Quality Manual Procedure Work Instruction Examples - Inspection report - Calibration certificate - Training records - Audit report

1. SIVASANKARAN.N

2. ✓ Few Facts about ISO
✓ ISO 9001:2015 Principles
✓ High Level Structure
✓ Clause wise correlation
✓ Internal Quality Audit

3. Name:
Function :
Years of experience:
Knowledge on ISO (1-10):
Expectation :

5. ISO is an independent, non-governmental
membership organization and the world's
largest developer of voluntary
International Standards.
ISO is an international standard that direct & control the organization to
achieve their goal or target, that released by International Organization for
Standardization
What is ISO ?

6. International Organization for Standardization
✓ Founded in 1946 , Switzerland
✓ Made up of over 160 National Standards Bodies (“NSB’s”)
✓ Almost 20,000 standards in the ISO portfolio
✓ All standards are based on INTERNATIONAL CONSENSUS
International Organization for Standardization would have different acronyms in different
languages
English - IOS
French - OIN or Organisation internationale denormalisation
ISO standards are usually developed by its Technical Committees (“TC’s”) and Sub-
committees (“SC’s”)
ISO/TC176/SC2 (Quality Systems) is responsible for ISO 9001
Decided to give it the short form ISO.
ISO is derived from the Greek isos, meaning equal.
What ever the country, what ever the language, we are always ISO.

8. All ISO standards are reviewed every five years
✓ Keep it current and ensure it stay up-to-date
✓ Compatible with other management system
✓ Responds to the latest trends
Year of
Revision
Key changes
1987 This release gained popularity across Europe however US
remained focused on other customer requirements
1994 This revision put ISO 9001 on the map across the US and was
led by auto industry
2000 Significant changes from what was termed as the elemental
approach to process approach
2008 Changes based upon gaps in the standard
2015 Moving the standard beyond process to performance and
integration with business priority through risk and
opportunity identification

9. New standard is
proposed to
relevant
technical
committee
1
Working group
of experts start
the discussion to
prepare a
working draft
2
1st working draft
shared with
technical
committee and
with ISO CS
3
Draft shared
with all ISO
national
members , who
are asked to
comment
4 Final draft to all
ISO members
5 ISO International
Standard
6
Proposal
Stage
Preparatory
stage
Committee
stage
Enquiry
stage
Approval
stage
Publication
stage
1-2
Months
4-5
Months
10-12
Months
3-4
Months
5-6
Months
10-12
Months

10. ✓ 3 Years transition period from September 2015

11. Essentialbackgroundfor
theproperunderstandingand
implementationof
ISO9001
Requirementsaimedprimarilyat
givingconfidenceintheproducts
andservices
anorganizationprovides,thereby
improving
customersatisfaction
Guidancefororganizationsthat
choosetoprogressbeyondISO
9001requirementstoaddress
abroaderrangeoftopicsthatcan
leadtocontinualimprovementof
theorganization'soverall
performance
ISO9000
Threestandardsintheseries
ISO9001 ISO9004
Qualitymanagement
systems—Fundamentalsand
vocabulary
Qualitymanagement
systems—Requirements
Managingforthesustained
successofanorganization—
Aqualitymanagement
approach
✓ ISO 9001 are among ISO's most well known standards ever
✓ It is implemented by more than a million organizations in some 175 countries.
✓ All requirements of ISO 9001 are generic and are intended to be applicable to all organizations,
regardless of type, size and product provided

12. Potentialbenefits
✓ The ability to consistently provide products and services that meet customer and applicable
statutory requirements and regulatory requirements
✓ Facilitating opportunities to enhance customer satisfaction
✓ Addressing risk and opportunities associated with its context and objectives
✓ The ability to demonstrate conformity to specified quality management system requirements
✓ Better process integration
✓ Improve your evidence for decision making
✓ Engagement of employees
✓ Improvement of your credibility and image

14. ✓ Fitness for use
✓ Conformance to requirements
✓ Accuracy
✓ Perfection
✓ Zero Defect
✓ Adequacy
✓ Cost Effectiveness
“ THE TOTALITY OF FEATURES AND CHARACTERISTICS OF A PRODUCT OR SERVICE THAT BEAR
UPON ITS ABILITY TO SATISFY STATED OR IMPLIED NEEDS “

15. ✓ A group of interacting, interrelated, or interdependent
elements forming a complex whole
✓ Set of detailed methods ,procedures and routines
established or formulated to carry out a specific activity ,
perform a duty , or solve a problem

16. Quality Management System
A System of coordinated activities which is meant to “direct”
and “control” an organization with regard to quality.

17. “ Quality management principles ” are a set of fundamental beliefs, norms,
rules and values that are accepted as true and can be used as a basis for
quality management.

18. ISO 9001:2008
1. Customer Focus
2. Leadership
3. Involvement of People
4. Process Approach
5. System Approach to management
6. Continual Improvement
7. Factual approach to decision making
8. Mutually beneficial supplier relationships
ISO 9001:2015
1. Customer Focus
2. Leadership
3. Engagement of People
4. Process Approach
5. Improvement
6. Evidence – based decision making
7. Relationship management

19. ✓ The primary focus of quality management is to meet customer requirements and to strive to
exceed customer expectations.
✓ Every aspect of customer interaction provides an opportunity to create more value for the
customer
✓ Understanding current and future needs of customers and other interested parties contributes to
sustained success of the organization
▪ Increased customer value
▪ Increased customer satisfaction
▪ Improved customer loyalty
▪ Enhanced repeat business
▪ Enhanced reputation of the organization
▪ Expanded customer base
▪ Increased revenue and market share
Benefits

21. Leaders at all levels establish unity of purpose and direction and create conditions in which people
are engaged in achieving the organization’s quality objectives.
▪ Increased effectiveness and efficiency in meeting
the organization’s quality objectives
▪ Better coordination of the organization’s processes
▪ Improved communication between levels and
functions of the organization
▪ Development and improvement of the capability of
the organization and its people to deliver desired
results
Benefits

22. The revised principle still describes the involvement of people at all levels .
It adds that it is essential for these people to be competent , empowered , and engaged to
create and deliver value .
Benefits
▪ Improved understanding of the organization’s quality objectives
▪ Enhanced involvement of people in improvement activities
▪ Enhanced personal development , initiatives and creativity
▪ Enhanced people satisfaction
▪ Enhanced trust and collaboration throughout the organization
▪ Increased attention to shared values and culture throughout the
organization

23. Activities
+
Resources
Input Output
Control
Process :
Any Activity that takes “ input ” and converts them to “outputs”
Process Approach :
The systematic identification and management of these activities and the
interaction between activities.

24. Example - Purchasing Process
Performance Measurements
•Delivery status – On-time, On spec, etc
•Supplier evaluation
Outputs
• Receipt of Material
on right condition
• Right Quality Right
Quantity
• Right Time
Purchasing
Process
Interactions to
•Storage
•Inspection and Testing
•Manufacturing
•Finance
Inputs
• Demand for
material
• Item specs and Date
• Supplier source
• Suppliers capability
to meet our
requirements

25. Benefits
▪ Enhanced ability to focus effort on key processes and
opportunities for improvement
▪ Consistent and predictable outcomes through a system of
aligned processes
▪ Optimized performance through effective process
management, efficient use of resources, and reduced cross-
functional barriers
▪ Enabling the organization to provide confidence to interested
parties as to its consistency, effectiveness and efficiency
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 .

26. Deming’s wheel
(P.D.C.A.)
ISO
9000
PLAN DO
ACT CHECK Continual
Improvement
Customer Focus
Understanding PDCA

27. Benefits
▪ Improved process performance, organizational
capabilities and customer satisfaction
▪ Enhanced focus on root-cause investigation and
determination, followed by prevention and corrective
actions
▪ Enhanced ability to anticipate and react to internal and
external risks and opportunities
▪ Enhanced consideration of both incremental and
breakthrough improvement
▪ Improved use of learning for improvement
▪ Enhanced drive for innovation
Successful organizations have an ongoing focus on improvement.

28. Benefits
▪ Improved decision-making processes
▪ Improved assessment of process performance and ability
to achieve objectives
▪ Improved operational effectiveness and efficiency
▪ Increased ability to review, challenge and change opinions
and decisions
▪ Increased ability to demonstrate the effectiveness of past
decisions
Decisions based on the analysis and evaluation of data and information are more likely to
produce desired results

29. Benefits
▪ Enhanced performance of the organization and its
interested party
▪ Common understanding of goals and values among
interested parties
▪ Increased capability to create value for interested parties
▪ A well-managed supply chain that provides a stable flow of
goods and services
For sustained success, an organization manages its relationships with interested parties, such as
suppliers.

38. The clause structure and some of the terminology have been changed to improve
alignment with other management systems standards

45. Why Documentation / Formats ?
✓ Communication
✓ Avoid Subjectivity
✓ Bench marking
✓ Auditing

46. Difference between documents & records
It provides guidelines
Documents are dynamic and can be
revised
It provides evidence of work done
Records cannot be changed
Examples
- Procedure for production
planning
- Drawing
- Quality Standard
- Work Instruction
Examples
- Production Report
- Inspection Report
Document Record

47. Why ?
Who ?
When ?
Where ?
How ?
Evidence
✓ Must be a book and must address every
shall
✓ Purpose
✓ Scope
✓ Responsibility
✓ Procedure
✓ For everything linked to a procedure
✓ For everything is a record linked to work
instruction

48. ✓ Scope of the QMS (clause 4.3)
✓ Quality policy (clause 5.2)
✓ Quality objectives (clause 6.2)
✓ Criteria for evaluation and selection of suppliers (clause 8.4.1)
Mandatory Documents

49. Mandatory Records
✓ Monitoring and measuring equipment calibration records* (clause 7.1.5.1)
✓ Records of training, skills, experience and qualifications (clause 7.2)
✓ Product/service requirements review records (clause 8.2.3.2)
✓ Record about design and development outputs review* (clause 8.3.2)
✓ Records about design and development inputs* (clause 8.3.3)
✓ Records of design and development controls* (clause 8.3.4)
✓ Records of design and development outputs *(clause 8.3.5)
✓ Design and development changes records* (clause 8.3.6)
✓ Characteristics of product to be produced and service to be provided (clause 8.5.1)
✓ Records about customer property (clause 8.5.3)
✓ Production/service provision change control records (clause 8.5.6)
✓ Record of conformity of product/service with acceptance criteria (clause 8.6)
✓ Record of nonconforming outputs (clause 8.7.2)
✓ Monitoring and measurement results (clause 9.1.1)
✓ Internal audit program (clause 9.2)
✓ Results of internal audits (clause 9.2)
✓ Results of the management review (clause 9.3)
✓ Results of corrective actions (clause 10.1)

55. SPC
Benchmarking
Quality Circles
Risk Assessment
Teamwork for Quality
Quality Function Deployment
Problem Solving Techniques

56. Thank You !