Punyam Management Services Pvt.

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Seven
principle
of
Seven
principle
of
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9001:2015
ISO 9001:2015

Punyam

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level
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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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level
A B C
Interested
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Interested
parties
parties
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Third
levellevel
Fifth level
Fourth level
Support Processes

Fifth level
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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Punyam Management Services Pvt.

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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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Punyam

Phases of text
Risk
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Second
Risk Analysis
Risk Evaluation
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level
Third user
level
Intended
Identification
Risk acceptability decisions
Area wise
risk identification
Third
Fourth
level
level
Risk estimation
Fifth level
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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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Punyam Management Services Pvt.

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Main
Changes
Main Changes
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Risk-based thinking throughout the standard
supersedes
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Second
a single
clause on
preventive
Second
level

Third
level
The term documented information replaces
Fourth
documents
level
Third
level
and
records
Fifth level
Fourth level
The term outsourcing is replaced by external
provision
Fifth level
Increased leadership requirements

No requirement for a management representative

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Punyam Management Services Pvt.

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Clause
4.2
Understanding
the
needs
&&
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Clause
4.2
Understanding
thetitle
needs
expectations
expectationsofofinterested
interestedparties
parties
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Punyam

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Interested parties:
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Second
The organization shall consider the following relevant interested
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level
parties:
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Fourth
Third
levellevel
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a)
customers
Direct
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level
b)
users;
End
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level

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

Punyam

Governanc
e

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level
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Internal
Fourth
Third
levellevel Context
Fifth level
Fourth level
Fifth level
Decision
making
process

Organizati
onal
Structure

Current
Roles &
Resp.

Process
maturity

Current
system and
tools

Strategy

Resource
levels

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Current
capabilities

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Punyam Management Services Pvt.

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Areas
to
considered
in
risk
and
to considered
intitle
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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level
Third level
Contractual Requirement
Fourth
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levellevel
Client/customer
Fifth level
Requirement
Fourth
level
Process and product requirements
Fifth
level
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
Third
level
19.
Information
needed
to demonstrate
( 8.3.2j)
Fifth level

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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