ISO 9001:2015 ISO 450001:2018 ISO 14001:2015

1 SCOPE 1 SCOPE 1 SCOPE

2 NORMATIVE REFERENCES 2 NORMATIVE REFERENCES 2 NORMATIVE REFERENCES

3 TERMS AND DEFINITIONS 3 TERMS AND DEFINITIONS 3 TERMS AND DEFINITIONS

4 CONTEXT OF THE ORGANIZATION 4 CONTEXT OF THE ORGANIZATION 4 CONTEXT OF THE ORGANIZATION

(Title) (Title) (Title)

4.1 Understanding the organization & its 4.1 Understanding the organization & its 4.1 Understanding the organization & its
context context context

4.2 Understanding the needs and 4.2 Understanding the needs and 4.2 Understanding the needs and
expectations of interested parties expectations of interested parties expectations of interested parties

4.3 Determining the scope of the OH & S

4.3 Determining the scope of the QMS 4.3 Determining the scope of the EMS
management system

4.4 QMS and its processes (Title) Corresponding Clause does not exist Corresponding Clause does not exist

4.4.1 (paragraph-1 about QMS) 4.4 OH & S management system 4.4 Environmental management system

4.4.1 (paragraph-2 about processes of

Corresponding Clause does not exist Corresponding Clause does not exist
QMS)

4.4.2 (about documented information on

Corresponding Clause does not exist Corresponding Clause does not exist
processes)

5 LEADERSHIP (Title) 5 LEADERSHIP (Title) 5 LEADERSHIP (Title)

5.1 Leadership and commitment (Title) Corresponding Clause does not exist Corresponding Clause does not exist

5.1.1 General 5.1 Leadership and commitment 5.1 Leadership and commitment

5.1.2 Customer focus Corresponding Clause does not exist Corresponding Clause does not exist

5.2 Policy (Title) Corresponding Clause does not exist Corresponding Clause does not exist

5.2.1 Establishing the quality policy 5.2 OH & S policy, paragraph-1 5.2 Environmental policy, paragraph-1

5.2.2 Communicating the quality policy 5.2 OH & S policy, paragraph-2 5.2 Environmental policy, paragraph-2

5.3 Organizational roles, responsibilities 5.3 Organizational roles, responsibilities 5.3 Organizational roles, responsibilities
and authorities and authorities and authorities
 5.4 Consultation and participation of
Corresponding Clause does not exist Corresponding Clause does not exist
workers

6 PLANNING (Title) 6 PLANNING (Title) 6 PLANNING (Title)

6.1 Actions to address risks & 6.1 Actions to address risks & 6.1 Actions to address risks &
opportunities (Title) opportunities (Title) opportunities (Title)

6.1.1 (about requirements when

6.1.1 General 6.1.1 General
planning QMS)

6.1.2 (about addressing risks &

opportunities) Corresponding Clause does not exist Corresponding Clause does not exist

6.1.2 Hazard Identification and

Corresponding Clause does not exist 6.1.2 Environmental aspects
assessment of risks and opportunities

6.1.3 Determination of legal

Corresponding Clause does not exist 6.1.3 Compliance obligations
requirements and other requirements

Corresponding Clause does not exist 6.1.4 Planning action 6.1.4 Planning action

6.2 Quality objectives and planning to 6.2 OH & S objectives and planning to 6.2 Environmental objectives and
achieve them (Title) achieve them (Title) planning to achieve them (Title)

6.2.1 (about quality objectives) 6.2.1 OH & S objectives 6.2.1 Environmental objectives

6.2.2 Planning actions to achieve OH & S 6.2.2 Planning actions to achieve

6.2.2 (about achievement planning)
objectives environmental objectives

6.3 Planning of changes 8.1.3 Management of change Corresponding Clause does not exist

7 SUPPORT (Title) 7 SUPPORT (Title) 7 SUPPORT (Title)

7.1 Resources (Title) Corresponding Clause does not exist Corresponding Clause does not exist

7.1.1 General 7.1 Resources 7.1 Resources

7.1.2 People Corresponding Clause does not exist Corresponding Clause does not exist

7.1.3 Infrastructure Corresponding Clause does not exist Corresponding Clause does not exist

7.1.4 Environment for the operation of

Corresponding Clause does not exist Corresponding Clause does not exist
processes

7.1.5 Monitoring and measuring

Corresponding Clause does not exist Corresponding Clause does not exist
resources (Title)
7.1.5.1 General Corresponding Clause does not exist Corresponding Clause does not exist

7.1.5.2 Measuring traceability Corresponding Clause does not exist Corresponding Clause does not exist

7.1.6 Organizational knowledge Corresponding Clause does not exist Corresponding Clause does not exist

7.2 Competence 7.2 Competence 7.2 Competence

7.3 Awareness 7.3 Awareness 7.3 Awareness

Corresponding Clause does not exist 7.4 Communication (Title) 7.4 Communication (Title)

7.4 Communication 7.4.1 General 7.4.1 General

Corresponding Clause does not exist 7.4.2 Internal Communication 7.4.2 Internal Communication

7.4.3 External Communication 7.4.3 External Communication

7.5 Documented information (Title) 7.5 Documented information (Title) 7.5 Documented information (Title)

7.5.1 General 7.5.1 General 7.5.1 General

7.5.2 Creating and updating 7.5.2 Creating and updating 7.5.2 Creating and updating

7.5.3 Control of documented information Corresponding Clause does not exist Corresponding Clause does not exist
(Title)

7.5.3 Control of documented 7.5.3 Control of documented

7.5.3.1 (about purpose of control)
information, paragraph-1 information, paragraph-1

7.5.3 Control of documented 7.5.3 Control of documented

7.5.3.2 (about requirements for control)
information, paragraph-2 & 3 information, paragraph-2 & 3

8 OPERATION (Title) 8 OPERATION (Title) 8 OPERATION (Title)

8.1 Operational planning and control 8.1 Operational planning and control 8.1 Operational planning and control

8.2 Emergency preparedness and

Corresponding Clause does not exist ;
response

8.2 Requirements for products &

services (Title) Corresponding Clause does not exist Corresponding Clause does not exist
8.2.1 Customer communication Corresponding Clause does not exist Corresponding Clause does not exist

8.2.2 Determining the requirements for

Corresponding Clause does not exist Corresponding Clause does not exist
products & services

8.2.3 Review of the requirements for

Corresponding Clause does not exist Corresponding Clause does not exist
products & services (Title)

8.2.3.1 & 8.2.3.2 (about review,

Corresponding Clause does not exist Corresponding Clause does not exist
documented info)

8.2.4 Changes to requirements for

Corresponding Clause does not exist Corresponding Clause does not exist
products & services

8.3 D & D of products and services (Title) Corresponding Clause does not exist Corresponding Clause does not exist

8.3.1 to 8.3.6 – General, Planning, Inputs,

Corresponding Clause does not exist Corresponding Clause does not exist
Controls, Outputs, Changes

8.4 Control of externally provided

processes, products and services (Title) Corresponding Clause does not exist Corresponding Clause does not exist

8.4.1 General Corresponding Clause does not exist Corresponding Clause does not exist

8.4.2 Type and extent of control Corresponding Clause does not exist Corresponding Clause does not exist

8.4.3 Information for external providers Corresponding Clause does not exist Corresponding Clause does not exist

8.5 Production and service provision Corresponding Clause does not exist Corresponding Clause does not exist
(Title)

8.5.1 Control of production and service

Corresponding Clause does not exist Corresponding Clause does not exist
provision

8.5.2 Identification and traceability Corresponding Clause does not exist Corresponding Clause does not exist

8.5.3 Property belonging to customers or

Corresponding Clause does not exist Corresponding Clause does not exist
external providers

8.5.4 Preservation Corresponding Clause does not exist Corresponding Clause does not exist

8.5.5 Post-delivery activities Corresponding Clause does not exist Corresponding Clause does not exist

8.5.6 Control of changes Corresponding Clause does not exist Corresponding Clause does not exist

8.6 Release of products and services Corresponding Clause does not exist Corresponding Clause does not exist
8.7 Control of nonconforming outputs
Corresponding Clause does not exist Corresponding Clause does not exist
(Title)

8.7.1 (about required control) Corresponding Clause does not exist Corresponding Clause does not exist

8.7.2 (about required documented

Corresponding Clause does not exist Corresponding Clause does not exist
information)

9 PERFORMANCE EVALUATION (Title) 9 PERFORMANCE EVALUATION (Title) 9 PERFORMANCE EVALUATION (Title)

9.1 Monitoring, measuring, analysis and 9.1 Monitoring, measuring, analysis and 9.1 Monitoring, measuring, analysis and
evaluation (Title) evaluation (Title) evaluation (Title)

9.1.1 General 9.1.1 General 9.1.1 General, paragraph-2, 4, 6

Corresponding Clause does not exist 9.1.1 General 9.1.1 General, paragraph-1, 3, 5

Corresponding Clause does not exist 9.1.2 Evaluation of compliance 9.1.2 Evaluation of compliance

9.1.2 Customer satisfaction Corresponding Clause does not exist Corresponding Clause does not exist

9.1.3 Analysis and evaluation Corresponding Clause does not exist Corresponding Clause does not exist

9.2 Internal audit (Title) 9.2 Internal audit (Title) 9.2 Internal audit (Title)

9.2.1 (about general requirements) 9.2.1 General 9.2.1 General

9.2.2 (about audit programmes) 9.2.2 Internal audit programme 9.2.2 Internal audit programme

9.3 Management review (Title) Corresponding Clause does not exist Corresponding Clause does not exist

9.3.1 General 9.3 Management review, paragraph-1 9.3 Management review, paragraph-1

9.3.2 Management review inputs 9.3 Management review, paragraph-2 9.3 Management review, paragraph-2

9.3.3 Management review outputs 9.3 Management review, paragraph-3 9.3 Management review, paragraph-3

10 IMPROVEMENT (Title) 10 IMPROVEMENT (Title) 10 IMPROVEMENT (Title)

10.1 General 10.1 General 10.1 General

10.2 Nonconformity and corrective
Corresponding Clause does not exist Corresponding Clause does not exist
action (Title)

10.2 Incident, Nonconformity & 10.2 Nonconformity & corrective action,

10.2.1 (about required actions)
corrective action, paragraph-1, 2 paragraph-1, 2

10.2.2 (about required documented 10.2 Incident, Nonconformity & 10.2 Nonconformity & corrective action,
information) corrective action, paragraph-3 paragraph-3

10.3 Continual improvement 10.3 Continual improvement 10.3 Continual improvement

http://surgicalunits.com/3-4-participation-489.html
 QMS OHSMS
ISO 9001:2015 ISO 450001:2018
CLAUSE CLAUSE

1.0 1.0 SCOPE SCOPE

2.0 2.0 NORMATIVE REFERENCES NORMATIVE REFERENCES

2.0 3.0 TERMS AND DEFINITIONS TERMS AND DEFINITIONS

CONTEXT OF THE CONTEXT OF THE

4.0 4.0
ORGANIZATION (Title) ORGANIZATION (Title)

Understanding the organization & its Understanding the organization & its
4.1 4.1
context context

Understanding the needs and Understanding the needs and

4.2 4.2
expectations of interested parties expectations of interested parties

Determining the scope of the OH &

4.3 4.3 Determining the scope of the QMS
S management system

4.4 QMS and its processes (Title) Corresponding Clause does not exist

4.4.1 4.4 (paragraph-1 about QMS) OH & S management system

(paragraph-2 about processes of

4.4.1 Corresponding Clause does not exist
QMS)

(about documented information on

4.4.2 Corresponding Clause does not exist
processes)

5.0 5.0 LEADERSHIP (Title) LEADERSHIP (Title)

5.1 Leadership and commitment (Title) Corresponding Clause does not exist

5.1.1 5.1 General Leadership and commitment

5.1.2 Customer focus Corresponding Clause does not exist

5.2 Policy (Title) Corresponding Clause does not exist

5.2.1 5.2 Establishing the quality policy OH & S policy, paragraph-1

5.2.2 5.2 Communicating the quality policy OH & S policy, paragraph-2

Organizational roles, responsibilities Organizational roles, responsibilities

5.3 5.3
and authorities and authorities
 Consultation and participation of
5.4 Corresponding Clause does not exist
workers

6.0 6.0 PLANNING (Title) PLANNING (Title)

Actions to address risks & Actions to address risks &

6.1 6.1
opportunities (Title) opportunities (Title)

(about requirements when planning

6.1.1 6.1.1 General
QMS)

(about addressing risks &

6.1.2 Corresponding Clause does not exist
opportunities)

Hazard Identification and

6.1.2 Corresponding Clause does not exist assessment of risks and
opportunities

Determination of legal requirements

6.1.3 Corresponding Clause does not exist
and other requirements

6.1.4 Corresponding Clause does not exist Planning action

Quality objectives and planning to OH & S objectives and planning to

6.2 6.2
achieve them (Title) achieve them (Title)

6.2.1 6.2.1 (about quality objectives) OH & S objectives

Planning actions to achieve OH & S

6.2.2 6.2.2 (about achievement planning)
objectives

6.3 8.1.3 Planning of changes Management of change

7.0 7.0 SUPPORT (Title) SUPPORT (Title)

7.1 Resources (Title) Corresponding Clause does not exist

7.1.1 7.1 General Resources

7.1.2 People Corresponding Clause does not exist

7.1.3 Infrastructure Corresponding Clause does not exist

Environment for the operation of

7.1.4 Corresponding Clause does not exist
processes

Monitoring and measuring resources

7.1.5 Corresponding Clause does not exist
(Title)
7.1.5.1 General Corresponding Clause does not exist

7.1.5.2 Measuring traceability Corresponding Clause does not exist

7.1.6 Organizational knowledge Corresponding Clause does not exist

7.2 7.2 Competence Competence

7.3 7.3 Awareness Awareness

7.4 Corresponding Clause does not exist Communication (Title)

7.4 7.4.1 Communication General

7.4.2 Corresponding Clause does not exist Internal Communication

7.4.3 External Communication

7.5 7.5 Documented information (Title) Documented information (Title)

7.5.1 7.5.1 General General

7.5.2 7.5.2 Creating and updating Creating and updating

Control of documented information

7.5.3 Corresponding Clause does not exist
(Title)

Control of documented information,

7.5.3.1 7.5.3 (about purpose of control)
paragraph-1

Control of documented information,

7.5.3.2 7.5.3 (about requirements for control)
paragraph-2 & 3

8.0 8.0 8 OPERATION (Title) 8 OPERATION (Title)

8.1 8.1 8.1 Operational planning and control 8.1 Operational planning and control

8.2 Emergency preparedness and

8.2 Corresponding Clause does not exist
response

8.2 Requirements for products &

8.2 Corresponding Clause does not exist
services (Title)
 8.2.1 8.2.1 Customer communication Corresponding Clause does not exist

8.2.2 Determining the requirements

8.2.2 Corresponding Clause does not exist
for products & services

8.2.3 Review of the requirements

8.2.3 Corresponding Clause does not exist
for products & services (Title)

8.2.3.1
8.2.3.1 & 8.2.3.2 (about review,
& Corresponding Clause does not exist
documented info)
8.2.3.2

8.2.4 Changes to requirements for

8.2.4 Corresponding Clause does not exist
products & services

8.3 D & D of products and services

8.3 Corresponding Clause does not exist
(Title)

8.3.1 to 8.3.1 to 8.3.6 – General, Planning,

Corresponding Clause does not exist
8.3.6 Inputs, Controls, Outputs, Changes

8.4 Control of externally provided

8.4 processes, products and services Corresponding Clause does not exist
(Title)

8.4.1 8.4.1 General Corresponding Clause does not exist

8.4.2 8.4.2 Type and extent of control Corresponding Clause does not exist

8.4.3 Information for external

8.4.3 Corresponding Clause does not exist
providers

8.5 Production and service provision

8.5 Corresponding Clause does not exist
(Title)

8.5.1 Control of production and

8.5.1 Corresponding Clause does not exist
service provision

8.5.2 8.5.2 Identification and traceability Corresponding Clause does not exist

8.5.3 Property belonging to

8.5.3 Corresponding Clause does not exist
customers or external providers

8.5.4 8.5.4 Preservation Corresponding Clause does not exist

8.5.5 8.5.5 Post-delivery activities Corresponding Clause does not exist

8.5.6 8.5.6 Control of changes Corresponding Clause does not exist

8.5.7 8.6 Release of products and services Corresponding Clause does not exist
 8.7 Control of nonconforming
8.7 Corresponding Clause does not exist
outputs (Title)

8.7.1 8.7.1 (about required control) Corresponding Clause does not exist

8.7.2 (about required documented

8.7.2 Corresponding Clause does not exist
information)

9 PERFORMANCE EVALUATION 9 PERFORMANCE EVALUATION

9.0 9.0
(Title) (Title)

9.1 Monitoring, measuring, analysis 9.1 Monitoring, measuring, analysis

9.1 9.1
and evaluation (Title) and evaluation (Title)

9.1.1 9.1.1 9.1.1 General 9.1.1 General

9.1.1 Corresponding Clause does not exist 9.1.1 General

9.1.2 Corresponding Clause does not exist 9.1.2 Evaluation of compliance

9.1.2 9.1.2 Customer satisfaction Corresponding Clause does not exist

9.1.3 9.1.3 Analysis and evaluation Corresponding Clause does not exist

9.2 9.2 9.2 Internal audit (Title) 9.2 Internal audit (Title)

9.2.1 9.2.1 9.2.1 (about general requirements) 9.2.1 General

9.2.2 9.2.2 9.2.2 (about audit programmes) 9.2.2 Internal audit programme

9.3 9.3 Management review (Title) Corresponding Clause does not exist

9.3 Management review, paragraph-

9.3.1 9.3 9.3.1 General
1

9.3 Management review, paragraph-

9.3.2 9.3 9.3.2 Management review inputs
2

9.3 Management review, paragraph-

9.3.3 9.3 9.3.3 Management review outputs
3

10.0 10.0 10 IMPROVEMENT (Title) 10 IMPROVEMENT (Title)

10.1 10.1 10.1 General 10.1 General

 10.2 Nonconformity and corrective
10.2 Corresponding Clause does not exist
action (Title)

10.2 Incident, Nonconformity &

10.2.1 10.2 10.2.1 (about required actions)
corrective action, paragraph-1, 2

10.2.2 (about required documented 10.2 Incident, Nonconformity &

10.2.2 10.2
information) corrective action, paragraph-3

10.3 10.3 10.3 Continual improvement 10.3 Continual improvement

9001:2015 PLAN

4. Context of
5. Leadership 6. Planning 7. Support
Organization

4.1 Understanding
of the Leadership & Action to Address
Resources
organization and Commitment Risk & Opportunity
its context

4.2 Needs &

Expectations of Quality Policy Quality Objectives Competence
Interested Parties

Roles,
4.3 Scope of the Planning &
Responsibilities & Awareness
QMS Changes
Authority

4.4 QMS & Its

Communication
Processes

Documented
Information

45001:2018 PLAN

4. Context of
5. Leadership 6. Planning 7. Support
Organization

4.1 Understanding 6.1 Action to

5.1 Leadership &
the organization Address Risk & 7.1 Resources
Commitment
and its context Opportunities
4.2 Understanding 6.2 OH & S
the Needs & Objectives and
5.2 OH & S Policy 7.2 Competence
Expectations of Planning to
Interested Parties Achieve Them

4.3 Determine the 5.3 Organizational

Scope of the OH&S Roles,
7.3 Awareness
Management Responsibilities &
System Authorities

4.4 OH&S
Management 5.4 Participation 7.4 Information &
System and Your & Consultation Communication
Processes

7.5 Documented
Information
 DO CHECK ACT

9. Performance
8. Operation 10. Improvement
Evaluation

Monitoring,
Nonconformity
Operation Measurement,
and Corrective
Planning & Control Analysis and
Action
Evaluation

Determination of
Continual
Requirements for Internal Audit
Improvement
Product/Services

Design & Management

Development Review

Control of
Externally Provide
Products and
Services

Production &
Service Provision

Release of Product
& Services

Control of
Nonconforming
Process Output,
Products &
Services

DO CHECK ACT

Performance
8. Operation Improvement
Evaluation

9.1 Monitoring
10.1 Incident Non
8.1 Operation Measurement
Conformity &
Planning & Control Analysis and
Correction Action
Evaluation
8.2 Management 10.2 Continual
9.2 Internal Audit
of Change Improvement

9.3 Management
8.3 Outsourcing
Review

8.4 Procurement

8.5 Contractors

8.6 Emergency
Prepardness &
Response