F 176-06

SANAS R48 and R80 Organisation’s

PROFICIENCY TESTING REQUIREMENTS FOR CALIBRATION, TESTING, BTS SANAS No/s.
AND MEDICAL LABORATORIES
(ISO/IEC 17025:2017 Clause 7.7.2, ISO 15189 Clause 5.6 & Standards of practice
for blood transfusion in SA – Standard 11)

Date/s of evaluation

Assessor/s & Observers

Laboratory

Area / field of operation

Laboratory
Representative
This report covers the following:
Document Review only Implementation on Site Visit only Document Review and Site Visit Other

Compliance = C, Non-compliance = NC

REQUIREMENTS & COMMENTS. Compliance = C, Non-compliance = NC

REFER TO ISO/IEC 17025:2017 and ISO 15189 FOR DETAIL AND CLARIFICATION NOTES.

NOTE 1: For CAB’s comments: The CAB must provide information on how requirements have been addressed, documented and/or implemented.
Make reference to policies / procedures, incl. clause numbers and relevant records.

NOTE 2: For Assessor’s Comments: The Assessor must provide information on the CAB’s conformity with the requirements

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ISO/IEC 17025:2017 / ISO 15189 / BTS

CAB’s COMMENTS AND REFERENCE TO C/
CLAUSE REQUIREMENTS ASSESSOR’s COMMENTS
DOCUMENTS & RECORDS NC
How are the following addressed / implemented

ENSURING THE VALIDITY OF RESULTS / INTERLABORATORY COMPARISONS

ISO/IEC 17025 clauses 7.7.2 a) and 7.7.2 b)
ISO 15189 clause 5.6.3
BTS Standard 11.4.1 How are the following addressed/implemented?
7.7.2 Has the laboratory participated in Proficiency
5.6.3 Testing (PT) and/or Interlaboratory (ILC)
11.4.1 Comparisons for all parameters on the Scope of
Accreditation?

Note: Provide details of the PT / ILC / EQA activity

that the laboratory has participated in, particularly
since the application / last assessment. Issues to
be addressed include: - what was covered; were
the results satisfactory; who arranged the PT / ILC /
EQA
7.7.2 b If the laboratory has not participated in PT activities
5.6.3.2 because PT is either not practical or non-existent:
11.4.1
i) List the tests not covered by PT / ILC:

7.7.2 b
5.6.3.2 ii) What are the reasons for not participating in
11.4.1 PT / ILC activities, and are they valid verifiable
reasons?

7.7.2 b
5.6.3.2 iii) Have suitable alternative activities been
11.4.1 proposed by the laboratory and agreed to by
SANAS?

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F 176-06

ISO/IEC 17025:2017 / ISO 15189 / BTS

CAB’s COMMENTS AND REFERENCE TO C/
CLAUSE REQUIREMENTS ASSESSOR’s COMMENTS
DOCUMENTS & RECORDS NC
How are the following addressed / implemented

7.7.2 b If the laboratory has not participated in PT activities

5.6.3.2 because PT is either not practical or non-existent
11.4.1
iv) Which alternative activities are being used by
the laboratory?
7.7.2 b
5.6.3.2 v) Comment on the suitability of the alternative
11.4.1 activities used in assuring the quality of Test
and Calibration Results?

Appropriateness of PT / ILC / EQA Activity: How are the following addressed / implemented?

7.7.2 & Is the amount of PT / ILC / EQA activity (or

8.5 alternative activities) appropriate to the volume and
5.6.3 associated risk for the testing and or calibration
11.4 activities of the Laboratory?

Analysis of Results of PT / ILC / EQA Testing: How are the following addressed / implemented?

7.7.3 Has the Laboratory analysed the results of the PT/

5.6.7 ILC / EQA results (or alternatives) and have
11.4.2 appropriate steps been taken when results are
found outside pre-defined criteria
(En>1, or Z score > 3)

Note: Comment on analysis of results, provide

information on what actions the laboratory has
taken where the results were found to be
unsatisfactory:

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ISO/IEC 17025:2017 / ISO 15189 / BTS

CAB’s COMMENTS AND REFERENCE TO C/
CLAUSE REQUIREMENTS ASSESSOR’s COMMENTS
DOCUMENTS & RECORDS NC
How are the following addressed / implemented
Is the laboratory experiencing any problems with
participating in PT / ILC / EQA?

What difficulties, if any, has the laboratory

experienced in participation? Are there any issues
that need to be referred to the STC?

SANAS R 48 (Calibration Laboratories)

SANAS R 80 (Testing, Medical and BTS Laboratories)
CAL
Has the laboratory prepared and implemented an
R 48
activity plan that indicates how and when PT and/or
i)
ILC activities are to be implemented for the next 5
years?

CAL

R 48 Does the activity plan cover all the major

ii) parameters and instruments listed on the
laboratory’s scope of accreditation?

MED
BTS Has the laboratory prepared and implemented a
plan that indicates how and when PT / ILC / EQA
R 80 activities are to be implemented for at least 2
i) accreditation cycles, i.e. the activity schedule for
the past accreditation cycle (where possible) and
the plan for the subsequent accreditation cycle?

MED
BTS
Does the activity plan cover all accredited activities
R 80 listed on the laboratory’s scope of accreditation,
ii) and in a period not exceeding 1 accreditation
cycle?

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ISO/IEC 17025:2017 / ISO 15189 / BTS

CAB’s COMMENTS AND REFERENCE TO C/
CLAUSE REQUIREMENTS ASSESSOR’s COMMENTS
DOCUMENTS & RECORDS NC
How are the following addressed / implemented
R 48
PT, ILC, EQA Reports
R 80
Are the PT scheme / ILC / EQA reports clear and
comprehensive and does it include at least the
following minimum information:

• Identification of the participants

• Measurement protocol
• Identification of the measurement
standard or Artefact;
• Measurement results
• The reference value(s) and how these were
established
• Evaluation of the measurement results
• An indication of the performance
of individual participants;
• Minimum acceptance criteria;
• Conclusion

Comment on ILC / PT / EQA reports received.

Where requirements have not been met, what was
missing or incorrectly reported?

Technical
Team Leader
Assessor Date
Signature
Signature

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