17025 Flexible Scopes of Accreditation - Laboratory to 'self-assess' new test method

S

Simon123456

#1
Hi

First posting so wish me luck!

I'm a Continuous Improvement Manager ( :( ) who looks after our 9k and 17025 approvals (Mainly Testing with some limited Calibration approval) as well as working on the procedural side of going for 14k and 18k so I'm a busy boy!

What I am trying to get my head around is 17025 and flexible scopes of accreditation which in my understanding allow a 17025 Accredited lab to 'self-assess' new test methods and add them to their scope of accreditation.

We are a Test and Development house in the UK for many Tier 1 companies who are accredited to QS9000, 16949, etc. The new 16949 states that they must use suppliers accredited to 17025.

That’s us!

Seems easy to follow so far, but, we carry out hundreds of different types of test for many customers and the cost implications alone of adding all of that to our 17025 approval are scary to say the least, especially as the Tier 1 marketplace cannot stand the extra costs.

From my limited 2-year exposure to UKAS, firstly it seems like a very good technical standard, which ensures that a test or calibration is carried out correctly, but to me, at the moment it seems restrictive due to the cost implications, which smaller companies cannot easily afford.

Now that we have been informed about Flexible Scopes (Certainly here in the UK anyway - UKAS Website - Publication LAB 39) it seems to allow us a way out in terms of the costs to add tests. Obviously we still have the internal costs of doing it.

Has anyone had any experience of working with Flexible Scopes of Accreditation? :confused: and any guidance on where to start?

:thanx:

Simon
 
Elsmar Forum Sponsor

Hershal

Metrologist-Auditor
Trusted Information Resource
#2
Hello Simon,

Welcome to posting in the Cove.

Flexible scopes are one of the really hot topics in accreditation right now, especially in the testing world, and to a lesser degree in calibration and inspection accreditations.

The basic concept runs something along the lines of a lab is accredited for some given TYPE of test (e.g. compression force) and specific methods may well be mentioned. In the U.S. that could be the ASTM methods for example.

The lab is then considered (in general) competent to perform any test which uses the same equipment and basic test methods, even if the specific test is different than ones listed on the scope. An example is a lab that can do calibration of force compression machines, and then uses that capability to calibrate a weight lift machine at the gym.

Accrediting bodies are working through it, and some are using it now. Of those, UKAS is one of the leading groups.

There are obvious potentials for issues. One is that some tests may actually be beyond the lab's true ability to carry out, but the flexible scope would allow the lab to proceed. Most labs would not knowingly exceed their scope, but a few may try and get into trouble because they discover the test is beyond what they can do. That brings up contract review of course, but also the question of how much oversight the accrediting body really has in a flexible scope.

The best thing for you to do is to have a discussion with UKAS and find out EXACTLY how they work the flexible scope approach, including the required oversight and any limitations on your lab.

Hope this helps.

Hershal
 
S

Simon123456

#3
Hello Hershall

Thanks for the reply. I am trying the UKAS route with my assessment manager but there is confusion there as well at the moment in terms of interpreting it and also how to police it.

New things take time!

Thanks for the help.

Simon
 
Thread starter Similar threads Forum Replies Date
R Basic Lab Practices - related to ISO 17025 testing labs ISO 17025 related Discussions 1
D Training for ISO 17025 ISO 17025 related Discussions 2
D How to handle suppliers that are not ISO 17025 certified ISO 17025 related Discussions 5
J What risk to cover when NOT using ISO 17025 accredited/certified labs for calibration ISO 17025 related Discussions 3
Q Quick question on the sequence of ISO 17025 external audits ISO 17025 related Discussions 14
E 17025 Accredited Microbiological Testing Laboratory ISO 17025 related Discussions 3
X Looking for 17025 auditor to perform internal audit on IT software testing laboratory ISO 17025 related Discussions 3
K ISO 17025 Facilities and environmental conditions SOP ISO 17025 related Discussions 6
M ISO 17025:2017 Clause 6.4 - Measuring Equipment Validity ISO 17025 related Discussions 2
G Why are 17025 scope angle measurements limited to 5 to 85 degrees? ISO 17025 related Discussions 2
B ISO 17025:2017 Clause 7.1.3 - Decision Rule ISO 17025 related Discussions 2
E Organisational Chart-ISO 17025 Laboratory ISO 17025 related Discussions 3
Casana ISO 17025 - Contractor certification? IATF 16949 - Automotive Quality Systems Standard 5
B Sanctioned interpretation #10 - ISO 17025 IATF 16949 - Automotive Quality Systems Standard 2
G Compliance with ISO 9001-2015 for ISO 17025 Accredited Labs? ISO 17025 related Discussions 5
D Management reviews ISO 17025 ISO 17025 related Discussions 3
I ISO 17025:2017 / ANAB 3125 - Articulating / Communicating Risks vis-a-vis Audit Findings ISO 17025 related Discussions 2
W Do Reference materials for IATF need to be 17025? IATF 16949 - Automotive Quality Systems Standard 15
W What is okay to use as a reference material for ISO 17025? ISO 17025 related Discussions 4
AllTheThings ISO-17025 accredited TEST lab performing internal calibrations (Yes: Here is how) ISO 17025 related Discussions 8
M Must a company be 17025 accredited to perform internal calibrations? ISO 17025 related Discussions 10
P Filled in F48/F49 for internal audit ISO 17025:2017 Internal Auditing 2
D Question on Documented Calibration versus ISO 17025 Accredited Calibration ISO 13485:2016 - Medical Device Quality Management Systems 2
M Transferring ISO 17025 from one company to another ISO 17025 related Discussions 1
W 17025 and NIST handbook relationship (need advice) ISO 17025 related Discussions 8
K Integrating ISO 9001:2015 with ISO 17025:2017 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
X ISO 17025 certification for Laboratory for online gambling products ISO 17025 related Discussions 3
R ISO 17025 - ISO Guides 33 & 80 ISO 17025 related Discussions 1
T ISO 17025: Lockout/Tagout Requirement ISO 17025 related Discussions 2
R ISO 17025 vertical audit checklist wanted Document Control Systems, Procedures, Forms and Templates 2
A ISO 17025 - Methods validation and clients ISO 17025 related Discussions 3
S Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
T ISO 17025:2017 requirement 5.7.b. about maintenance the integrity of the management system ISO 17025 related Discussions 1
R Who is the customer in the ISO/IEC 17025:2017? ISO 17025 related Discussions 1
C Compliance with ISO 17025 requirement 8.4.2 - Controls - Records recovery ISO 17025 related Discussions 4
G ISO 17025-2017 Management Review reporting items - Inputs ISO 17025 related Discussions 14
S High voltage testing - ISO 17025 - 7.2.2 Validation of methods and 7.3 Sampling ISO 17025 related Discussions 3
S Internal calibrations - Part of an ISO 17025 accredited testing laboratory (Automotive) ISO 17025 related Discussions 16
I Approved Suppliers ISO/IEC 17025:2017 and used test equipment ISO 17025 related Discussions 6
W Issuing reports under ISO 17025:2017 ISO 17025 related Discussions 2
S The (E) in ISO/IEC 17025:2017(E) ISO 17025 related Discussions 3
T ISO 17025:2017 Clause 4.2.2 - The difference between "be notified" and "be informed" ISO 17025 related Discussions 4
G ISO 17025:2017 Uninterrupted chain of traceability for test laboratories ISO 17025 related Discussions 6
DuncanGibbons Who are ISO/IEC 17065 and 17025 applicable to? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
V IS/ISO/IEC 17025:2017 Clause 7, sub clause 7.11 Control of data and information management ISO 17025 related Discussions 1
V IS/ISO/IEC 17025:2017 Clause 4.1 Impartiality ISO 17025 related Discussions 3
F ISO 17025:2017 Clause 7.7 Ensuring the validity of results - Threshold ISO 17025 related Discussions 9
A ISO 17025 Requirement 6.2 - Department Manager Testing Qualifications ISO 17025 related Discussions 1
F ISO 17025 8.6.2 Customer Feedback Analysis ISO 17025 related Discussions 5
F ISO 17025 8.8 Internal Audits in a segmented company ISO 17025 related Discussions 5

Similar threads

Top Bottom