CH 371 Week 2

SOME QUALITY TERMINOLOGY

& ISO 9001
 Quality System

Quality Assurance

Quality Control
 ❑ Quality Control
❑ Quality Assurance
❑ Quality Improvement
❑ Quality Indicators
❑ Quality System and
❑ Quality Management

What are their meanings (find definitions)?

 Organizational structure, resources, processes and
procedures needed to implement quality management.

Quality Management (QM)

 All activities of the overall management function that
determine quality policy, objectives, implement them by
means such as quality planning, quality control, quality
assurance, and quality improvement within the system.
❖ the process of testing and measuring products or services or
activities to ensure they meet a standard or customer
requirements.
❖ a process by which entities review the quality of all factors
involved in production or service to ensure that they comply to
specifications.
❖ a system of maintaining standards in manufactured products
or services by testing a sample of the output against the
specification.
❖ a process that uses tools to check and ensure that product or
service quality is maintained or improved.
❖ are objective parameters which help to assess the effectiveness of
the working system in any laboratory.
❖ tools to monitor and control efficiency of the system key segments,
and the results collected serve as a basis for implementation of
corrective measures and continuous quality improvement.
❖ are systematically measured data collected to monitor laboratory
performance leading to process improvements and good decision-
making.
❖ These may include turnaround time (TAT), misidentified laboratory
errors, sample rejection rate, corrected reports, IQC failure rate,
number of failed parameters per QA phase, etc.
Internal Quality control

❖ key tools for improving the quality of laboratory services, by reducing

error rates and safeguarding sample safety.
 Inter-Laboratory Comparison

external Quality A sseemnt Services

➢ QI is the framework used to systematically improve
processes and systems in implementing quality.
➢ a continuous and ongoing effort to achieve measurable
improvements in the efficiency, effectiveness, performance,
accountability, outcomes, and other indicators of quality in
services or processes
➢ to continuously look for ways to improve the quality of the
organization’s outputs, which could be products, services,
or outcomes.
➢ QI models - Model for Improvement, Lean, Six Sigma and
plan-do-study-act (PDSA) cycle, etc.
Phase one: Complete three fundamental questions:
❖ What are you trying to accomplish?
❖ How will you know whether a change is an improvement?
❖ What changes can you make that will result in
improvement?
Answering these questions will help you set your aims,
establish your measures, and select an intervention.
Phase two:
❖ Test your intervention using the PDSA cycle, then act on
what you learned. Take a look at your results and either
adopt, adapt or abandon the intervention.
➢ Quality planning is the method of deciding what’s most important
to the project. This occurs during the planning stage, where you
determine the critical factors for a successful project. This
includes the resources needed to deliver the project, what steps to
take and the specifications that have to be met.
➢ A quality plan is a document, or several documents, that together
specify quality standards, practices, resources, specifications, and
the sequence of activities relevant to a particular product, service,
project, or contract.
➢ Quality plans should define policies, objectives, responsibilities, steps
in the processes, expected outcomes, etc.
Quality Reviews PMCIA
Quality reviews are a key tool for quality assurance and for quality
control. They will be conducted as set out in the ‘Quality Plan’ and
‘Quality Manual’. Five overall objectives for review are:
1) Provide assurance that the project is proceeding according to
agreed plans & processes.
2) Measure effectiveness of implementation of agreed
plans/processes.
3) Capture “lessons learned” from activities.
4) Identify areas of non-compliance and opportunities for
improvement.
5) After do/conduct the appropriate improvements, check if they
worked as planned.
❑ QA – All the planned and systematic activities implemented
within the quality system, and demonstrated as needed, to
provide adequate confidence that an entity will fulfill the
requirements for quality [ISO 8402]

❑ Includes Internal Quality Control, pre-analytic phase, test

standardization, post-analytic phase, management, and
organization (WHO, 1992)
❖ It refers to all procedures, data, and documents required to
produce reliable analytical results and to demonstrate that
results are accurate and precise.
❖ involves pre-planned, regular reviews and independent audits
that are documented to verify that work is being carried out
consistently in accordance with defined procedures and to
provide confidence to stakeholders that the project satisfies
relevant quality requirements and standards.
❖ It covers the whole project/production/service lifecycle and is
not concentrated on any particular phase.

(ISO 8402:1994 Quality management and quality assurance -

Vocabulary)
 Pr
e-
Has three Preparations for

An
phases Sample Collection

aly
tic
Post-Analytic
Personnel Competency
Reporting Test Evaluations
•Data and Laboratory
Management
•Safety
•Customer Service
Sample Receipt
and Accessioning

Record Keeping
Sample Transport
Quality Control
Testing

Analytic
 a formal, independent verification that a program or
institution meets established quality standards and is
competent to carry out specific conformity assessment
tasks e.g., testing, inspection, or certification.
 the action or process of officially recognizing someone as
being qualified to perform a particular activity or having a
particular status.
 The Tanzania Bureau of Standards (TBS) is accredited to
provide Certification for ISO 9001, ISO 14001, ISO 45001,
TZS 1770, ISO 17025, etc.
➢ ISO 9000:2015 Principles of Quality Management - Guidance
for quality in manufacturing and service industries.
➢ It has broad applicability, can be used by many kinds of
organizations, large or small, regardless of field of activity.
➢ ISO 9001:2015 Quality Management Systems – Requirements
Model for QA in design, development, production, installation and servicing.

❑ There are more than 1.4 million companies & organizations in 170
countries certified to ISO 9001.
➢ ISO 45001:2018 Occupational Health and Safety Management
systems – Requirements
This is a workplace safety standard.
 ISO 15189:2012 Medical laboratories - Requirements for
quality and competence
can be used in developing medical laboratories quality management systems
and assessing the competence.
 ISO 14001:2015 Environmental Management Systems -
Requirements
 ISO 17025:2017 General requirements for the competence of
testing and calibration laboratories.
 ISO 31000:2018 Risk Management - Guidelines.
provides a common approach to managing any type of risk and is
not industry or sector specific.
We shall concentrate on ISO 9001 and ISO 17025.
 ISO 9001 is a certifiable quality management system (QMS)
for organisations who want to prove their ability to consistently
provide products and services that meet the needs of their
customers and other relevant stakeholders.

 ISO 9001:2015 sets out the criteria for a quality management

system and is the only standard in the ISO 9000 family that
one can be certified to (although this is not a requirement). It
can be used by any organization, large or small, regardless of
its field of activity or number of employees.
1) Customer focus.
2) Leadership.
3) Engagement of people.
4) Process approach.
5) (Continual) Improvement.
6) Evidence-based decision making.
7) Relationship management.
Regardless of whether you want to get an
ISO 9001 certificate or not, applying these
principles will help improve
any organization (or process) no matter its
size, kind or type.
• Let us look at these principles
A successful organization always focuses on its
customers. It is critical to understand what
your current and future customers want, what
they need and you must aim to meet their
requirements to succeed.

You also need to have ways of keeping in

touch with how they perceive your product and
its performance, i.e., how well they (not you!)
think you've met their requirements.

[Discuss]
❖ Align organizational objectives with customer
needs and expectations.
❖ Meet customer requirements.
❖ Measure customer satisfaction.
❖ Manage customer relationships.
❖ Aim to exceed customer expectation.
❖ Obtain customer experience (feedback).
❖ Understand the needs of existing and future
customers.
➢ Leaders provide clear direction and unity of purpose
to an organization, pointing the way and being clear
about its purpose (mission/ vision/ whatever-you-
call-it).
➢ They should encourage and develop a culture and
environment in which people do what needs to be
done to satisfy customers. Leadership isn't telling or
directing people, it is leading them.
➢ And the culture required is one that goes beyond
just 'doing the work' to reinforcing how people think,
talk and behave: ‘the culture of the organization’.
❖ Establish a vision and direction for the
organization.
❖ Set challenging goals for everyone.
❖ Model organizational values.
❖ Establish trust.
❖ Equip and empower employees.
❖ Recognize employee contributions.
➢ The most effective way to achieve quality is by involving
people across all levels of the organization.
➢ People at all levels are the essence of an organization
and their full involvement enables their abilities to be
used for the organization’s benefit.
➢ Everyone contributes to the success (or prosperity) of
an organization and has a part to play in it, as well as a
responsibility for quality.
➢ Whether the word quality appears in their job title is
quite immaterial.
❖ Ensure that people’s abilities are used and valued.
❖ Make people accountable.
❖ Enable participation in continual improvement.
❖ Evaluate individual performance.
❖ Enable learning and knowledge sharing.
❖ Enable open discussion of problems and constraints.
❖ ‘Employee involvement’ is the key phrase.
➢ Efficiency is better achieved when things are
managed as processes, rather than as individual
tasks or separate departments.

A process is a sequence of related activities,

organized to achieve a particular purpose.

➢ An example: (For a restaurant)

Creating and serving a meal is a process. Its
activities include buying the correct stuff,
preparing it, cooking and then serving it; the
inputs are the raw materials, cooks and recipe/s;
the output is the meal itself and the serving.
❖ Manage all activities as processes.
❖ Measure the capability of activities.
❖ Identify linkages between activities.
❖ Prioritize improvement opportunities.
❖ Deploy resources effectively.
❖ Utilize process analysis tools.
To apply a process approach means that you first decide
what you plan to do (e.g., provide a particular service/
create a particular gadget), and then work out what
processes you need in order to provide that service/create
that gadget.

For it to be a process, You have to decide:

❖ what the tasks are,
❖ how and where they relate,
❖ what resources and inputs you need,
❖ what quality of each you require,
❖ who will do what (qualification & experience) and
❖ how to do things (prioritize) in order to arrive at the result that
you want (the process).
Always aim to do better. Make ‘improving what you do’
a permanent objective in your organization.

Use problem-solving approaches / tools

❖ Establishing goals to guide, and measures to track
continual improvement.
❖ Recognize, acknowledge and reward improvements.
❖ Use PDCA, DMAIC, PROFIT like models as tools.
❖ Improve organizational performance and
capabilities.
❖ Align improvement activities.
❖ Empower people to make improvements.
❖ Measure improvement consistently.
❖ Celebrate improvements.
❖ Make improvement a continuous objective.
❖ Make decisions only based on facts.
❖ Use suitable, appropriate information (facts/data) when
making decisions - as opposed to opinions, feelings,
knee jerk responses, snap reactions, 'gut instinct’,
intuitions, etc.
❖ Effective decisions are based on the analysis of data
and information.
❖ To do this, you need to decide first what data you will
need, collect it, analyze it and review it before taking any
actions.
❖ Ensure the accessibility of accurate and reliable data.
❖ Use appropriate methods to analyze data.
❖ Make decisions based on analysis.
❖ Balance data analysis with practical experience.
❖ Use tools for decision making, e.g.,
➢ Decision matrix: Evaluates and prioritizes a list of options, using
predetermined weighted criteria,
➢ Multivoting: Narrows a large list of possibilities to a smaller list of the
top priorities or to a final selection, and allows an item that is favored
by all to rise to the top.
➢ Fishbone diagram and Pareto chart.
❖ The organization must manage its relationships with
suppliers, customers and staff.
❖ An organization and its suppliers are interdependent.
Therefore a mutually beneficial relationship (win-win
situation) is necessary as it enhances the ability of
both to create value from the activity they are
conducting.
❖ Identify and select suppliers to manage costs, optimize
resources, and create value.
❖ Establish relationships considering both the short and
long term.
❖ Share expertise, resources, information, and plans with
partners.
❖ Collaborate on improvement and development activities.
❖ Recognize supplier successes.
❖ Manage both the supply and marketing chains.
 Quality – fitness for purpose ISO 9001:2005
Establish the quality policy & quality objectives & direct &
control the organization to ensure objectives are achieved. Quality
Assurance
Equipment,
Quality
chemicals,
Control
facilities,
personnel.
Quality
Assessment

Problem
solution
(x ± y) units

Samples & Report - (x ± y)

information units
Analytical
Have QA/QC/QA method
38
 ISO 9001:2015 Quality Management Systems -
Requirements
• ISO 9001 is defined as the international standard that specifies
requirements for a quality management system (QMS).
• Organizations use the standard to demonstrate the ability to
consistently provide products and services that meet customer and
regulatory requirements.
• It specifies requirements to plan, establish, implement, operate,
monitor, review, maintain and continually improve a
documented management system used to manage quality.
• The requirements are generic, flexible and useful to all types of
organizations regardless of its type or size, or the products and services
it provides.
ISO 9001:2015
• ISO 9001:2015 specifies requirements for a quality management
system when an organization:
a) needs to demonstrate its ability to consistently provide
products and services that meet customer and applicable
statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective
application of the system, including processes for
improvement of the system and the assurance of conformity
to customer and applicable statutory and regulatory
requirements.
Benefits of ISO 9001
➢ Customers consistently receive high quality products and services.
➢ Get satisfied customers, management and employees.
➢ Organizations find that using the standard helps them
❖ Organize a QMS.
❖ Organize processes.
❖ Create satisfied customers, management and employees.
❖ Continually improve process efficiency.
❖ Save costs.
➢ ISO 9001 is the only standard in the ISO 9000 series to which
organizations can be certified to.
❑ Clause 1. Scope
❑ Clause 2. Normative References
❑ Clause 3. Terms and Definitions
1 to 3 provide background to the standard.
❑ Clause 4. Context of the organization
❑ Clause 5. Leadership
❑ Clause 6. Planning
❑ Clause 7. Support.
❑ Clause 8. Operation
❑ Clause 9. Performance Evaluation
❑ Clause 10. Improvement
 4 to10 provide the requirements.
Structure of the ISO 9001:2015 Document

Background to
Standard
Clause 0: Introduction
• This section/clause introduces the purpose, principles and key
concepts of the standard, including risk-based thinking and the
process approach.
• It includes the seven Quality principles.

Clause 1: Scope
This section/clause defines the scope of the ISO 9001:2015
standard. In summary, the scope includes specifying
requirements for a QMS of any organization and what it covers.
Clause 2: Normative References
The supporting standards that are referenced in ISO 9001:2015 and is
indispensable for its application as ISO 9000:2015 which covers
terminology and fundamentals. This and other supporting standards
make up the 9000 series.

Clause 3: Terms and Definitions

Terminology used throughout this standard comes directly from ISO
9000:2015, Quality management systems – Fundamentals and
vocabulary.
Structure of the ISO 9001:2015 Document
4. Context of the Organization
When implementing your Quality Manual System (QMS), the first step for ISO 9001
requirements is to thoughtfully align your business objectives and intent with the
QMS. Determine external and internal issues, the needs and expectations of
interested parties, QMS Scope and its processes.
4.1 The Organization and its context.
4.2 Needs and expectations of interested parties.
4.3 Scope of the QMS.
Document required.
4.4 QMS and its processes.
A process states what needs to be done and why.
A procedure states how the process needs to be done.
A work instruction explains how to carry out the procedure.
Document required.
Record (of implementation) required.
4.2 Interested parties
• An interested party can be a stakeholder, person or organization
that can affect, be affected by, or perceive itself to be affected by a
decision or activity.
• The clause defines relevant interested parties as those that provide
significant risk to organizational sustainability if their needs and
expectations are not met. Examples include suppliers, customers,
partners, employees, investors, owners, bankers, regulatory bodies.
• Once you have identified who those interested parties are you will
need to determine what their requirements are and have a system to
monitor or review those requirements.
QMS Scope
4.3 The quality management system needs to have a defined scope,
which specifies its boundaries and applicability. The scope will
assist you to know what areas to audit.
Where a requirement of this International Standard within the
determined scope can be applied, then it shall be applied to the
organization.– i.e., once the scope of the QMS is defined,
every requirement must be applied within the boundaries defined
by the statement of scope.
 Relationship Between Processes, Procedures and Work
Instructions
• Think about a process as a high level, strategic method of control,
in effect, a summary of objectives, specifications, and broad
resources needed.
• The procedure adds more specifics such as responsibilities,
specific tools, methods, and measurement.
• And a work instruction (Standard Operating Procedure, SOP) is a
step-by-step guideline to implement the process and procedure,
often segmented in some way to focus those who are doing the
actual work.
Exclusions and Requirements

4.3 Where a requirement of this International Standard within the

determined scope can be applied, then it shall be applied to the
organization.– i.e., once the scope of the QMS is defined,
every requirement must be applied within the boundaries defined
by the statement of scope.
Any requirement may be excluded if it cannot be applied. Or if
compliance would undermine the performance of the product or
service.
For example, if you do not design and develop products and
services, you would want to state within your QMS scope that the
design and development clause 8.3 of the ISO 9001:2015
requirements is excluded from your QMS.
5. Leadership (responsibility)
5.1 Leadership and Commitment.
Top management must demonstrate leadership and commitment,
establish and communicate a quality policy, and ensure responsibilities
and authorities are assigned, communicated and understood.
5.2 (Quality) Policy.
The management should formulate and distribute a Quality Policy
Statement for the Organization. The policy statement sets a clear goal
for the organization and will give direction and purpose. E.g., use
published, validated analytical and test methods, preferably in the
order international, regional, national and locally developed.
Document required.
5.3 Organizational roles, responsibilities and authorities.
6. Planning
The act of planning may be defined as thinking out in advance the
sequence of actions necessary to accomplish a proposed course of
action in doing work to achieve certain objectives. It should address
organizational risks, opportunities, any changes and quality objectives.
Planning for quality must be geared to delivering acceptable quality
results and services at an acceptable cost.
6.1 Actions to address risks and opportunities.
6.2 Quality objectives and planning to achieve them.
Document required.
6.3 Planning of changes.
6.1 Address risks and opportunities
• Risk-based thinking A risks is a positive or negative deviation from
the expected. The better your organization manages risks, the better
prepared you are to face uncertainties.
• ISO 9001 has always advocated mitigating and avoiding risk; it has
implicitly addressed the issue through “preventative actions” in
previous revisions. ISO 9001:2015 replaced the term preventative
actions with Clause 6.1 “actions to address risks and opportunities”.
It should cover
1) Severity (If the risk occurs, how serious is it or its effect?).
2) Probability (What is the probability of the risk occurring?).
6.2 Quality objectives
• Specific objectives for management, technical staff, administrative
staff and customer service personnel should be formulated
communicated and appropriate training provided.
• What is expected of everyone and how it will be achieved needs to be
stated clearly so that all are aware of this.
• Examples of objectives:
1) To upgrade the overall quality of organization performance.
2) Obtain 100% customer on-time-delivery of product.
3) Reduce production defects by 10%.
4) Average operation efficiency to be >90%
5) To ensure product and service integrity.
7. Support
Requirements covers the resources needed for the QMS. These include;
providing resources, ensures employees are competent and aware, and
documented information to support your QMS.
7.1 Resources management.
Record required. Should cover:
1) People.
2) Infrastructure (Facilities, technology and equipment).
3) Environment (Social, psychological and physical).
4) Monitoring and Measuring Resources.
5) Organizational Knowledge.
7.2 Competence.
Record (of this) required.
7.3 Awareness.
7.4 Communication.
7.5 Documented Information.
Structure of the ISO 9001:2015 Document continues
8. Operation
8.1 Operational Planning and Control.
8.2 Requirements of products and services.
Records required.
8.3 Design & development of products ans services.
5 Records required.
8.4 Control of externally provided processes, products and services.
Recordz required.
8.5 Production & service provision.
3 Records required.
8.6 Release of products and services.
Records required.
8.7 Control of nonconforming outputs.
Records required.
9. Performance evaluation

9.1 Monitoring, measurement, analyses and evaluation.

Records required.
9.2 Internal audit.
Records required.
9.3 Management review.
Records required.
10. Improvement

10.1 General.
10.2 Nonconformity and corrective action.
Records required.
10.3 Continual improvement.
Document how it was done!
 ISO 17025:2017
• ISO 17025 is an international standard that specifies the general requirements for the
competence of testing and/or calibrations laboratories.
• These requirements outline what a laboratory must do to become competent and get
accredited.
• It specifies the activities that must be included in laboratory operations to provide
confidence in its ability to produce valid and consistently reliable testing,
calibration and sampling results.
• It has eight elements (chapters), five are for implementation i.e., General
requirements, Structural requirements, Resource requirements, Process
requirements and Quality Management requirements.
• Very Important and a must for laboratories that want to show they are reliable and
can provide accurate results.