1. ISO 17025 – MANAGEMENT
REQUIREMENTS

2. Management requirements:
 Contracts
 Subcontracting
 Suppliers
 Complaints
 Corrective and preventive actions (CAPA)
 Internal audits
 Management reviews

3. Review of request tenders and
contracts -1 (ISO 17025: 2005, 4.4)
 Policy and procedures required
 Differences between request and the
contract shall be resolved before work
starts
 Relevant discussions with a customer are
registrated

4. Review of request tenders and
contracts - 2 (ISO 17025: 2005, 4.4)
 Contract has to be acceptable for customer and
laboratory
In contract procedure:
 Requirements including the method are
adequately defined, documented and
understood
 Capacity ad resources of laboratory are assured
 How to act in case of deviations

5. Review of request tenders and
contracts - 3 (ISO 17025:2005, 4.4)
 A contract can be a written or oral
agreement
 Review of compatibility by earlier work or
proven skills to perform

6. Subcontracting tests
(ISO 17025; 2005, 4.5)
 Documented policy and procedure available
including review of subcontractors (ISO 17025
accreditation preferred)
 Contracts with subcontractors are documented
in a register
 Laboratory is also responsible for subcontracted
tests
 Gain approval of customer for subcontracting

7. Suppliers -1 (ISO 17025: 2005, 4.6)
 Policy and procedure for selection and
use of supplies and services
 Procedures for inspection, acceptance
and storage of supplies

8. Suppliers -2 (ISO 17025: 2005, 4.6)
Evaluation of suppliers critical for the quality
of test results
 Services
 Subcontracting
 Equipment
 Reference substances
 Reagents
 Critical consumables

9. Suppliers - 3 (ISO 17025: 2005, 4.6)
 Criteria for evaluation of suppliers
 Documentation of evalution
 Preventive action in case of poor
performance

10. Complaints
The laboratory shall have a policy and procedure for the resolution of
complaints (ISO 17025:2005, 4.8)

11. Control of nonconforming testing
work (ISO 17025; 2005, 4.9)
 Policy and procedure required for
nonconforming work and registration
 Evalution of the significance is made
 Correction is taken immediately
 When necessary customer is notified and
work recalled
 Authorization of resumption of work is
defined

12. Corrective Actions -1
(ISO 17025; 2005, 4.11)
 The laboratory shall establish a policy
and procedure and shall designate
appropriate authorities for implementing
corrective action when nonconforming
work or departures from the policies and
procedures in the quality system or
technical operations have been
identified.

13. Corrective actions -2
 Analyse cause, select and implement
corrective actions (if necessary audit
related activities)
 Document changes resulting form
corrective actions

14. Preventive actions (ISO 17025; 2005, 4.12)
 Needed improvements and potential
sources of nonconformities shall be
identified
 Pro-active process: elements can be risk
analysis, possibility for quality
improvement

15. Internal audits -1 (ISO 17025: 2005, 4.12)
 Verify that laboratory operations continue
to comply the requirements of the
management system and ISO 17025:2005

16. Internal audits - 2 (ISO 17025: 2005, 4.12)
 All elements of the management system have to
be audited periodically
 Audit programme made by Quality manager
 Carried out by trained and qualified independent
personnel (if allowed by resources)
 If audit findings results in doubts about
effectiveness of results/processes timely
corrective actions are taken
 Follow up audit activities shall verify undertaken
actions

17. Audits in general
 Horizontal audits 1 subject example
personnel and competence
 Vertical audits following a process through
an organization

18. Management reviews
(ISO 17025: 2005, 4.15)
The laboratory’s
executive management
shall periodically
conduct a review of the
laboratory's
management system

19. Pitfalls
 Managerial system
 Bureaucratic
 Static system
 Not flexible

20. Building a Quality System
license
management
law es
reg
ist
Do
pl rat
am ion
cu
s
on
me
ati
od
nt
mm
co
calibr
sta rence
rds
ntr
o
Analytical
acc
ol
nda
ation
e
methods
ref
permits
va
pe lid
rs t
on atio en
g cy
m
st en
ne n
uip environment
te ofi
l eq
in
Pr
(local) government storage

21. Final Remark
 Laboratory Accreditation
is a tool to demonstrate
the true underlying quality
of the analytical testing
program
!