1. P R E S E N T E D B Y
MUHAMMAD ASIM
B . E H A M D A R D U N I V E R S I T Y
M B A I Q R A U N I V E R S I T Y
L E A D A U D I T O R T U V A U S T R I A
Core Knowledge about
QMS (Quality Management System)

2. What is QMS?
A Quality Management System (QMS) is a collection
of business processes focused on achieving your Quality
Policy and Quality Objectives i.e. what your customer
wants and needs. It is expressed as the organizational
structure, policies, procedures, processes and resources
need to implement Quality Management System.

3. What is an Audit ?
Audit is a systematic, independent, planned and
documented activity performed by qualified
personnel to determine by Investigation,
Examination, or Evaluation of Objective
Evidence, the adequacy and compliance with
established procedures, or applicable documents,
and the effectiveness of implementation of QMS.

4. Types of Audit
 First Party Audit
The company Audit its own system (Internal Audit)
 Second Party Audit
Customer based Audit (because of Commercial
Interest)
 Third Party Audit
An Independent body certifies an Organization.

5. What is an Auditor ?
 An auditor is a professional who is responsible for
Evaluating or Examining some aspects of a
project, business, organization or any individual.
 Auditor guidelines ISO 19011:2011

6. Discussion on following Terms useful for an
Auditor
 Audit Criteria (Policies, Procedures)
 Audit Evidence (Objective evidence)
 Audit Team (Members)
 Audit Client (Organization)
 Audit Findings (Conformance or Non-
Conformance)
 Audit scope (depend upon organization structure)
 Audit plan (Plan Activities & Arrangements)
 Audit Checklist (List of Task’s)
 Risk (Uncertainty)
 Audit Conclusion (Outcome)

7. An Auditor must be aware about
 Audit Plan
 Audit Checklist
 Audit Summary Report
 Audit Sampling Method
 Boundaries of an Audit
 Recommendation
 Roles and Responsibilities

8. Auditor Behavior must be
 Ethical (Truthful)
 Open minded (Alternatives)
 Broad minded (Ideas)
 Diplomatic (Tactful)
 Observant (follow)
 Decisive (Logical thinking)
 Self reliant (Independently)
 Perceptive (Understand situation)

9. Audit Trick
 Ask (Mainly open ended question which provide
information).
 Look (Observe what is happening)
 Check (Availability of procedures, awareness of
Auditees, Conformance of procedures,
consistency)
 Record (The Objective evidence Positive & Negative)

10. Performing an Audit Program
 Initiating the Audit
(Contact with client and determine feasibility).
 Preparing an Audit Activity
(Document review, Audit Plan, Distribution of
Activity.)
 Conducting an Audit Activity
Opening meeting, demand of guide (Auditee),
document verification, collection of information.
 Meeting of all Auditor’s (Info. Collection)
 Preparing Audit Conclusion.
 Closing Meeting ( Discuss all NCR’s with Auditee)
 Preparing and Distribution of Audit Report.
 Must ensure the follow-up on NCR’s.

12. Difference b/w Continuous Improvement and
Continual Improvement
 Discuss and illustrate Graph

13. 08 Principles of Quality Management
 Leadership
 Involvement of Peoples
 Customer focus
 Process Approach (relates to productivity)
 System Approach (relates to QMS)
 Factual Approach to Decision Making
 Continual Improvement
 Mutually beneficial supplier relationship

14. 08 Clauses of Quality Management System
(ISO 9001:2008)
1 - Scope
2 - Normative reference
3 - Terms and Conditions
4 – Quality Management System
 General requirements
 Documentation requirements
5 – Management Responsibility
 Customer Focus
 Quality Policy
 Planning
 Quality Objectives
 Responsibilities, Authority & Communications
 Management Representative.

15. 08 Clauses of Quality Management System
(ISO 9001:2008)
 Management Review
6 - Human Resources
 Competence, training and awareness
 Infrastructure
 Work environment
7 – Product Realization
 Customer related processes
 Design and Development
 Purchasing
 Product and service provision
8 – Measurement, analysis and improvements.
 Internal Audit
 Analysis of Data
 Control of Non-Conforming Product
 Corrective Actions
 Preventive Actions

16. Discussion
 Relationship of 08 Principles of Quality
Management.
With
 08 Clauses of Quality Management System
ISO 9001:2008

17. Mind
Mapping
Questions

18. What is Factual Approach to Decision
Making ?
Identify minimum Four Clauses that support such an
approach?

19. Identify two ways in which an Auditor can
verify that agreed corrective actions have
been implemented ?

20. The level of customer satisfaction is
one measure of the performance of
a Quality Management System.
List Two methods which can use to
determine its satisfaction level?

21. Continual Improvements
Continual
Improvements
Quality Policy
???
???
Quality
Objectives
???
???

22. Situation # 01
At opening meeting of an External Audit, MR inform you
that a recent Internal Audit has found many non-
conformities relating to the in-house purchasing
department.
Corrective Action has already been planed. The MR
suggested that to Audit this department again would add
no value and ask if you could delete this depart from
Audit Plan and spend more time in production area.
Is it correct ???
If not then outline at least four issues that can be face.

23. Situation # 02
During a routine Audit visit, Auditee of Design and
Development department informs you that they no
longer carry out any design work. The activity is now
outsourced to a contractor.
Give four examples of Audit Evidence you would look for
determine the conformance of the current system with
ISO 9001.
Must mention Clauses of ISO 9001 standard that relates to
this situation.

24. Situation # 03
During an Audit of an Insurance co. you ask Training
Manger to show training record and you found that all
employees attend trainings.
You ask that how they are evaluated, manager replies that
we evaluate via questionnaire after completion of each
training.
You did a sampling audit and examine 03 questionnaire,
and surprisingly all 3 persons got highest marks and
awarded satisfactory score from Trainer.
What is your Thinking ??? Express in your words ???
Is this NCR or Audit Trail ???

25. Situation # 04
You are Auditing a design department of Industrial
equipment.
They are currently dealing with a serious customer complaint
relating to faulty safety mechanism, and their engineers
have some difficulty in repairing of safety mechanism due to
the Old drawing issue and drawing does not contain
modification step of safety mechanism, Engineer’s opinion
is to incorporate modification step in drawing.
Manager reply that it is not recorded due to some minor
changes and did not affect customer contract.
What is your Opinion ????
Is this a Major non-compliance or not ???
Raise NCR or perform Audit Trail ???

26. Situation # 05
You found a problem during Audit at Testing department that
the word ‘OK’ is written with initial of junior inspector on
testing report.
You ask with supervisor that Who has authorized to test and
release this product, and he replied that authorization is
not necessary in routine product, and it is clear from Chief
Inspector if any abnormality or a problem is occur.
You verify the documented procedure and found that Chief
Inspector is responsible for authorizing final release of all
products.
What is happening there ???
Is this NCR or Audit Trail ???

27. Preparation of Checklist with reference to
Standard Clause
You are conducting an ISO Audit in an Injection
Molding company (a process by which components
are manufactured). The next activity on your Audit
Plan is the organization Final Inspection and Testing
department.
Outline your checklist on a paper with clause reference