17025 BASICS & PRINCIPLES.pptISO 17025 fundamentalsc and requirements

Basic concepts of Laborstory mananaemet and requirements of ISO 17025

2. PLEASE PUT YOUR
CELL PHONE ON
VIBRATION

3. About the Course

Introduction

Objectives

Coverage

Daily Programme

Assignments

Test of understanding

Next level

4. DAILY PROGRAMME

HOURS ACTIVITY

07.00 Breakfast

08.30 Registration- Day 1 only

08.30 Lectures-From Day 2

09.00 Lectures Day 1 only

10.30 Tea/Coffee break

10.45 Lectures

13.00-14.00 Lunch

16.00 Tea/Coffee break

16.15 Lectures

18.30 Lectures end

19.00 Dinner

20.00 upwardsSyndicate sessions

6. Outline
Brief history of development
What the accreditation process requires of
assessors
How the use of principles benefits labs and
assessors
The eight principles
Technical competence

7. Why is Analytical Science so Important?
Analytical Science truly is an inter-disciplinary science, being essential not only in
Chemistry, but in the Bio-sciences, Geo-sciences Environmental and Forensic
Sciences, Agriculture, Medicine as well as Engineering and Manufacturing
Technologies. It is the means by which measurements (both qualitative and
quantitative) are made. It is essential that the data obtained is accurate, so that
the decisions made which are based upon that data are correct and appropriate.

8. WHAT IS ISO?
ISO MEANS:
THE INTERNATIONAL ORGANIZATION FOR
STANDARDIZATION
ELABORATES PRODUCTS,PROCESSES AND
SYSTEMS STANDARDS
If you don’t know where you are, then a map If you don’t know where you are, then a map
will not helpwill not help

Watts HumphreyWatts Humphrey

9. •IT tools
•Standards
development
procedures
•Consensus
building
•Dissemination
162 national members
98% of world GDP
97% of world population
224 active TCs
3 335 technical
bodies
56 100 experts
Central
Secretariat
in Geneva
151 FTE staff
Collection o overf22,000
ISO Standards as at Jan
2017
1206 standards
produced in 2011
The ISO System
Average of 15 TC ‘s
each working day
somewhere in
the world

10. What Is ISO QUALITY MANAGEMENT SYSTEM
A compilation of system and process requirements
that an organization would have to establish,
implement, and document if that organisation
were to be considered capable of meeting
customer requirements and sustaining
continual/performance improvement
Why Use the ISO Standard?
Widely-recognized
European Union has adopted it as a common
standard
Many government and intergovernmental agencies
have adopted it or incorporated it as a
requirement (e.g., Panama Canal, NASA, NATO)

11. Quality – The Key to Success
Common “language” for quality management
QMS vocabulary, models, and expectations are now globally
expressed and universally applied
Makes a public statement about one’s quality commitment
Builds confidence in the credibility of the laboratory conclusions,
and in the efficiency and effectiveness of its processes
DEFINITIONS
Quality
•Totality of characteristics of an entity that bear on its ability to
satisfy stated and implied needs.
Conformance with requirements
Fitness for Purpose
All the features and characteristics of a product or service that
satisfy stated or implied needs
Fitness for Use
The degree to which a set of inherent characteristics fulfils
requirements

12. About ISO/IEC 17025
“General requirements for the competence of
testing and calibration laboratories”
It sets specific requirements for laboratories to
produce competent (valid) results.

13. Development of 17025
Prepared by ISO/CASCO WG 10 and amended by
WG25. Is now 5th version of the original standard
developed within ISO (ISO/IEC Guide 25).
Groups of experts from around the world – some
have 30 years of experience – national and
international inputs: e.g., ANSI - NCSLI - SCC
(Canada) - most of Europe – other national and
international organizations
Competence is the issue
Also used for accreditation

14. Definition of Accreditation
ISO/IEC 17000: third-party attestation that a conformity
assessment body fulfils specified requirements and is
competent to carry out specific conformity assessment
tasks
= recognition of competence
Laboratory Accreditation: The formal recognition of the
competence of a laboratory to carry out specific tests
or specific types of tests

15. •A determination of competence
•Assessment of technical competence by trained assessors
•Assessor must be fully cognizant of each requirement which applies to the
scientific discipline within the scope

16. 17025 Assessor vs 9000 Auditor
9000 Auditor:
Have you defined your
processes, policies and
procedures?
Are they documented in
accordance with the
standard?
Are you following them?
17025 Assessor
Have you defined and validated your
technical procedures? Are they
documented in accordance with the test
standard or method? Are you following
them?
Do your procedures ensure valid results?
Do you understand the science behind
the procedures?
Can you foresee and cope with any
technical problems that may arise?
Do you have the correct equipment? Do
you have adequate personnel?
Have you calculated your uncertainties or
do you know the uncertainty inherent in
your testing procedure?

17. A concern:
Assessors may be required to defend a
requirement to the applicant but may not be able
to articulate why the requirement exists.

18. Principles: if no map, need compass!
Principles that underlie the requirements were
developed and presented to ISO/CASCO/WG25
Ned Gravel represented Canada on this Committee

19. •Principles replace blind adherence to the requirements of 17025
WITH
•Understanding that instills confidence in a system that should produce
competent (valid) results
= VALUE ADDED

20. Value added, cont’d
Principles are not requirements and CANNOT be
used to justify ANY assessment finding
Principles help us understand why a specific
requirement exists.

21. ISO 9000:2005: “MODEL FOR
EXCELLENCE”…has great strength in its
clear basis on principles
ISO/IEC 17025:2005 PRINCIPLES… give
an understanding of the basis for
requirements

22. Principles behind ISO/IEC 17025
Capacity
Exercise of Responsibility
Scientific Method
Objectivity of Results
Impartiality of Conduct
Traceability of Measurement
Repeatability of Test
Transparency of Process

23. Capacity
Concept that a laboratory has the resources
(PEOPLE with the required skills and
knowledge, the ENVIRONMENT with the
required facilities and equipment, the QUALITY
CONTROL, and the PROCEDURES) in order to
undertake the work and produce competent
results.

24. Exercise of Responsibility
Concept that persons in the organisation have the
authority to execute specific functions within the overall
scope of work – and that the organisation can
demonstrate accountability for the results of the work.

25. Scientific Method
Concept that the work carried out by the organisation
is based on accepted scientific approaches,
preferably consensus-based, and that any deviations
from accepted scientific approaches can be
substantiated in a manner considered generally
acceptable by experts in that field.

26. Objectivity of Results
Concept that the results produced within the scope of
work of the organisation, are mainly based on
measurable or derived quantities.
Concept that subjective test results are produced
only by persons deemed qualified to do so and that
such results are noted as being subjective or are
known by experts in the field of testing to be mainly
subjective.

27. Impartiality of Conduct
Concept that the pursuit of competent results through
the use of generally accepted scientific approaches is
the primary and overriding influence on the work of
persons executing tests - all other influences being
considered secondary and not permitted to take
precedence.

28. Traceability of Measurement
Concept that the results produced, within the scope of
work of the laboratory, are based on a recognised
system of measurement that derives from accepted,
known quantities (SI system) or other intrinsic or well-
characterised devices or quantities.
Concept that the chain of comparison of measurement
between these accepted, known quantities or intrinsic
devices or quantities, and the device providing the
objective result, is unbroken for the transfer of
measurement characteristics, including uncertainty, for
the whole of the measurement chain.

29. Repeatability of Test
Concept that the test which produced the objective
results, will produce the same results, within accepted
deviations during subsequent testing, and within the
constraints of using the same procedures, equipment
and persons used during a previous execution of the
test.

30. Transparency of Process
Concept that the processes existent within the
laboratory producing the objective results, are open to
internal and external scrutiny, so that factors which
may adversely affect the laboratory's pursuit of
objective results based on scientific method, can be
readily identified and mitigated.

31. ITU
IEC
WHO
CODECs
ISO 9000
ISO 17025
ISO 15189
Standards Development
Shewhart
Deming
US Military
NATO
ABCA
ISO
BSI
THE
WORLD

32. Quality Control
Quality Control (QC) is the combination of systems,
procedures, instructions and activities that are
performed to control and maintain work quality
One of the most important elements of QC is to make a
method perform reproducibly
Internal Quality Control
Internal quality control comprises the routine practical
procedures that enable the analysts to
accept a result or group of results as fit for purpose
. reject the results and repeat the analysis
Quality control is what analysts do to ensure their
results are correct

33. Internal quality control includes;
•Blank samples (reagent/matrix blanks)
•“spikes” (fortification or recovery samples)
•Replicate or triplicate measurements
(injections)
•System Suitability Tests
•Usage of different analytical standards
•Measurements on two different instruments
•Application of different analytical method.
External Quality Control
External Quality Control comprises
participation of the laboratory in appropriate
inter-laboratory comparison.

34. It includes:
•Between laboratory comparison
•“Proficiency testing schemes
•round robin” tests
•Collaborative studies

35. External QC :Inter-laboratory Proficiency
Tests

food labelling,
water quality,
animal feeds,
pesticide residues.
Many laboratory tests are used for international or national
standard and regulations, for example:
The authorised laboratories must show that their results are
comparable with others doing the same tests.

36. Show labs how well they
compare with others;
Help them to reduce the
overall variability in testing;

Proficiency Schemes
•Give the regulatory
authorities and consumers
confidence that their quality
criteria are meaningful
Participation in proficiency testing schemes offer the
following benefits:

37. all participating labs
receive identical samples;
a ‘true’ value is assigned for
the result of a test (for
example it may be the mean
of all participants’ results);
participants do not know
the ‘true’ result before they
do the test.
For accreditation, the
accreditation body usually
organizes the tests

Proficiency testing
Organisers of such schemes must
ensure that:

38. Proficiency testing
rank the laboratory’s
performance by calculating its
“z-score”;
identify the laboratories that
can produce acceptable
results for the test;
show divergent laboratories
how they need to improve
their performance of the test.

From the results submitted by the participating laboratories,
the organisers can:

39. -10
-8
-6
-4
-2
0
2
4
6
8
10
1
Laboratory identity number
z
-
s
c
o
r
e
Calculation of
‘z’ scores
A laboratory’s z-score
is calculated from:
[(x - X)/SD]
x = the lab result
X = the true or
accepted result
SD = target value for
the standard deviation
The best performing laboratories have ‘z’ values close to
zero. The acceptable range is +2 to -2
The graph above shows the ‘z’ scores
obtained by 120 laboratories who
participated in a particular proficiency
testing scheme

40. QUALITY ASSURANCE
Quality Assurance
Quality Assurance is all activities needed
•To provide a degree of confidence that Quality Control system
are utilized in a manner to ensure work products are of the
highest quality
•To provide evidence that the obtained results are reliable
through documentation of practices, conditions and controls
•Quality Assurance includes all planned and systematic actions
necessary to provide adequate confidence that a product or
service will satisfy given requirements for Quality .
•It is what the organization does to ensure that the analyst is
correctly carrying out the quality control procedures

41. QA and QC systems -
summary
Quality Control:
planned activities designed to provide a quality
product.
Quality Assurance:
planned activities designed to ensure that the
quality control activities are being properly
implemented.
(As defined by the Association of Official Analytical Chemists)

42. Quality Management
The aspect of the overall management function that
determines and implements quality policy.
It includes; strategic planning, allocation of resources
and systematic activities for quality such as quality
planning, operations and evaluation
QUALITY MANAGEMENT SYSTEM
The organization, responsibilities procedures,
processes and resources that are used to manage
quality
Is not just inspecting or checking products and
services
Is everything you do that affects the quality of
products and services you deliver to both internal and
external customers.

43. RELATIONSHIP BETWEEN QC,QA &QS
Quality System
Quality Assurance
Quality Control

44. It involves , in terms of ISO 17025 emphasis
Measurement, monitoring and continual
improvement
Process description
Internal audits
Management reviews
Corrective and preventive actions
Customer satisfaction
Records
Technical competence

45. Problems with Existing MS
Evolutionary not revolutionary
Reactive rather than proactive
Lack of clearly defined responsibility and
authority
Inefficient processes burdened by complexity
Paperwork and fragmented documentation
Lack of accountability
What about your organisation?

46. Common Management Problems
•Limited Top Management participation – bottom up
approach
Limited lower level understanding – top down approach
Programme of the day’ management
Lack of understanding of employee capabilities and needs
Common human Problems
Not trained or otherwise unqualified for their jobs
Not aware of customer requirements
Do not have access to procedures
Not complying with or unaware of policy or procedure
Temporary employees not included in system
Technicians, general workers and cleaners not included in
system! Remember NASA
Cultural and language difficulties
Political issues

47. Common Documentation Problems
Unapproved documents in use
Procedures do not match practices
Unofficial changes made to documents
Missing or unavailable documents
Obsolete documents in use
Poor documentation structure
THE BOTTOMLINE -Deming’s 85/15 rule
•85% of effectiveness determined by system
•15% of effectiveness determined by skill

48. Why Change Your QMS?
If you always do what your’ve always done,
you’ll always get what you’ve always got.
Insanity is doing the same thing over and over
and expecting different results.
Identify processes and analyzing data for
continual improvement
To communicate proactively with customers and
suppliers
Continual improvement on products and services
Prevent non-conformities
 Change from reactive to proactive management
style
Enhances Ability to change

49. Benefits of an Effective MS -cont
Quality of product/service meets customer and
regulatory requirements at lowest cost
Assure ourselves that we are getting the quality
we planned for
Achieve customer satisfaction, prevent non-
conformities and continually improve the way we
do business
Elimination of:
Duplication of effort;
Non value added activities
Provision of:
Simplest most cost effective system that
meets customer requirements

50. Con’t
Improve safety and morale
Standardization
Ensure adequacy of resources
Build-in improvement tools
Facilitates changes & easier problem solving

51. Client expectation of a quality test result
Provision of reliable data which is meaningful,
on-time and within budget
Reliable = precise and accurate
Meaningful = fit-for-purpose
On-time = for intended purpose
Within budget = cost competitive

52. CERTIFICATION
Certification is defined in ISO/IEC Guide 2 as a
procedure by which a third party gives written
assurance that a product, process or service
conforms to specified requirements.

53. Certification

Means compliance with a standard or
specification (e.g. systems or product
standards)

Uses Management system auditors who are
certified by an independent body as meeting
internationally agreed criteria

May be general in scope of recognition

Considers the total business

54. ACCREDITATION
An Accreditation is the procedure by which an
authoritative body gives formal recognition
that a body or person is competent to carry
out specific tasks (ISO/IEC 17000: 2005)
Accreditation

Is the recognition of specific competence, and

Its scope is normally highly specific

Evaluates people, skills and knowledge

Uses assessors who are recognized specialist
in their field

Evaluates the supporting management
systems for a specific activity

Involves practical tests as appropriate
(proficiency testing and measurement audits.

55. WHY ACCREDITATION ?

56. ACCREDITATION ENSURES YOU DO IT RIGHT
FIRST TIME

58. WHAT IS LABORATORY ACCREDITATION?
Formal recognition that a laboratory is technically
competent to carry out specific calibrations or
types of calibration and tests.
It provides independence assurance of
•Technical competence
•Operation of quality management system
•Use of appropriate, experienced staff
•Use of appropriate and calibrated equipment
•Use of appropriate sample handling and up-to-
date technical methods

59. WHO WANTS RELIABLE
CALIBRATION & TEST RESULTS?

60. WHO WANTS RELIABLE CALIBRATION & TEST RESULTS?
 Government departments
Regulations, Defence, Forensic
 Manufacturers
Product labeling
 * Health services
blood typing, dosage of radiation,
HIV Test
Consumers
Electrical safety, colour fastness
ISO 15189:2003 particular requirements for
medical laboratories

61. WHAT ARE LABORATORIES ACCREDITED
AGAINST?
Accreditation can only be achieved following
demonstration of compliance with

ISO/IEC 17025 (2005)

Supporting documents e.g.
Organization’s (Laboratory) quality management
system

Regulatory documents of accreditation body

62. Business Benefits of Accreditation
Demonstrate that the laboratory:
operates a quality system
Is technically competent
Is capable of generating technically valid
results
Minimizes quality costs;
failure costs, appraisal costs, ---
Recognition & status to the laboratory
Global trade requires ---Quality test data which are,
Scientifically credible
Legally defensible
Possess documentary evidence to
demonstrate historically the quality of data.

63. What is a calibration?–
• The process of comparing one instrument’s unit of
measure to another device of greater accuracy for
the purpose of obtaining a certain level of accuracy
and confidence which is traceable to a higher
standard
– This chain of ever tightening comparisons is tied to a
national or international standard (NIST/NRC or BIPM)

64. TEST
A test is defined by ISO/IEC Guide 2 as a
“technical operation that consists of the
determination of one or more characteristics of a
given product, process or service according to a
specified procedure”
Test data result from the performance of a test.
If the test method is well written, it is sufficient
that the test data comply with the test method’s
requirements for accuracy and variability requirements

65. TYPES OF TESTING LABORATORIES
Testing can be performed by laboratories differing
widely in size, legal status, purpose, range of testing
services offered, and technical competence. Test
laboratories can be for-profit or non-profit, operate
facilities in one or multiple locations and may even
operate in multiple countries
They may be:
?????? government regulatory laboratories
?????? government research laboratories
?????? government-supported laboratories
?????? college/university laboratories
?????? independent private sector laboratories
?????? laboratories affiliated with or owned by industrial
firms or industry associations
?????? manufacturers’ in-house laboratories.

66. TYPES OF LABORATORIES
FIRST PARTY LABORATORY
oLaboratory that performs tests/ or calibration services
for it’s parent organization e.g a laboratory in a
manufacturing outfit
SECOND PARTY LABORATORY
oLaboratory that performs tests/ or calibration services
as it’s business e.g a commercial laboratory
THIRD PARTY LABORATORY
oIndependent Laboratory that performs tests/ or
calibration services e.g a laboratory in regulatory
agency

67. Quality in laboratory is achieved by:
Determining the customer’s precise requirements
Ensuring that all resources, facilities and skills required
to meet the customer’s requirements are available
Planning, documenting and implementing management
procedures to ensure that the customer’s requirements
are met consistently
Ensuring that staff are trained and provided with the
resources to do the job right the first time

68. QUALITY is ACHIEVED BY: [cont]
Ensuring that all activities are undertaken
correctly
Ensuring that when things go wrong, effective
corrective action is taken to avoid repetition of
errors
Undertaking regular reviews and audits of all
processes
Total and organised commitment from
management

69. THESE ACHEIVEMENTS CAN ONLY BE REALIZED
ON THE BACKBONE OF …..
A quality management system such as ISO/IEC 17025:
2005
Accreditation to such a quality management system
further provides assurance to the laboratory’s ability
to meet and even exceed client’s expectations.
ISO/IEC 17025:2005 essentially provides sound
requirements for the following activities :

70. Organization
Support from the top level of the organization
Involve all persons in the organization
Conform with any regulatory requirements
A culture
committed
to quality
Quality policy
& standards
Clearly defined
responsibility
& accountability
Sufficient
resources

71. Personnel
Retention
Human resource
planning
Hiring
Performance
management
Training Supervision

72. Equipment Management
Maintenance,
service & repair
Selection Acquisition
Installation &
initial calibration
TroubleshootingDisposition

73. Purchasing and Inventory
Inventory
management
Procurement Receiving Storage
Record
keeping

74. Process Control
External
Quality
Assessment
Standard
operating
procedures
Sample
management
Quality
control

75. Information Management
Information
flow
Data collection
& management
Computer
skills
Client’s privacy &
confidentiality

76. Documents and Records
Document
storage/retrieval
Standardized
forms
Document
destruction
Document
distribution
Document
approval

77. Occurrence Management
Written
procedures for
addressing errors
Corrective
actions
Occurrence
records
Occurrence
reporting

78. Assessment
Internal audit
or self
evaluation
External
evaluation
Improvement
measures

79. Process Improvement
On-going
data
collection
Improvement
measures

80. Service and Satisfaction
Monitoring
Customer
satisfaction
Process
improvement
Rewards

81. Facilities and Safety
Testing and
storage
areas
Safety practice
Safety
procedures
& records

82. Technical Criteria – ISO/IEC 17025:2005
4. Management Requirements
4.1 Organization
4.2 management system
4.3 Document control
4.4 Review of request,
tenders or contract
4.5 Subcontracting of tests
and calibrations
4.6 Purchasing services
and supplies
4.7 Service to the client
4.8 Complaints
4.9 Control of NC Testing
and/or calibration work
4.10 Improvements
4.11 Corrective action
4.12 Preventive action
4.13 Control of records
4.14 Internal audits
4.15 Management Reviews

83. 5. Technical Requirements
5.1 General
5.2 Personnel
5.3 Accommodation &
environment
conditions
5.4 Tests & calibration
methods and methods
validation
5.5 Equipment
5.6 Measurement
traceability
5.7 Sampling
5.8 Handling of test
and calibration items
5.9 Assuring the
quality of test
5.10 Reporting the
results

84. STEPS FOR INSTALLATION OF ISO : 17025-2005 QUALITY MANAGEMENT STEPS FOR INSTALLATION OF ISO : 17025-2005 QUALITY MANAGEMENT
SYSTEMSYSTEM
Conduct awareness program (top + middle + bottom level).
Form a steering committee and task force for documentation
Identify and define Procedure
Define quality policy and establish quality objectives
Prepare documents of quality system.
Implementation & train all personnel in the use of procedures &
formats.
Train internal auditors.
Assess the system through first internal audit.
Take corrective actions for non-conformities.
Apply for accreditation.
Assess the system through second round of internal audit.
Avail pre-assessment audit.
Take actions on suggestions given by them.
Maintain & improve the system by third round of internal audit.
Final audit by accreditation body.

85. ISO : 17025-2000 IS NOT FOR THOSE
Who Hate Documentation
Who Resist Assessment / Audit
Who Hang on to Their Own Ways of Working
Who Has Built Strong Walls / Compartments
Who Identify a “PROBLEM” in Every “SOLUTION”
Who Treat Temporary Solution As “PERMANENT ONE”
Whom “WHO IS WRONG” Is More Important Than “WHAT
IS WRONG”
Whom “RESULTS” Are More Important Than “PROCESSES”
Whom “TEAM WORK” Means “YES” Master

86. WHO IS RESPONSIBLE FOR QUALITY ?
Are responsible for Quality in
YOUR LABORATORY

87. THANK YOU