EHQMS Integrated System Manual

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ISO 9001:2015, ISO 14001:2015 & ISO 45001:2018

Table of Contents
1 INTRODUCTION ................................................................................................................................................5

2 QUALITY MANAGEMENT PRINCIPLES ..........................................................................................................6

3 REFERENCES & DEFINITIONS .........................................................................................................................6

4 ABOUT OUR ORGANIZATION ........................................................................................................................7

ORGANIZATIONAL CONTEXT ......................................................................................................................................................... 7

RELEVANT INTERESTED PARTIES .................................................................................................................................................... 8
MANAGEMENT SYSTEM SCOPE..................................................................................................................................................... 8
MANAGEMENT SYSTEM PROCESSES ............................................................................................................................................ 9

5 LEADERSHIP, COMMITMENT & WORKER PARTICIPATION ................................................................... 11

LEADERSHIP & COMMITMENT ....................................................................................................................................................11

5.1.1 General ...............................................................................................................................................................................11
5.1.2 Customer Focus ..............................................................................................................................................................12
MANAGEMENT SYSTEM POLICIES ...............................................................................................................................................12
5.2.1 Establishing our Policies .............................................................................................................................................12
5.2.2 Communicating our Policies .....................................................................................................................................13
ROLES, RESPONSIBILITIES & AUTHORITIES ................................................................................................................................13
5.3.1 Top Management ..........................................................................................................................................................13
5.3.2 QEHS Manager ...............................................................................................................................................................13
5.3.3 Quality Coordinator ......................................................................................................................................................14
5.3.4 Environmental Coordinator .......................................................................................................................................14
5.3.5 Health & Safety Advisors ............................................................................................................................................14
5.3.6 Managers & Supervisors.............................................................................................................................................15
5.3.7 Workers & Contractors................................................................................................................................................15
CONSULTATION & PARTICIPATION OF WORKERS AND CONTRACTORS ................................................................................15

6 PLANNING ...................................................................................................................................................... 17

ACTIONS TO ADDRESS RISK & OPPORTUNITIES .......................................................................................................................17

6.1.1 Risks & Opportunities ..................................................................................................................................................17
6.1.2 Environmental Aspects ................................................................................................................................................17
6.1.3 Hazard Identification & Assessment ......................................................................................................................19
6.1.4 Legal & Compliance Requirements ........................................................................................................................19
6.1.5 Planning Action ..............................................................................................................................................................20
MANAGEMENT SYSTEM OBJECTIVES ..........................................................................................................................................21
6.2.1 Integrated Objectives ...................................................................................................................................................21
6.2.2 Objectives & Planning to Achieve Them ..............................................................................................................22
PLANNING FOR CHANGE .............................................................................................................................................................23

7 SUPPORT......................................................................................................................................................... 25

RESOURCES ...................................................................................................................................................................................25
7.1.1 General ...............................................................................................................................................................................25

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7.1.2 People ................................................................................................................................................................................25

7.1.3 Infrastructure & Natural Resources ........................................................................................................................25
7.1.4 Operational Environment ...........................................................................................................................................26
7.1.5 Monitoring & Measurement Tools .........................................................................................................................26
7.1.6 Organizational Knowledge ........................................................................................................................................27
COMPETENCE ................................................................................................................................................................................28
AWARENESS ..................................................................................................................................................................................28
COMMUNICATION ........................................................................................................................................................................29
7.4.1 General ...............................................................................................................................................................................29
7.4.2 Internal Communication .............................................................................................................................................29
7.4.3 External Communication.............................................................................................................................................30
DOCUMENTED INFORMATION ....................................................................................................................................................31
7.5.1 Management System Documents ...........................................................................................................................31
7.5.2 Creating & Updating ....................................................................................................................................................31
7.5.3 Controlling Documented Information ...................................................................................................................31

8 OPERATION .................................................................................................................................................... 33

OPERATIONAL PLANNING & CONTROL.....................................................................................................................................33

8.1.1 Quality Operational Planning & Control ..............................................................................................................33
8.1.2 Environmental Operational Planning & Control ...............................................................................................33
8.1.3 OH&S Operational Planning & Control ................................................................................................................34
DETERMINING REQUIREMENTS FOR PRODUCTS .......................................................................................................................35
8.2.1 Customer Communication .........................................................................................................................................35
8.2.2 Determining Requirements .......................................................................................................................................36
8.2.3 Reviewing Requirements ............................................................................................................................................36
8.2.4 Changes in Requirements ..........................................................................................................................................36
DESIGN & DEVELOPMENT ...........................................................................................................................................................37
8.3.1 General ...............................................................................................................................................................................37
8.3.2 Planning .............................................................................................................................................................................37
8.3.3 Inputs ..................................................................................................................................................................................37
8.3.4 Controls .............................................................................................................................................................................38
8.3.5 Outputs ..............................................................................................................................................................................39
8.3.6 Changes .............................................................................................................................................................................39
CONTROL OF SUPPLIERS, EXTERNAL PROCESSES AND CONTRACTORS ..................................................................................39
8.4.1 General ...............................................................................................................................................................................39
8.4.2 Purchasing Controls ......................................................................................................................................................40
8.4.3 Purchasing Information ...............................................................................................................................................40
PRODUCTION & SERVICE PROVISION ........................................................................................................................................41
8.5.1 Control of Production & Service Provision..........................................................................................................41
8.5.2 Identification & Traceability ......................................................................................................................................41
8.5.3 3rd Party Property ...........................................................................................................................................................42
8.5.4 Preservation .....................................................................................................................................................................42
8.5.5 Post-delivery Activities ................................................................................................................................................43
8.5.6 Control of Changes .......................................................................................................................................................43

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RELEASE OF PRODUCTS & SERVICES ..........................................................................................................................................43

NON-CONFORMING OUTPUTS ...................................................................................................................................................44
EMERGENCY SITUATIONS.............................................................................................................................................................44

9 PERFORMANCE EVALUATION ..................................................................................................................... 46

MONITORING, MEASUREMENT, ANALYSIS & EVALUATION ....................................................................................................46

9.1.1 General ...............................................................................................................................................................................46
9.1.2 Customer Satisfaction ..................................................................................................................................................46
9.1.3 Analysis & Evaluation ...................................................................................................................................................47
9.1.4 Evaluation of Compliance ...........................................................................................................................................47
INTERNAL AUDIT...........................................................................................................................................................................48
9.2.1 General ...............................................................................................................................................................................48
9.2.2 Internal Audit Programme .........................................................................................................................................48
MANAGEMENT REVIEW ...............................................................................................................................................................48
9.3.1 General ...............................................................................................................................................................................48
9.3.2 Inputs ..................................................................................................................................................................................49
9.3.3 Outputs ..............................................................................................................................................................................49

10 IMPROVEMENT .......................................................................................................................................... 51

GENERAL........................................................................................................................................................................................51
INCIDENT, NON-CONFORMITY & CORRECTIVE ACTION .........................................................................................................51
10.2.1 Non-conformity & Corrective Action ....................................................................................................................51
10.2.2 Incident Investigation ..................................................................................................................................................52
IMPROVEMENT ..............................................................................................................................................................................52

APPENDICES .......................................................................................................................................................... 54

A.1 INTEGRATED MANAGEMENT SYSTEM INTERACTION ................................................................................................................54

A.2 INTEGRATED MANAGEMENT SYSTEM DOCUMENT INDEX .......................................................................................................55
A.2.1 List of Procedures ..........................................................................................................................................................55
A.2.2 List of Report & Forms ................................................................................................................................................55
A.2.3 List of Audit Documents .............................................................................................................................................56
A.2.4 List of Gap Analysis Documents ..............................................................................................................................56
A.3 ORGANIZATION CHART ...............................................................................................................................................................57

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ISO 9001:2015, ISO 14001:2015 & ISO 45001:2018

1 Introduction
Your organization has developed and implemented an integrated Quality, Environmental and Occupational
Health & Safety (QEHS) Management System, which uses ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018
as framework for our organization to document and improve our operational practices in order to better satisfy
the needs and expectations of our workers, customers, stakeholders and interested parties.

This integrated system manual is used to familiarise our workers, customers, interested parties, or individuals
with the controls that have been implemented and to assure them that the integrity of our management system
is maintained and is focused on meeting its intended outcomes.

This manual also describes the structure and interactions of our management system, delineates authorities,
inter relationships and responsibilities of personnel who operate within the boundaries of your organization’s
QEHS management system, whilst providing reference to the procedures, forms, reports, process and activities
that comprise it.

The Figure below illustrates our methodology for the development of an integrated management system, which
uses the iterative Plan, Do, Check, Act cycle to implement the process approach that helps deliver management
system objectives, stakeholder requirements and customer satisfaction.

Figure 1: QEHS Management System Process Model

Internal & External Issues Needs & Expectations of Interested Parties

Context of the Organization

Scope of the QEHS Management System

Planning

PLAN

Operation

ACT Leadership,
Commitment & Support &
Improvement
Worker Operation
DO
Participation

CHECK

Performance
Evaluation

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Our integrated QEHS management system addresses and supports our wider strategies for the design,
development, manufacturing, installation and service of our products. Insert the registered address of your
organization and/or facilities here.

Insert your scope statement here. This should succinctly summarize what your business does and what your
products and or services are. A couple of sentences and some bullet points is all that is required, as this text
will be shown the certificate.

The following table identifies any ISO 9001:2015 requirements, from Section 8.0, that are not applicable to our
organization as well as providing a brief narrative to justify their omission from the scope of the QEHS
management system:

Clause Justification for Exclusion

2 Quality Management Principles

Your organization has adopted and realizes the benefits of the ISO 9000:2015 quality management principles
into our daily activities. The intent of the quality management principles is to provide a foundation to
continually improve upon our performance. Subsequent sections of this management system manual
demonstrate our commitments of the following principles:

1. Customer focus;
2. Leadership;
3. Engagement of our people;
4. Process approach;
5. Improvement;
6. Evidence‐based decision making;
7. Relationship management.

3 References & Definitions

In addition to ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018, we also make reference to other relevant
national or International standards as well as customer specifications appropriate to our context.

Standard Title Description

BS EN ISO 9000:2015 Quality management systems Fundamentals and vocabulary
BS EN ISO 9004:2000 Quality management systems Guidelines for performance improvements
BS EN ISO 19011:2011 Auditing management systems Guidelines for auditing
BS EN ISO 14004:2016 Environmental management systems Guidelines for implementation

This document does not introduce any new definitions but rather relies on the following:

1. Definitions typically used by our customers, stakeholders or marketplace;

2. Terms typically used in standards and regulations as they relate to our products and services;
3. Standard business terminology;
4. Terms and vocabulary commonly used in quality and <engineering, construction, manufacturing>
practices.

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4 About Our Organization

Organizational Context
Your organization is committed to defining our position in the marketplace and understanding how relevant
factors arising from legal, political, economic, social and technological issues influence our strategic direction
and our organizational context. To ensure that our QEHS management system is aligned with our strategy,
whilst taking account of relevant internal and external factors; we collate and analyze pertinent information in
order to determine the potential impact on our context and subsequent business strategy.

Figure 2: Examples of Internal & External Influences Your organization identifies, analyzes, monitors and
reviews factors that may affect our ability to satisfy
• Stakeholders our customers and stakeholders, as well as; factors
• Legislators that may adversely affect the stability of our
Types of • Regulators processes and the integrity of the management
external • Consumers
system. Broadly, these issues are defined as:
influence • Media
• Community Internal issues are conditions related to our
organizational activities, products, services,
Types of strategic direction, culture, people, knowledge,
internal processes and systems. Using SWOT analysis
influence provides our organization with framework for
reviewing and evaluating our strategies, and the
• Unions Organizational position and direction of our organization, business
• Workers Context
propositions and other ideas;
• Contractors
• Culture External issues are conditions related to cultural,
• Knowledge social, political, legal, regulatory, financial,
• Shareholders technological, economic, competition at local,
national or international levels. Using PESTLE
analysis provides our organization with framework for measuring our market and growth potential according
to external political, economic, social, technological, legal and environmental factors.

Your organization monitors and reviews this information to ensure that a continual understanding of each
party’s requirements is derived and maintained. To facilitate the understanding of our context, we regularly
consider issues that influence our context during management review meetings using the Context & Interested
Party Analysis template.

The results of which are conveyed via minutes and business planning documents. We maintain and retain; in
addition to this document, the following documented information to describe our organizational context and
decisions relating to it:
1. Analysis of business plans, strategies, and statutory and regulatory commitments;
2. Analysis of technology, competitors, economic reports from relevant business sectors or from
technical experts and consultants;
The outputs from these activities are evident as an input to determining the scope of our management (4.3)
and its processes (4.4), as well as, the consideration of risks and opportunities that may affect the QEHS
management system, and the resulting actions that we take to address them (6.1).

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Relevant Interested Parties

Your organization identifies and classifies its interested parties, based on current information and knowledge
held within our business. Each interested party is allocated to one or more categories and is analyzed to
determine whether any relevant needs or expectations exist; which could impact our business activities or the
QEHS management system, and which must be adopted by the organization.

Interested parties and their requirements are ranked Figure 3: Types of Interested Party
and scored using simple, subjective criteria to create a
Risk Potential Number (RPN). This is captured using
the Context & Interested Party Analysis template.
Consumers
Prioritized relevant needs or expectations are
converted into requirements which become inputs to
planning, and product and/or service designs. The Community Regulators
outputs from this process are typically used to inform
the following sections and processes of the QEHS Parties that may
management system: be affected by our
organization's
1. Management system scope - 4.3; activities

2. Management system processes - 4.4;

Shareholders Suppliers
3. Risk and opportunities - 6.1.1;
4. Environmental aspect and impacts - 6.1.2;
5. OH&S hazard identification - 6.1.3;
Media
6. Legal and compliance requirements - 6.1.4;
7. Communication - 7.4;
8. Operations - 8.0.
Your organization recognizes that we have a unique set of interested parties whose needs and expectations
change and develop over time, and furthermore; that only a limited set of their respective needs and
expectations are applicable to our operational purpose.

Management System Scope

Your organization is able to exert authority and differing levels of control and influence over our activities, as
they relate to our products and services, as performed at our facilities. The functional and organizational
boundaries for the different physical locations (where applicable) and the level of control and influence are
summarised below:

Physical Functional Organizational Authority

The facilities at All activities performed and Complete organizational We have a high degree of
our registered managed by our organization which control over current authority in order to control or
address result in product or service outputs activities influence related processes
External process 3rd Parties are controlled and
Undertaking process as per our Purchasing and
performed by influenced through contractual
specifications contractual controls
3rd parties mechanisms

Based on the scope of our activities described in Section 1 - Introduction and the analysis of the issues and
requirements identified in Sections 4.1 and 4.2, your organization has established the scope of our QEHS
management system in order the implement the objectives and policies that are relevant to our context, our

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physical and organizational boundaries, product life-cycles and related interested parties. In order for our
management system to be robust, all the activities, products and services undertaken by your organization are
included with in the scope of the management system. In this way, we are able to control and influence our
activities, products and services.

The scope of this document describes our management system, delineates authorities, inter-relationships and
responsibilities of process owners and personnel that operate within management system and the sequence
and interaction of our processes. Conformance to ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018 has been
verified utilizing a formal assessment and review process undertaken by <insert the name of your Registrar>.

Although we recognize that ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018 does not require a formal
manual, we have decided to retain and update our integrated manual, as our employees, customers, suppliers
and other stakeholders perceive it to add value to our operations.

Management System Processes

Your organization has implemented the QEHS management system which exists as part of a broader
management landscape that has established, documented and implemented our processes, integrated policies
and objectives, whilst satisfying the requirements of ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018.

To achieve this, your organization has adopted the process approach advocated by the above management
system standards by adopting the ‘process approach’ into our daily operations and by using the PDCA cycle to
for process management and to stimulate improvement. The utilization of risk‐based thinking is considered
and applied when developing, implementing, and improving the effectiveness of our management system.

The process landscape is defined three key groups, their sub-processes, and by managing their inputs, activities,
controls, outputs and interfaces; our organization ensures that management system effectiveness is established,
monitored, maintained and improved. The process landscape is described and reported using tools such as
documented procedures, process maps, turtle diagrams, matrices, schedules and charts, etc.

Process Landscape
Key Process Sub-processes Output
Business Planning, Sales & Marketing, QEHS
Business Management
Management, Business Review & Improvement, and
Processes Customer satisfaction and all
Operational Planning
supporting information,
Order/Quote Fulfilment, Design & Development, documented information and
Operation & Production Procurement & Supply, Production/Manufacturing, indicators necessary to
Processes Inspection & Calibration, and Storage, Packing & demonstrate the ability of the
Shipping QHES management system
and processes to achieve
Facilities & Maintenance, Corrective Action, Internal
Support & Assurance planned results.
Audit, Customer Service, Training & Human Resources,
Processes
and Document Control & Knowledge

Refer to Appendix A.1 for the sequence and the interaction of the processes comprising our QEHS
management system and refer to Appendix A.2 for schedules of current QEHS procedures, reports, forms and
checklists.

The monitoring of key performance indicators (KPIs), which are linked to our objectives, is used to measure,
monitor and communicate process performance. This approach allows Top management to regularly review
QEHS management system performance and to ensure its ongoing integration with business processes.

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As part of the decision-making process; we use trends and statistical data and trends related to non-
conformities, environmental, quality and OH&S related aspects, targets, objectives and corrective actions, as
well as, monitoring and measurement results, audit results, levels of customer satisfaction, process performance
data and compliance data, to ensure that objective management decisions can be made.

Where your organization identifies the requirement to outsource any process, or part thereof, which affects
conformity with the stated requirements; your organization identifies control criteria such as; the competence
of workers and contractors, inspection regimes, the provision of product conformity certificates, adherence to
specifications and specific job files, etc.

Refer to the Process Matrix & Application template which is used to map out and assign responsibilities for
achieving requirements to relevant functions, processes, and departments. This information forms the basis for
our internal audit programme.

Supporting documentation:
Ref. Title & Description
01 Organizational Context Procedure

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A.2 Integrated Management System Document Index

A.2.1 List of Procedures
Ref. Title & Description Ref. Title & Description
01 Organizational Context 14 Design & Development
02 Risks & Opportunities 15 Purchasing & Procurement
03 Aspect Identification & Assessment 16 Product & Service Provision
04 Hazard Identification & Assessment 17 Testing & Inspection
05 Legal & Compliance Requirements 18 Non-conforming Outputs
06 Objectives, Targets & Indicators 19 Emergency Situations
07 Infrastructure & Natural Resources 20 Customer Satisfaction
08 Calibrated Equipment 21 Data Analysis & Evaluation
09 Competence & Awareness 22 Internal Audits
10 Communication & Participation 23 Management Reviews
11 Documented Information 24 Non-conformity & Corrective Action 
12 Operational Control 25 Incident Investigation
13 Contract Review 26 Continual Improvement

A.2.2 List of Report & Forms

Ref. Title & Description Ref. Title & Description
01 Context & Interested Parties 27 Supplier Evaluation
02 Process Matrix & Application 28 Receiving Inspection Log
03 SWOT Analysis Template 29 Customer Property Log
04 PESTLE Analysis Template 30 Production Control Plan
05 Risk & Opportunity Register 31 Traceability Log
06 Aspect Identification Register 32 Inspection & Test Report
07 Hazard Identification Register 33 First Article Inspection Log
08 OHS Hazard Assessment 34 In-process Inspection Log
09 Legal & Compliance Register 35 Final Inspection Log
10 Register of QEHS Objectives & KPIs 36 Non-conformity Report
11 Objectives Management Programme 37 Concession Request
12 Equipment Maintenance & Service Log 38 Concession Request Log
13 Competency Review 39 Emergency Equipment Log
14 Training Attendance 40 Emergency Preparedness & Response Matrix
15 Training Evaluation 41 Customer Feedback Log
16 Controlled Equipment Log 42 Customer Satisfaction Survey
17 Calibration Log 43 Internal Audit Report
18 Software Validation Log 44 Internal Audit Assignment
19 Master Document & Record Index 45 Internal Audit Feedback
20 Document Issue Sheet 46 Management Review Agenda & Minutes
21 Document Change Request 47 Corrective Action Report
22 Life Cycle Analysis Template 48 Corrective Action Log
23 Requirements Review Checklist 49 Incident Investigation Form
24 Design Change Request 50 Incident Report
25 Design Change Request Log 51 Improvement Activity Form
26 Approved Supplier Index 52 Process Effectiveness Assessment Form

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A.2.3 List of Audit Documents

Ref. Title & Description
01 Internal Audit Programme (10-year & 2-year programmes)
02 Integrated Audit Checklist (with compliance charts)
03 Process Audit Report
04 Supplier Audit Checklist

A.2.4 List of Gap Analysis Documents

Ref. Title & Description
01 ISO 9001-2015 Gap Analysis & Transition Guide
02 ISO 14001-2015 Gap Analysis & Transition Guide
03 ISO 45001-2018 Gap Analysis & Transition Guide

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