.

QMS/EMS Auditing Standard Focus of US Activity
Of the three standards, the one that has the most complicated path forward is ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing. The ANSI ASC Z1 Committee on QEDS (Quality, Environment, Dependability and Statistics) recently concluded a consensus ballot of ISO 19011:2002 for adoption as an American National Standard. "ISO 19011 did pass the Z1 consensus ballot," confirmed Patricia Kopp Ghanam of ASQ, who serves as Administrator to the US TAGs to both ISO/TCs 176 and 207. "However, we must redo the public comment process with ANSI, and we expect to announce the availability of the American National Standard by August 2003."

According to Ghanam, the problem is a matter of deadlines. ISO 19011 was approved as an International Standard in balloting that concluded August 13, 2002, with publication on October 2, 2002. However, the decision to ballot the joint EMS/QMS auditing guidance document as an American National Standard was held up because of consideration that it might be better to wait until a US supplement to ISO 19011 was completed and to publish the standard and supplement together. It was subsequently decided that it would be best to complete the adoption process for ISO 19011 while awaiting completion of the US supplement.

Since ANSI requires that ISO standards be balloted as American National Standards within 6 months of their ISO publication, ISO 19011 must be reballoted with a 45-day public comment period for adoption. This public comment period is to allow ANSI members the opportunity to consider the standard’s suitability for US adoption. "We thought we’d squeak in under the wire with the previous, ISO balloting period, but the clock ran out," commented Ghanam. "So, June 30 will be the closing date for the public comments, after which we can file for approval to publish the US adoption of QE 19011."

As previously reported, a Joint Task Group (JTG) to develop a US supplement was approved by the Z1 EMS and QMS subcommittees in the summer of 2002 and held its first meeting August 28, 2002, to begin the drafting of what is tentatively titled QE 19011S, Guidelines on quality and/or environmental management systems auditing—US version with supplemental guidance. The JTG started significant work on QE 19011S during a meeting simultaneous with those of the US TAGs to TC 207 and TC 176 March 10-13, 2003, in Dallas.

"The JTG made good progress in Dallas, but we do not yet have a Working Draft ready," reported Gary L. Johnson, Environmental Engineer at the US Environmental Protection Agency, who is a member of the US TAG to TC 207, was a US delegate to the JWG and is Co-Chair of the JTG. "We are still soliciting input for the supplementary text to ISO 19011, and a group of us plan to meet during the AQC [Annual Quality Congress] in Kansas City May 19-21, 2003, to continue to review the text suggested.

"Our goal is to have a complete Working Draft for review within the JTG and within selected circles in the TAGs to TC 176 and TC 207 by early June. The next step is to complete a CD [Committee Draft] at the US Standards Group meetings in Washington, DC, in August and to distribute the CD for public comment and ballot in September 2003." Based on this timetable, the JTG hopes that QE 19011S can be published in late 2003 or early 2004.

In all three cases, the standards have been adopted on one level or another and will be available in US and ISO form within the next few months, while the US supplement to ISO 19011 will take a little longer to complete. THE OUTLOOK will continue to provide updates and examinations of these standards and their usage.