This is a sample set of the slides associated with the delivery of the ISO 9001 Foundation training course.

1. © 2021 BT&CS Ltd 1
ISO 9001 Foundation
Prepared by: Stratos Lazaridis
Corporate Trainer and Management Consultant

2. © 2021 BT&CS Ltd 2
Course Overview
▪ Module 1: Introduction
▪ Module 2: Quality Management Systems (QMS)
▪ Module 3: ISO 9000 Family of Management System Standards
▪ Module 4: ISO 9001 Standard - The Clauses Explained
▪ Module 5: ISO 9001 - QMS Documentation
▪ Module 6: ISO 9001 - QMS Implementation
▪ Module 7: ISO 9001 Certification
▪ Module 8: Continual QMS Improvement
Notes:
1. This is a small sample of the slides associated with the delivery of the ISO 9001 Foundation training course.
2. Cont’d indicates there are more slides in the module
3. For an overview of the course please click on the link https://www.btcsltd.co.uk/iso-9001-foundation
4. This course is delivered on demand to corporate clients; however, it can also be delivered on demand to
small groups of individual learners (min. 6 delegates).
5. If interested please contact our Lead Trainer on 0749 114 7156 or email stratoslaz@aol.com

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Module 1: Introduction

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Module 1.1: Introduction - QMS Terms & Acronyms

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Key QMS Terms - Management System
▪ Management system - set of interrelated
or interacting elements of an
organization to establish policies and
objectives, and processes to achieve
those objectives
▪ Management system can address a single
discipline or several disciplines, e.g., quality
management, financial management or
environmental management.
▪ Management system cont’d
▪ The management system elements establish
the organization’s structure, roles and
responsibilities, planning, operation, policies,
practices, rules, beliefs, objectives, and
processes to achieve those objectives.
▪ The scope of a management system can
include the whole of the organization, specific
and identified functions of the organization,
specific and identified sections of the
organization, or one or more functions across
a group of organizations.
•
ISO management system model

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Key QMS Terms - Quality
•
▪ Quality - degree to which a set of
inherent characteristics of an object
fulfils requirements
▪ The term “quality” can be used with
adjectives such as poor, good, or excellent.
▪ “Inherent”, as opposed to “assigned”,
means existing in the object.
▪ This term is applied in a few different
ways.
▪ For starters, quality can be represented by
how time and energy is being used to
accomplish tasks. Quality can also represent
how many ISO 9001 requirements are met.

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Key QMS Terms - Quality Management System (QMS)
▪ Quality Management System (QMS) - part
of a management system about quality
▪ QMS is an organization’s system which
implements policies and objectives into the
processes that help improve a standard of
quality.
▪ Some QMS implementations include:
▪ Records
▪ Techniques
▪ Programs
▪ Rules
▪ Role distribution
▪ Responsibility distribution
▪ This term is by far one of the most important
to be familiar with
▪ It is the basis of what ISO 9001 standards
can help you accomplish.
•
Model of process-based QMS
Process-Based QMS - reflects processes that are
integrated within an organization to improve
quality.

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Key QMS Terms - Quality Management Principles (QMPs)

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Key QMS Terms - Quality Policy, Quality Objective
▪ Quality Policy - The quality policy is a
document that shows the standards your
organization has set for itself in terms of
improving and maintaining quality for
customers, providers, and employees.
▪ The quality policy revolves around the
quality management principles mentioned
in ISO 9001.
▪ With quality management principles, the
main drive is on customers and those
interested in the product/service and
provide them with the resources they need.
▪ Quality Objective - This term represents
the plan laid out to ensure that quality
results are achieved properly.
Example of Quality Policies & Objectives
Graphic Era Hill University (GEHU) - ISO 9001 certified

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Key QMS Terms - Customer, Supplier
▪ Customer - person or organization that
could or does receive a product or a
service that is intended for or required
by this person or organization
▪ EXAMPLE: Consumer, client, end-user,
retailer, receiver of product or service
from an internal process , beneficiary and
purchaser.
▪ Provider, a.k.a. supplier - organization
that provides a product or a service
▪ EXAMPLE: Producer, distributor, retailer or
vendor of a product or a service.
▪ External provider, a.k.a. external supplier
- provider that is not part of the
organization
▪ EXAMPLE: Producer, distributor, retailer or
vendor of a product or a service

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Key QMS Terms - Requirement
▪ Requirement - need or expectation that is
stated, generally implied or obligatory
▪ “Generally implied” means that it is
custom or common practice for the
organization and interested parties that
the need or expectation under
consideration is implied.
▪ A specified requirement is one that is
stated, for example in documented
information.
▪ Requirement cont’d
▪ A qualifier can be used to denote a specific
type of requirement, e.g.
- Product requirement
- Quality management requirement
- Customer requirement
- Legal/ regulatory requirement.
▪ Requirements can be generated by different
interested parties or by the organization
itself
- It can be necessary for achieving high customer
satisfaction to fulfil an expectation of a customer
even if it is neither stated nor generally implied
or obligatory.

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Key QMS Terms - Corrective Action, Preventive Action
▪ Corrective action - action to eliminate the
cause of a nonconformity and to prevent
recurrence
▪ There can be more than one cause for a
nonconformity.
▪ Corrective action is taken to prevent
recurrence whereas preventive action is
taken to prevent occurrence.
▪ This constitutes one of the common terms
and core definitions for ISO management
system standards.
▪ Preventive action - action to eliminate the
cause of a potential nonconformity or other
potential undesirable situation
▪ There can be more than one cause for a
potential nonconformity.
▪ Preventive action is taken to prevent
occurrence whereas corrective action is
taken to prevent recurrence.

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Key QMS Terms - Audit
▪ Audit - systematic, independent, and
documented process for obtaining
objective evidence and evaluating it
objectively to determine the extent to
which the audit criteria are fulfilled
▪ An audit can be:
▪ Internal audit (first party), or
▪ External audit (second party or third
party),
▪ A combined audit or a joint audit.
▪ The fundamental elements of an audit
include the determination of the conformity
of an object according to a procedure
carried out by personnel not being
responsible for the object audited.
▪ This constitutes one of the common terms
and core definitions for ISO management
system standards.

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Key QMS Terms - Improvement, Continual Improvement
▪ Improvement - activity to enhance
performance
▪ The activity can be recurring or singular.
▪ Continual improvement - recurring activity
to enhance performance
▪ The process of establishing objectives and
finding opportunities for improvement is a
continual process through the use of audit
findings and audit conclusions, analysis of
data, management reviews or other means
and generally leads to corrective action or
preventive action.
cont’d …

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Module 1.2: Issuers of Standards

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International Standards
▪ An international standard is a document
that has been developed through the
consensus of experts from many
countries and is approved and published
by a globally recognized body.
▪ It comprises rules, guidelines, processes, or
characteristics that allow users to achieve
the same outcome time and time again.
▪ International Standards:
▪ Make things work.
▪ Provide world-class specifications for
products, services and systems, to ensure
quality, safety and efficiency.
▪ They are instrumental in facilitating
international trade.

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Who Produces International Standards?
▪ The most prominent standards’ organization
is the International Organization for
Standardization (ISO).
▪ Examples of other standards organizations:
▪ International Electrotechnical Commission (IEC)
▪ International Telecommunication Union (ITU)
▪ International Labour Organisation (ILO)
▪ International Civil Aviation Organization
▪ Internet Society
Examples of organisations producing international standards
▪ International standards are developed by
international standards organizations.
▪ They are available for consideration and use
worldwide.
▪ The primary activities of Standards
organizations:
▪ Develop, coordinate, promulgate, revise,
amend, reissue, interpret, or otherwise
produce technical standards intended to
address the needs of a group of affected
adopters.

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ISO (International Organization for Standardization)
▪ Information about the ISO organisation:
▪ Formed in 1947
▪ NGO (Non-Governmental Organisation)
▪ HQ in Geneva, Switzerland
▪ Network of 162 national standardization
bodies, forming an international
cooperative
▪ Three (3) official languages: English,
French, and Russian
▪ ISO, through its members:
▪ Brings together experts to share knowledge
and develop voluntary, consensus-based,
market relevant International Standards
▪ Standards support innovation and provide
solutions to global challenges.
▪ To date ISO has issued 22,000+
standards covering almost all aspects of
technology and manufacturing.

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ISO Management System Standards (MSS)
▪ ISO MSS help organizations to improve
their performance by specifying
repeatable steps that organizations
consciously implement to achieve their
goals and objectives
▪ ISO MSS help organizations to create an
organizational culture that reflexively
engages in a continuous cycle of self-
evaluation, correction and improvement
of operations and processes
▪ This is achieved through heightened
employee awareness and management
leadership and commitment.

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Popular ISO Standards, Including MSS
▪ ISO 639 Codes for the representation of names of languages
▪ ISO 4217 Codes for the representation of currencies
▪ ISO 8601 Data elements and interchange formats - Information interchange - Representation of dates
and times
▪ ISO 9001 Quality Management Systems - Requirements
▪ ISO 13485 Medical Devices - Quality management systems - Requirements for regulatory purposes
▪ ISO 14001 Environmental Management Systems - Requirements
▪ ISO 17025 General requirements for the competence of testing and calibration laboratories
▪ ISO 20121 Event sustainability management systems - Requirements with guidance for use
▪ ISO 22000 Food Safety Management Systems - Requirements for any organization in the food chain
▪ ISO 26000 Guidance on Social Responsibility
▪ ISO 27001 Information Security Management Systems - Requirements
▪ ISO 31000 Risk Management - Principles and guidelines
▪ ISO 37001 Anti-bribery management systems
▪ ISO 45001 Occupational health and safety management systems - Requirements with guidance for use
▪ ISO 50001 Energy management systems - Requirements with guidance for use

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IEC (International Electrotechnical Commission)
▪ The IEC is made up of members, called
national committees (NCs)
▪ Each NC represents its nation's
electrotechnical interests in the IEC.
▪ Information about the IEC organisation:
▪ Formed in 1906 in London, UK
▪ Private standard-setting organisation
▪ HQ in Geneva, Switzerland
▪ Three (3) official languages: English,
French and Russian
▪ Prepares and publishes standards for
all electrical, electronic and related
technologies
▪ The above technologies are collectively
known as electrotechnology.

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BSI Group (British Standards Institution)
▪ Information about the BSI organisation:
▪ Founded in 1901
▪ National standards body of the United Kingdom
▪ Produces technical standards on a wide range
of products and services
▪ Supplies certification and standards-related
services to businesses.
▪ Helps organizations all over the world make
excellence a habit.
▪ BSI clients range from high profile brands
to small, local companies in 182 countries
worldwide.

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Module 2: Quality Management Systems (QMS)

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Module 3: ISO 9000 Family of Management
System Standards

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ISO 9000 Family of Quality Management System Standards (MSS)
▪ ISO 9000 is defined as a set of
international standards on Quality
Management (QM) and Quality
Assurance (QA)
▪ The above set of MSS is known as the “ISO
9000 family” or “ISO 9000 series”
▪ The standards were developed to help
companies effectively document the
quality system elements needed to
maintain an efficient quality system.
▪ Most standards in the series:
▪ Are not specific to any one industry
▪ Can be applied to organizations of any type,
size, complexity, and scope of operations.
▪ ISO 9000 can help a company to:
▪ Satisfy the needs and requirements of its
customers, and other business stakeholders
(interested parties)
▪ Meet regulatory requirements associated
with product and service quality
▪ Meet contractual requirements and
obligations
▪ Achieve continual improvement.
▪ It should be considered to be a first step
or the base level of a quality system.

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ISO 9000 Family of Quality Management System Standards (MSS)
▪ The ISO 9000 family contains these
standards:
▪ ISO 9000:2015: Quality Management
Systems - Fundamentals and Vocabulary
(definitions)
▪ ISO 9001:2015: Quality Management
Systems - Requirements
The ISO 9000 family contains these
standards cont’d:
▪ ISO 9004:2018: Quality Management -
Quality of an Organization - Guidance to
Achieve Sustained Success (continuous
improvement)
▪ ISO 19011:2018: Guidelines for Auditing
Management Systems

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Most Recognised Benefits of The ISO 9000 Series

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Principles of The ISO 9000 Series of Standards
▪ The ISO 9000 series are based on
seven quality management principles
(QMP)
▪ The seven quality management principles
are:
▪ QMP 1 - Customer focus
▪ QMP 2 - Leadership
▪ QMP 3 - Engagement of people
▪ QMP 4 - Process approach
▪ QMP 5 - Improvement
▪ QMP 6 - Evidence-based decision making
▪ QMP 7 - Relationship management

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Quality Management Principles of ISO 9000 Series
cont’d …

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Module 4: ISO 9001: 2015 Quality management
systems - Requirements
The ISO 9001 Clauses Explained

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The Clauses of ISO 9001
▪ ISO 9001:2015 Quality management
systems - Requirements is:
▪ A document of approximately 30 pages
▪ Available from the national standards
organization in each country.
▪ Directly audited against for third-party
assessment purposes.
▪ Sections (clauses):
▪ 1 - 3 are informational clauses, rather
than clauses that outline any kind of
actions or requirements.
▪ 4 - 10 specify QMS requirements and are
used to determine QMS compliance for
audit purposes, including internal and
external audits.
▪ The 10 clauses of the ISO 9001:2015
standard are as follows:
▪ Section 1: Scope
▪ Section 2: Normative references
▪ Section 3: Terms and definitions
▪ Section 4: Context of the organization
▪ Section 5: Leadership
▪ Section 6: Planning
▪ Section 7: Support
▪ Section 8: Operation
▪ Section 9: Performance evaluation
▪ Section 10: Continual Improvement

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The ISO 9001 Standard
▪ The layout of the standard is similar to
the previous ISO 9001:2008 standard
in that:
▪ It follows the Plan, Do, Check, Act
(PDCA) cycle in a process-based
approach
▪ It is encouraging a risk-based thinking
(section 0.3.3 of the introduction).
▪ The purpose of the quality objectives is
to:
▪ Determine the conformity of the
requirements (customers and organizations)
▪ Facilitate effective deployment
▪ Improve the quality management system
(QMS)

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ISO 9001 Clauses

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ISO 9001 Clauses

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ISO 9001 Clauses

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cont’d …

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Module 5: ISO 9001 - QMS Documentation

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Process
▪ Process - set of interrelated or interacting
activities that use inputs to deliver an
intended result
▪ Two or more interrelated and interacting
processes in series can also be referred to
as a process.
▪ Whether the “intended result” of a process
is called output, product or service depends
on the context of the reference.
▪ Inputs to a process are generally the
outputs of other processes and outputs of a
process are generally the inputs to other
processes.
Process cont’d
▪ Processes in an organization are generally
planned and carried out under controlled
conditions to add value.
▪ A process where the conformity of the
resulting output cannot be readily or
economically validated is frequently referred
to as a “special process”.
▪ Processes are closely related to procedures,
and work instructions.

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Process

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Process Approach
▪ Process Approach - This term refers to
how management plans strategies to
improve processes.
▪ ISO 9001:2015 states that: ‘Consistent
and predictable results are achieved more
effectively and efficiently when activities
are understood and managed as
interrelated processes that function as a
coherent system.’
▪ An ISO 9001 process approach is a
management strategy which incorporates the
plan-do-check-act cycle and risk-based
thinking.
▪ It means that:
▪ All business processes are managed and
controlled
▪ We should understand what the core,
management, and supporting processes are,
and consider how they fit together.

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Process Approach, Procedures, Work Instructions
▪ Process, Procedure, and Work Instruction
▪ A process states what needs to be done and
why.
▪ A procedure states who has to do what,
when, and where, and, at high-level how the
process must be done.
▪ A work instruction explains in detail how to
carry out the procedure.
Process Approach cont’d
▪ The implementation of the process
approach, as required by ALL ISO
standards, begins with a basic
understanding of the hierarchy of the terms
process, procedure, work instruction, and
record.
Why?
Who, What, Where, When
How?
Evidence

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Procedures
▪ Procedure - specified way to carry out an
activity or a process
▪ Procedures can be documented or not.
▪ There are six (6) mandatory procedures
in the ISO 9001: 2015 (see next slide)
▪ When a company documents its QMS, it is an
effective practice to clearly and concisely
identify their processes, procedures and work
instructions
▪ This is essential to help understand, explain
and control how it meets the requirements of
ISO 9001:2015.

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Work Instructions
▪ Work Instruction is the most detailed and
company-specific of all ISO 9001 QMS
documents:
▪ Work instructions:
▪ Describe in detail how particular tasks must
be performed
▪ Are typically written by the people who
perform the actual work.

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Standard Operating Procedure - Example

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Work Instruction Template and Example

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Records
▪ The ISO 15489-1:2016 standard, for
records management, defines records as
"information created, received, and
maintained as:
▪ (Objective) evidence, for audit purposes,
proving that a specified requirement of an
ISO standard is fulfilled
▪ Asset by an organization, or person, in
pursuit of legal obligations, or in the
transaction of business"
▪ ISO 9001:2015 requires that organizations
control the documents required by the
quality management system.
▪ Records are a special type of document and
must be controlled as required by clause
7.5.
▪ Quality record is any record:
▪ Where data is taken where the data is a
result of inspection and/or test
▪ Used for traceability of product
▪ Related to a nonconformance

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Control of Records
▪ ISO 9001:2015 requires that organizations
control the documents required by the
quality management system.
▪ Records are a special type of document
and must be controlled as required by
clause 7.5
▪ Organisations adopting the standard must
establish and control records:
▪ As evidence of conformity to requirements
▪ To demonstrate the effective operation of the
quality management system.

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Control of Records
▪ Organisations must establish a documented
procedure to define the controls needed for
QMS records:
▪ Identification
▪ Storage
▪ Protection
▪ Retrieval
▪ Retention
▪ Disposition
▪ Keep records legible, readily identifiable,
and retrievable.
▪ Controls are defined by documented
procedures.
▪ The procedure can consist of text, but a
flowchart or any other form of documentation
that the company can use is acceptable.
▪ The point is that:
▪ The procedure for the control of QMS
documents and records must be documented
▪ The controls during their lifecycle must be
defined.
Stages of documents and
records lifecycle

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Difference Between QMS Documents and Records
▪ Documents, such as SOPs, and records
may sound alike but there is a big
difference between the two.
▪ Examples of QMS documents:
▪ Quality Policy Required
▪ Quality Objectives Required
▪ Quality Manual Required
▪ Procedures Required (12)
▪ Work instructions Optional
▪ Examples of required QMS records :
▪ Monitoring and measuring resources
▪ Records of competency in staff
▪ Product/service requirements review
records
▪ Identification and Traceability records

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Difference Between QMS Documents and Records
▪ Documents
▪ Originate in the planning phase of the PLAN,
DO, CHECK, ACT, cycle of the process
approach.
▪ Are created by planning what needs to be done
▪ Consist of any information you use to run your
company.
▪ Can be revised and change, whereas records
don’t (must not) change.
▪ Records
▪ Are generated in the “DO” phase of PDCA
▪ Are created when something is done and record
the event.
▪ Consist of any data you collect during the
operation of your business QMS
▪ Are facts and should not change. If new facts
arise that contradict the old facts (an error), then
you should strike through the old fact and record
the new fact.

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Module 6: ISO 9001 - QMS Implementation

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Module 7: ISO 9001 Certification

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Module 8: Continual QMS Improvement

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Popular ISO MSS
Continued …
Notes:
1. This is a small sample of the slides associated with the delivery of the ISO 27001 Foundation training course.
2. Cont’d indicates there are more slides in the module
3. For an overview of the course please click on the link https://www.btcsltd.co.uk/iso-27001-foundation
4. This course is delivered on demand to corporate clients; however, it can also be delivered on demand to small
groups of individual learners (min. 6 delegates).
5. If interested please contact our lead trainer on 0749 114 7156 or email stratoslaz@aol.com

59. © 2021 BT&CS Ltd 59
USEFUL INFORMATION
About the Trainer: Stratos Lazaridis
▪ LinkedIn: linkedin.com/in/stratos-lazaridis-604aab5
▪ E-mail stratoslaz@aol.com
▪ Mob: +44(0)0749 114 7156
About our company: BT&CS (Business Training & Consulting Services Ltd)
For questions, regarding our training courses and consulting services, please visit our website
https://www.btcsltd.co.uk
For other queries, including non-obligation quotes), please contact me:
▪ E-mail stratoslaz@aol.com
▪ Mob: +44(0)0749 114 7156
Useful Links to web pages on our website
• Catalogue of ALL training courses https://www.btcsltd.co.uk/catalogue-of-training-courses
• General course information https://www.btcsltd.co.uk/general-course-information
• Frequently asked questions about our courses https://www.btcsltd.co.uk/faq-for-training-courses
• Customer satisfaction charter https://www.btcsltd.co.uk/customer-satisfaction-charter
• Terms & conditions https://www.btcsltd.co.uk/terms-and-conditions