Quality Management and ISO standards

(Iche4116)
Fantahun Aklog (PhD)

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 Course Objectives

 Upon completion of this course the students will be able to:

• Familiarized with some international standards (ISO) for quality
management system of the laboratories and industries.
• Use quality control parameters in the laboratory and productions in
industries.
• Identify requirements for laboratory accreditation and certification for ISO’s.
• Describe basic features of analytical laboratory and its management.
• Identify precautions should be given attention in laboratory and protect
themselves and the laboratory from accidents.
• Manage laboratory installation, equipment and consumables.
• Identify type of documents and provide attention for their proper
management.
• Audit the quality management system of laboratories.

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 Chapter One: International Quality Standards

International quality standards

 They are criteria or rules set up by organizations that help determine
compliance across national borders.
Definitions of Quality
There are two viewpoints of quality that coexist and cooperate
 Producers (manufacturers or service providers) view quality as a set of standards
and specifications that must be met (called conformance).
 Customers view quality as attributes that please them.
 While the consumer’s perception of ‘‘good’’ quality is important, the
perception of poor or terrible quality is a disaster.
 Alienating existing customers with product weaknesses and failures has a host
of other side effects, which are undesirable.
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Quality has been defined in a variety of ways by a number of different people
and organizations:
 Fred Smith defines quality as “performance to the standards expected by the
customer.”
 Boeing defines quality as “providing our customers with products and services
that consistently meet their needs and expectations.”
 The U.S. Department of Defense defines quality as “doing the right thing right
the first time, always striving for improvement, and always satisfying the
customer.”
 Gitlow states “Quality is surpassing customer needs and expectations
throughout the life of the product.”
 W. Edwards Deming
 According to him Quality has many different criteria and these criteria
change continually.
 Mr. Philip B. Crosby
 Quality is “Conformance to requirements”
 Dr. Joseph M. Juran
 'Fitness for purpose sense which relates the evaluation of a
product or service to its ability to satisfy a given need.”
 Dr. Armand V. Feigenbaum
 “The total composite product/service characteristics of marketing,
engineering, manufacture, and maintenance through which the
product/service in use will meet the expectations of customers.”

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 Dimensions of Quality
 The dimensions of quality are the descriptors that must be examined to determine the quality
of a product.
 Define the relevant set of quality dimensions, recognizing the special needs of market places
and segments.
Examples:
 The quality of wine is characterized by aroma, color, and taste plus chemical analyses.
 Cars are evaluated within categories of cost, by their power, safety features, capacities, fuel
efficiencies, and style, among other things.
 Appearance and style dimensions, so often important, are difficult to rate.
 When rating the quality of cities to live in, the criteria include amount of crime, cost of
living, job availability, transportation, winter mildness, and the quality of schools for families
with children.

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Quality dimensions in Manufactured organization
 A quality product is a product that meets the expectations of the customers.
 The eight dimensions of quality help producers to meet these expectations.
 It is a strategic management tool that can be used as a framework to analyse
characteristics of quality.
 The eight dimensions are performance, features, reliability, conformance,
durability, serviceability, aesthetics, and perceived quality.

Garvin’s Eight Quality Dimensions

1. Performance
 Performance is the primary operating characteristic of product.
 Performance is one of the leading dimensions of quality and most customers judge
the product’s quality based upon performance.
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 For example, if you want a television set, you will be looking for
factors like sound, picture clarity, colors, etc.
 This is what performance means in the case of a television set.
 For a car, performance would include characteristics like millage per
gallon, acceleration, handling, traveling speed etc.
 For a smartphone, performance would include characteristics like
clear phone reception, data speed etc.
 The performance of a product often influences profitability or
reputation of the end-user.

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2.Features
 Features are a secondary aspect of performance.
 They are "the bells and whistles" of products.
 They are the ones who add extra functionality to their essential
functions. Example:
 For a car, features would include the built-in GPS, seat warmer,
smartphone integration etc.
 For a smartphone, features could include a high-resolution camera,
retina or fingerprint sensor etc.
 Sometimes it might be challenging to say which is a performance
dimension and which is a feature dimension.
3.Reliability
 This dimension of quality is also related to the functioning of the product and how
likely it is to fail or malfunction during a specific time period.
 Garvin has highlighted three measures of reliability which are:
o The mean time to the first failure
o The mean time between failures
o The failure rate per unit time
 Now, these measures of reliability require a product to stay functional for a given
time period and therefore they apply mainly to durable goods instead of the
products that are consumed instantly.

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4. Conformance
 Conformance quality whether the final product meet a certain
standards determined by the producer.
 In other words, it’s a measure of how close products come to meeting
planned criteria once they are delivered.
 If a product strictly meets target specifications, it is categorized as
excellent conformance quality.
 On the other hand, if the product varies greatly from the planned
design, that product is said to have poor conformance quality.
5. Durability
 It refers to the length of time that a certain product performs before replacement
becomes necessary.
 When the product can be repaired, estimating durability is more complicated.
 The item will be used until it is no longer economical to operate it.

6. Serviceability
 It is the speed with which the product can be put into service when it breaks down.
 Serviceability (as well as reliability) is becoming an increasingly important
dimension of quality and criteria for product selection.
7. Aesthetics
 The last two dimensions of quality are the most subjective.
Aesthetics are a matter of personal judgment and individual
preference.
 How much a customer likes the look, feel, sound, taste or smell of
a product is all a matter of individual preference.
 Someone likes a small and quiet car, and another one wants a big
car with a loud engine.
 Since not all people prefer the same flavor or color, companies
need to search for a niche.
 It is impossible to please everyone on this dimension of quality.
8. Perceived Quality
 Consumers do not always have complete information regarding a
product or service’s attributes.
 Therefore, they use indirect measures to make a comparison.
 One cannot directly observe durability but can infer it from the
various tangible or intangible aspects of the product.
 In such a situation, brand name, advertising, and images are critical to
building the customers’ perception of quality.
 Reputation is the main basis for perceived quality.
 It affects people’s perception of a product deeply.
 For example, if Sony makes great televisions and walkmans, it makes
good smartphones also.
 If Honda makes great cars, its bikes are also good.
 It is a kind of unstated analogy where customers compare a new line of products
by a company with its existing line of products.
Dimensions of Quality in Service organizations
 Service organizations produce intangible products that must be experienced.
 There are 5 dimensions that customers use to evaluate the service quality.
 These dimensions are generally used to establish levels of customer satisfaction;
comparing their perception of the service they received with their expectations.
 While this may seem natural, when expectations are met, the quality of service
is perceived as satisfactory; when expectations are not met, service quality is
determined to be unacceptable.

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 These five dimensions are used primarily in surveys to determine how
a company is perceived by its’ customers and provides insight on
where the company may need to make adjustments to fulfill the
expectations of customers.
1. Reliability
  Reliability refers to the organizations ability to perform the service
accurately.
 There are 3 basic components to this dimension, the ability to
complete the service; 1) on time, 2) consistently (routine tasks should
be completed in a consistent manner) and 3) error free, every time.
2. Responsiveness
 The willingness of the service provider to be helpful, be prompt in providing
services, and to respond to customers’ requests, problems or complaints.
 Eg. The speed of helping customer online or by telephone
 Example: avoid keeping customers waiting for no apparent reason.

3. Assurance
  The knowledge and politeness of employees and their ability to inspire trust
and confidence  creating trust and confidence will gain the customers’
loyalty. Example
 The excellent reputation and high levels of trust based on previous
experiences with the company.
 Being polite and showing respect for customer
 This dimension is characterized by 4 components; 1) competence (the ability
to perform the service), 2) respect for the customer, 3) effective
communication and 4) the basic attitude conveyed to the customer.

4. Empathy
 It is the ability to sense other people's emotions, coupled with the ability to
imagine what someone else might be thinking or feeling.
 An employee’s ability to take care and genuine concern for the customer
establishes the dimension of empathy.
 There are 3 main components that a customer evaluates, even unconsciously,
when measuring the level of empathy; 1) is the customer service representative
approachable, 2) does she/he seems sensitive and 3) is the representative trying
to understand my needs.
 Ability to be approachable.
 Example: being a good listener.
5. Tangibles
 Includes the physical appearance of the physical service facilities, the
equipment, the personnel who do the servicing, the communication
materials and all tangible elements of service provider facilities or
surroundings.
 Eg. Cleanliness of the environment; personnel uniform; vehicles;
flight.
 Quality Control (QC)
 Quality Control (QC) is part of quality management focused on
fulfilling quality requirements.
 Online QC: This type of quality control is carried out without
stopping the production process.
 During the running of production process a set up is automatically
performs and detect the fault and also takes corrective action.
 Raw Material Control :
o As the quality product depends on the raw material quality so we must
be provided with the best quality raw material with an economical
consideration.
 Process Control:
o The method chosen for the process must be provided with the
necessary accurate parameters.
 Laboratory :
o Higher precision lab can aid easily to achieve the goal of the
organization.
o Before bulk production a sample for the approval from industry is sent
to the buyer.
o As per the requirement of the buyer the shade is prepared in a lab
considering the economical aspects.
 Off line Quality Control
 Performed in the laboratory and other production area by stopping the
production process consisting of fabric inspection and laboratory and
other test.
 Correction steps are taken according to the test result.
 Off-Line Tests: All the Off-Line tests for finished fabrics can be
grouped as follows:
A. Physical tests
 GSM (Grams per Square Meter) test  Pilling resistance
 Shrinkage test  Button Strength Testing
 Spirality test  Crease resistance
 Tensile strength  Dimentional stability
 Abrasion resistance  Brusting strength test
B. Chemical Tests:
 Color Fastness to washing
 Color Fastness to light
 Color Fastness to heat
 Color Fastness to Chlorinated water
 Color Fastness to water spotting
 Color Fastness to perspiration
 Color Fastness to Seawater
 Fibre analysis
 PH test
 Repellency
 Quality Assurance (QA)
 A part of quality management focused on providing confidence that quality
requirements are fulfilled.
 The confidence provided by quality assurance is twofold—internally to
management and externally to customers, government agencies, regulators,
certifiers, and third parties.
 An alternate definition is "all the planned and systematic activities implemented
within the quality system that can be demonstrated to provide confidence that a
product or service will fulfill requirements for quality.
 Quality assurance is about the process of managing quality and quality control is
used to verify the correctness and quality of the product.
 Quality assurance is a process based approach whose prime objective is to prevent
defects in deliverables in the planning stage to avoid rework, which costs a lot.

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The Difference Between Quality Assurance and Quality Control
 The following are a few differences between the quality assurance and quality control
processes:
 Quality assurance focuses on defect prevention and quality control focuses on defect
identification.
 In quality assurance, you check if the plan was efficient to avoid any anticipated defect.
 In quality control, you try to find defects and correct them while making the product.
 Quality assurance is a proactive process while quality control is a reactive process.
 Quality assurance is a process based approach while quality control is a product based
approach.
 Quality assurance involves processes managing quality, and quality control is used to verify
the quality of the product.
 Quality audit is an example of quality assurance. Inspection and testing are examples of
the quality control process.

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 Quality Planning

 Quality planning is a methodology which can be used when a

situation exhibits one or more of the following characteristics:
 A service has never existed before.
 Customer requirements are not known.
 The existing service/process performance is not capable of meeting
customer requirements.
 The service/process is extremely variable; never been well.
 The environment is unstable, characterized by major market,
technology or organizational change.
 Performance data does not exist or it would require excessive
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Quality Planning Steps
 Identify customers, both external and internal.
 Determine customer needs.
 Develop service/product features that respond to customer needs.
 Establish quality goals that meet the needs of customers and suppliers
alike, and do so at a minimum combined cost.
 Develop a process that can produce the needed service/product
features.
 Prove process capability prove that the process can meet the quality
goals under operating conditions.

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 Quality Improvement (QI)

 Quality improvement (QI) is a structured approach to evaluating the

performance of systems and processes, then determining needed

improvements in both functional and operational areas.

 Quality Improvement (QI) consists of systematic and continuous

actions that lead to measurable improvement in services and/or the status

of targeted individuals or groups.

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Why do QI?
 Reduces costs and waste; improves delivery of services and outcomes.
 Allows for better organizational strategic planning.
 Aligns departmental goals and objectives with an organization’s
mission and vision.
 Creates accountability for actions.
 Fosters positive inter-professional team relationships.
 Recognizes excellence.

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 Quality Management System ISO 9001:2008

 A system comprised of quality planning and quality improvement

activities, the establishment of a set of quality policies and objectives that
will act as guidelines within an organization.
 A quality management system (QMS) can be defined as the
organizational structure, procedures, processes and resources needed to
implement quality management.
 In other words, a quality management system should be viewed as a set of
interrelated or interacting components that organizations use to direct and
control how quality policies and procedures are implemented and quality
objectives are achieved.

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 International Organization for Standardization (ISO)
 The International Organization for Standardization (ISO) is an international
nongovernmental organization made up of national standards bodies that
develops and publishes a wide range of proprietary, industrial, and commercial
standards.
 The International Organization for Standardization (ISO) was founded in 1947
and is headquartered in Geneva, Switzerland.
 In addition to producing standards, ISO also publishes technical reports,
technical specifications, publicly available specifications, and guides.
 The ISO plays an important role in facilitating world trade by providing
common standards among different countries.
 ISO standards cover all fields, from healthcare to technology to manufacturing
to security to the environment.
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How Are ISO Standards Developed And Revised?
 ISO standards are developed according to the following principles:
1. Consensus:
 The views of all interests are taken into account: manufacturers, vendors and
users, consumer groups, testing laboratories, governments, engineering
professions and research organizations etc.
2. Industry-wide:
 Global solutions to satisfy industries and customers worldwide.
3. Voluntary:
 International standardization is market-driven and therefore based on voluntary
involvement of all interests in the market-place.
 Standards are revised periodically to remain relevant and current with
advancements in technology and global business conditions.
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 The International Organization for Standardization develops and publishes
International Standards and it defines a standard as follows:
 A standard is a document that provides requirements, specifications, guidelines
or characteristics that can be used consistently to ensure that materials, products,
processes and services are fit for their purpose.
 The focus of the ISO International Standards is to make sure that products and
services are safe, reliable and of good quality.
 In the business environment these standards are strategic tools that help to
reduce costs by minimizing waste and errors and increasing productivity.
 It helps companies to access new markets, level the playing field for developing
countries and facilitate free and fair global trade.

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Development of ISO Standards
 An ISO standard is developed by a panel of experts, within a technical
committee.
 Once the need for a standard has been established, these experts meet to
discuss and negotiate a draft standard.
 As soon as a draft has been developed it is shared with ISO’s members who
are asked to comment and vote on it.
 If a consensus is reached the draft becomes an ISO standard, if not it goes
back to the technical committee for further edits.
The key principles in developing a new standard are:
1. ISO standards respond to a need in the market.
2. ISO standards are based on global expert opinion.
3. ISO standards are developed through a multi-stakeholder process.
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4. ISO standards are based on a consensus.
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Some of the well-known ones are:
 ISO 50001 – Energy Management.
 ISO 9001 – Quality Management.
 ISO 14000 – Environmental Management.
 ISO 22000 – Food Safety Management.
ISO 9001 (Quality Management System – Requirements)
 ISO 9001 is an International Standard that gives requirements for an
organization’s quality management system (QMS).
 It is part of a family of standards published by the International Organization
for Standardization (ISO) and often referred to collectively as the ISO 9000
series or ISO 9000 family.

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 ISO 9001 helps organizations ensure their customers consistently receive
high quality products and services, which in turn brings many benefits,
including satisfied customers, management, and employees.
 Because ISO 9001 specifies the requirements for an effective quality
management system, organizations find that using the standard helps them:
 Organize a QMS.
 Create satisfied customers, management, and employees.
 Continually improve their processes.
 Save costs.

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 Since its first major revision in the year 2000, ISO 9001 has adopted a “process
approach” to quality management, with the following key requirements:
 a clear commitment of the organization’s top management to the quality
management system.
 a “customer focus” throughout the organization.
 a clear quality policy and policy objectives defined by top management.
 definition of the responsibility and authority of the various personnel involved in
the quality management system and communication between them.
 ensuring the availability of resources (including competent personnel).
 appropriate levels of documentation; and control of the various operational
processes, from sales through design and development of the product or service
provided, manufacture (or service provision), process monitoring, inspection and
after-sales support.

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 This standard assures quality for all interested parties involved in
businesses that are certified.
 ISO 9001 is considered as a key factor for doing business in global
markets and for improving competitiveness.
 ISO 9001 applies to all types and sizes of organizations that wish
to:
 Establish, implement, maintain and improve an QMS;
 Assure conformity with the organization’s stated quality policy;
 Demonstrate conformity to others;
 Seek certification/registration of its QMS by an accredited third party
certification body; and
 Make a self-determination and self-declaration of conformity with this
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 ISO 9001 and ISO 9004 are both quality management standards designed to
complement each other; nonetheless, may be used independently.
 ISO 90001 specifies requirements for a QMS that can be used for internal
application by organizations, for certification, or for contractual purposes.
 It focuses on the effectiveness of the QMS in meeting customer
requirements.
 Whereas, ISO 9004 provides guidance for achieving sustained success for
any organization and it provides a wider focus on quality management than
ISO 9001.
 However, it is not intended for certification, regulatory or contractual use.

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 ISO 9001:2008 is a quality management system standard, first published in
1987 by ISO (International Organization for Standardization).
 This standard is designed to help organizations ensure that they meet all
requirements of customers and stakeholders.
 It is neither an industry nor product specific standard.
 This standard can be used by manufacturing or service providing companies.

General requirements for ISO 9001:2008

 The organization shall establish, document, implement and
maintain a quality management system and continually improve
its effectiveness in accordance with the requirements of this
International Standard.

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 ISO 9001:2008 specifies requirements for a quality management system
where an organization:
 needs to demonstrate its ability to consistently provide product that meets
customer and applicable statutory and regulatory requirements.
 aims to enhance customer satisfaction through the effective application of
the system, including processes for continual improvement of the system
and the assurance of conformity to customer and applicable statutory and
regulatory requirements.
 All requirements of ISO 9001:2008 are generic and are intended to be
applicable to all organizations, regardless of type, size and product
provided.

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 The organization shall:
a) Determine the processes needed for the quality management system and
their application throughout the organization.
b) Determine the sequence and interaction of these processes.
c) Determine criteria and methods needed to ensure that both the operation
and control of these processes are effective.
d) Ensure the availability of resources and information necessary to
support the operation and monitoring of these processes.
e) Monitor, measure where applicable, and analyse these processes.
f) Implement actions necessary to achieve planned results and continual
improvement of these processes.

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Documentation requirements

 The quality management system documentation shall include:

a) Documented statements of a quality policy and quality objectives.
b) A quality manual.
c) Documented procedures and records required by this International
Standard.
d) Documents, including records, determined by the organization to be
necessary to ensure the effective planning, operation and control of
its processes.

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Quality manual
 The organization shall establish and maintain a quality manual that
includes:
a) The scope of the quality management system, including details of
and justification for any exclusions.
b) The documented procedures established for the quality management
system, or reference to them.
c) A description of the interaction between the processes of the quality
management system.
Control of documents
 Documents required by the quality management system shall be
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 Records are a special type of document and shall be controlled.
 A documented procedure shall be established to define the controls needed.
a) To approve documents for adequacy prior to issue.
b) To review and update as necessary and re-approve documents.
c) To ensure that changes and the current revision status of documents are
identified.
d) To ensure that relevant versions of applicable documents are available at
points of use.
e) To ensure that documents remain legible and readily identifiable.

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f) To ensure that documents of external origin determined by the
organization to be necessary for the planning and operation of the quality
management system are identified and their distribution controlled.
g) To prevent the unintended use of obsolete documents, and to apply
suitable identification to them if they are retained for any purpose.

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ISO 9001:2008 Structure

 Scope Section 1
 Normative References Section 2
 Terms & Definition Section 3
 Quality Management System Section 4
 Management Responsibility Section 5
 Resource Management Section 6
 Product Realisation Section 7
 Measurement, Analysis and Improvement Section 8
 Section 0 mentions the benefits of implementing a QMS and the
quality management principles, and presents the process approach, the
Plan-Do-Check-Act cycle, and risk-based thinking.
 People often overlook this section, but they shouldn’t, as it frames
much of the information that comes next, especially about how the
various clauses relate to each other.
 Section 1 through 3 include no requirements, but instead deal with the
scope of the standard, references to better understand the standard,
and terms and definitions.
QMS-Section 4
Clause-4, Quality Management System

4.1 General Requirements

4.2 Documentation Requirements
(Process Approach)

Determine what processes? General- Quality Policy, Objectives,

Quality Manual, Procedures, Documents
& Records
Sequence & Interaction of processes
Quality Manual

Control methods for processes

Control of Documents

Provided resources for processes

Control of Records

Measure and analyze processes

Improve Processes
Management Responsibility-Section 5
• Management commitment - evidence of commitment to the
development and improvement of QMS
• Customer focus - ensure customer needs and expectations are
understood and satisfied
• Quality policy - appropriate for company, communicated and
reviewed
• Planning - quality objectives and planning
• Administration - responsibility and authority, management
representative and internal communication
• Review - QMS to be reviewed at planned intervals
 Resource Management-Section 6
 General – Required and competent resources
 Competence, Training & Awareness
 Infrastructure- Building, workspace, process equipment &
other services
 Facilities - workspace, equipment and supporting services
 Work environment
 Product Realization-Section 7
 Product realisation is the sequence of processes and sub-processes
required to achieve the product - must be planned
 Customer-related processes - identification of requirements, product
obligations and communication
 Design and/or development - planning, inputs and outputs, review,
verification and changes control
 Purchasing - control and purchasing information
 Production and service operations - operations control, traceability,
preservation and verification
 Control of measuring and monitoring devices
Measurement, Analysis & Improvement-Section 8

 Measurement, analysis and improvement (Processes, Customer

satisfaction, Product & Equipment)
 Planning
 Customer satisfaction
 Internal audit
 Control of nonconformity
 Analysis of data
 Improvement
Steps to Implement ISO 9001:2008 QMS
• Management Decision and Commitment
• Establishment of Quality Council
• Appoint your Management Representative
• Establish Quality Policy and Objectives
• Establish QMS Organization
• Provide Infrastructure and other Resources
• Review of Current QMS (Gap Analysis)
• Documentation Process (Technical & QA)
• Implementation of Processes and Monitoring through KPIs
• Perform Internal Audit
• Improve performance by corrective and preventive actions
• Perform Assessment
• External Audit and Certification
ISO 9001:2015
 The current revision of the standard is ISO 9001:2015. The ISO 9001
2015 standard, sometimes called ISO 9001 revision 2015, was released in
October 2015 and replaced the previous revision ISO 9001:2008.
 This updated revision includes many of the processes from the previous
revision of the standard, with a greater focus on risk-based thinking and
understanding the context of the organization.
 To support this change, there was a major structural change from the ISO
9001:2008 standard – the main clauses of the standard are different
between the 2015 and 2008 revisions.

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 The structure of the ISO 9001:2015 standard is split into 10 sections (clauses).
 The first three are introductory, while the last seven contain the requirements for
the Quality Management System against which a company can be certified.
Here is what the seven main clauses are about:
1. Clause 4: Context of the organization
 This section talks about requirements for understanding your organization in
order to implement a QMS.
 It includes the requirements for identifying internal and external issues,
identifying interested parties and their expectations, defining the scope of the
QMS, and identifying your processes and how they interact. Expectations of
interested parties include regulatory requirements as well.

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Clause 5: Leadership 
 The leadership requirements cover the need for top management to be
instrumental in the implementation of the QMS.
 Top management needs to demonstrate commitment to the QMS by
ensuring customer focus, defining and communicating the quality policy,
and assigning roles and responsibilities throughout the organization.
Clause 6: Planning 
 Top management must also plan for the ongoing function of the QMS.
Risks and opportunities of the QMS in the organization need to be
assessed, and quality objectives for improvement need to be identified and
plans made to accomplish these objectives.
Clause 7: Support
 The support section deals with the management of all resources for
the QMS, covering the necessity to control all resources, including
human resources, buildings and infrastructure, the working
environment, monitoring and measurement resources, and
organizational knowledge.
 The section also includes requirements around competence,
awareness, communication, and controlling documented information
(the documents and records required for your processes).

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Clause 8: Operation
 The operation requirements deal with all aspects of the planning and
creation of the product or service.
 This section includes requirements on planning, product requirements
review, design, controlling external providers, creating and releasing the
product or service, and controlling nonconforming process outputs.
Clause 9: Performance evaluation
 This section includes the requirements needed to make sure that you can
monitor whether your QMS is functioning well.
 It includes monitoring and measuring your processes, assessing customer
satisfaction, internal audits, and ongoing management review of the
QMS.
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Clause 10: Improvement
 This last section includes the requirements needed to make your QMS
better over time.
 This includes the need to assess process nonconformity and taking
corrective actions for processes.
 These sections are based on the Plan-Do-Check-Act cycle, which uses
these elements to implement change within the processes of the
organization in order to drive and maintain improvements within the
processes.

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 ISO 9001:2015 doesn’t dictate what an organization’s objectives should be or
how to achieve them.
 In other words, it doesn't tell anyone how to run their business.
 It's a flexible standard that allows each organization to define for itself what its
objectives and adherence to the standard ought to be.
 ISO 9001:2015 defines the guiding principles that can be used to create
efficiencies by aligning and streamlining processes throughout the organization,
in an effort to bring down costs, create new opportunities, meet regulatory
requirements, and help organizations expand into new markets in which clients
demand ISO 9001 certification (the last of which is increasingly crucial for
businesses working in or with the public sector or serving as suppliers in
automotive or private OEM (Original Equipment Manufacturer).

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Why a new version?
 ISO regularly reviews all standards to ensure they are up-to-date and continue
to be relevant for the needs of organizations around the world.
 The last major revision of ISO 9001 was in 2008.
 While that might not seem like such a long time ago, the exponential increase
in the availability of technology, products, and services for consumers, as well
as the size and complexity of the global supply chain, have meant that ISO
needed to make 9001 meet several new requirements.
 Customer demands on products and services, and the impact on the brand
reputations of those companies that can meet them, grow each day, and ISO
9001 needed to meet these enhanced expectations.

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 ISO9001:2015 contains a subset of tactical  elements  that 
complement  the principles QMS.
 These five elements, which represent a significant advance on ISO
9001:2008, are:
 The Plan-Do-Check-Act cycle
 Risk-based thinking
 Leadership participation
 Unified structure
 Clarified documentation requirements.
 These elements are complementary and are highly integrated into the
fabric of ISO 9001:2015.
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Plan-Do-Check-Act
 Plan-Do-Check-Act (PDCA) is a process approach that manages
processes and systems to create a cycle of continuous improvement.
 It considers the QMS as an entire system and provides systematic
management of the QMS from planning and implementation through 
to checks and improvement.
 PDCA helps organizations achieve better customer satisfaction and,
consequently, higher levels of customer confidence in an
organization's abilities to meet customer requirements.

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Risk-Based Approach and Context of the Organization
 Clause 4 in ISO 9001:2015 is “Context of the organization,” which deals
with understanding the priorities of the organization and its stakeholders, as
well as the risks involved with impending change.
 Context refers to all issues (internal and external, negative and positive) that
impact an organization and that are impacted by the opportunities and risks
at hand.
 Risk-based thinking has always been part of ISO 9001, but the 2015
standard has made this approach more explicit.
 While ISO 9001:2015 sometimes seems to present “risk” as the opposite of
“opportunity,” it actually provides a more nuanced concept of risk as it
applies to an organization.
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Leadership Participation
 ISO 9001:2015 requires leadership to move from a position of supporting
the QMS to participating in its success.
 Leadership is responsible for ensuring that the QMS remains focused on
customer requirements and for establishing and communicating the overall
QMS policy for the organization.
 Leadership also has the following requirements for demonstrating its
commitment to the QMS.
 For the leadership of many organizations, even those certified to ISO
9001:2008 or other standards, these new responsibilities could be new
territory, so Quality professionals should prepare to take on the role of
introducing and teaching these principles to their leadership.
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Unified High-Level Structure
 ISO has been developing a unified structure for Management System
Standards (MSS) since the early 1990s.
 The ISO Technical Management Board created a technical advisory
group to develop these requirements and in 2011 published them as
Annex SL in the ISO/IEC directives.
 The fundamental impact of Annex SL is that all ISO standards
dedicated to management system requirements, including ISO
9001:2015, ISO 14001:2015 and ISO 45001:2018.

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 Benefits Of Quality Management Systems
 Implementing a quality management system affects every aspect of an
organization's performance.
 Benefits of a documented quality management system include:
 Meeting the customer's requirements, which helps to instill
confidence in the organization, in turn leading to more customers,
more sales, and more repeat business.
 Meeting the organization's requirements, which ensures compliance
with regulations and provision of products and services in the most
cost- and resource-efficient manner, creating room for expansion,
growth, and profit.
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 Management systems are needed in all areas of activity, whether large
or small businesses, manufacturing, service or public sector.
 A good QMS will:
 Set direction and meet customers’ expectations
 Improve process control
 Reduce wastage
 Lower costs
 Increase market share
 Facilitate training
 Involve staff
 Raise morale
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 Quality Management Principles
 The following Quality Management Principles apply to the broader
sphere of Business Management which underlies the ISO 9000
series of Quality Assurance Standards:
1. Customer focus
2. Leadership
3. Process approach
4. Systems approach to management
5. Continual Improvement
6. Factual Approach to decision-making
7. Involvement of people
8. Mutually beneficial supplier relationships
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 1. Customer-focused Organization
 Organizations depend on their customers and should, therefore,
understand current and future customer needs, meet customer
requirements, and strive to exceed customer expectations.
Key benefits

 Increased income and market share obtained through flexible and fast
responses to market opportunities
 Increased effectiveness in the use of the organization’s resources to
enhance customer satisfaction
 Improved customer loyalty leading to repeat business.

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Applying the principle of customer focus typically leads to:
 Researching and understanding customer needs and expectations.
 Ensuring that the objectives of the organization are linked to customer
needs and expectations.
 Communicating customer needs and expectations throughout the
organization.
 Measuring customer satisfaction and acting on the results.
 Systematically managing customer relationships.
 Ensuring a balanced approach between satisfying customers and other
interested parties (such as owners, employees, suppliers, financiers, local
communities etc).

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Customers may be of two types
External customer

 External customers are the people that pay for and use the products or
services your company offers.
 “The customer is always right” is generally the guiding principle
when serving this group, and the revenue they generate is the
lifeblood of your company.
 Without them, your company fails.

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Internal customer
 Internal customers have a relationship with, and within, your
company, either through employment or as partners who deliver your
product or service to the end user, the external customer.

 Less obvious but certainly still significant, stakeholders and

shareholders are also internal customers.
 All of these may or may not purchase your product or service.

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2. Leadership
 Leaders establish unity of purpose and direction of organizations.
 They should create and maintain the internal environment in which
people can become fully involved in achieving the organization’s
objectives.

Key benefits
 People will understand and be motivated towards the organization’s goals
and objectives.
 Activities are evaluated, aligned and implemented in a unified way.
 Miscommunication between levels of an organization will be minimized.

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Applying the principle of leadership typically leads to:

 Considering the needs of all interested parties including customers,

owners, employees, suppliers, financiers, local communities and society
as a whole.
 Establishing a clear vision of the organization’s future.
 Setting challenging goals and targets.
 Creating and sustaining shared values, fairness and ethical role models at
all levels of the organization.
 Establishing trust and eliminating fear
 Providing people with the required resources, training and freedom to act
with responsibility and accountability.
 Inspiring, encouraging and recognizing people’s contributions.
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Difference between manager and leader

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3. Process Approach In Management
 A process is defined as a set of interrelated or interacting activities,
which transforms inputs into outputs.
 Process approach is the application of a system of processes within an
organization, together with the identification and interactions of these
processes, and their management.
 The purpose of the process approach is to enhance an organization’s
effectiveness and efficiency in achieving its defined objectives.
 Process effectiveness and efficiency are usually assessed through
internal or external review processes.
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 Effective design and management of key processes is an important
differentiator and source of competitive advantage in the manufacturing as
well as in the services.
 Processes permeate all sides of an organization. Some processes exist within
one functional area, while others cut across functional areas.
 Process management is the application of knowledge, skills, tools,
techniques and systems to define, visualize, measure, control, report and
improve processes with the goal to meet profitably the requirements of the
customers.

Understanding of the process approach

 Process approach to management is a powerful way of organizing and managing
activities in order to create value for the customers and interested parties.
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 Organizations are usually structured into a hierarchy of functional units
and are normally managed vertically.
 In such organizations the responsibilities for the intended output rest with
the respective functional units.
 The end customer or the other interested party is often not visible to those
involved in the functioning of different processes.

 Hence the problems that occur at the interface boundaries do not receive
proper attention and get lesser priorities than the short term goals of the
organization.
 This results into actions being focused on the functions rather than on the intended
output leading to little or no improvement for the customer or the interested parties.
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 The process approach to management introduces horizontal management,
crosses the barriers between different functional units and unifies the
focus of the different units on the main goals of the organization.

Characteristics of a process
 Each work involves a process which consists of things going
in (inputs), getting worked upon (conversion), and coming out as
products (output).
 The value adding conversion activity within a process transforms input
into output.
 Process inputs and outputs can be tangible (e.g. raw materials or finished
product) or intangible (e.g. information or service).
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 Each process has a supplier, a customer and an owner. The supplier and
customer may be internal or external to the organization.
 The process owner has having defined responsibility and authority to
operate, control and improve the process.

 Every process needs resources such as people, equipment, materials, and

technology etc.
 These resources can be inputs (raw materials or information) as well as
the value adding conversion activity (use of machinery, equipment,
technology, and people etc.) for transforming inputs into output.

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 Every process has also to meet various requirements which may be
specified by the customer or may be applicable regulatory requirements
or may be the requirements of the organization.
 The performance of the processes needs monitoring to determine how
they are performing.
Key benefits
 Lower costs and shorter cycle times through effective use of resources.
 Improved, consistent and predictable results.
 Focused and prioritized improvement opportunities.

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4. System approach to management
  A system approach is set of interrelated and inter dependent parts
arranged in a manner that produces a unified whole.

 It is Identifying, understanding and managing interrelated processes as a

system contributes to the organization’s effectiveness and efficiency in
achieving its objectives.

Key benefits:
 Integration and alignment of the processes that will best achieve the
desired results.
 Ability to focus effort on the key processes.
 Providing confidence to interested parties as to the consistency,
effectiveness and efficiency of the organization. 85
Applying the principle of system approach to management typically
leads to:

 Structuring a system to achieve the organization’s objectives in the most

effective and efficient way.
 Understanding the interdependencies between the processes of the system.
 Structured approaches that harmonize and integrate processes.
 Providing a better understanding of the roles and responsibilities necessary
for achieving common objectives and thereby reducing cross-functional
barriers.
 Understanding organizational capabilities and establishing resource
constraints prior to action.

 Targeting and defining how specific activities within a system should operate.
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5. Continuous Improvement

 It is a management philosophy that views quality improvement as a

never-ending process that will always lead to incremental
improvements.
Key benefits:

 Performance advantage through improved organizational capabilities.

 Alignment of improvement activities at all levels to an organization’s
strategic intent.
 Flexibility to react quickly to opportunities.

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Applying the principle of continual improvement typically leads to:

 Employing a consistent organization-wide approach to continual

improvement of the organization’s performance.
 Providing people with training in the methods and tools of continual
improvement.
 Making continual improvement of products, processes and systems an
objective for every individual in the organization.
 Establishing goals to guide, and measures to track, continual
improvement.
 Recognizing and acknowledging improvements.

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The Continuous Process Improvement Tools
1. The plan-do-check-act (PDCA) cycle
 Plan: Identify an opportunity and plan for change.
 Do: Implement the change on a small scale.
 Check: Use data to analyze the results of the change and determine
whether it made a difference.
 Act: If the change was successful, implement it on a wider scale and
continuously assess your results.
 If the change did not work, begin the cycle again.
 One of the key benefits of PDCA is that it’s easy to understand and
remember.

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Why CI?

Predictable
Variable P D Quality
Inputs
A C Outputs

CI provides a system of responsive

processes to produce high-quality
outputs

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2. Benchmarking
 A method for identifying and importing best practices in order to
improve performance.

 The process of learning, adapting, and measuring outstanding

practices and processes from any organization to improve
performance.
Why Benchmark? Because it used to:

 Identify opportunities to improve performance.

 Learn from others’ experiences.

 Set realistic but ambitious targets.

 Better prioritize and allocate resources.

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3. Quality Auditing

 Quality audit is an independent examination of the quality program

to determine if quality initiatives comply with planned quality
programs.
Nature of Audit
 In general, there must be a basis (specific requirements) for an audit
and a systematic method for gathering facts or evidence.

 An auditor compares the evidence with the requirements and comes

up with observations, which can be either positive or negative.

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4. Vendor Selection and Certification Programs
 A vendor is a general term used to describe any supplier of goods or services.
 A vendor sells products or services to another company or individual.
 The vendor selection is a minor process that allows clearly stating, defining and
approving those vendors which meet requirements of the procurement process.
 Delivery an ability of the contractor to procure all required items within desired
delivery dates.
 The purchasing department takes responsibility for the vendor selection which is
an integral part of the procurement management process.

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 Often vendor selection criteria vary between organizations; however,
they need to be identified and included as a component of the inventory
management plan.
 The criteria for vendor selection include the following:
There are eight common supplier selection criteria, in no formal order:

 Cost  Social Responsibility

 Delivery  Convenience/Simplicity

 Quality & Safety  Agility(quickness)

 Service  Risk

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 6. Factual approach to decision making

 Effective decisions are based on the analysis of data and information.

 Fact (data) based decision making is the key to ensure customer (internal
& external) satisfaction and overall improvement in the organizational
performance.

 To make fact decision based, it is very important for an organization to

generate right quality and quantity of data at right place (i.e. measurement
system should be implemented).
 This principal encourages an origination to do quantitative or statistical
analysis based on data before making any conclusion or decision at any
level within the organization.
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Key benefits
 Informed decisions.
 An increased ability to demonstrate the effectiveness of past decisions
through reference to factual records.
 Increased ability to review, challenge and change opinions and decisions.

Applying the principle of factual approach to decision making typically

leads to:
 Ensuring that data and information are sufficiently accurate and reliable.

 Making data accessible to those who need it.

 Analyzing data and information using valid methods.
 Making decisions and taking action based on factual analysis, balanced
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with experience and intuition.
7. Employee Involvement and empowerment

Employee (people) involvement: Participation of employees in decisions

on how to improve their work processes.
Key benefits of involvement

 Motivated, committed and involved people within the organization.

 Innovation and creativity in furthering the organization’s objectives.
 People being accountable for their own performance.
 People eager to participate in and contribute to continual
improvement.

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Applying the principle of people involvement typically leads to:

 People understanding the importance of their contribution and role in

the organization.
 People identifying constraints to their performance.
 People accepting ownership of problems and their responsibility for
solving them.
 People evaluating their performance against their personal goals and
objectives.
 People actively seeking opportunities to enhance their competence,
knowledge and experience.
 People freely sharing knowledge and experience.
 People openly discussing problems and issues. 98
 People (Employee) empowerment: means sharing with non-
managerial employees the power and authority to make and
implement decisions.
 It is giving employees the authority to identify and solve guest
problems or complaints “on the spot,” and to make improvements in
work processes when necessary.
Quality circles: Team approach
 Group of workers that meet periodically to identify ways to improve
their products and processes.
 It helps in improving both Productivity & Quality by improving skill,
capacity, and creativity though collective process knowledge
increment, training, discussion etc. 99
 Quality Circle is originally a Japanese management technique
introduced by Japanese lecturer Dr. Edward Deming.

 The size of the quality circle is important-both too big and too small
should be avoided.

 In big group everybody will not get enough opportunities to

participate & in too small group someone may dominate.
 A quality circle is formed with group of mates who do the same of
similar type of works.
 The main idea is to select a group of people ideally small in size who
can meet & discuss regularly to identify, analyze and solved work
related problem.
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Why Quality Circle is required?
 Quality Circle plays an important role in increasing companies profit
by improving both process & product.
 It helps in increasing engagement and ownership of employees.

How to start a Quality Circle?

 In first place, we need to explain about quality circle and purpose to
our target group and urge then for volunteering.
 Once you get a volunteer team, form a steering committee with
facilitator, co-coordinator, Team Leader and members.
 Train team on their role on the basics of Quality Circle approach.

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8. Mutually beneficial supplier relationships
 An organization and its suppliers are interdependent and a mutually
beneficial relationship enhances the ability of both to create value.

Key benefits :

 Increased ability to create value for both parties.

 Flexibility and speed of joint responses to changing market or customer
needs and expectations.
 Optimization of costs and resources.
Applying the principles of mutually beneficial supplier relationships
typically leads to:

 Establishing relationships that balance short-term gains with long-term

considerations. 102
 Pooling of expertise and resources with partners.
 Identifying and selecting key suppliers.
 Clear and open communication.
 Sharing information and future plans.
 Establishing joint development and improvement activities.
 Inspiring, encouraging and recognizing improvements and achievements
by suppliers.

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Chapter Two: Quality Laboratory management
The importance of laboratory quality
 Laboratory quality can be defined as accuracy, reliability and timeliness of
reported test results.
 The laboratory results must be as accurate as possible, all aspects of the laboratory
operations must be reliable, and reporting must be timely in order to be useful in a
clinical or public health setting.
 When making measurements, there is always some level of inaccuracy. The
challenge is to reduce the level of inaccuracy as much as possible, given the
limitations of our testing systems. An accuracy level of 99% may at first glance
appear acceptable, but the resulting 1% error can become quite large in a system
where many events occur, such as laboratory testing.

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ISO/IEC 17025: General requirements for the competence of testing
and calibration laboratories
 ISO/IEC 17025, General requirements for the competence of testing and
calibration laboratories, is the international reference for testing and calibration
laboratories wanting to demonstrate their capacity to deliver reliable results.
 A new version of the standard was published by ISO and the International
Electrotechnical Commission (IEC) in 2017 to update its content and better
serve the laboratories that use it.
 ISO/IEC 17025 was developed by laboratory experts from all over the world,
along with 18 liaison organizations, such as the International Laboratory
Accreditation.
 Cooperation (ILAC), and many associations representing laboratories.

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 ISO/IEC 17025 enables laboratories to demonstrate that they operate
competently and generate valid results, thereby promoting confidence
in their work both nationally and around the world.
 It also helps facilitate cooperation between laboratories and other
bodies by generating wider acceptance of results between countries.
 Test reports and certificates can be accepted from one country to
another without the need for further testing, which, in turn, improves
international trade.
 ISO/IEC 17025 is useful for any organization that performs testing,
sampling or calibration and wants reliable results.
 This includes all types of laboratories, whether they be owned and
operated by government, industry or, in fact, any other organization.
 The standard is also useful to universities, research centres,
governments, regulators, inspection bodies, product certification
organizations and other conformity assessment bodies with the need to
do testing, sampling or calibration.
 The last version of ISO/IEC 17025 was published in 2005 and, since
then, market conditions and technology have changed.
 The new version covers technical changes, vocabulary and
developments in IT techniques.
 It also takes into consideration the latest version of ISO 9001.
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 ISO/IEC 17025 takes into consideration the new ways of working of
laboratories today.
 The most substantive changes are as follows:
 The scope has been revised to cover all laboratory activities, including
testing, calibration and the sampling associated with subsequent calibration
and testing.
 A new structure has been adopted to align the standard with the other
existing ISO/IEC conformity assessment standards such as the ISO/IEC
17000 series on conformity assessment.
 The process approach now matches that of newer standards such as ISO
9001 (quality management), ISO 15189 (quality of medical laboratories) and
the ISO/IEC 17000 series (standards for conformity assessment activities),
putting
7/11/22 the emphasis on the results of a process instead of the detailed
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108
 The standard has a stronger focus on information technologies.
 In recognition of the fact that hard-copy manuals, records and reports
are slowly being phased out in favor of electronic versions, it
incorporates the use of computer systems, electronic records and the
production of electronic results and reports.
 A new section has been added introducing the concept of risk-based
thinking and describes the commonalities with the new version of
ISO 9001:2015, Quality management systems – Requirements.

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General requirements for the competence of testing and calibration
laboratories

1. Scope
 This document specifies the general requirements for the competence,
impartiality and consistent operation of laboratories.
 This document is applicable to all organizations performing
laboratory activities, regardless of the number of personnel.
 Laboratory customers, regulatory authorities, organizations and
schemes using peer-assessment, accreditation bodies, and others use
this document in confirming or recognizing the competence of
laboratories.

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2. Normative references
 The following documents are referred to in the text in such a way that
some or all of their content constitutes requirements of this document.
 For dated references, only the edition cited applies.
 For undated references, the latest edition of the referenced document
(including any amendments) applies.
 ISO/IEC Guide 99, International vocabulary of metrology — Basic
and general concepts and associated terms (VIM)1) ISO/IEC 17000,
Conformity assessment — Vocabulary and general principles.

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3. Terms and definitions
 For the purposes of this document, the terms and definitions given in
ISO/IEC Guide 99 and ISO/IEC 17000.
Example 1: Impartiality:
 Presence of objectivity
 Objectivity means that conflicts of interest do not exist, or are
resolved so as not to adversely influence subsequent activities of the
laboratory.
 Other terms that are useful in conveying the element of impartiality
include “freedom from conflict of interests”, “freedom from bias”,
“lack of prejudice”, “neutrality”, “fairness”, “open-mindedness”,
“evenhandedness”,
7/11/22 “detachment”, “balance”.
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Example 2:complaint
 Expression of dissatisfaction by any person or organization to a
laboratory, relating to the activities or results of that laboratory, where
a response is expected.
Example 3: Inter-laboratory comparison
 Organization, performance and evaluation of measurements or tests
on the same or similar items by two or more laboratories in
accordance with predetermined conditions.
Example 4: intra-laboratory comparison
 Organization, performance and evaluation of measurements or tests
on the same or similar items within the same laboratory in accordance
with
7/11/22 predetermined conditions.
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Example 5: Proficiency testing
 Evaluation of participant performance against pre-established criteria
by means of inter-laboratory comparisons.
Example 6: Laboratory
 Body that performs one or more of the following activities:
 testing
 calibration
 sampling, associated with subsequent testing or calibration.
Example 7: Decision rule
 Rule that describes how measurement uncertainty is accounted for
when stating conformity with a specified requirement.
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Example 8: Verification
 Provision of objective evidence that a given item fulfills specified
requirements.
 EXAMPLE 1: Confirmation that a given reference material as claimed
is homogeneous for the quantity value and measurement procedure
concerned, down to a measurement portion having a mass of 10 mg.
 EXAMPLE 2: Confirmation that performance properties or legal
requirements of a measuring system are achieved.
 EXAMPLE 3: Confirmation that a target measurement uncertainty can
be met.

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Example 9: Validation
 Verification, where the specified requirements are adequate for an
intended use EXAMPLE A measurement procedure, ordinarily used
for the measurement of mass concentration of nitrogen in water, may
be validated also for measurement of mass concentration of nitrogen
in human serum.
Example 10: working standard
 Standard that is used routinely to calibrate or check material
measures, measuring instruments or reference materials.

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 4.General requirements

Impartiality
 Laboratory activities shall be undertaken impartially and structured and managed so as to
safeguard impartiality.
 The laboratory management shall be committed to impartiality.
 The laboratory shall be responsible for the impartiality of its laboratory activities and
shall not allow commercial, financial or other pressures to compromise impartiality.
 The laboratory shall identify risks to its impartiality on an on-going basis. This shall
include those risks that arise from its activities, or from its relationships, or from the
relationships of its personnel.
 However, such relationships do not necessarily present a laboratory with a risk to
impartiality.
 If a risk to impartiality is identified, the laboratory shall be able to demonstrate how it
eliminates or minimizes such risk.
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Confidentiality
 The laboratory shall ensure the protection of its customers' confidential information
and proprietary rights, including protecting the electronic storage and transmission
of results.
 The laboratory shall be responsible, through legally enforceable commitments, for
the management of all information obtained or created during the performance of
laboratory activities.
 The laboratory shall inform the customer in advance, of the information it intends to
place in the public domain.
 Except for information that the customer makes publicly available, or when agreed
between the laboratory and the customer (e.g. for the purpose of responding to
complaints), all other information is considered proprietary information and shall be
regarded as confidential.

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5. Structural requirements
 The laboratory shall be a legal entity, or a defined part of a legal entity, such that it
can be held legally responsible for all its activities.
 NOTE For the purpose of this international standard a governmental laboratory is
deemed to be a legal entity on the basis of its governmental status.
 The laboratory shall identify management who have overall responsibility for the
laboratory.
 It is the responsibility of the laboratory to carry out its activities in the laboratory’s
permanent facilities, or at sites away from its permanent facilities, or in associated
temporary or mobile facilities, or at a customer’s facility, in such a way as to meet
the requirements of this International Standard and to satisfy the needs of the
customer, the regulatory authorities and the requirements of the organizations
providing recognition.
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 The laboratory shall have adequate provision (e.g. insurance or reserves) to cover
liabilities arising from its activities.
 The laboratory shall define the range of laboratory activities for which it conforms
with this International Standard.
The laboratory shall:
 Have managerial and technical personnel who, irrespective of other responsibilities,
have the authority and resources needed to carry out their duties, including the
implementation, maintenance and improvement of the management system, and to
identify the occurrence of deviations from the management system or from the
procedures for performing tests and/or calibrations, and to initiate actions to prevent
or minimize such deviations.
 Define the organization and management structure of the laboratory, its place in any
parent organization, and the relationships between management system, technical
operations and support services.
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6. Resource requirements
General
 The laboratory shall have available personnel, accommodation and environmental
conditions, measuring equipment, information system(s) and support services
necessary to perform its laboratory activities.
Personnel
 All personnel of the laboratory, either internal or external, that could influence the
laboratory activities shall act impartially, be supervised and competent and shall
work in accordance with the laboratory's management system.
 The laboratory shall define and document the competence requirements for each
function involved in laboratory activities, including requirements for education,
qualification, training, technical knowledge, skills, experience, duties,
responsibilities and authorities.
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Laboratory facilities and environmental conditions
 The facilities and environmental conditions shall be suitable to realize the laboratory
activities and do not adversely affect the validity of results.
 In those cases where the laboratory needs to use facilities outside its permanent control,
it shall ensure that the requirements of this International Standard are met.
 There shall be effective separation between areas in which there are incompatible
laboratory activities.
 The facility and environmental requirements necessary for the performance of the
laboratory activities shall be documented.
 Measures shall be taken to control the facility and environmental requirements. These
measures shall be monitored and periodically reviewed and include, but not limited to:
a) access to and use of areas affecting laboratory activities.
b) processes to prevent contamination, interference or adverse influences on the laboratory
activities.

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Equipment
 The laboratory shall have access to all equipment required for the correct
performance of the laboratory activities.
 Equipment shall include software, measurement standards, reference materials,
reagents and consumables or auxiliary apparatus or combination thereof necessary
to realize a measurement process and which may influence the measurement result.
 In those cases where the laboratory needs to use equipment outside its permanent
control, it shall ensure that the requirements of this International Standard are met.
 The laboratory shall have documented processes for appropriate handling, transport,
storage, use and planned maintenance of equipment to ensure proper functioning
and in order to prevent contamination or deterioration.

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7. Process requirements
 Review of requests, tenders and contracts
General
 The laboratory shall establish and maintain procedures for the review of requests,
tenders and contracts.
 The procedures for these reviews leading to a contract for laboratory activities shall
ensure that: a) the requirements are adequately defined, documented and
understood; b) the laboratory has the capability and resources to meet the
requirements and where external providers are necessary, c) the appropriate
methods or procedures are selected and are capable of meeting the customers'
requirements.

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8. Management requirements
General
 The laboratory shall establish, document, implement and maintain a management system that
is capable of supporting and demonstrating the consistent achievement of the requirements of
this International Standard and assuring the quality of the laboratory results.
 Laboratory management shall establish, document, and maintain policies and objectives for
the fulfillment of the purpose of this International Standard and shall ensure that the policies
and objectives are acknowledged and implemented at all levels of the laboratory
organization.
 The policies and objectives shall address the competence, impartiality and consistent
operation of the laboratory.
 Laboratory management shall provide evidence of commitment to the development and
implementation of the management system and to continually improving its effectiveness.

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Introducing ISO/IEC 15189: Medical laboratories management
systems

ISO 15189 Medical Laboratories:

 Particular requirements for quality and competencies a ‘variant’ standard derived
from ISO/IEC 17025 with specific focus on clinical laboratories.
 The standard covers an ‘end-to-end’ approach to the application of quality
assurance methodologies in a clinical environment.
 This ranges from definition of services offered through to collection of patient
samples, sample transport, storage, transportation and test and includes the reporting,
interpretation and delivery of test results.
 The standard also focuses on management responsibilities as well as supporting
processes such as facilities, calibration, method validation, training etc. 
ISO 22870:2016 specifies additional requirements that relate to Point of Care
Testing (POCT).
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