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Non-Conformities against ISO/IEC 17025 in Pakistani labs: A study based on

Accreditation Body Reports

Preprint · April 2020

DOI: 10.13140/RG.2.2.29619.78888

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Non-Conformities against ISO/IEC 17025 in Pakistani labs: A study based on Accreditation Body Reports

Abstract:
ISO/IEC 17025 deals with the “General requirements for the competence, impartiality and
consistent operation of testing and calibration laboratories” (Standardization, Publications and
products, 2017) by focusing on both management and technical requirements of laboratories.
Management requirements related to lab personnel, testing activities, auditing, and
management review etc. while technical related to testing activities. This study is based on
analysis of 3rd party audit reports of first time accreditation in 26 different sectors Pakistani
laboratories. Audit reports of these laboratories are analyzed to find out the problems and non-
conformance that highlighted in audit of Pakistani laboratories. Around 69% of laboratories are
facing problems in PT/ILC process, similarly 50% of the laboratories are facing problems in non-
conformance significance evaluation. All of these non-conformities are categorized in this paper.

Keywords: ISO/IEC 17025 Challenges, Lab Accreditation Challenges, Lab Audit Handling, Common
Audit Findings

1. INTRODUCTION
Laboratories are the first and final check for receiving of raw material or passing out product
to end user. If the raw material used in product manufacturing is not as per standard then it
will ultimately effect the final product or if final product is not as per mark (due to variation
in process) irrespective of raw material quality then it will effect end user. In both cases,
society will suffer the result of non-conformance product. There are many cases when
products failed to meet the requirement as a result society suffered from it. According to
market research on drugs sample in under developing countries, around 13.6% of drugs found
substandard or falsified as a result these countries are suffered from financial loss of $10
billion to $200 billion. (Ozawa S, 2018) As per report of Federal Road Safety Corps (FRSC); 772
out of 9000 reported road side accidents in 2015 were due to sub-standard or expired tyres.
(Ajibola Hamzat (Features Editor), 2016) As per public reports, around 24 bike riders were
lost their life in Karachi due to usage of sub-standard helmets and it could not save them from
serious head injuries. (Abbas, 2019)

ISO/IEC 17025 deals with the “General requirements for the competence, impartiality and
consistent operation of testing and calibration laboratories” (Standardization, 2017) and ISO

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Non-Conformities against ISO/IEC 17025 in Pakistani labs: A study based on Accreditation Body Reports

15189:2012 with Medical laboratories —Requirements for quality and competence

(Standardization, Standards catalogue, 2012). Laboratory Accreditation is the confirmation
by a competent body, on basis of demonstrated objective evidence that a laboratory’s
management system operates in compliance with the relevant standard (ISO/IEC 17025).
During this implementation and operation process of ISO/IEC 17025, laboratories are facing
number of challenges in system development, implementation and continuation. This study
is based on challenges faced by Pakistani Laboratories derivate from 3rd party audit reports
during ISO/IEC 17025 accreditation process. Name and any other identification of labs are
kept confidential.

From last 3-5 years in Pakistan market, Accreditation of laboratory management system
(ISO/IEC 17025) become precarious issue especially for pharmaceutical, electrical, pesticide
& automobile due to following reasons:
i. In pesticide sector, number of complaints were raised against manufacturing companies
passed product that failed to reproduce the results in government or appellate
laboratories which ultimately leads to FIRs (First Information Report) against companies
CEO. From 31st May 2018 onward it became compulsory for pesticide companies in
Punjab to get their lab ISO certified (The Punjab Gazette, 2018)
ii. Accreditation of laboratory management system ISO/IEC 17025 becomes mandatory
requirement for electrical transmission vendors to participate in tenders due to non-
quality testing of vendors. (Waleed, 2019) Transmission department auditors can’t
reproduced all test in their laboratories, so onsite inspection of electrical products are
done in vendor laboratories and based on that results products are accepted or rejected
iii. In pharmaceutical sector, if QC passed products failed in appellate laboratories then FIRs
are registered against companies CEO, Production Manager & QC Lab. In 169 th meeting
of Provincial Quality Control Board (PQCB), 65 cases substandard drugs were present out
of which 26 cases were referred to drug court for prosecution. (26 cases referred to drug
court, 2017)
iv. Foreign customers do not trust on our local laboratories because there are many cases
when samples failed to reproduced results in customers’ or international labs. (Ibraz,
2018)

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Non-Conformities against ISO/IEC 17025 in Pakistani labs: A study based on Accreditation Body Reports

In 2018 more than 50 companies’ ghee and cooking oil samples are failed by Punjab Food
Authority that had been passed by company own lab which ultimately leads to legal actions
on it. (Authority, 2018)

2. LITERATURE REVIEW

ISO/IEC 17025 Lab Management System is internationally developed standard of ISO that is
focused on improving the quality of test results by target following: (ISO, 2017)
i. Lab Personnel mainly focused on Education, Qualification, Training, Experience, Technical
knowledge & Skill lab personnel. And on the basis of these requirement authorization for
tests are assigned to lab Personnel. Having proper system for managerial & technical
personnel selections and development is the key for running effective lab management
system. (Sari, 2018) All authorized person should act as impartial and confidential in their
scope of work.
ii. Lab Environment for testing including but not limited to humidity, temperature, microbial
contamination, particles, vibrations, dust, air, electromagnetic disturbance, electrical
supply and sound are also contribute in test results. For example, in chemical testing
laboratories technical/actives are used in minor quantities (mg) for testing activities, for
this purpose sensitive weighing balance are used. The reading of this balance fluctuate
with vibration, analyst respiration, sound etc.
iii. Latest and valid test methods that are published by International, national & regional
bodies, methods developed by reputable organization or published in relevant science
journal or specified by equipment supplier. Irrespective of this; method need to be
verified prior to use in routine testing. Internationally developed methods are verified in
laboratory and modified or out of scope methods are required validation in laboratory.
iv. Material/Reagents that are directly used in testing or calibration activities should be
standardized having proper Certificate of Analysis that is traceable to direct
manufacturer.
v. Testing Equipment should be calibrated from accredited lab having proper meteorological
traceability to national and international standards where meteorological traceability is
not possible; it should be traceable to consensus standards or competent producer

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Non-Conformities against ISO/IEC 17025 in Pakistani labs: A study based on Accreditation Body Reports

vi. Management System (ISO 9001:2015) to manage the matters related to testing or
calibration of laboratories
Accreditation is provided by national accreditation bodies; if this is a signatory of ILAC, the
MRA (Mutual Recognition Agreement) provides an outlook for international acceptance of the
laboratory’s results (Karthiyayini Nagarajan, 2016) As per research, countries with high GPD
having more accredited laboratories than the countries having low GDP. (Grochau, 2017) In
Figure 1, comparison of number of accredited laboratories and GDP are shown

Figure 1: Number of Accredited Laboratories and GDP of the Country

Laboratory accreditation has positive effect on organization performance. Furthermore due

to system documentation, everything is done; considering this due to which internal and
external issues of lab are resolved (Elhuni, 2016) Lab Accreditation increased the awareness
of lab staff, enhancing their technical knowledge skills, credibility, reliability & confidence of
test results. Customer received more detailed reports as per guidelines of ISO/IEC 17025
standard. (Abdel‐Fatah, 2010) Currently is Pakistan, there is abrupt increase of 40 % lab
accreditation last year 2018 (PNAC, 2019) but still a deficiency of literature, related to lab
accreditation exist specifically related to Pakistan’s regional constraints.

3. METHODOLOGY
For this study, data are extracted from the accreditation body audit reports collected from
respective labs for research purpose in 2019 and by ensuring the confidentiality of lab names;
assigning them numeric coding scheme. Accreditation body audit reports are completely
analyzed and highlighted non-conformances (NC) are noted based on ISO/IEC 17025 clauses
requirement. Only highlighted non-conformance are segregated based on standard clauses
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Non-Conformities against ISO/IEC 17025 in Pakistani labs: A study based on Accreditation Body Reports

requirement. Analysis of these non-conformances are conducted in Table 1. Lab having

following non-conformance is recorded positive.

17025
Clause title Document & Non-Conformance Points
Cls.
4.1  Policy & Procedure for Risk Assessment is not defined or not
Impartiality and followed properly.
Confidentiality  Risk Related to Lab Activities are not identified or no action has
4.2
been taken against identified risks
 Organogram is not developed or conflict of interest in
organogram. Lab Internal customers have influence on lab
Structural
5 activities
Requirement
 Job Description are not properly defined or conflict in JDs & on
ground activities
 Lab Authorization Permits are not developed or properly
followed
Personnel  Training Need Analysis (TNA) are not conducted
6.2
 Training Plan is not developed or followed
 Training Effectiveness is not conducted or system is not exist
Facilities and  Un-controlled testing Environment
6.3 Environment
 Environment conditions are not monitored
condition
 Equipment Documentation like Log Books, manual issue
 Equipment Corrective & Preventive Maintenance Plan related
Equipment issue
6.4
 Non-Calibrated Equipment or Correction Factors are not
considered during testing activities
Meteorological  Calibration from non-accredited lab or lack of availability of
6.5
Traceability traceable Certified Reference Material
Externally  Product as well as services suppliers selection criteria is not
6.6
provided defined or followed

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Non-Conformities against ISO/IEC 17025 in Pakistani labs: A study based on Accreditation Body Reports

product and
services
Review of  Review of Request system is not exist.
7.1 Request, tenders  Test Request Form or unique sample ID issue.
and contracts  Customer is not informed about change in lab practices
 Test Method Verification is not being done
Selection,
 Non-Standard Test Method is in practice or amendment is done
verification of
7.2 in internationally developed standard
methods
 Old Version of testing method is in practiced
7.3 Sampling  Sampling Plan or international method is not followed
Handling of test
 Test items are not handled properly. No system for sample
7.4 or calibration
retention and disposal
items
7.5 Technical Record  Technical data (rough readings, log books) are not maintained
 Training on Uncertainty Calculation is not conducted. Lab
Evaluation of
persons are not aware of it
Measurement
 Uncertainty measurement is not calculated or complete
7.6 Uncertainty
 parameters that are effecting the results are not incorporated
(MU)
during calculation
Ensuring the  Equipment Intermediate checks system is not exist
7.7 validity of test  No Certified Reference Material is available
results (PT/ILC)  PT/ILC of scope test are not conducted or qualified
 Report format is not as per ISO/IEC 17025 or in case of simplified
Reporting of
7.8 report, lab is not maintaining complete information mention in
Results
ISO/IEC 17025
Complaints &  Customer Feedback is not collected or its analysis is missing
7.9
Feedback  Complains of customers are not addressed properly
 Non-Conformance Significance Evaluation is not addressed in
Non-conforming
7.10 SOP
Work
 Practice mention in relevant SOP is not followed

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Non-Conformities against ISO/IEC 17025 in Pakistani labs: A study based on Accreditation Body Reports

 Awareness issue of non-conformance in testing

 Control of data and information management issues.
Control of data
 Data backup is not available
7.11 and information
 Hard form document handling and amendments are not defined
management
 Disposal of document are not addressed
Management  Document are not approved from respective authorities.
8.3 & System  Practice mention in relevant SOP is not followed.
8.4 Documentation  Master lists of document & records are not maintained.
& Records  Retention of documentation is not defined
Action to  Risk Assessment related to lab activities (Personnel, equipment,
8.5 address risk and methods, testing, sampling, disposal, environment) are not
opportunity conducted
 Statistical Analysis of lab related activities for improvement
purpose is not done
8.6 Improvement
 Objectives to bring improvement in lab are not developed or
properly tracked
 Corrective Action Request system is not exist in lab
Corrective
8.7  Corrective Action Request Root Cause Analysis is not properly
Actions
done by lab
 Internal Audit system is not exist or followed. Internal Audit plan
is not developed or shared with auditee
 Internal Audit is conducted but all activities like testing, sample
8.8 Internal Audit
handling is not covered in it
 Audit Checklist has any issue not properly developed or followed
during audit
Management  MRM meeting Agenda is not circulated timely or during meeting
8.9 Review Meeting minimum agenda points as per ISO/IEC 17025 are not discussed
(MRM) during MRM

Table 1: Standard Clauses and Issues Area

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 Non-Conformities against ISO/IEC 17025 in Pakistani labs: A study based on Accreditation Body Reports

4. RESULTS ANALYSIS
For graphical analysis of results; bar graphs are used against each clause as mention in table 1.
Analysis results are given in figure 2.

MRM Agenda Discussion 38%

Audit Checklist 4%
Interna Audit Execution 46%
Internal Audit plan 8%
CPA Root Cause Analysis 35%
CPA not followed 8%
Objectives 19%
Statistical Analysis 35%
Management System Documentation 27%
Control of data and information management 46%
NC Significance Evaluation 50%
Complaint 4%
Customer Feedback 12%
Reporting of Results 19%
PT/ILC Issue 69%
CLAUSE AGAINST NON-COMPLAINCE

Equip. Intermediate checks 12%

MU Parameter Missed 27%
MU not Calculated 4%
Training on MU 23%
Report Issue 12%
Handling of test items 15%
Sampling Plan 8%
Old Version of method 19%
Non-Standard Methods 4%
Method Verification 23%
Review of Request 12%
Supplier Evaluation 15%
Calibration from non-accredited lab 8%
Non-Calibrated Equipment 15%
Equipment Maintenance Plan 15%
Equipment Doc. Issue 15%
Environment not monitored 15%
Un-controlled Environment 35%
Training Effectiveness 12%
Training Plan 4%
TNA 19%
Authorization issue 31%
JD Issue 35%
Organogram 31%
Non-Disclosure Agreement 12%
Risk Assessment 23%
0% 10% 20% 30% 40% 50% 60% 70% 80%

% PERCENTAGE NON-COMPLIANCE

Figure 2: Percentage Non-Compliances during Accreditation Audits

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Non-Conformities against ISO/IEC 17025 in Pakistani labs: A study based on Accreditation Body Reports

Analysis results in figure 2 clearly elaborate the non-conformance and weak areas of laboratories.
As per this results, 69% laboratories have faced problem in Proficiency Testing/Inter lab
comparison activities, similarly 50% are facing problem in Non-conformance significance
evaluation, 46% in Control of data & information management and Internal Audit Execution, 38%
in Management Review Meeting and so on. According to study, newly accredited labs have more
non-conformances as compare to labs that are already accredited. (Vongsheree, 2018)

5. CONCLUSION
Majority laboratories are facing problems related to Proficiency Testing/Inter lab comparison
activities and this is the major & uncontrollable point for labs because in Pakistan first thing is to
search out ISO 17043 Accredited Proficiency testing provider that requires expertise in web
browsing; this problem has been resolved after development of eptis search engine, dedicatedly
developed for PT providers. But in some cases, instead of availability of PT providers; they refuse
to provide PT program due to regional constraints as they are reluctant to send samples when it
is equipment or device; laboratory need to send back the PT sample to its programmer. (Li, 2018)
Till May 2019 there are 4 Proficiency Testing providers (PNAC, 2019) available in Pakistan that
covers only water, microbial, petroleum, pharmaceutical & limited textile (Socks/yarn) testing.
For other sectors like electrical, material mechanical testing, calibration, chemical testing etc.
local laboratories are working to get ISO 17043 Accreditation so for time being, laboratories need
to contact with international PT providers that are expensive and most of the PT providers of
electrical (Rasheed, 2019) & calibration (Sohaib, 2019) sector have refused to provide their
services in Pakistan so to cover this requirement laboratories conduct its own design Inter Lab
Comparison with local laboratories that is sometime not accepted by Accreditation body. In other
areas like risk assessment, document control, Un-controlled Environment, Corrective Action
Request Root Cause Analysis & Internal Audit Execution etc. are controllable because it can be
closed by proper trainings and some physical improvement.

REFERENCES

26 cases referred to drug court. (2017, August 28). Retrieved from www.thenews.com.pk:
https://www.thenews.com.pk/print/226397-26-cases-referred-to-drug-court

Abbas, G. (2019). Substandard helmets being manufactured, imported. Islamabad: Pakistan Today.

Abdel‐Fatah, H. T. (2010). ISO/IEC 17025 Accreditation: Between the Desired Gains and the Reality. Quality
Assurance Journal, 13, 21-27.
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 Non-Conformities against ISO/IEC 17025 in Pakistani labs: A study based on Accreditation Body Reports

Ajibola Hamzat (Features Editor), K. J. (2016). How expired, new tyres increase rate of road accident. The
Guardian.

Authority, P. F. (2018, December 27). 61 ghee, oil brands declared injurious to health. Retrieved from
www.dawn.com: https://www.dawn.com/news/1453775

Elhuni, R. M. (2016). QUALITY MANAGEMENT SYSTEM AUDIT AND ITS IMPACT ON COMPANY'S.
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Grochau, I. ˆ. (2017). Current American landscape in laboratory accreditation. Accred Qual Assur.

Ibraz, W. (2018, July). Quality Control Lab Accreditation. (Y. Ayub, Interviewer)

ISO. (2017, November). ISO/IEC 17025:2017(E) General requirements for the competence of testing and
calibration laboratories. ISO/IEC 17025:2017(E). Geneva, Swizerland: ISO.

Karthiyayini Nagarajan, C. R. (2016). Critical Factors and Performance Indicators: Accreditation of

Testingand Calibration-Laboratories. Benchmarking: An International Journal, 24(07), 1814-1833.

Li, M. (2018, March 01). Participation in Rotary Gas Flowmeter Proficiency Testing Program. Sydney,
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Ozawa S, E. D. (2018). Prevalence and Estimated Economic Burden of Substandard and Falsified Medicines
in Low- and Middle-Income Countries: A Systematic Review and Meta-analysis.
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PNAC. (2019, February 25). Accredited CABs. Retrieved from https://pnac.org.pk:

https://pnac.org.pk/accredited-labs/#

Rasheed, E. R. (2019, Feb 2). Electrical Labs Accreditation. (Y. Ayub, Interviewer)

Sari, I. P. (2018). Analysis Implementation Effectiveness of ISO/IEC 17025 on Testing Laboratories.

Proceedings of the International Conference on Industrial Engineering and Operations
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Sohaib, M. (2019, March 4). Calibration Lab Accreditation Process. (Y. Ayub, Interviewer)

Standardization, I. O. (2012). Standards catalogue. Retrieved from ISO.org:

https://www.iso.org/standard/56115.html

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https://www.iso.org/publication-list.html?t=conformity

The Punjab Gazette. (2018, May 31). The Punjab Gazette, Agriculture Department. Lahore, Punjab,
Pakistan: Government of the Punjab Law and Parlimentary Affairs Department.

Vongsheree, S. (2018). Lower frequency of certain nonconformities against ISO/IEC 17025 after many
year. Journal of Associated Medical Sciences, 19-25.

Waleed, H. (2019, February 12). Smart metering project designed to facilitate foreign bidders. Retrieved
from Business Recorder: https://fp.brecorder.com/2019/02/20190212446442/

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