PLEASE PUT YOUR

CELL PHONE ON
VIBRATION
About the Course
 Introduction
 Objectives
 Coverage
 Daily Programme
 Assignments
 Test of understanding
 Next level
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 upwards Syndicate sessions
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
 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.
 If you don’t know where you are, then a map
will not help
 Watts Humphrey

WHAT IS ISO?
ISO MEANS:
THE INTERNATIONAL ORGANIZATION FOR
STANDARDIZATION
ELABORATES PRODUCTS,PROCESSES AND
SYSTEMS STANDARDS
 The ISO System
162 national members
98% of world GDP
97% of world population

1206 standards
produced in 2011

Collection o overf22,000 Average of 15 TC ‘s

ISO Standards as at Jan each working day
2017 • IT tools somewhere in
the world
• Standards
development
procedures
224 active TCs • Consensus Central
3 335 technical building Secretariat
bodies • Dissemination in Geneva
56 100 experts 151 FTE staff
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)
 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
Quality
– The Key to Success
• 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
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.
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
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
• 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
17025 Assessor vs 9000 Auditor
17025 Assessor
 Have you defined and validated your
technical procedures? Are they
documented in accordance with the test
standard or method? Are you following 9000 Auditor:
them?  Have you defined your
 Do your procedures ensure valid results? processes, policies and
 Do you understand the science behind procedures?
the procedures?  Are they documented in
 Can you foresee and cope with any accordance with the
technical problems that may arise? standard?
 Do you have the correct equipment? Do  Are you following them?
you have adequate personnel?
 Have you calculated your uncertainties or
do you know the uncertainty inherent in
your testing procedure?
A concern:
Assessors may be required to defend a
requirement to the applicant but may not be able
to articulate why the requirement exists.
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
• 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
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.
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
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
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.
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.
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.
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.
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.
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.
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.
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.
Standards Development
BSI

ISO
NATO
ISO 9000
ISO 17025
ISO 15189
ITU
ABCA IEC
WHO
CODECs
US Military

Deming
THE
Shewhart
WORLD
 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
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.
It includes:
• Between laboratory comparison
• “Proficiency testing schemes
• round robin” tests
• Collaborative studies
 External QC :Inter-laboratory Proficiency
Tests
Many laboratory tests are used for international or national
standard and regulations, for example:

food labelling,
water quality,
animal feeds,
pesticide residues.

The authorised laboratories must show that their results are

comparable with others doing the same tests.
 Proficiency Schemes
Participation in proficiency testing schemes offer the
following benefits:

Show labs how well they

compare with others;
Help them to reduce the
overall variability in testing;

• Give the regulatory

authorities and consumers
confidence that their quality
criteria are meaningful
 Proficiency testing
Organisers of such schemes must
ensure that:
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
From the results submitted by the participating laboratories,
the organisers can:

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.
 Calculation of 10

‘z’ scores 6

A laboratory’s z-score

z-score
2

0
is calculated from: -2
1

-4

[(x - X)/SD] -6

-8

-10

x = the lab result Laboratory identity number

X = the true or
The graph above shows the ‘z’ scores
accepted result obtained by 120 laboratories who
SD = target value for participated in a particular proficiency
the standard deviation testing scheme

The best performing laboratories have ‘z’ values close to

zero. The acceptable range is +2 to -2
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
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)

 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.
RELATIONSHIP BETWEEN QC,QA &QS

Quality System

Quality Assurance

Quality Control
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
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?

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
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
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
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
Con’t
Improve safety and morale
Standardization
Ensure adequacy of resources
Build-in improvement tools
Facilitates changes & easier problem solving
 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
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.
 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
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.
WHY ACCREDITATION ?
ACCREDITATION ENSURES YOU DO IT RIGHT
FIRST TIME
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
WHO WANTS RELIABLE
CALIBRATION & TEST RESULTS?
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
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
 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.
 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)
 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
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.
TYPES OF LABORATORIES
FIRST PARTY LABORATORY
o Laboratory that performs tests/ or calibration services for it’s
parent organization e.g a laboratory in a manufacturing
outfit

SECOND PARTY LABORATORY

o Laboratory that performs tests/ or calibration services as it’s
business e.g a commercial laboratory
THIRD PARTY LABORATORY
o Independent Laboratory that performs tests/ or calibration
services e.g a laboratory in regulatory agency
 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
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
 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 :
Organization
Support from the top level of the organization
Involve all persons in the organization
Conform with any regulatory requirements

Quality policy Sufficient

& standards resources

Clearly defined A culture

responsibility committed
& accountability to quality
Personnel
Human resource
Hiring Retention
planning

Performance
Training Supervision
management
Equipment Management
Installation &
Selection Acquisition
initial calibration

Maintenance,
Troubleshooting Disposition
service & repair
Purchasing and Inventory
Procurement Receiving Storage

Inventory Record
management keeping
Process Control
Standard
Sample
operating
management
procedures

External
Quality
Quality
control
Assessment
Information Management
Information Data collection
flow & management

Client’s privacy & Computer

confidentiality skills
Documents and Records
Standardized Document Document
forms approval distribution

Document Document
storage/retrieval destruction
Occurrence Management
Written
Corrective
procedures for
actions
addressing errors

Occurrence Occurrence
records reporting
Assessment
Internal audit
External
or self
evaluation
evaluation

Improvement
measures
Process Improvement
On-going
Improvement
data
measures
collection
Service and Satisfaction
Monitoring
Process
Customer
improvement
satisfaction

Rewards
Facilities and Safety
Testing and
storage Safety practice
areas

Safety
procedures
& records
Technical Criteria – ISO/IEC 17025:2005
4. Management Requirements
4.1 Organization 4.8 Complaints
4.2 management system 4.9 Control of NC Testing
4.3 Document control and/or calibration work
4.4 Review of request, 4.10 Improvements
tenders or contract 4.11 Corrective action
4.5 Subcontracting of tests 4.12 Preventive action
and calibrations 4.13 Control of records
4.6 Purchasing services and 4.14 Internal audits
supplies
4.15 Management Reviews
4.7 Service to the client
5. Technical Requirements
5.1 General 5.6 Measurement
5.2 Personnel traceability
5.3 Accommodation & 5.7 Sampling
environment conditions 5.8 Handling of test and
5.4 Tests & calibration calibration items
methods and methods 5.9 Assuring the quality
validation
of test
5.5 Equipment
5.10 Reporting the results
 STEPS FOR INSTALLATION OF ISO : 17025-2005 QUALITY MANAGEMENT
SYSTEM

 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.
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

WHO IS RESPONSIBLE FOR QUALITY ?

Are responsible for Quality in

YOUR LABORATORY
THANK YOU