Awareness Session on QMS Introduction ISO 9001:2008

1. Pearl confectionery (Pvt) Ltd

2. . Program Objective
. Introduction to ISO
. What is ISO 9001:2008 (QMS)
. Eight Principles of QMS
. PDCA Cycle of QMS
. Key Definition Of QMS
. Corrective Action Request
. List of procedures
. Benefits of QMS
. Brief of ISO 9001:2008 Requirements

3. Awareness of ISO 9001:2008

4. . International Organization for Standardization( English)
. ISO derived from Greek word ISOS means equal.
. Founded on 23,Feb,1947 and headquartered in
Switzerland, Geneva
. Non-Governmental Organization
. Network of the national standard bodies of 175 Countries
. Around 175 countries member
. Technical committees are formed to produce standards.

5. . By 31 Dec, 2008- 17765 standards.
. ISO 9001:2008 (for QMS) and ISO 14001:2004 (for EMS) are among
the most well known and widely implemented ISO standards ever
. Implemented by 1 million organization in 175 countries.
. ISO standards are generic standards
. ISO does not carry out certification and does not issue or approves
certificates

6. . ISO 9001:2008 for quality management system (QMS)
. QMS is about how to manage the quality aspects of all processes
more effectively, taking into consideration customer Satisfaction and
compliance of contractual requirements
9001 = code to denote QMS Family
2008 = year of last revision
Initially Released in 1987
Second edition 1994
Third edition 2000
Fourth edition 2008
In coming edition 2015

7. What is ISO 9001:2008 (Continued):
 ISO 9000 (QMS) Standards Family
. ISO 9000:2005
QMS- Fundamentals & Vocabulary
. ISO 9001:2008
QMS- Requirements
. ISO 9004:2000
QMS- Guidelines for performance Improvement

8. What is ISO 9001:2008 (Continued):
 Other Supporting Standards:
. ISO 10005:2005
QMS- Guidelines for Quality plan
. ISO 10006:2003
QMS- Guidelines for quality management in projects
. ISO 19011:2002
Guidelines for QMS &/or EMS Auditing

9. Eight Key principles Of QMS:
 Customer focus
 Leadership
 Involvement of people
 Process approach
 System approach to management
 Continual improvement
 Factual approach to decision making
 Mutual beneficial supplier relation ship

10. Eight Key principles Of QMS(Continued):
 Customer focus
. Organization Depends on their Customers
. Determine Customer Need & Expectation
. Meet Customer Requirements
. Customer Satisfaction
 Leadership
. Leaders must set the direction of the organization
. Leaders must create and maintain internal environment
that encourages people to achieve the organization’s
objectives

11. Eight Key principles Of QMS(Continued):
 Involvement of people
. Must help people to develop and use their abilities
. Must encourage the involvement of people at all level
 Process approach
. Any activity that takes “inputs” and converts them to “outputs”
. The systematic identification and management of these
activities and the interaction between activities
. A desired result is more efficiently achieved when
resources and activities are managed as a process

12. Eight Key principles Of QMS(Continued):
 System approach to management
Identifying , understanding and managing a
system of interrelated process for a given
objective improves the organization effectiveness
and efficiency
 Continual improvement
Continual improvement of the organization's overall
performance should be a permanent objective of the
organization

13. Eight Key principles Of QMS(Continued):
 Factual approach to decision making
Effective decisions are based on the analysis of
data and information
 Mutual beneficial supplier relation ship
An organization and its suppliers are interdependent, and a mutually
beneficial relationship enhances the ability of both to create value

14. PDCA Cycle (Process improvement):
 Plan : Define objectives
 Do : Implement the process
 Check : Check the process and Result
 Act: Take corrective Action, Preventive Action &
Improves the process
ACT PLAN
CHECK DO

15. Key definitions of QMS
1 - Quality
. Fit to purpose
. Degree to which a set of inherent characteristics fulfils
requirements
2 - Quality Policy
. Overall intentions and directions of an
organization related to its quality performance,
as formally expressed by top management.

16. Key Definitions of QMS (Continued):
3 - Quality Control (Q.C)
. A process employed to ensure a specified
level of quality is there in a product or
service
4 – Quality Assurance (Q.A)
. A process of verifying or determining
whether product or service meet or
exceed customer expectation and QA
is determined using (PDCA) cycle.

17. Key definition of QMS (Continued):
Quality Assurance Quality Control
. Prevention Based . Detection Based
. Process Oriented . Product Oriented
. Phase Building Activity . End Phase Activity
. Responsibility Of All . Responsibility of Inspection
. QA is about Experience . QC is about Instrument
. QA is Built in Product . QC is Inspected Production

18. Key Definitions of QMS (Continued):
5 - Document:
Information and its supporting medium.
The medium can be paper, magnetic, electronic,
photograph, etc.
Example:
. Forms, Procedures
. Inspection Sheets
. ISO Standards

19. Key Definitions of QMS((Continued):
6 - Record
Document stating result achieved or providing
evidence of activities performed.
Example:
. Audit Report
. Material Test Report
. Daily Progress Report
. Training Attendance Sheet

20. Key definition of QMS((Continued):
7 - Process
Set of inter –related or interacting activities which
transforms input into output.
Example:
Weighing
of
ingredients
Mixing Cooking
Flavor and
Color
addition
FormingWrappingPacking
Process Activity

21. Key definition of QMS((Continued):
8 - Procedure
Specified way to carry out an
activity or a process.
Example:
. Complaint Procedure
. Production Procedure
. Material Approval Procedure
. Auditing Procedure

22. Key definition of QMS(Continued):
9 – Audit
Examine carefully with intent of verification.
So Quality Audit is systematic inspection to
determine whether quality activity comply
with QMS requirements & are implemented
effectively or not.
Types of Audit
First-Party
Second-Party
Third-Party

23. Key definition of QMS(Continued):
First-Party:
. Auditing your own organization using a planned schedule and
trained internal auditors.
Second-Party:
. Audit is initiated by one company on another
for example customer
Third-Party:
. Audit performed by independent organization or regulatory body,
e.g. ISO 9001:2008 registrar. Example QMI, BSI, BvQi, UL, Loyds

24. The Purpose of an Audit is ...
To collect objective evidence to permit an
informed judgment about the status of the quality
management system
Objective Evidence
Records, statements of fact or
other information, which are
relevant to the audit criteria and
verifiable
OR
Information collect during an audit

25. Key definition of QMS(Continued):
10 - Auditor
Person with the competence to conduct an audit.
Roles & Responsibilities:
The Auditor is responsible for :
. Audit execution with in the scope of audit.
. Documenting audit finding and reporting it
. Help auditee by suggesting corrective action

26. Key definition of QMS(Continued):
11 - Auditee
Organization or dept. being audited
Roles & Responsibilities:
The Auditee is responsible for :
. Informing employees about the scope of audit
. Showing professional and positive attitude
. Providing all relevant resources to auditor
. Providing root cause and corrective action
for the CARs raised by auditor

27. Key definition of QMS(Continued):
12 - Conformance:
Fulfillment of a requirement
Example:
. Purchase only Approved Material
. QC Testing at Defined Stages
. Use Calibrated Equipment for Testing
. Use Approved Formats/ Documents

28. Key definition of QMS(Continued):
13 - Non- Conformance (NC)
Non- fulfillment of a requirement
Example:
. Procedure is not updated
. Record is not Available
. Obsolete Specification, Drawing or Documents are
used

29. Key definition of QMS(Continued):
13.a – Major NC:
Any violation which shows a gap in
system or an ultimate fall in quantity
of the product.
OR
. System element is missing
. System element is not implemented
or is not effective
Example:
In Store currant stock report and physical quantity of PF-01 was
found not aligned i.e. stock shows 28.27. However, present 190
liters.

30. Key definition of QMS(Continued):
13.b – Minor NC:
Partial lack in quality system which
has no direction impact on
product quality
OR
A single/isolated lapse in
the system
Example:
Attendance record was found
not mentioned for training
conducted on ISO 22000, dated 24/3/2014

31. Key definition of QMS(Continued):
13.c – Observation:
The cause of a potential nonconformity
or other undesirable situation which
needs improvement
Example:
Web cobs were found above chilling
unit in wrapping area.

32. Key definition of QMS(Continued):
14 – Root Causes:
A root cause is a factor that caused a nonconformance
and should be permanently eliminated through process
improvement.
Example:
Ignored as the 3 different
categories of staff is involved
in housekeeping
e.g. Maintenance helpers,
Operators, and
Housekeeping staff.

33. Key definition of QMS(Continued):
15 - Corrective Action:
Action to eliminate the cause of a detected non- conformity
or other undesirable situation
Examples:
. NC- Procedure is not updated
after changes were made
. CA- Production Manager to
review the procedure per
month

34. Key definition of QMS(Continued):
16 - Preventive Action :
Action to eliminate the cause of a
potential non conformity or other
undesirably potential situation
Example:
. Potential NC - Procedure is not
available in some departments.
. Preventive Action - Establish System of distribution
sheet

35. Corrective Action Request
PCL/FM 04:

36. LIST OF PROCEDURES:
S.# Procedure
Document
Ref #
Department
Revision
Status
1 System Of Management Review PCL/PR 01 Compliance 1
2 System Of Document Control PCL/PR 02 Compliance 2
3 System of Record Control PCL/PR 03 Compliance 1
4 System Of Training and development PCL/PR 04 HR 2
5 System of Recruitment & Separation PCL/PR 04-B HR 0
6 System Of Internal Auditing PCL/PR 05 Compliance 1
7
System Of Corrective & Preventive
Actions
PCL/PR 06 Compliance 1
8 System Of General Store PCL/PR 07 Engineering 1
9 System Of Calibration PCL/PR 08 Engineering 0
10 System Of Handling Customer PCL/PR 09 Local & Export 1

37. LIST OF PROCEDURES(Continued):
S.# Procedure
Document
Ref #
Department
Revision
Status
11 System Of Maintenance PCL/PR 10 Engineering 0
12
System Of Export Mkt & Order
Review
PCL/PR 11 Export 2
13 System Of Supplier's Evaluation PCL/PR 12 Purchase 2
14 System Of Export Order Delivery PCL/PR 13 Export 2
15 System Of Confectionery Production PCL/PR 14 Production 2
16
System Of Main Store (Raw
Materials)
PCL/PR 15 Store/MM 1
17 System Of Finished Goods Storage PCL/PR 16 Warehouse 1
18 System Of Local Purchase PCL/PR 17 Purchase 1
19 System Of Import Purchase PCL/PR 18 Purchase 1
20 System Of Inspection PCL/PR 19 QA&D 2

38. LIST OF PROCEDURES(Continued):
S.# Procedure
Document
Ref #
Department
Revision
Status
21 System Of Monitoring & Analysis PCL/PR 20 QA&D 2
22 System Of Local Order Review PCL/PR 21 Local Sales 1
23 System Of Product Development PCL/PR 22
Product
Development
0
24 System Of Corporate Order Review PCL/PR 23 Corporate 0
25 System of Sampling PCL/PR 24 QA&D 0
26 System Of IT Control and Security PCL/PR 25 I.T 3
27 System Of Material Management PCL/PR 26 Store/MM 0
28
System of Work Environment &
Measurements
PCL/PR 27 Engineering 0
29 System of Internal Communication PCL/PR 28 Compliance 0
30 System of Research & Development PCL/PR 29 QA&D 1
31
System Of Confectionery Production
- Chocolate
PCL/PR 30 Chocolate 0

39. Steps OF AUDIT ACTIVITES:
1 - Planning and scheduling audit
2 - Conducting document review
4 - Conducting audit
5 - Prepare CARs
6 - Conducting follow-up
3 - Preparing for on-site activities
1
2
3
4
5
6

40. Benefits of QMS:
 Decrease in wasted time, materials, and efforts.
 Establish leadership role within organization.
 Increased recognition and satisfaction by customers.
 Ability to maintain standards of quality and excellence.
 Roles and responsibilities are clearly defined via documented procedures
 As variation is eliminated, efficiency improves.
 As efficiency improves the cost of quality service is reduced.
 Increased employee morale as they are asked to take control of their
processes (empowerment).

41. Benefits of QMS(Continued):
 Reduction in conflicts.
 Transformation from a reactive
organization to a pro-active,
preventative organization
 Improved communications.
 Major transformation that would change the mind set.
 Institutionalize a culture of excellence.
 Performance evaluation (Continuous Improvement)

42. Brief of ISO 9001:2008 Requirements:
 Section 1 : Scope
Talks about the standard and how it applies to the
organizations
Section 2 : Normative Reference
References another document that
should be used along with ISO 9001:2008
Section 3 : Terms and Definitions
Gives definition used in the standard
Section 4: General Requirements
Gives requirements for the overall quality management system

43. Brief of ISO 9001:2008 Requirements(Continued):
 Section 5 : Management Responsibility
gives requirement for top management and their role in the quality
management system
Section 6: Resource Management
Gives requirement for resources including personal, training, facility and work
environment
Section 7 : Product Realization
Gives requirement for a realization of product or service, including planning,
customer related processes, design, purchasing and process control
Section 8 : Measurement, analysis and improvement
Gives requirements on monitoring processes and improving those processes