Awareness on ISO 9001:2015 (QMS) QMS= Quality Management System In this presentation, there is basic awareness regarding quality management system. In this we will be discussing Quality Assurance and Quality Control and methodology to achieve continual improvements. PDCA- Plan, do, Check, Act activity for continual improvements

1. Awareness
Awareness S
Session Based on
ession Based on
ISO 9001:2015
ISO 9001:2015
Quality Management System
Quality Management System
By
Anees Ur Rehman
Associate Consultant
Delta X Consultants
arainanees74@gmail.com
Dated: March 30th , 2022

2. Anees Ur Rehman
Associate Consultant Consultant
• MS – Food Safety and Quality Management
• B.Sc (Hons.) in Food Technology
Facilitator Profile
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• B.Sc (Hons.) in Food Technology
• More then 3 year Experience of Working in
Management Systems

3. Term
Introduction to ISO
Basic Concepts & Terms and Requirements of QMS
Participants Training Feedback
Course Time Table
Course Time Table
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3
Participants Training Feedback
End of Session

4. Introduction to ISO
Introduction to ISO
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5.  Established 1947
 (ISO) International Organization for Standardization.
 ISO is an independent, non-governmental international
organization with a membership of 162 national standards bodies.
 ISO doesn’t provide certification or conformity assessment. You’ll
need to contact an external certification body for that.
ISO Introduction
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 Equal, same
 Pakistan Member Body. (PSQCA)
 Published “22247” standards.
 Headquarter- Geneva Switzerland.
 ISO 9001:2015 (Fifth Edition),
 Helping save time and reduce barriers to international trade.

6. SOME ISO STANDARDS
SOME ISO STANDARDS
ISO 9001 : Quality Management System
ISO 14001 : Environmental Management System
ISO 14001 Requirements and guidance for use
ISO 14020 Environmental Labelling
ISO 14030 Environmental Performance
ISO 14040 Life Cycle Assessment
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ISO 14040 Life Cycle Assessment
ISO 14050 Environmental Management: Vocabulary
ISO 14060 Environmental Aspects in Products
ISO 15189 : Lab Management System
ISO 20000 : IT Services Management System
ISO 22000 : Food Safety Management System
ISO 27001 : Information Security Management System

7. Basic Concepts in QMS
 Quality
 How we can achieve Quality
 QMS (Quality Management System)
 Process
 Process Approach
 Conformity / Non-Conformity (NC)
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 Conformity / Non-Conformity (NC)
 QA vs QC
 PDCA Cycle
 Quality Risk Assessment
 Objectives
 QMS Level of Documentation
 Certification Process

8. WHAT IS QUALITY
Quality is conformance to the specified
requirements
QUALITY IS…
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QUALITY IS…
“CUSTOMER SATISFACTION”
Or
“MEET THE CUSTOMER
REQUIREMENTS” 8

9. How Can We Achieve
QUALITY
How Can We Achieve
QUALITY
QUALITY IS CONSISTENCY
OR
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OR
ABSENCE OF VARIATION
OR
DOING RIGHT THE FIRST TIME

10. QUALITY MANAGEMENT
SYSTEM
Quality
Achieving desired result
Management
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Management
establishing policy and objectives and providing resources to
achieve them through a
System
set of interrelated or interacting processes

11. • Set of interrelated or interacting activities that use
inputs to deliver an intended result.
Process
Process
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Transformation
Inputs Outputs

12. • Systematically define activities necessary to obtain
desired results
• Establish responsibilities and accountability to
manage key activities
• Analyze and measure capability of activities
Process
Process Approach
Approach
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12
• Analyze and measure capability of activities
• SIPOC Diagram
Transformation
Inputs
Outputs
Resources

13. Conformity
 Compliance with standards, rules,
or laws and SOP or any
requirement.
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 Non-fulfilment of a requirement
Non-Conformity (NC)

14. Quality Control (QC)
VS
Quality Assurance (QA)
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15. Plan-Do-Check-Act cycle &
continual improvement
Act
• How to
improve
next time?
Take actions to
continually
improve process
performance –
effectiveness and
efficiency
Plan
• What to
do
• How to
Establish
objectives
necessary to
deliver results in
accordance
with customer
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next time? • How to
do it
with customer
requirements
and the
organisation's
policies
Check
• Did things
happen
according to
plan?
Monitor and measure
processes and product
against policies, objectives
and requirements
Do
• Do what
was
planned
Implement the
processes

16. Structure of QMS Clauses
New High level structure comprises of Ten clauses.
ISO 9001:2015 QMS
1. Scope
2. Normative references
3. Terms and Definitions
4. Context of the organization
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5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement

17. What is Risk
“Effect of uncertainty”
OR
Combination of the likelihood of an occurrence of
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an event (s) and the consequences that can be
caused by that event (s)
Risk is the Product of…
“(Probability) x (Consequences)”
R= P x C

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19. Quality Risk Assessment
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23. Sr.# Required Action
Resource
Required
Responsible Person Target Date
Extension (if
any)
Current Status
1
Approval from Board of Directors and
CEO
Budget EMS Team Leader Jan-17 --- DONE
2 Call for Technical/Financial Proposals Meetings EMS Team Leader Jan-17 --- DONE
3
Negotiations and Final Hiring of an ISO
consultant
Meetings Visits EMS Team Leader Jan-17 --- DONE
Department: Management:
Objective: To Achieve EMS ISO 9001:2015 Certification for SSH-SD till 20-
March-2022.
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4 Conduct EMS Training
External
Consultants
EMS Coordinator Jan-17 --- DONE
5
Preparation and Implementation of four
levels of Documents (EMS Manual,
ISP’s, Policies, Organogram, JD’s, PFC,
SOP’s, SOR’s, formats and records)
Consultants
and Team
EMS Team Leader Mar-17 --- DONE
6
Negotiations and Finalization of
Certification Body.
Financial
Approvals
EMS Team Leader Aug-17 --- DONE
7 Conduct Internal Audit based on EMS EMS Team EMS Team Leader Oct-2017 --- DONE

24. LEVEL I
QMS
Manual, LEVEL II LEVEL III
7.5 Documented Information
7.5 Documented Information
QMS Documentation
QMS Documentation
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Manual,
Policy,
Organogram,
LEVEL II
QMS
System
Procedures
LEVEL III
JD’s
Work
Instructions,
Technical
SOPs
LEVEL IV
Records,
Forms &
Formats

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