iso 17025 and sanas guidelines for use of reference materials...

ISO 17025 and SANAS guidelines for use of

reference materials and PT scheme

participation

T & M Conference

1. Introduction – ISO/IEC 17025

2. Requirements for use Reference Materials / Certified Reference

Materials

3. Requirements for use of Proficiency Testing

4. Challenges facing testing laboratories

Presentation layout

ISO/IEC 17025 contains the

criteria necessary for a

laboratory to implement in order

for it to perform its test work

competently

The criteria that a laboratory

must comply with to be

internationally acceptable is

ISO/IEC 17025.

What is ISO/IEC 17025?

1. These are the base requirements necessary for a laboratory to be able to implement and operate to demonstrate it is competent

– They are not “super” requirements

– Cost (of compliance and/or Accreditation) is cost of achieving consistently good results

– Cost of not having consistently good results could be much higher

2. 17025 focus is on:

– Management requirements and Technical requirements

– Annex A Cross reference to ISO 9001

– Annex B Guidelines for establishing application for sector fields

ISO/IEC 17025

ISO/IEC 17025:2005

Requirements for use of Reference / Certified

Reference Materials

Definitions:

Reference Material:

Material or substance one or more whose property values are sufficiently

homogeneous and well established to be used for calibration of an apparatus,

assessment of a method, or assigning values to materials

Certified Reference Material:

Reference material accompanied by a certificate, one or more of whose

property values are certified by a procedure which establishes traceability to an

accurate realization to the unit in which the property values are expressed, and

for which each certified value is accompanied by an uncertainty at a stated

level of confidence


Reference Materials

SI Units

Secondary Standards

(Inter)national (Primary)

Standards

In-house Standards

Measurement / Calibration

C

o

m

p

a

r

i

s

o

n

s

uncertainty


Reference Materials

ISO/IEC 17025 Clause 5.6.3.2

“Reference materials shall, where possible, be traceable to SI units of

measurement, or to certified reference materials”.

Note: Values associated with Reference Materials may not be

metrological traceable. Values associated with certified

Reference Materials are metrological traceable.

Requirements for use of Reference Materials

ISO/IEC 17025 Clause 5.9

“The laboratory shall have quality control procedures for monitoring the

validity of tests and calibrations undertaken. The monitoring shall be

planned and reviewed and may include”:

a) Regular use of certified reference materials and/or internal control

using secondary reference materials

Uses of Reference Materials / Certified

Reference Materials

The use of Reference materials / Certifies Reference Materials in quality

assurance testing helps to ensure that the data generated by a particular

testing lab is:

a) Consistent

b) High Quality

c) Reliable

d) Traceable

NB: They are also used to evaluate the performance of

laboratories and laboratory personnel through proficiency

testing (PT).

Definitions:

Proficiency testing (PT):

is the evaluation of participant performance against pre-established criteria by

means of interlaboratory comparison (ISO/IEC 17043).

Interlaboratory Comparison (ILC):

is the organizations performance and evaluation of measurements or tests on

the same or similar items by two or more laboratories in accordance with

predetermined conditions (ISO/IEC 17043). .

Requirements for Proficiency Testing

Clause 5.9…

“ The laboratory shall have quality control procedures for monitoring the

validity of tests and calibrations undertaken. The resulting data shall be

recorded in such a way that trends are detectable and, where

practicable, statistical techniques shall be applied to the reviewing of the

results”. The monitoring shall be planned and reviewed and may

include:

a) participation in interlaboratory comparison or proficiency- testing

programmes


The minimum PT activity according to a laboratory’s scope is:

i. Evidence of satisfactory participation prior to gaining accreditation where

PT is available and appropriate

ii. Further and ongoing activity that is appropriate to the scope of

accreditation and consistent with the PT participation plan.


ISO/IEC 17011 [7] requires accreditation bodies to take into account during

assessment and the decision making process participation and performance in

proficiency testing

SANAS R80:

“ All applicant testing laboratories are required to participate in appropriate

proficiency testing or interlaboratory comparisons for the scope of

accreditation required and provide SANAS with the relevant proof on

application of participation and satisfactory performance”.

Requirement for Proficiency Testing

SANAS R80:

“ Where nor formal PT is practicable or available, the laboratory shall indicate

suitable alternative means by which performance will be assessed and

monitored. This may include activities such as intra-laboratory comparison,

the use of reference materials or other comparisons. SANAS shall

consider these alternative arrangements as part of the laboratory’s planned

activities. The onus is on the laboratory to provide the details of the plan

and its justification thereof and obtain approval from SANAS”.

Proficiency Testing

Challenges faced by testing laboratories

Unavailability of some reference materials for some tests then the lab starts using an assumed to be positive sample.

Usually difficult to get hold of or to import them e.g. toxicants and certain zoonotic pathogens

No Certificate of analysis therefore wrong ATCC strains of reference materials are used.

Maintenance/verification of reference material Certain PT schemes only address a partial identification of some of the bacteria

Financial constraints

Questions

Thank You

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