Total quality management system ..... slides

1. Quality Managment System 16/26/2015

2. Quality Management system
(Total Quality Management)
Presented by: Aqib Zia
Qaisar Mehmud
Amir ishaq
Presented to: Sir Sajjid Ali
Quality Managment System 26/26/2015

3. Sequence of presentation
• The ISO
• Evolution of ISO
• Introduction of ISO
• Importance of ISO
• ISO benefits
• ISO 9000 Family
• ISO 9000 series
• ISO survey
• Sector Specific standards
• ISO 9000 Requirements
• Implementation
• Documentation
• Internal Audit
• Registration Quality Managment System 36/26/2015

4. The ISO
In London, in 1946, 65 delegates from 25 countries meet to
discuss the future of International Standardization. In 1947,
ISO officially comes into existence with 67 technical
committees (groups of experts focusing on a specific subject).
4Quality Managment System6/26/2015

5. Quality Managment System 56/26/2015

6. Introduction of ISO
ISO
Composed of 90
member countries
US. Rep is (ANSI)
176 (TC)
ISO 9000 as
national standards
FDA
(Like wise)
Quality Managment System 66/26/2015

7. Quality Managment System 76/26/2015

8. ISO 9000
• ISO 9000 is among ISO most well known standards ever.
• They are implemented by more than a million organizations in some 175
countries.
• ISO 9000 helps organizations to implement quality management.
Quality Managment System 86/26/2015

9. Quality management
• ISO 9001 is for quality management.
• Quality refers to all those features of a product (or service) which are required by
the customer.
• Quality management means what the organization does to
• ensure that its products or services satisfy the customer's quality requirements
and
• comply with any regulations applicable to those products or services.
Quality Managment System 96/26/2015

10. Generic standards
ISO 9000 is generic standards.
Generic means that the same standards can be applied:
• to any organization, large or small, whatever its product or service,
• in any sector of activity, and
• whether it is a business enterprise, a public administration, or a
government department.
Quality Managment System 106/26/2015

11. Generic standards (cont.)
Generic also signifies that
• no matter what the organization's scope of activity
• if it wants to establish a quality management system, ISO 9000 gives
the essential features
Quality Managment System 116/26/2015

12. Management system
• Management system means what the organization does to manage its processes,
or activities in order that
• its products or services meet the organization’s objectives, such as
• satisfying the customer's quality requirements,
• complying to regulations, or
• meeting environmental objectives
Quality Managment System 126/26/2015

13. For Two party Contractual situations
Internal
Importance of ISO
Conformationof
qualityassurance
Both supplier and customer
Quality Managment System 136/26/2015

14. Quality Managment System 146/26/2015

15. Benefits of ISO Registration
ISO
9000
Benefit
s
Eliminate
process
errors and
inefficienc
y
Your
customer
get
consistent
quality
products
increase
market
share and
profitabilit
y
Enhance
customer
satisfactio
n
Internal
effectiven
ess and
efficiency
Easy
approval
of bank
loans and
business
licenses
Easy
market
entry for
new
product
Quality Managment System 156/26/2015

16. ISO 9000
Benefits
Eliminate
process
errors and
inefficiency Your
customer
get
consistent
quality
products
increase
market
share and
profitability
Enhance
customer
satisfaction
Internal
effectivenes
s and
efficiency
Easy
approval of
bank loans
and
business
licenses
Easy market
entry for
new product
Quality Managment System 166/26/2015

17. Quality Managment System 176/26/2015

18. Examples for Benefits of
Registration
• The American institute of Certified Public Accountants (AICPA) now has
a quality system that works, and there was a 4% increase in gross
margins, which was the largest improvement in their history.
• North town Ford automobile dealership in Toronto, Ontario raised
customer satisfaction and loyalty by 20% and it had 55% increase in
customers who would recommend the dealership.
Quality Managment System 186/26/2015

19. The ISO 9000 family
• ISO 9001 Is the standard That gives the requirement for a Quality
management system.
• ISO 9001:2008 Is the latest, improved version.
• It Is the only standard in the ISO 9000 family That Can bé used for
certification.
• There are 16 other standards in the family That Can help an
organisation on specific aspects such as performance improvement,
auditing, training…
Quality Managment System 196/26/2015

20. ISO 9000 Series
• ISO 9000 (a guide)
• ISO 9001 (a set of requirements for the quality system of the supplier)
• ISO 9002 (product standards)
• ISO 9003 (final inspection and testing)
• ISO 9004 (guidelines for developing and implementing quality system
principles, structure, auditing and review)
Quality Managment System 206/26/2015

21. The ISO Survey
Quality Managment System 216/26/2015

22. The ISO Survey (cont.)
• The worldwide total of certificates to ISO 9001:2001 at the end of
2007 was 951 486.
• This was increase of 6 % over 2006 when the total was 896 929
certificates.
• Certificates had been issued in 175 countries compared to 170 the
previous year.
Quality Managment System 226/26/2015

23. Sector specific
Standards
ISO 9000 systems are simple and that can be used in any industry
But some other systems are developed only specific sectors to particular industry
Such as automotive or aerospace.
AS9100
ISO/TS
16949
TL
9000
Quality Managment System 236/26/2015

24. Sector specific
Standards Cont.…
Quality Excellence for Suppliers of Telecommunication Forum (QuEST).
TL9000
Motorola, Lucent and telecom
service provider such as AT&T,
Verizon. etc
Quality Managment System 246/26/2015

25. Sector specific
Standards Cont.…
It is based on ISO 9001 that specific set of requirement that define the design
development ,production ,maintenance, and installation of telecommunication
products and services.
TL9000
Benefits
• Continues improvement
• Enhanced relationship
• Efficient management of external audit
• Worldwide standards , competitiveness
Quality Managment System 256/26/2015

26. Sector specific
Standards Cont.…
TL9000
Quality Managment System 266/26/2015

27. Sector specific
Standards Cont.…
AS9100
Officially released may 1997.
Unify the
requirements of
NASA,FAA,DOD.
March 2001:
International Aerospace Group
aligned AS9100 with ISO 9001 :2000
Quality Managment System 276/26/2015

28. Sector specific
Standards Cont.…
ISO/TS 16949
Particular requirements for application of ISO 9001
Relevance to automotive Suppliers
QS 9000 (1994) by Ford , general motors
Fundamental of QS…
• Continuous improvement
• Emphasizing defect prevention
• Reduction of variation and waste in supply chain.
Quality Managment System 286/26/2015

29. Sector specific
Standards Cont.…
ISO/TS 16949
Levels of standard
W.r.t requirements
Company
Sector-
specific
ISO 9001
Quality Managment System 296/26/2015

30. ISO 9001 Requirements
Clauses of
standard
Scope
Normative
Reference
Terms and
Definitions
QMS
Management
Responsibility
Resource
Management
Product
Realization
Measurement,
analysis and
improvement
Informative Clauses Compulsory Clauses
Quality Managment System 306/26/2015

31. Model of a process QMS
Quality Managment System 316/26/2015

32. Scope
Purpose of standard is….
• Product meets customer and regulatory
requirements
• Customer satisfaction
Purpose accomplished by...
Evaluating & continually improving the system
Rather then Product
Quality Managment System 326/26/2015

33. Normative Reference
ISO 9000:2000 QMS
• Fundamentals and vocabulary are a normative
reference that provides applicable concepts and
definitions
Terms and definitions
• http://www.praxiom.com/iso-definition.htm
Quality Managment System 336/26/2015

34. Quality Management system
(QMS)
Organization shall
• Establish
• Document
• Implement
• And maintain QMS
• Continually improve its effectiveness
Organization shall also…
a) Identify needed processes
b) Determine sequence and interaction
c) Determine criteria and methods for effective operation
d) Ensure the availability of resources
e) Monitor, measure and analyze the processes
f) Implement actions to planned results
General requirements
Quality Managment System 346/26/2015

35. Documentation
• Statements of quality policy and quality objectives
• Quality manual
• Document procedures
• Needed documents to ensure effective planning
• Required records
Quality Management system
(QMS) cont.…
Quality Manual
• The scope of QMS with details and justification for any exclusions
• The documented procedure or reference to them
• Description of the interaction among the QMS processes
Control of Documents
• Approve documents prior to sue
• Review , update and re approve as necessary
• Identify the currents revision status
• Ensure that current versions are available at point of use
• Ensure that documents are legible and readily identified
• Identify and distribute documents of external origin
Quality Managment System 356/26/2015

36. Control of record
Quality Management system
(QMS) cont.…
A documented procedure shall be established to define the control needed for the
identification, storage, protection, retrieval, retention time, and disposition of
records.
Management Responsibility
Management commitment
• Communicating the need to meet customer, legal, and regulatory expectation
• Establishing a quality policy
• Ensuring that quality objectives are established
• Conducting management reviews
• Ensuring the availability or resources
Quality Managment System 366/26/2015

37. Customer focus
Management Responsibility cont.…
Quality policy
• Appropriate to the organizations mission
• Includes commitment to comply with requirements and continually improve the
effectiveness of the QMS
• Provides the framework for establishing and reviewing the quality objectives
• Communicated and understood with in the organization
• Is reviewed for continuing stability
Planning
Quality objectives
Quality Management system
planning
Quality Managment System 376/26/2015

38. Responsibility, authority, and communication
Responsibility and authority
Management representative:
• Ensuring that processes needed for QMS are
established implemented and maintain
• Reporting to top management on the
performance of the QMS and any need of
improvement
• Ensuring the promotion of awareness of
customer requirements throughout the
organization
Internal communication:
Management Responsibility cont.…
Quality Managment System 386/26/2015

39. Management review
Management Responsibility cont.…
General
Review input
• Results of audits
• Customer feedback
• Process performance and product conformity
• Status of corrective and preventative performance
• Follow up actions from past management reviews
• Changes that could affect the QMS
• Recommendation for improvement
Review output
• Improvement of the effectiveness of the QMS and its processes
• Improvement of the product related to customer requirements
• Recourse needs. Quality Managment System 396/26/2015

40. Provision of resources
Resource management
• To implement and maintain the QMS and continually improve
its effectiveness
• To enhance customer satisfaction by meeting customer
requirements
Human Resources
General
Competence awareness and training
• Determine the necessary competence for personal performing work
affecting product quality
• Provide training or take other action to satisfy these needs
• Evaluate the effectiveness of the action taken
• Ensure that its personal are aware of the relevance and importance of
there activities
• Maintain appropriate records of educations training skills and experienceQuality Managment System 406/26/2015

41. Infrastructure
Resource management
• Buildings work space and associated utilities
• Process equipment
• Supporting services
Work envoirement
Product realization
Planning of product realization
• Quality objectives and requirements for the products
• Need to established processes documents and provide resources
specific to the product
• Require verification, validation, monitoring, inspection and test
activities specific to the product and the criteria for product acceptance
• Records needed to provided evidence that the realization processes
and resulting product or service meet requirements.Quality Managment System 416/26/2015

42. Customer related processes
Product realization
Determination of requirements
related to the product
• Requirements specified by the customers including the
requirements for delivery and post delivery activities
• Requirements not stated by the customer but necessary for
specified or intended use, where known
• Statutory and regulatory requirements related to the product
• Any additional requirements determined by the organization
Review of requirements related to the product
• Product requirements are defined
• Contract or order requirements differing from those
previously expressed are resolved
• The ORG has the ability to meet the defined requirements
Quality Managment System 426/26/2015

43. Customer communication
Product realization
• Product information
• Inquires, contacts, or order handling, including amendments
• Customer feedback, including customer complaints
Design and development
a) Design and development stages
b) Review verification, validation that are appropriate to each design and
development stage
c) The responsibilities and authorities for design and development
Design and development planning
Design and development inputs
a) Functional and performance requirements
b) Applicable statutory and regulatory requirements
c) Where applicable, information derived from previous similar design
d) Other requirements essential for design and development.Quality Managment System 436/26/2015

44. Design and development output
Product realization
• Meet the input requirements for design and development
• Provide appropriate information for purchasing, production
and for service provision
• Contain or reference product acceptance criteria
• Specify the characteristics of product
a) Evaluate the ability of the result of design and development to meet
requirements
b) Identify any problems and propose necessary actions
Design and development review
Design and development verification
Design and development validation
Control of design and development changes
Quality Managment System 446/26/2015

45. Product realization
a) Requirements for approval of products, procedures, processes, and
equipment's
b) Requirements of qualification of personnel
c) QMS requirements
Purchasing information
Verification of purchase product
Inspection or other activities to verification of product
Purchasing
Purchasing process
Production and service provision
Control of production and service provision
a) Availability of information that describes the characteristics of product
b) Availability of work instructions as necessary
c) Use of suitable equipment's
d) Availability and use of monitoring and measuring devices
e) Implementation of measuring and monitoring
f) Implementation of release delivery and post delivery activates
Quality Managment System 456/26/2015

46. Validation of processes for production and service provision
Product realization
a) Define criteria for review and approval of processes
b) Approval of equipment and qualification of personnel
c) Use of specific methods and procedures
d) Requirements for records
Identification and traceability
Customer property
Preservation of product
Control of monitoring and measuring devices
a) Verified at specified intervals or prior to use, against measurement standards
b) Be adjusted or readjusted as necessary
c) Be identified to enable calibrated status to be determined
d) Be safeguarded from adjustments that would invalidate the measurement
result,
e) Be protected from damage and deterioration during handling, maintenance.
Quality Managment System 466/26/2015

47. Measurement, Analysis, and
Improvement
General
a) Define criteria for review and approval of processes
b) Approval of equipment and qualification of personnel
c) Use of specific methods and procedures
d) Requirements for records
Monitoring and measurement
Customer satisfaction
Internal audit
a) Conforms to the planed arrangements, to the requirements of the standard,
and to the requirements established by the organization
b) Effectively implemented and maintain.
Monitoring and measurement of processes
Monitoring and measurement of product and service
Quality Managment System 476/26/2015

48. Measurement, Analysis, and
Improvement
Control of nonconforming product
a) By taking action to eliminate the detected nonconformity
b) By authorizing its use, release or acceptance under conation by a relevant
authority
c) Taking action to preclude its original intended use or application.
Analysis of data
a) Customer satisfaction
b) Conformity to product requirements
c) Characteristics trends of processes and products,
d) suppliers
Improvement
Continual improvement
Quality Managment System 486/26/2015

49. Corrective action
a) Reviewing nonconformities
b) Determining the causes of nonconformities
c) Evaluating the need for action to ensure that nonconformities don’t recur
d) Determining and implementing action needed
e) Records of the results of action taker
f) Reviewing corrective action taken
Measurement, Analysis, and
Improvement
Preventive action
a) Determining potential nonconformities and their causes
b) Evaluating the need for action to prevent occurrence of nonconformities
c) Determining and implementing action needed
d) Records of results of action taken
e) Reviewing preventing action taken
Quality Managment System 496/26/2015

50. Implementation
Implementation
Top
management
commitment
Appoint the
management
representative
Awareness
Appoint an
implementation
team
Training
Time
schedule
Select
element
owners
Quality Managment System 506/26/2015

51. Implementation
Implementation
Review
the
present
system
Write the
documents
Install
the new
system
Internal
audit
Management
review
Preassessment
Registration
Quality Managment System 516/26/2015

52. Documentation policy
Work
instruction
procedure
records
WHY
Stated once
Define what will
be done
WHO
WHEN
WHERE
HOW
Evidence
Quality Managment System 526/26/2015

53. Internal Audits
• Is the key elements of the ISO 9000
• To checks policies, procedures, and instructions
have been developed and implemented
• Elements should be audited at least once per year
and some more frequently,
Objectives
• Determine that actual performance conforms to the documented QMS.
• Initiate corrective action activities in response to deficiencies.
• Follow up on noncompliance items from previous audits.
• Provide continued improvement in the system through feedback to management
• Cause the auditee to think about the process, thereby encouraging possible
improvements.
Quality Managment System 536/26/2015

54. Internal Audits
Auditor
• Knowledge of requirements
• Ability to communicate with team members and representatives
• Ability to ask open-ended questions
• Ability to synthesize information into systems
• Ability to manage information in a confidential manner
• Ability to relate observations to specific requirements
Quality Managment System 546/26/2015

55. Registration
By third party called registrar
Selecting Registrar
Registrar Accreditation Board (RAB), 1989 U.s
Affiliated with American society of Quality (ASQ)
Criteria for selection of Registrar
Qualification and Experience
Certification Recognition
The Registration Process
Structure registration process, tailored to organization
Responsive to request
No just evaluate , should recommendation for efficient
Quality Managment System 556/26/2015

56. Registration
Time and cost constraints
Auditor Qualifications
Lead time
Time and cost required for initial audit
Additional cost such as subcontracts (language ,expert
skills knowledge
• Must Know the standards
• Know the type of processes, the organization, and
customer
• Have the knowledge, temperament, and experience to
be credible.
Quality Managment System 566/26/2015

57. Quality Managment System 576/26/2015