ISO/IEC 17025:20xx

Accreditation Forum
Halifax, N.S.
June 6, 2017
Objectives

• Provide an update on the revision

process;
• Share ideas and gather feedback on the
transition plan; and,
• Start a discussion on how some of the
new requirements may be applied and
incorporated into management systems.

1
Quiz time!

• How many in this

room have read
the any version of
the revised
standard?

2
How many people…

• …are responsible for implementing the

revised standard?
• …are responsible for the internal audit or
external assessment of the system?
• …will be working in the revised system?

3
Status

• Draft International Standard (DIS)

– 91% approval (80 of 88 countries)
– Still 1785 comments!
• Drafting Group met May 1-3, 2017 in
Vancouver, B.C.
• ISO/CASCO WG44 will meet in mid-July
in Geneva

4
WG44 Meeting – July 2017

• Possible
outcomes
– Final Draft
International
Standard (FDIS);
or,
– Publication of
ISO/IEC
17025:2017

5
Looking ahead…

Where and when

can the new version
of ISO/IEC 17025 be
purchased?

6
Where and when can a laboratory receive
some training on the revised version of
ISO/IEC 17025?
– CALA course entitled “ISO/IEC
17025:2017 – What’s New and
Different?”
– Target date: September 2017

7
When can CALA assessors expect to
receive training on the revised standard?
– Planning some webinar-based training
– CALA “biennial” assessor training:
April 26 – 27, 2018

8
 If a laboratory is due
for a reassessment
in 2018, will it be
assessed against
ISO/IEC 17025:2005
or the revised
standard?

9
What we know for sure!

• Three (3) year transition period from the date

of publication for the ABs
– CALA must demonstrate that accredited
laboratories conform to the revised standard
• Timeline will be clearer after WG meeting
(July)
• Coordinating with the SCC on a common
approach
• CALA will publish a transition plan as soon as it
is available
10
Important – take note!

• Laboratories will be required by CALA

to detail how they plan to implement the
revised standard!

11
Transition plan: Constraints

• Training/qualifying
assessors
• Common approach
with SCC
• ILAC/APLAC/17011
requirements
• Deadline set by
international
community

12
Transition plan: To be decided

• When should CALA start to offer assessments

using the new version (17025:20XX)?
• When should CALA stop offering assessments
to the current version (17025:2005)?
• What should a “transition” assessment look
like?
• How should CALA assess “gaps”?
• How should CALA assess “plans”?

13
 Do quality manuals
need to be re-
written to reflect
the new format of
the standard?

14
• Short answer: no
• Considerations:
– Revisions are likely necessary
– The system is for the laboratory – not
the accreditation body or the
assessors – or the Quality Manager!

15
• Are quality manuals even a requirement
any more?

16
• Short answer: no
• Does that mean you’re going to get rid
of your quality manual?
– If there is no quality manual, then
what do I have in place in my system
to demonstrate that a requirement is
met? Is it shareable and usable?
– If it ain’t broke, don’t fix it…

17
You may note slight changes in
wording…
17025:2005 17025:20xx
• Lab shall have policies • The lab shall ensure
and procedures to the protection of
ensure protection of confidential
confidential information….
information… including including electronic
electronic storage and storage and
transmission of results transmission of results

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• Even though a “policy” or “procedure”
may not be explicit, how does a
laboratory demonstrate that it meets the
requirement?
• Caveat – if a policy and procedure is
working for a laboratory, there is no
need to delete it from the system just
because the requirement is seemingly
gone!
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 MORE…
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Stay Informed

• SCC Mirror Committee on Conformity

Assessment
– dethier@scc.ca
• CALA Newsletter
• Direct e-mails and updates from CALA
regarding training opportunities and
transition plans as they become
available

21
Contribute

• CALA, SCC, BNQ and NRC CLAS will be

collating and updating a joint FAQ page
– submit your questions/comments to:
ccotter@cala.ca
• Submit suggestions on:
– Implementation process;
– Application of requirements; and/or,
– Assessment process, in general.

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