ISO 9001 Training Presentation

Punyam Management Services Pvt.
Ltd.
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Ltd.
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Seven
principle
of
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principle
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9001:2015
ISO 9001:2015
Punyam

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Schematic
Representation
of
Process
Schematic
Representation
of
Process
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Approach
Approach
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Management Process
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outputs Customers /
inputs
Customers /
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A B C
Interested
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Interested
parties
parties
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levellevel
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Fourth level
Support Processes
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Top management processes include, for example, planning,
REALISATION PROCESSES
allocation of resources, management review, etc.
Realization processes include, for example, customer related

processes, design and development, product realization, etc.
Support
processes
maintenance, etc.
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include,
for
example,
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training,
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Risk
and
Opportunity
Risk
and
Opportunity
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The objective of this presentation are to appreciate and
understand how an QMS is established in terms of:
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Phases of text
Risk
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Risk Analysis
Risk Evaluation
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Third user
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Intended
Identification
Risk acceptability decisions
Area wise
risk identification
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Risk estimation
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Risk monitoring and control
Post production information
Post-production experience
Review of Risk management
experience- customer use
Take appropriate actions
OPTION analysis
Implementation of measures
RESIDUAL RISK evaluation
Overall RISK acceptance
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Main
Changes
Main Changes
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Risk-based thinking throughout the standard
supersedes
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a single
clause on
preventive
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The term documented information replaces
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documents
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and
records
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The term outsourcing is replaced by external
provision
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Increased leadership requirements
No requirement for a management representative

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Clause
4.2
Understanding
the
needs
&&
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Clause
4.2
Understanding
thetitle
needs
expectations
expectationsofofinterested
interestedparties
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Interested parties:
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The organization shall consider the following relevant interested
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parties:
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a)
customers
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b)
users;
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c) Suppliers, distributors, retailers or others involved in the supply

chain
d) Regulators
e) Any other relevant interested parties.
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Internal
Internal
Context
Context
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Relationshi
p with
internal
stake
holders
Organizat
ion Culture
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Governanc
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Internal
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Decision
making
process
Organizati
onal
Structure
Current
Roles &
Resp.
Process
maturity
Current
system and
tools
Strategy
Resource
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Current
capabilities
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Areas
to
considered
in
risk
and
to considered
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risk
and
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opportunity
opportunityidentification
identification
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Corporate
Requirement
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Business Requirement
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Contractual Requirement
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Client/customer
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Requirement
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level
Process and product requirements
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Legal Requirement
Regulatory Requirement
Statutory Requirements
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Documented Information Required by

Documented Information Required by
ISO 9001 : 2015
ISO 9001 : 2015
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Punyam

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16. Contract
review resultslevel
and information on customer requirements (8.2.3.2a)
Second
17.
Information
for any newlevel
requirements for the products and services( 8.2.3.2b)
Second
Third
level
18. Changes to the customer requirement in cases of amendment ( 8.2.3)
Fourth
level Design and development requirements have been met
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level
19.
Information
needed
to demonstrate
( 8.3.2j)
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Fourth
level
20. Information on design
and development inputs ( 8.3.3)
21. Information for design and development controls( 8.3.4)
Fifth level
22. Information on design and development outputs output and suitability- development
15. Confirmation of customers requirement in cases of verbal orders or no written statement
provided by customer(8.2.3.1)
verification sheet ( 8.3.5)

23. Information on design and development changes, result of reviews, authorization of the
changes, action taken to prevent adverse impacts ( 8.3.6)
24. Information for evaluation, selection, monitoring of performance and re evaluation and
actions arising from evaluation on external providers(8.4.1)
25. Results of evaluation of external providers - External providers selection and evaluation
records (8.4.2)
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Punyam Management Services Pvt.

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Copyrights 2015 @ I Global Manager Group | [email protected] |

Punyam Management Services Pvt.

Click to edit Master text styles

Copyrights 2015 @ I Global Manager Group | [email protected] |

Punyam Management Services Pvt.

allocation of resources, management review, etc.

Realization processes include, for example, customer related

Copyrights 2015 @ I Global Manager Group | [email protected] |

Punyam Management Services Pvt.

Risk monitoring and control

Post production information

Copyrights 2015 @ I Global Manager Group | [email protected] |

Punyam Management Services Pvt.

No requirement for a management representative

Copyrights 2015 @ I Global Manager Group | [email protected] |

Punyam Management Services Pvt.

Click to edit Master text styles

c) Suppliers, distributors, retailers or others involved in the supply

Copyrights 2015 @ I Global Manager Group | [email protected] |

Punyam Management Services Pvt.

Click to edit Master text styles

Copyrights 2015 @ I Global Manager Group | [email protected] |

Punyam Management Services Pvt.

Copyrights 2015 @ I Global Manager Group | [email protected] |

Punyam Management Services Pvt.

Documented Information Required by

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verification sheet ( 8.3.5)

Copyrights 2015 @ I Global Manager Group | [email protected] |

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