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Rockford ASQ,
Sep 20, 2012
Presenter:
Ken Berger
EVERYTHING YOU EVER
NEEDED TO KNOW
ABOUT ISO 17025 AND
MORE…..
TITLE: General requirements for the competence of
testing & calibration laboratories
laboratories who “…wish to demonstrate that
they
operate a management system,
are technically competent,
and are able to generate technically valid results.”
PURPOSE OF THE STANDARD
Taken from ISO17025“Introduction”
AN OVERVIEW (1 OF 3)
Clause 4
•requirements for sound management
Clause 5
•requirements for technical competence
17025 at-a-glance, Technical (2 0F 3)
Testing (5.4) Sample
Handling (5.8)
Personnel
(5.2)
Environment
(5.3)
Report
(5.10)
Results Quality
(5.9)
Equipment
(5.5)
Traceability
(5.6)
Sampling
(5.7)
Consumables
(4.6)
Co
ntr
ol o
f N
/C
(4.9
)
17025 at-a-glance, Management (3 0F 3)
Management
System (4.2)
Review of
Contracts (4.4)
Org
an
iza
tio
n (4
.1)
Service to
Customers (4.7)
Improvement
(4.10)
Control of N/C
(4.9)
Complaints
(4.8)
Mgmnt Review (4.15)
Corrective
Action (4.11)
Preventive
Action (4.12)
Records Control
(4.13)
Internal Audits
(4.14)
Document
Control (4.3)
ISO9001 VS. ISO17025 (2 OF 5)
Management
System (4.2)
Document
Control (4.3)
Organization
(4.1)
Mgmnt
Review (4.15)
ISO9001 VS. ISO17025 (3 OF 5)
Management
System (4.2)
Review of
Contracts (4.4)
Organization
(4.1)
Mgmnt
Review (4.15)
Corrective
Action (4.11)
ISO9001 VS. ISO17025 (4 OF 5)
Management
System (4.2)
Review of
Contracts (4.4)
Organization
(4.1)
Mgmnt
Review (4.15)
Corrective
Action (4.11)
Report
(5.10)
Testing Method
(5.4)
Improvement
(4.10)
Personnel
(5.2)
Preventive
Action (4.12)
Environment
(5.3)
General
(5.1)
Assurance of
Qlty (5.9)
ISO9001 VS. ISO17025 (5 OF 5)
Management
System (4.2)
Review of
Contracts (4.4)
Organization
(4.1)
Mgmnt
Review (4.15)
Corrective
Action (4.11)
Report
(5.10)
Testing Method
(5.4)
Improvement
(4.10)
Personnel
(5.2)
Preventive
Action (4.12)
Environment
(5.3)
General
(5.1)
Assurance of
Qlty (5.9)
Subcontracting
(4.5)
Service
(4.7)
Complaints
(4.8)
Test Eqmnt
(5.5, 5.6 )
Handling T&CI
(5.8)
Purchasing
(4.6) Internal Audits
(4.14)
Incorporates all ISO 9001 requirements relevant to the scope
of testing and calibration … will therefore operate in
accordance with ISO 9001.
ISO9001 ≠ ISO17025
(… does not of itself demonstrate the competence of the laboratory to
produce technically valid data and results.)
ISO17025 ≠ISO9001
Nor does demonstrated conformity (of).. all the requirements of ISO
9001.
ISO9001 VS. ISO17025 (1 OF 5)
Testing or Calibration, or both
Policy vs. procedure
Handling test items, 5.8 &
handling test equipment, 5.5.6
Equipment meets specification 5.5.5
Including test/cal activities in Internal Audits
Purchasing records – PO, Inspection, Suppliers
NC Work procedure scope
COMMON ERRORS
what to look at first –
Start with 5.2 – easy
Do 4.9 before 5.5, so you know the NC
procedure
Do 4.9 with 4.11 Corrective Action
Save doc & records control for last
Repeated requirements:
procedure to protect client info in 4.1.5, also
in 4.13 & 5.4.7
Section 5.1 refers to all following section 5
items
AUDITING TIPS/EXPECTATIONS (1 OF 2)
Top Management:
Continually Improve - 4.2.3/4.10
communication of syst. effectiveness &
importance of meeting requirements -
4.1.6 & 4.2.4
how changes won't affect integrity -
4.2.7
review to ensure suit/effect, changes &
improve - 4.15
AUDITING TIPS/EXPECTATIONS (2 OF 2)
AUDITING APPROACH
Section Procedure* Record**
4.1 Organization Yes (ref)
4.2 Top Mngmt Yes (ref)
4.3 Document Control, Yes
4.4 Review of …Contracts Yes Yes
4.5 Subcontracting Yes
4.6 - Purchasing Services & Supplies yes Yes
4.7 Service to Customer Yes
4.8 Complaints Yes Yes
4.9 Control of N/C Test Work Yes
4.10 Improvement Yes
*term used 79 times, **used 53 times
AUDITING APPROACH
Section Procedure Record
4.10 Improvement Yes
4.11 Corrective Action Yes Yes
4.11 Preventive Action Yes Yes
4.13 Control of Records Yes
4.14 Internal Audits Yes Yes
4.15 - Top Mngmt Yes Yes
AUDITING APPROACH
Section Procedure Record
5.1 Technical Requirements Yes (ref)
5.2 Personnel Yes
5.3 Accommodation & Environmental
Conditions
Yes
(special)
5.4 Test & Calibration Methods &
Method Validation
Yes
5.5 Equipment Yes Yes
5.6 Measuring Traceability Yes Yes
5.7 Sampling Yes Yes
5.8 Handling of Test Items Yes
5.9 QC Yes Yes
5.10 Reporting the Results Yes