4. Develop the
ISO standards
Develop the
ISO standards
National Representative
Promotes & endorse Ex.
BIS (India), ANSI
(America)
National Representative
Promotes & endorse Ex.
BIS (India), ANSI
(America)
Accredit the
certification body &
determine the guideline
that registration body
follow
Accredit the
certification body &
determine the guideline
that registration body
follow
Which certify the
corporate Identify
against ISO standards
Technical
committee
Technical
committee
Member
body
Member
body
Accreditation
body
Accreditation
body
Registrar
body
Registrar
body
5. Standardization is defined as:
The development and implementation of concepts, doctrines, procedures
and designs
to achieve and maintain the required levels of compatibility,
interchangeability or commonality and interoperability
in the operational, procedural, materiel, technical and administrative
fields
In statistics, standardization refers to conversion to standard scores.
In test theory, standardization refers to measurements or assessments
conducted under exact, specified, and repeatable conditions.
In supply chain management, standardization refers to approaches
for increasing commonality of either part, process, product or
procurement. Such change will enable delayed making of
manufacturing or procurement decisions, thus reducing variability
found in having many non-standard components.
7. Standards are produced by many
organizations, some for internal usage
only, others for use by a groups of people,
groups of companies, or a subsection of an
industry. A problem arises when different
groups come together, each with a large
user base doing some well established
thing that between them is mutually
incompatible. Establishing international
standards is one way of preventing or
overcoming this problem.
8. ISO standards
Product standards System standards
ISO 9001:2000
ISO14001:2001
ISO 18000:1999
Quality management system
Environment management
system
Safety management system
ISO/TS 8611
ISO 1003:1980
ISO 11286:2004
Pallets for
materials handling
Spices and
condiment
Tea - Classification of
grades by particle size
analysis
9. Quality Management SystemQuality Management System
Definition: Management system to direct and control an organization with
regard to quality
Definition: Management system to direct and control an organization with
regard to quality
Quality system is consist of
1. Organizational structures
2. Procedures
3. Processes
4. Resources needed to implement quality management
Quality system is consist of
1. Organizational structures
2. Procedures
3. Processes
4. Resources needed to implement quality management
Description of quality management system:
•Determine what is required to be done
•Convert this in to clear and unequivocal instruction
•Confirm that it is followed
•Check that everyone has knowledge, eligibility and will to do the job, if necessary
•Provide equipment and procedures to enable the work to be done
•Check that the job has been done correctly
Description of quality management system:
•Determine what is required to be done
•Convert this in to clear and unequivocal instruction
•Confirm that it is followed
•Check that everyone has knowledge, eligibility and will to do the job, if necessary
•Provide equipment and procedures to enable the work to be done
•Check that the job has been done correctly
What is the
Aim of
QMS ?
What is the
Aim of
QMS ?
10. The aim of quality management system is
CUSTOMER SATISFACTION
CUSTOMER
SATISFACTION
DELIVAR
Y
COST
QUALITY
Value for
money
Conformanc
e of
requirement
On time
every time
11. Phenomena o f customer satisfaction & dissatisfactionPhenomena o f customer satisfaction & dissatisfaction
PercievedValueofproduct
ActualValueofproduct
Satisfied
Customer
Successful
Seller
CUSTOMERCUSTOMER SELLERSELLER
WIN WIN SITUATIONWIN WIN SITUATION
12. QMS requirement as per ISO9001:2000
Total requirement of QMS is clubbed in to 8 Main Clauses
1. Scope
2. Normative reference
3. Terms & Definition
4. Quality Management System
5. Management responsibility
6. Resource Management
7. Product Realization
8. Measurement, analysis and improvement
Inactive
Clause
Active
Clause
14. 1. Customer focus
2. Leadership
3. Involvement of people
4. Process approach
5. Systems approach to management
6. Continual improvement
7. Factual approach to decision making
8. Mutually beneficial supplier relationships
QUALITY MANAGEMENT PRINCIPLE
15. PDCA cycle
ISO 9001:2000
Section
Title
4.1 General requirements
4.2.1
4.2.3
4.2.4
5.1 Management commitment
5.5 Responsibility, authority and communication
7.6 Control of monitoring and measuring devices
8.1 Measurement, analysis and improvement (general)
4.2.2 Quality manual
5.2 Customer focus
5.3 Quality policy
5.4 Planning
6.3 Infrastructure
6.4 Work environment
7.1 Planning of Product Realization
6.1 Provision of resources
6.2 Human resources
7.3 Design and Development
7.4 Purchasing
7.5 Production and Service Provision
8.3 Control of noncomforming product
5.6 Management review
8.4 Analysis of data
8.5.1 Continual Improvement
8.5.2 Corrective Action
8.5.3 Preventive Action
ISO 9001:2000 in the form of PDCA Cycle
All
DO
CHECK
Documentation requirements covering control of
documentation and control of
ACT
PLAN
16. Quality Management principle ISO Clause
Customer focus 7.2.1 Determination of requirements related to the product
7.2.2 Review of requirements related to the product
7.2.3 Customer communication
8.2.1 customer satisfaction
Leadership 5.1 Management commitment
5.3 Quality Policy
5..4 Quality objectives & quality management system planning
5.5 Responsibility authority & communication
5.6 Management review
Involvement of people 6.2.2 competence,awareness & training
6.4 Work environment
Process approach 4.1 identify the process needed for quality management system & it application
5.6.2 Review input: process performance
5.6.3 Review: improvement in process performance
8.2.3 Monitoring & measurement of processes
Systems approach to
management
4.1 Determine the sequence and interaction of processes in quality management a system
4.2.1 Documentation of quality management system
5.4.2 The integrity of quality management system is maintained
5.6.2 Review input: Changes that could affect the quality management system
Clause 7 system of interrelated process
Continual improvement 8.5.1 Continual improvement
5.1 Commitment to continually improving the effectiveness of QMS
Factual approach to decision
making
8.4 Analysis of data
8.3 Control of nonconforming product
8.5.2 Corrective action
8.5.3 Preventive action
Mutually beneficial supplier
relationships
8.2.1 Customer satisfaction
Quality management principle and ISO Clause
18. 4.1
Establish your quality system
• Develop your quality management
system.
• Implement your quality management
system.
• Improve your quality management
system.
Requirements of ISO 9001:2000 with illustration
19. 4.2
Document your quality system
• 4.2.1 Develop quality system
documents.
• 4.2.2 Prepare quality system manual.
• 4.2.3 Control quality system
documents.
• 4.2.4 Maintain quality system records.
Requirements of ISO 9001:2000 with illustration
21. 5.1
Management responsibility
• Promote the importance of quality.
• Develop a quality management system.
• Implement your quality management
system.
• Improve your quality management
system.
Requirements of ISO 9001:2000 with illustration
22. 5.2
Satisfy your customer
• Identify customer requirements.
• Meet your customers' requirements.
• Enhance customer satisfaction.
Requirements of ISO 9001:2000 with illustration
23. 5.3
Establish a quality policy
• Define your organization's quality
policy.
• Manage your organization's quality
policy.
Requirements of ISO 9001:2000 with illustration
24. 5.4
Carry out quality planning
• 5.4.1 Formulate your quality
objectives.
• 5.4.2 Plan your quality management
system.
Requirements of ISO 9001:2000 with illustration
25. 5.5
Control your quality system
• 5.5.1 Define responsibilities and
authorities.
• 5.5.2 Appoint management
representative.
• 5.5.3 Support internal
communications.
Requirements of ISO 9001:2000 with illustration
26. 5.6
Perform management reviews
• 5.6.1 Review quality management
system.
• 5.6.2 Examine management review
inputs.
• 5.6.3 Generate management review
outputs.
Requirements of ISO 9001:2000 with illustration
28. 6.1
Provide quality resources
• Identify quality resource
requirements.
• Provide quality system resources.
Requirements of ISO 9001:2000 with illustration
29. 6.2
Provide quality personnel
• 6.2.1 Use competent personnel.
• 6.2.2 Support competence.
Requirements of ISO 9001:2000 with illustration
30. 6.3
Provide quality infrastructure
• Identify infrastructure needs.
• Provide needed infrastructure.
• Maintain your infrastructure.
Requirements of ISO 9001:2000 with illustration
31. 6.4
Provide quality environment
• Identify needed work environment.
• Manage needed work environment.
Requirements of ISO 9001:2000 with illustration
33. 7.1
Control realization planning
• Plan product realization processes.
• Develop product realization
processes.
Requirements of ISO 9001:2000 with illustration
34. 7.2
Control customer processes
• 7.2.1 Identify customers' product
requirements.
• 7.2.2 Review customers' product
requirements.
• 7.2.3 Communicate with your
customers.
Requirements of ISO 9001:2000 with illustration
35. 7.4
Control purchasing function
• 7.4.1 Control purchasing process.
• 7.4.2 Document product purchases.
• 7.4.3 Verify purchased products.
Requirements of ISO 9001:2000 with illustration
36. 7.5
Control operational activities
• 7.5.1 Control production and service
provision.
• 7.5.2 Validate production and service
provision.
• 7.5.3 Identify and track your products.
• 7.5.4 Protect property supplied by
customers.
• 7.5.5 Preserve your products and
components.
Requirements of ISO 9001:2000 with illustration
37. 7.6
Control monitoring devices
• Identify monitoring and measuring needs.
• Select monitoring and measuring devices.
• Calibrate monitoring and measuring
devices.
• Protect monitoring and measuring
devices.
• Validate monitoring and measuring
software.
• Use monitoring and measuring devices.
Requirements of ISO 9001:2000 with illustration
39. 8.1
Perform remedial processes
• Plan remedial processes.
• Implement remedial processes.
Requirements of ISO 9001:2000 with illustration
40. 8.2
Monitor and measure quality
• 8.2.1 Monitor and measure customer
satisfaction.
• 8.2.2 Plan and perform regular internal
audits.
• 8.2.3 Monitor and measure quality
processes.
• 8.2.4 Monitor and measure product
characteristics.
Requirements of ISO 9001:2000 with illustration
41. 8.3
Control nonconforming Products
• Develop a procedure to control
nonconforming products.
• Identify and control your nonconforming
products.
• Re-verify nonconforming products that
were corrected.
• Control nonconforming products after
delivery or use.
• Maintain records of nonconforming
products.
Requirements of ISO 9001:2000 with illustration
42. 8.4
Analyze quality information
• Define quality management
information needs.
• Collect quality management system
data.
• Provide quality management
information.
Requirements of ISO 9001:2000 with illustration
43. 8.5
Make quality improvements
• 8.5.1 Improve quality management
system.
• 8.5.2 Correct actual nonconformities.
• 8.5.3 Prevent potential
nonconformities.
Requirements of ISO 9001:2000 with illustration
44. Major changes in the revised version of
ISO 9001:2000
Significant points which has been highlighted in the revised standard
Process approach
Continual improvement
Customer satisfaction
Balanced approach for documentation
47. BUSINESS
(DSL GUWAHATI)
SYSTEM (F&A) SYSTEM (QMS) SYSTEM (IT)
PROCESS
(TRAINING &
DEVELOPMENT)
PROCESS
(MANUFACTURING OF
PAN MASALA)
PROCESS
(MATERIAL
MANAGEMENT)
PROCESS
(PURCHASING)
ACTIVITY
(DRYING OF
SUPARI)
ACTIVITY
(PROCESSING OF
GHAN)
ACTIVITY
(PACKAGING OF
MASALA)
ACTIVITY
(DESPATCH OF
MATERIAL)
49. Continual Improvement
Aim of continual improvement of a QMS is to
increase the probability of enhancing the
satisfaction of customers and other interested
parties (people in the organisation, suppliers,
owners, society)
50. Continual Improvement
Action for improvements include the following
• Analysing & Evaluating the existing situation to
identify areas for improvement.
• Establishing the objectives for improvement
• Searching for possible solutions to achieve the
objectives;
• Evaluating these solutions and making a solution;
51. Continual Improvement
Action for improvements include the following
• Implementing the selected solution
• Measuring,Verifying,Analysing & Evaluating results
of the implementation to determine that the objectives
have been met.
• Formalising changes
52. Customer Focus
• Top management is to communicate the
importance of meeting customer requirements.
(5.1a).
• Customer needs and expectations are to be
determines (not just contractual requirements).
(5.2)
• Communication arrangements with the
customer are to be identified and implemented.
(7.2.3)
53. Customer Focus
• Requirements not specified by the customer but
necessary for specified use or known and intended
use is to be determined. (7.2.1b)
• The organisation needs to monitor information on
customer satisfaction and / or dissatisfaction. (8.2.1)
• Promotion of awareness of customer requirements
throughout the organisation by the Management
Representative (5.5.2c)
54. Balanced emphasis on
documentation & results
The mandatory requirement for documented
procedures has reduced. There are only 6 areas
that specifically require documented procedures
• Control of Documents (4.2.3)
• Control of Quality Records (4.2.4)
• Internal Audit (8.2.2)
• Control of Non Conforming Products (8.3)
