ISO Introduction

From QC Department
To Staff members

1 By R.G.Trivedi 11/09/2022
Outline
 Quality Policy
 Quality Objective
 What is ISO ?
 What is ISO 9001 ?
 Benefits of ISO 9001
 Scope
 Normative references
 Terms and Conditions
 Context of the organization
 Leadership
 Planning
 Support
 Operation
 Performance evaluation
 Improvement

2 By R.G.Trivedi 11/09/2022
Quality policy
 WE ARE COMMITTED TO MANUFACTURE ELECTRIC
POWER CABLE, HOUSE WIRE, SUBMERSIBLE FLAT CABLE,
CONTROL CABLE AND INSTRUMENTATION CABLE TO
ENHANCE OUR CUSTOMERS SATISFACTION BY ON TIME
DELIVERY WITH REQUIRE QUALITY AND ATTENTION ON
CUSTOMER NEEDS THROUGH CONTINUAL IMPROVEMENT
IN QUALITY MANAGEMENT SYSTEM.

 WE ARE COMMITTED TO IMPROVE ORGANIZATION

PERFORMANCE BY TRAINING OF ALL EMPLOYEES,
REDUCING PROCESS WASTE, REDUCING CUSTOMER
COMPLAINT, CREATING SAFE AND HEALTHY
ENVIRONMENT WITH LEGAL REQUIREMENT.

3 By R.G.Trivedi 11/09/2022
QUALITY OBJECTIVES
 Budget vs plan
 Plan vs actual
 To reduce In-process and Finish NC
 To reduce Customer complaint
 Safety
 To save Energy
 To reduce process waste
 To achieve Business growth

4 By R.G.Trivedi 11/09/2022
What is ISO ?
 ISO (International Organization for Standardization) is a
worldwide federation of national standard bodies.

 The work of preparing International Standards is normally

carried out through ISO technical committees.

5 By R.G.Trivedi 11/09/2022
What is ISO 9001 ?
 ISO 9001 is a QMS – Quality Management System.

 ISO 9001 defines how organizations can establish and

maintain effective quality assurance systems for
manufacturing and service industries.

 ISO 9001 : 2015 represents that Version of Standard 9001

is released in 2015.

6 By R.G.Trivedi 11/09/2022
Benefits of ISO 9001
 Increases efficiency
 Greater employee moral
 Better supplier relationships
 Improves record and documents
 Improves customer satisfaction
 Continual improvement
 Vendor development

7 By R.G.Trivedi 11/09/2022
1. Scope
 When an organization :
1. Needs to prove its ability to provide products that meet
statutory and regulatory requirements.

2. Aims to enhance customer satisfaction through effective

application of the system.

8 By R.G.Trivedi 11/09/2022
4. Context of the organization
4.1 Understanding the organization and its context
 External issue : price variation, throat cut competition, skilled
manpower, power supply issues.
 Internal issue : Seasonal manpower shortage, Unskilled
manpower, space constrain.

4.2 Understanding needs and expectations of interested parties.

 Interested parties : Employees, Govt. bodies, Customer,
Supplier.
 Needs of customer : Best quality, Best service, Timely delivery
 Requirement : FOR delivery.

9 By R.G.Trivedi 11/09/2022
4. Context of the organization –
Cont.
4.3 Determining the scope of the Quality Management System
 External and internal issues
 Req. of relevant interested parties
 Products and service of the organization

4.4 Quality Management System and its processes.

Processes includes
 Sequence and interaction
 Responsibility and authority
 Maintain documented information

10 By R.G.Trivedi 11/09/2022
5. Leadership
5.1 Leadership and commitment
5.1.1 General
 Top management shall demonstrate Leadership and commitment.
 Quality Policy and objectives are established for QMS
 Promoting use of process approach and risk based thinking (PDCA)
 Supports other relevant management towards their leadership.

11 By R.G.Trivedi 11/09/2022
5. Leadership - Cont.
5.1.2 Customer focus
 Applicable statutory and regulatory requirement are determined
, understood and consistently met.
 Enhance customer satisfaction
 Focus on above are maintained.

12 By R.G.Trivedi 11/09/2022
5. Leadership – Cont.
5.2 Policy
5.2.1 Establishing the Quality Policy
 Top management shall establish, It shall
 Appropriate to the purpose and context
 Provide framework for quality objectives
 Includes commitments for continual improvement

5.2.2 Communicating the Quality Policy

 Be available and maintained as documented information
 Be communicated, understood and applied within organization
 Be available to relevant interested parties.

13 By R.G.Trivedi 11/09/2022
5. Leadership – Cont.
5.2.3 Organizational roles, responsibilities and
authorities.
 Top management shall ensures that responsibility and
authorities for relevant roles are assigned for
a. Ensuring that QMS conforms to the requirement of this
international standard
b. Ensuring that the process are delivering intended outputs
c. Ensuring the promotion of customer focus throughout the
organization
d. Reporting on the performance of the QMS and on
opportunities for improvement

14 By R.G.Trivedi 11/09/2022
6. Planning
6.1 Actions to address risks and opportunity
6.1.1 Risk and opportunities based on 4.1 and 4.2, (SWOT)
 Gives assurance that QMS cab achieve its intended results
 Enhance desirable effects
 Prevent or reduce undesirable effetcs
 Achieve improvement.

15 By R.G.Trivedi 11/09/2022
SWOT – PRODUCTION DEPT.
 Strength :
 We can produce conductor upto 61 strands in single process.

 Weakness :
 Frequent maintenance occurs due to old age machineries

 Opportunity
 We can produce more cable if frequent maintenance does not occur.

 Threat
 Employee retention is more.

16 By R.G.Trivedi 11/09/2022
6. Planning – Cont.
6.1.2 Organization shall plan
 Integrate and implement actions into its QMS process
 Evaluate effectiveness of these actions

6.2 Quality objectives and Planning to achieve them

It shall
 Consistent with quality policy
 Be measurable
 Be monitored
 Be communicated
 Be updated as appropriate
 Be relevant to conformity of the product and services and enhancement
of customer satisfation

17 By R.G.Trivedi 11/09/2022
QUALITY OBJECTIVES
 Budget vs plan
 Plan vs actual
 To reduce In-process and Finish NC
 To reduce Customer complaint
 Safety
 To save Energy
 To reduce process waste
 To achieve Business growth

18 By R.G.Trivedi 11/09/2022
6. Planning – Cont.
6.3 Planning of changes
 When organization determines need for changes to the QMS it
shall be carried out in a planned manner. Organization shall
consider,
a. Purpose of the changes and their potential consequences.
b. Integrity of the QMS
c. Availability of the resources
d. Allocation and reallocation of responsibilities and authorities.

19 By R.G.Trivedi 11/09/2022
7. Support
7.1 Resources
7.1.1 General
 Organization shall provide resources need for establishment,
implementation and continual improvement of QMS.

7.1.2 People
7.1.3 Infrastructure
 Buildings
 Equipment including hardware and software
 Transportation
 ICT

20 By R.G.Trivedi 11/09/2022
7. Support - Continue
7.1.4 Environment for the operation of processes
 Organization shall determine and provide necessary
environment for operation and processes to achieve conformity
of products and services.

7.1.5 Monitoring and measuring resources

7.1.5.1 General
 Resources are suitable for monitoring and measurement activities
being undertaken.

21 By R.G.Trivedi 11/09/2022
7. Support - Continue
7.1.5.2 Measurement traceability
 Calibrated or verified at specified intervals, against measurement
standards traceable to international or national measurement
standards.
 Identified in order to determine status
 Safeguarded from adjustments, damage or deterioration that invalidate
the calibration status.

7.1.6 Organizational Knowledge

 Organization shall determine knowledge necessary for its
operation and achieve conformity of products and services.
 It shall be maintained and available to the extent necessary.

22 By R.G.Trivedi 11/09/2022
7. Support - Continue
7.2 Competence
 Determine necessary competence of person
 On basis of education, training or experience
 Take action to acquire necessary competence
 Retain appropriate documented information of competence.

7.3 Awareness
 Quality policy
 Quality objectives
 Contribution to effectiveness of the QMS
 Implications of not confirming with the QMS

23 By R.G.Trivedi 11/09/2022
7. Support - Continue
7.4 Communication
 Organization shall determine external and internal
communication
 On what it will communicate
 When to communicate
 With whom to communicate
 How to communicate
 Who communicates

24 By R.G.Trivedi 11/09/2022
7. Support - Continue
7.5 Documented Information
7.5.1 General
 Documented information shall be determine by organization as
being necessary for the effectiveness of the QMS
7.5.2 Creating and updating
 When creating and updating documented information
 Identification and description
 Format
 Review and approval for suitability and adequecy

25 By R.G.Trivedi 11/09/2022
7. Support - Continue
7.5.3 Control of documented information
 It is available for use where and when it is needed.
 It is adequately protected from loss of confidentiality, Improper
use, etc.

26 By R.G.Trivedi 11/09/2022
8. Operation
8.1 Operational planning and control
 Organization shall plan, implement and control the processes
(4.4) to meet the requirements
 Establishing criteria for processes
 Acceptance of products and services
 Determining, maintaining and retaining documented
information
 To have confidence that the process has been carried out as planned
 To demonstrate the conformity of the product.

27 By R.G.Trivedi 11/09/2022
8. Operation - continue
8.2 Requirements for products and services
8.2.1 Customer communication
 Providing information related to products and services
 Handling inquiries, orders, etc.
 Customer feedback related to products and services

8.2.2 Determining the requirements for products and

services
 Any applicable statutory and regulatory requirement
 Organization can meet the claims for products and services it offers.

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8. Operation - continue
8.2.3 Review of the requirements for product and
services
 Organization shall conduct a review before committing to
supply products, to include
 For delivery and post delivery activities
 Requirements not stated by customer, but necessary for
specified and intended use
 Requirements specified by the organization
 Contract or order requirements differs from those previously
expressed.

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8. Operation - continue
8.2.4 Changes to requirements for products and
services
 Organization shall ensure that relevant documented information
are amended and relevant persons are made aware of changed
requirements.

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8. Operation - continue
8.3 Design and development of products and services
8.3.1 General
 Organization shall establish, implement and maintain design and
development process to ensure subsequent provision of products.

8.3.2 Design and development planning

 Organization shall consider
 Nature, duration and complexity
 Required process stages
 Responsibility and authorities involved in design and development
 Internal and external sources needs
 Documented information needed to demonstrate that design and
development requirements have been met.

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8. Operation - continue
8.3.3 Design and development inputs
 Statutory and regulatory requirements
 Standards or codes that committed to implement
 Potential consequences of failure due to nature of products.

8.3.4 Design and development controls

 Results to be achieved are defined
 Reviews are conducted to evaluate ability of result
 Any necessary action are taken on problems determined during
the reviews or verification activities
 Documented information are retained

32 By R.G.Trivedi 11/09/2022
8. Operation - continue
8.3.5 Design and development outputs
 Meet the input requirements
 Adequate for subsequent process for provision of products

8.3.6 Design and development changes

 Design and development changes
 Results of reviews
 Authorization of changes
 Action taken to prevent adverse impacts

33 By R.G.Trivedi 11/09/2022
8. Operation - continue
8.4 Control of externally provided processes, products
and services
8.4.1 General
 Organization shall ensure that externally provided products
conform to the requirements
 Determine the controls to be applied to externally provided
process or products.
 Organization shall determine and apply criteria for the
evaluation, selection, monitoring of performance based on their
(external providers) ability to provide products.

34 By R.G.Trivedi 11/09/2022
8. Operation - continue
8.4.2 Type and extent of control
 Organization shall ensure that externally provided services or
products meets conformity of the products
 Externally provided processes remain within the control of
QMS
 Potential impact on organizations ability to consistently meet
customer and statutory and regulatory requirement.

35 By R.G.Trivedi 11/09/2022
8. Operation - continue
8.4.3 Information for external providers
 Organization shall communicate to the external providers for :
 Products or process to be provided
 Competence including any required qualification of persons
 Control and monitoring of external providers’ performance.

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8. Operation - continue
8.5 Production and service provision
8.5.1 Control of production and service provision
 Availability of documented information that defines:
 Characteristics of products to be produced
 Results to be achieved
 Use of suitable infrastructures and resources
 Actions to prevent human error
 Appointment of competent persons including any required
qualification.

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8. Operation - continue
8.5.2 Identification and traceability
 Organization shall use suitable means to identify outputs when
it is necessary to ensure the conformity.
 Organization shall control identification of the output.

8.5.3 Property belonging to customers or external

providers
 Organization shall exercise care with property belongs to
customer or external providers
 When it is lost, organization shall retain documented
information on what has occurred.

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8. Operation - continue
8.5.4 Preservation
 Organization shall preserve the output during production to the
extent necessary to ensure conformity requirement.

8.5.5 Post delivery activities

 Organization shall meet requirement f post delivery activities.
 The nature, use and intended lifetime of its products.
 Customer requirements
 Customer feedback.

39 By R.G.Trivedi 11/09/2022
8. Operation - continue
8.5.6 Control of changes
 Organization shall review and control changes for production to
the extent necessary to meet conformity of the requirements
 It shall be documented available.

40 By R.G.Trivedi 11/09/2022
8. Operation - continue
8.6 Release of products and services
 Organization shall implement planned arrangements to verify that product
and service requirement has been met.
 Retain documented information on the release of product
 Evidence of conformity with acceptance criteria
 Traceability to the person authorizing to release.

8.7 Control of Non-conforming outputs

8.7.1 NC products are identified and controlled to prevent use for
delivery
 Organization shall deal with
 Correction
 Informing to the customer
 Segregation, containment, return or suspension of provision of products

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8. Operation - continue
8.7.1 Organization shall retain documented
information that
 Describes the NC
 Describes the action taken
 Describes any concessions obtained
 Identifies the authority deciding the action in respect of NC

42 By R.G.Trivedi 11/09/2022
9. Performance evaluation
9.1 Monitoring , measurement, analysis and evaluation
9.1.1 General
 What need to be monitored and measured
 Methods for monitoring , measurement, analysis and
evaluation
 Evaluate performance and effectiveness of the QMS
 Retain appropriate documented information.

9.1.2 Customer satisfaction

 Organization shall monitor customer’s perceptions of the
degree to which customer’s satisfaction have been fulfilled.

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9. Performance evaluation – cont.
9.1.3 Analysis and evaluation
 Conformity of products and services
 Degree of customer satisfaction
 Performance and effectiveness of QMS
 If planning has been implemented effectively
 Performance of external providers.

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9. Performance evaluation – cont.
9.2 Internal audit
9.2.1 Required for whether QMS
 Conforms to organizational own requirements for its QMS
 Requirement of this international standard
 Is effectively implemented and maintained

9.2.2 Organization shall define

 Audit criteria and scope for each audit
 Ensures that result of the audit are reported to relevant management
 Take appropriate and corrective actions without undue delay.
 Retain documented information as evidence of the audit programme

45 By R.G.Trivedi 11/09/2022
9. Performance evaluation – cont.
9.3 Management review
9.3.1 General
 Top management shall review organization’s QMS, at planned intervals to ensure its
continuing suitability and effectiveness with strategic direction of the organization.

9.3.2 Management review inputs

 Status of the actions from previous management reviews.
 Customer satisfaction and feedback form
 NC and corrective actions
 Audit results
 Performance of external providers
 Adequacy of resources
 Action taken to address risk and opportunities.
 Opportunities for improvement

46 By R.G.Trivedi 11/09/2022
9. Performance evaluation – cont.
9.3.3 Management review outputs
 Opportunities for improvements
 Any need of changes to the QMS
 Resource needs.

47 By R.G.Trivedi 11/09/2022
10. Improvement
10.1 General
 Improving product and services to meet customers
requirements
 Correcting, reducing or prevent any undesired effects
 QMS performance improvement

48 By R.G.Trivedi 11/09/2022
10. Improvement – cont.
10.2 Nonconformity and corrective action
10.2.1 When NC occurs
 action to control and correct it
 Review and analyze the NC
 Determine cause of NC
 Implement any action needed
 Review of effectiveness of corrective action taken.
10.2.2 Retain documented information
 Nature of NC and actions taken
 Result of any corrective action taken.

49 By R.G.Trivedi 11/09/2022
10. Improvement – cont.
10.3 Continual improvement
 Organization shall continually improve the suitability,
adequacy and effectiveness of QMS.
 Organization shall consider results of analysis and
evaluation and output from MRM to determine needs for
continual improvement

50 By R.G.Trivedi 11/09/2022
Colors for machine parts
Colors Description
Orange For rotating part or danger part
Blue For safe part or static part
Drum color
Yellow To show caution like safe guard or cage.
Red For fire extinguisher
Green Safety equipment
First aid
Area with no hazardous

51 By R.G.Trivedi 11/09/2022
52 By R.G.Trivedi 11/09/2022
 THANK
YOU

53 By R.G.Trivedi 11/09/2022