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GOOD MORNING TO ALL

WHAT IS ISO AFTER ALL?

WHAT IS ISO ?
ISO

= (International Organization for Standardization)

ISO

has representation from 162 countries and has issued


many standards.
ISO

9001 : 2015 is a model for a quality management


system.

OVER 3,50,00,000 COMPANIES IN WORLD ARE


REGISTERED TO ISO 9001. WHY?

Higher customer satisfaction levels.

Improve the productivity and efficiency.

Cost reductions.

Improve communications and job satisfaction.

Competitive advantage and increased marketing and sales.

Consistency in the delivery of your product or services.

ISO 9001:2015 ELEMENTS

ISO 9001:2015 REQUIREMENTS

MAIN CLAUSES OF ISO 9001:2015

4.CONTEXT OF THE ORGANIZATION

4.1 understanding the organization and its context


4.2 Understanding the needs and expectation of interested
parties.
4.3 scope of the quality management system.
4.4 quality management system and its processes.

4.1 UNDERSTANDING THE ORGANIZATION AND


ITS CONTEXT

THE ORGANIZATION SHALL


DETERMINE EXTERNAL AND INTERNAL ISSUES THAT AFFECT THE
OUTCOME OF QMS AND CONSIDER:
EXTERNAL ISSUES:
LEGAL.
COMPETITIVE.
MARKET.
SOCIAL AND ECONOMIC ENVIRONMENT.
INTERNAL ISSUES
WORK CULTURE.
PERFOMANCE AND KNOWLEDGE OF ORGANIZATION.
ISSUES CAN INCLUDE POSITIVE AND NEGATIVE FACTORS OR
CONDITIONS FOR CONSIDERATION.

4.2 UNDERSTANDING THE NEED AND


EXPECTATION OF INTERESTED PARTIES

The Organization shall determine


The

requirement of relevant interested parties such as ( direct


customer , End user, Supply chain and other etc..,)
Requirements of these interested parties THAT ARE
RELEVANT TO QMS

4.3 SCOPE OF THE QUALITY


MANAGEMENT SYSTEM

The organization shall Consider

The External and Internal issues.


The requirements of relevant interested parties.

Scope must be documented and available, justify any clauses


of ISO 9001 that is not applicable

Any N/A clauses must not effect conformity of


products/services and customer satisfaction.

4.4 QUALITY MANAGEMENT SYSTEM AND ITS PROCESS

Must establish, implement, maintain and continually improve the


QMS

Determine the Sequence of the process (but not documented)

Assign responsibilities and authorities for processes

Maintain documented information to support the Operation of its


processes.

Documented procedures are not necessarily required.


except where they are needed

5. LEADERSHIP
5.1 Leadership and commitment.

Top management shall Ensure Quality policy and objectives are established .
Ensure the Resources are available .
Communicating the importance of conforming to QMS
and requirements of goods and services.
Supporting persons to contribute to the effectiveness of
the QMS.

5.1.2

CUSTOMER FOCUS
Customer and regulatory requirements are met.
Risks and opportunities are determined and addressed
Focused on enhancing customer satisfaction.

5.2 QUALITY POLICY

QUALITY POLICY must be


documented

QUALITY POLICY must be available


internally and to interested parties.

5.3 ORGANIZATION ROLES ,


RESPONSIBILITY AND
AUTHORITIES

Top management shall ensure responsibility and authorities


are assigned and communicated.

No formal requirement for management representative

6 PLANNING
ADDRESS RISK
AND
OPPORTUNITIES

6.1 Actions to address risks and opportunities


When planning, must consider external/internal issues and interested parties.
Determine risks to ensure QMS to achieves results, and Improvement.
Must evaluate effectiveness of actions.

6.1 ORGANIZATION SHALL PLAN ACTIONS TO


ADDRESS THESE RISKS AND OPPORTUNITIES

Organization Address risk : Avoiding Risk,


: Taking risk in order to pursue an opportunity,
: Eliminating the risk source,
: sharing the risk (or) Retaining risk by
informed decision

Organization Address Opportunities : Adoption of new Practice,


: Launching New Product,
: Using new Technology,
: Opening New Market

6.2 QUALITY OBJECTIVES AND


PLANNING TO ACHIEVE THEM

Be monitored

Be Measurable

Be Communicated

Be Update as APPROPRIATE

The Organization shall establish objectives at relevant functions to


conformity of products and services.
Quality objectives must be documented

6.3 PLANNING OF CHANGE

Where change is needed, it needs to be carried out in a planned and


systemic manner

Organization shall undertake changes must ensure the integrity of


QMS

7 SUPPORT
7.1 RESOURCE

Resources and people

Infrastructure

Measuring and Monitoring Resources

Work Environment

7.2 COMPETENCE

Organization shall
Determined
Ensure

the necessary competence of persons

persons are competent based on appropriate education,

training or experience
Documented

competence.

information (record) must be obtained of

7.3 AWARENESS

Persons doing work under control of organization


shall be aware of

Quality policy.

Quality objective.

Contribution to the effective to management


system.

Implication of not conforming with QMS.

7.4 COMMUNICATION

Organization shall determined what will be communicated internally and


externally about the Quality Management systems.

7.5 DOCUMENTED INFORMATION

7.5.1 General
Organization QMS shall include:
Documented information required by the standard
Documented information required by organization
7.5.2 Creating and updating
Organization shall ensure when creating or updating documented
information :
Identification , description, format, review for approval.
7.5.3 Control of documented information(DI)
Organization ensure DI are available and protected
DI shall be controlled for distribution , access , retrieval , use , preservation
changes and retention and disposition
External origin DI shall be identified and controlled

8 - OPERATION

8.1 Operational planning and control.

Must plan, implement and control processes needed to meet


requirements for the provision of products and services

Must control planned changes and review unintended changes

Any outsourced processes must be controlled.

8.2 REQUIREMENT FOR PRODUCT AND


SERVICE

Customer Communication

Determine and review the requirement


related to product

Changes to requirement for product and service


are made in document information and Ensure
relevant persons aware of the change
requirements.

8.3 DESIGN AND DEVELOPMENT OF


PRODUCT AND SERVICE

8.3 DESIGN AND DEVELOPMENT OF


PRODUCT AND SERVICE

Design and development


Planning

Design and development Input, control and output

Design and development changes


1.Review of results.
2.Design and development changes.
3.Performance of the product.

8.4 CONTROL OF EXTERNALLY


PROVIDED PROCESSES, PRODUCTS
AND SERVICE

8.4.1 General
Organization shall ensure that externally provided goods are conforms with
requirements.

8.4.2 type and extent of control of external provision


Types and extent control applied depend up on
Risks identified and potential impact of the externally provider process.
The effectiveness of the control applied by the external provider.
Ensure that externally provided process remain with the control of QMS.

DI for monitoring result.

8.4.3 DOCUMENTED INFORMATION FOR


EXTERNAL PROVIDERS

Control and monitoring of the external providers performance.


Any verification activities that the organization, or its customer, intends to
perform at the external providers premises.
Requirements for handling of external providers property provided to the
organization.
Documented information describing on the results of monitoring shall be
maintained.

8.5 PRODUCTION AND SERVICE PROVISION

8.5.1 Control of production and service provision

The organization shall implement production and service Provision under


controlled conditions. Controlled conditions shall include, as applicable:

The availability of documented information.

Use of suitable equipment;

Use of monitoring and measuring devices.

competence of personnel.

validation and approval, and periodic revalidation, of any process for


production.

8.5.2 IDENTIFICATION AND


TRACEABILITY

Proper identification on file

Unique identification of the output

Property belonging to customer or


external providers
The Organization shall control the unique identification of the output
when traceability is a required.

8.5.4 PRESERVATION OF GOODS AND


SERVICES

Preservation can include identification, handling, contamination control,


packing, storage. Transmission or transportation and protection

8.5.5 POST DELIVERY ACTIVITIES

Where applicable , the organization shall determined and meet requirements for
post delivery activities associated with the nature and intended lifetime of the
goods and services

8.5.6 CONTROL OF CHANGES

The organization shall undertake change in a planned and systematic


manner , taking account of the review of the potential consequences of
changes

Maintain documented information describing the results of review and


the person who authorized the change.

8.6 RELEASE OF GOODS AND


SERVICES

Must verify that product and service requirements have been meet and
evidence of conformity retained

Release to customer does not proceed until the planned verification of


conformity has been satisfactorily completed, unless otherwise approved
by a relevant authority and by the customer

Documented information to provide traceability to the person(s)


authorising release for delivery to the customer.

8.7 NONCONFORMITY GOODS


AND SERVICES

Documented
information
required
describing
nonconformity, actions taken, any concessions and
authority for taking action.

9 PERFORMANCE EVALUATION

Must Determine what needs to be monitored and measured,


the methods for monitoring, measurement, analysis and
evaluation, as applicable, to ensure valid results.
Retain appropriate documented information as evidence of the
results.

9.1.2 CUSTOMER SATISFACTION

The organization shall monitor data relating to customer requirements have been
met.

Example: customer feedback, warranty claims , dealer report and market-share


analysis.

9.1.3 ANALYSIS AND EVALUATION OF DATA

Information resulting from monitoring and measuring appropriate data


should be analysed and evaluated.

The results of analysis shall be used to evaluate:

Conformity of product and service.


The customer satisfaction.

The performance of external providers.


If the planning has been implemented effectively.

9.2

The organization shall conduct IA at planned intervals to provide


information on whether the QMS comply with requirements and
effectively implemented.

Take appropriate action without undue delay.

Retain documented information as evidence of implementation of audit


program and the audit results.

9.3 MANAGEMENT REVIEW

Top management shall review the organization quality management


system , at planned intervals , to insure its continuing stability ,
adequacy and effectiveness.

Evidence of management review results must be documented.

10.

10.1 General
Action must be taken to meet customer requirements
and enhance customer satisfaction :
improve products and service
correcting, preventing or reducing undesired effects
improve performance and effectiveness of the QMS.

10.2 NON- CONFORMITY AND CORRECIVE ACTION

When NC occurred , the organization shall

React to the NC and as applicable and correct it and deal with the
consequence.

Root cause analysis must be considered based on its Importance.

Evidence of action taken from nonconformities must be documented.

Evidence of results of corrective action must be documented.

10.3 CONTINUAL IMPROVEMENT

The organization shall improve the suitability , adequacy and effectiveness of


the QMS.

The organization shall consider the results of analysis and evaluation, and
outputs from management review.

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