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 systemsRequirements
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
equipmentPart 1: Metrological confirmation system for measuring
- ISO 10012-2:1997, Quality assurance for measuring equipmentPart
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 10012:2003s 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 devicesQuality management
systemsRequirements 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
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-thirds 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 systemsMedical devicesParticular
requirements for the application of ISO 9001
- ISO 13488:1996, Quality systemsMedical devicesParticular
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 210s 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
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
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
standards suitability for US adoption. "We thought wed
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 auditingUS 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.