ehqms manual & policy document - iso 9001...

Quality management input comprises the

standard requirements from ISO 9001:2015

which are strategically deployed by our

organization to achieve customer satisfaction

through process control.

Environmental input comprises the standard

requirements from ISO 14001:2015 which

provides our organization with a framework to

help protect the environment and respond to

changing environmental conditions in balance

with socio-economic needs.

The health and safety management input meets

the requirements of OHSAS 18001:2007 to

enhance opportunities, control occupational

hazards and manage all aspects of health and

safety.

EHQMS

Manual &

Policy

Document ISO 9001:2015, ISO 14001:2015 &

OHSAS 18001:2007

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EHQMS Manual & Policy Document

ISO 9001:2015, ISO 14001:2015 & OHSAS 18001:2007

Document Ref. of 53

Table of Contents

1 INTRODUCTION ............................................................................................................................................... 5

2 REFERENCES & DEFINITIONS ......................................................................................................................... 6

3 COMMON REQUIREMENTS ............................................................................................................................ 7

4 ABOUT OUR ORGANIZATION ......................................................................................................................10

4.1 ORGANIZATIONAL CONTEXT ...................................................................................................................................................... 10

4.2 RELEVANT INTERESTED PARTIES ................................................................................................................................................. 11

4.3 INTEGRATED MANAGEMENT SYSTEM........................................................................................................................................ 11

4.3.1 EHQMS Scope ................................................................................................................................................................ 11

4.3.2 EHQMS Processes......................................................................................................................................................... 12

4.3.3 Outsourced Processes ................................................................................................................................................ 12

4.3.4 Documented Information .......................................................................................................................................... 12

5 LEADERSHIP & GOVERNANCE .....................................................................................................................14

5.1 LEADERSHIP & COMMITMENT ................................................................................................................................................... 14

5.1.1 EHQMS Management ................................................................................................................................................. 14

5.1.2 Customer Focus ............................................................................................................................................................. 15

5.2 CORPORATE POLICIES ................................................................................................................................................................. 15

5.2.1 Establishing & Communicating .............................................................................................................................. 15

5.2.2 Policy Statement ........................................................................................................................................................... 16

5.3 ROLE, RESPONSIBILITIES & AUTHORITIES ................................................................................................................................. 17

5.3.1 Top Management ......................................................................................................................................................... 17

5.3.2 IMS Manager .................................................................................................................................................................. 17

5.3.3 Department Managers ............................................................................................................................................... 18

5.3.4 Employees ....................................................................................................................................................................... 18

5.4 COMMUNICATION ....................................................................................................................................................................... 18

5.4.1 Internal Communication ............................................................................................................................................ 18

5.4.2 External Communication ........................................................................................................................................... 19

6 EHQMS PLANNING ........................................................................................................................................20

6.1 GENERAL....................................................................................................................................................................................... 20

6.1.1 Risks & Opportunities ................................................................................................................................................. 20

6.1.2 Environmental Impacts ............................................................................................................................................... 21

6.1.3 Occupational Hazards ................................................................................................................................................. 22

6.1.4 Compliance Obligations ............................................................................................................................................ 23

6.2 EHQMS OBJECTIVES .................................................................................................................................................................. 24

6.2.1 Objectives ........................................................................................................................................................................ 24

6.2.2 Objectives & Planning to Achieve Them ............................................................................................................. 25

6.3 PLANNING FOR CHANGE ............................................................................................................................................................ 26

7 SUPPORT .........................................................................................................................................................28 Sample

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7.1 RESOURCES .................................................................................................................................................................................. 28

7.1.1 General .............................................................................................................................................................................. 28

7.1.2 People & Training ........................................................................................................................................................ 28

7.1.3 Infrastructure & Natural Resources ....................................................................................................................... 29

7.1.4 Operational Environment .......................................................................................................................................... 31

7.1.5 Monitoring & Measurement Tools ........................................................................................................................ 31

7.1.6 Organizational Knowledge ....................................................................................................................................... 31

8 PRODUCT & SERVICE DEVELOPMENT ........................................................................................................33

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

8.1.1 Environmental Management ................................................................................................................................... 33

8.1.2 Quality Management .................................................................................................................................................. 33

8.1.3 Health & Safety Management ................................................................................................................................. 34

8.2 DETERMINING REQUIREMENTS FOR PRODUCTS ...................................................................................................................... 34

8.2.1 Customer Communication ........................................................................................................................................ 34

8.2.2 Determining Requirements ...................................................................................................................................... 35

8.2.3 Reviewing Requirements ........................................................................................................................................... 35

8.2.4 Changes in Requirements ......................................................................................................................................... 35

8.3 DESIGN & DEVELOPMENT .......................................................................................................................................................... 36

8.3.1 General .............................................................................................................................................................................. 36

8.3.2 Planning............................................................................................................................................................................ 36

8.3.3 Inputs ................................................................................................................................................................................. 37

8.3.4 Controls ............................................................................................................................................................................ 37

8.3.5 Outputs ............................................................................................................................................................................. 38

8.3.6 Changes ............................................................................................................................................................................ 38

8.4 CONTROL OF SUPPLIERS & EXTERNAL PROCESSES ................................................................................................................. 38

8.4.1 General .............................................................................................................................................................................. 38

8.4.2 Purchasing Controls .................................................................................................................................................... 39

8.4.3 Purchasing Information .............................................................................................................................................. 39

8.5 PRODUCTION & SERVICE PROVISION ....................................................................................................................................... 40

8.5.1 Control of Production & Service Provision ........................................................................................................ 40

8.5.2 Identification & Traceability ..................................................................................................................................... 40

8.5.3 3rd

Party Property .......................................................................................................................................................... 41

8.5.4 Preservation .................................................................................................................................................................... 41

8.5.5 Post-delivery Activities ............................................................................................................................................... 42

8.5.6 Control of Changes ...................................................................................................................................................... 42

8.6 RELEASE OF PRODUCTS & SERVICES ......................................................................................................................................... 42

8.7 CONTROL OF NON-CONFORMING OUTPUTS .......................................................................................................................... 43

8.8 ENVIRONMENTAL EMERGENCY SITUATIONS ............................................................................................................................ 43

8.9 ACCIDENT & INCIDENT INVESTIGATION ................................................................................................................................... 44

9 PERFORMANCE EVALUATION .....................................................................................................................45

9.1 MONITORING, MEASUREMENT, ANALYSIS & EVALUATION ................................................................................................... 45 Sam

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9.1.1 General .............................................................................................................................................................................. 45

9.1.2 Customer Satisfaction ................................................................................................................................................. 45

9.1.3 Analysis & Evaluation .................................................................................................................................................. 46

9.1.4 Evaluation of Compliance.......................................................................................................................................... 46

9.2 INTERNAL AUDIT .......................................................................................................................................................................... 47

9.3 MANAGEMENT REVIEW .............................................................................................................................................................. 48

9.3.1 General .............................................................................................................................................................................. 48

9.3.2 Inputs ................................................................................................................................................................................. 48

9.3.3 Outputs ............................................................................................................................................................................. 49

10 IMPROVEMENT ..........................................................................................................................................50

10.1 GENERAL....................................................................................................................................................................................... 50

10.2 NON-CONFORMITY & CORRECTIVE ACTION ........................................................................................................................... 50

10.3 IMPROVEMENT ............................................................................................................................................................................. 51

APPENDICES ...........................................................................................................................................................52

A.1 SEQUENCE & INTERACTION OF EHQMS PROCESSES ............................................................................................................ 52

A.2 ORGANIZATION CHART .............................................................................................................................................................. 53

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3 Common Requirements Your organization’s integrated management system (EHQMS) shares common requirements that are

stipulated by ISO 9001:2015 and ISO 14001:2015. Within this framework, the requirements for OHSAS

18001:2007 are also detailed. The table shown below cross refers these common requirements to the section

headings found in this document:

Environmental, Health & Safety and Quality Management System ISO/OHSAS Standard Clause Ref.

Section No. EHQMS Manual Heading BS EN ISO

9001:2015

BS EN ISO

14001:2015

OHSAS

18001:2007

4.0 About our Organization 4.0 4.0 4.0

4.1 Organizational Context 4.1 4.1 4.1

4.2 Relevant Interested Parties 4.2 4.2 4.3.2

4.3.1 EHQMS Scope 4.3 4.3 4.1

4.3.2 EHQMS Processes 4.4 4.4 4.1

4.3.4 Documented Information 7.5 7.5 4.4.4

4.3.4.1 Management System Documents 7.5.1 7.5.1 4.4.4

4.3.4.2 Creating and Updating 7.5.2 7.5.2 4.4.4

4.3.4.3 Controlling Documented Information 7.5.3 7.5.3 4.4.5 & 4.5.4

5.0 Leadership & Governance 5.0 5.0 4.4.1

5.1 Leadership and Commitment 5.1 5.1 4.4.1

5.1.1 EHQMS Management 5.1.1 5.1 4.4.1

5.1.2 Customer Focus 5.1.2 N/a N/a

5.2 Corporate Policies 5.2 5.2 4.2

5.2.1 Establishing & Communicating 5.2.1 5.2 4.2

5.2.2 Policy Statement 5.2.2 5.2 4.2

5.3 Roles, Responsibilities and Authorities 5.3 5.3 4.4.1

5.4 Communication 7.4 7.4.1 4.4.3

5.4.1 Internal Communication 7.4 7.4.2 4.4.3.2

5.4.2 External Communication 7.4 7.4.3 4.4.3.1

6.0 EHQMS Planning 6.0 6.0 4.3

6.1 General 6.1 6.1 4.3.1

6.1.1 Risk & Opportunities 6.1.1 6.1.1 4.3.1

6.1.2 Environmental Aspects 6.1.2 6.1.2 N/a

6.1.3 Occupational Hazards N/a N/a 4.3.1

6.1.4 Compliance Obligations 6.1.3 6.1.3 4.3.2

6.2 EHQMS Objectives 6.2 6.2.1 4.3.3

6.2.1 Objectives 6.2 6.2.1 4.3.3

6.2.2 Objectives & Planning to Achieve Them 6.2 6.1.4 & 6.2.2 4.3.3

6.3 Planning for Change 6.3 N/a N/a

7 Support 7.0 7.0 4.4

7.1 Resources 7.1 7.1 4.4.1

7.1.1 General 7.1.1 7.1 4.4.1

7.1.2 People 7.1.2 7.1 4.4.2

7.1.2.1 Competence 7.2 7.2 4.4.2

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ISO 9001:2015, ISO 14001:2015 & OHSAS 18001:2007


4 About Our Organization 4.1 Organizational Context

Your organization is committed to determining our position in the marketplace and understanding how

relevant factors arising from legal, political, economic, social and technological issues influence our strategic

direction and which define our organizational context.

Your organization identifies, analyzes, monitors and

reviews factors that may affect our ability to satisfy

our customers and stakeholders, as well as; factors

that may adversely affect the stability and integrity

of our processes and our management system.

To ensure that our organizational context is aligned

with our strategy, whilst taking account of relevant,

influential, internal and external factors; your

organization collates and analyzes information

pertinent to those influential factors to identify

issues that have the potential to be affected by our

activities, products and services. Similarly, we

identify internal and external issues that could be

capable of affecting our organization’s ability to

deliver products, services or activities.

Your organization collates, assesses and reviews

information about these relevant influential factors

to ensure that a continual understanding of each factor and its affects is derived and maintained in order to

develop our contextual intelligence. To facilitate the understanding of our context, Top management

regularly consider these issues using SWOT and PESTLE analysis to determine and plan for issues that may

influence our business. These are reviewed during management review meetings, the results of which are

recorded and conveyed via meeting minutes, revised objectives, corporate policies, and business planning

documents where appropriate.

The output from this activity is evident as an input to the consideration of risks and opportunities, and the

actions that we take to address them. For more information about our risk and opportunity management

framework, refer to Section 6.1. Although we acknowledge that ISO 9001:2015, ISO 14001:2015 and OHSAS

18001:2007 do not require our organizational context to be maintained as documented information, we

maintain and retain; in addition to this document, the following documented information that also describes

our organizational context:

1. Analysis of business plans, strategies, and statutory and regulatory commitments;

2. Analysis of technology and competitors;

3. Technical reports from experts and consultants;

4. SWOT Analysis Templates for internal issues;

5. PESTLE Analysis Templates for external issues;

6. Minutes of meetings (management and design review minutes), process maps and reports, etc.

External

Influences

External

Influences

Consumers Consumers

Regulators Regulators

Legislators Legislators

Media Media

Shareholders Shareholders

Community Community

Figure 1 External Interested Parties

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ISO 9001:2015, ISO 14001:2015 & OHSAS 18001:2007


SWOT analysis provides our organization with a framework for reviewing and evaluating our strategies, and

the position and direction of our organization, business propositions and other ideas. Similarly, 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.

4.2 Relevant Interested Parties

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 operations or to our EHQMS. Such needs and expectations broadly include

those shown in the table below.

To ensure that our products and processes continue

to meet all relevant requirements, we identify and

assess the potential impact of any relevant needs and

expectations that may be elicited from interested

parties.

Where appropriate, to ensure that our processes are

aligned to deliver the requirements of our interested

parties; we convert their relevant needs and

expectations into requirements which become inputs

to our EHQMS, and our product and service designs.

4.3 Integrated Management System

4.3.1 EHQMS Scope

Based on the analysis of the issues and requirements identified in Sections 4.1 and 4.2, your organization has

established the scope of our EHQMS in order to document our corporate policies and objectives relevant to

our context, compliance obligations, the life cycle of our products and activities, our authority and ability to

exercise control and influence over external impacts. This document describes the scope of our integrated

environmental, health and safety, and quality management system (EHQMS) and delineates authorities, inter-

relationships and responsibilities of process owners and personnel that operate within the management

system.

Although we recognize that neither ISO 9001:2015, ISO 14001:2015 nor OHSAS 18001:2007 require a

management system manual, we have decided to retain or update our EHQMS manual to these requirements

as our employees; customers, suppliers and other stakeholders perceive it to add value to our operations.

The scope statement, contained within this manual is available to interested parties via our website.

Interested Parties Needs & Expectations

Customers Price, reliability & value

Distributors & retailers Quality, price & logistics

Owners/shareholders Profitability & growth

Employees Shared values & security

Suppliers Beneficial relationships

Regulatory & statutory Compliance & reporting

Internal

Influences

Internal

Influences

Employees Employees

Unions Unions

Shareholders Shareholders

Board of

Directors

Board of

Directors

Contractors

& Suppliers

Contractors

& Suppliers

Management

Teams

Management

Teams

Figure 2 Internal Interested Parties

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ISO 9001:2015, ISO 14001:2015 & OHSAS 18001:2007


5 Leadership & Governance 5.1 Leadership & Commitment

5.1.1 EHQMS Management

Top management provides positive leadership for implementing and maintaining our EHQMS, including the

development and deployment of our business strategies, our corporate policies; objectives, targets, and

product or project-specific plans. Top management provides accountability and governance to all activities

related to the lifecycle of our processes and products. This includes defining the appropriate responsibilities,

authorities, and methods of communication to ensure the safe and effective performance.

Top management ensures that all necessary

resources, responsibilities and accountabilities are

allocated for the continual improvement of the

EHQMS. Refer to Appendix A.2 for a copy of our

Organization Chart.

Top management have appointed the IMS Manager

to ensure that the necessary financial, technological

and organizational resources, including the services

of specialists and competent HSE advisors, are

available to implement monitor and maintain the

EHQMS.

Cross-functional committees that comprise various

organizational levels, functions and work areas are

established to support the management of the

EHQMS. The Cross-functional committees oversee

the implementation of improvement plans. The

Cross-functional committees report to the IMS

Manager.

Your organization’s governance structure provides

necessary support for creating and establishing

processes that are important for achieving our

EHQMS objectives, targets and policies by using the

PDCA approach shown in Figure 3 opposite.

Governance activities include the systematic

verification of EHQMS effectiveness by undertaking internal audits and analyzing performance data,

reviewing trends and KPIs. Regular reviews and data reporting ensure that our EHQMS is effective and has

the ability to react to emerging issues. Top management is committed to implementing and developing the

EHQMS and this commitment is defined by our corporate policies and objectives.

Top management ensures that our corporate policies are understood, implemented and maintained

throughout at all levels of the organization through printed distribution of policy statements and through

periodic management reviews of the policy statements, functional objectives, and corporate level

•Plan

Establish your

context and

strategies. Determine

regluatory and

statutory

commitments.

•Do

Develop policies and

objectives. Provide

resources, assign

process owners.

Focus on

improvement.

Address risks,

opportunities and

significant impacts.

•Check

Review system and

process performance

data, ensure

alignment is

maintained between

context and strategy.

Review policy and

objectives.

•Act

Agree changes and

implement activties

to improve the

EHQMS and its

processes.

Leadership

Figure 3: Leadership PDCA Cycle

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ISO 9001:2015, ISO 14001:2015 & OHSAS 18001:2007


improvement objectives. Your organization communicates our mission, vision, strategy, policies and

processes to all employees in order to:

1. Create and sustain shared values of fairness and ethical behavior;

2. Establish a culture of trust and integrity;

3. Encourage commitment to quality;

4. Provide people with the required resources, training and authority to act with accountability;

5. Inspire, encourage and recognize people’s contribution.

In addition, our corporate policies, objectives and targets are communicated and deployed throughout the

business via individual, team and department performance objectives which are established and discussed

during employee performance reviews.

5.1.2 Customer Focus

Your organization strives to identify current and future customer needs, to meet their requirements and to

exceed their expectations. Top management ensures that the focus on improving customer satisfaction is

maintained by setting objectives related to levels of customer satisfaction at management review meetings.

Top management also ensures that customer requirements are understood and met. Customer requirements

are understood, converted into internal requirements, and communicated to appropriate personnel within

the organization, refer to Section 8.2.2. Customer complaints and other forms of customer feedback are

continually monitored and measured to identify opportunities for improvement. We continually look for ways

to interact directly with our customers to ensure that we focus on their unique needs and expectations.

5.2 Corporate Policies

5.2.1 Establishing & Communicating

Your organization’s corporate policies act as a compass by providing the direction and framework for

establishing key business performance measures, as well as related objectives and targets. Top management

ensures that our corporate policies are established and documented, and that the policies are available to all

interested parties via our website.

Top management has overall responsibility for defining, documenting, implementing and reviewing our

policies in consultation with our management teams and other personnel, or their representatives. The

policies are reviewed at least annually, as part of the formal management review programme or at a

frequency determined by:

1. The changing needs and expectations of relevant interested parties, Section 4.2;

2. The risks and opportunities that are presented through the risk management process, Section 6.1.1;

3. The impacts which are presented through the environmental aspect process, Section 6.1.2;

4. Occupational hazards identified in Section 6.1.3;

5. Any mandatory and voluntary compliance obligations identified in Section 6.1.4.

Our corporate policies are communicated to all employees at all levels throughout our organization via

training, regular internal communications and reinforcement during annual employee performance reviews.

Employee understanding of our policies and objectives is determined during internal audits and other

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ISO 9001:2015, ISO 14001:2015 & OHSAS 18001:2007


6 EHQMS Planning 6.1 General

In order for our organization to have a successful EHQMS, we consider and manage the risks and

opportunities relating to our stakeholders, and our external and internal context. This process uses the

information collected during context and strategy evaluations (SWOT & PESTLE), stakeholder and interested

party analysis, and from the evaluation of any hazards and impacts. Top management considers the risks and

opportunities and takes action to ensure that our EHQMS meets its intended outcomes, manages external

environmental conditions and achieves continual improvement.

Once the significant or material risks and opportunities are identified; from the activities and outputs

undertaken in Sections 6.1.1 to 6.1.4, our organization plans actions to avoid or mitigate perceived risks, or to

take advantage of opportunities. Action is taken in a variety of ways using our EHQMS system processes via

management reviews, setting objectives, targets and policies, operational control or emergency preparedness

planning, supplier evaluation, and other appropriate processes.

6.1.1 Risks & Opportunities

The aim of risk and opportunity management within your organization is to ensure that organizational

capabilities and resources are employed in an efficient and effective manner to take advantage of

opportunities and to mitigate risk to our strategic direction and business planning (4.1), our management

system and its processes (4.3), our products (8.1) and our suppliers (8.4). Top management are responsible

for incorporating risk based thinking in to our organization's culture. This includes the establishment of risk

management procedures and processes to ensure the effective risk and opportunity management principles

are undertaken throughout the lifecycle of our EHQMS, our products, services, and activities by:

1. Providing sufficient resources to carry out risk and opportunity management activities;

2. Assigning responsibilities and authorities for risk and opportunity management activities;

3. Reviewing information and results from audits and risk and opportunity management activities.

The scope of your organization’s risk and opportunity management process is communicated by the Control

of Risks & Opportunities Procedure which includes a methodology for the assessment of the internal and

external issues identified in Section 4.1, and the assessment of the needs and the expectations of any

interested parties identified in Section 4.2. Risk and opportunity management is undertaken as part of your

organization’s day-to-day operations and is captured in the hierarchy shown in Figure 5.

Establishing such a hierarchy that captures and reacts to perceived risk and opportunity, ensures that each

issue is managed at the most appropriate level within our organization. Typically, the following categories

Quality issues, environmental

aspects and H&S hazards

Compliance obligations

Organizational context and

interested parties expectations

Risks and

opportunities to

be addressed

Mitigation

Actions

Intended outcomes

Prevent undesired effects

Promote opportunities

Continual improvement

Figure 4 Sources of Risk & Opportunity

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ISO 9001:2015, ISO 14001:2015 & OHSAS 18001:2007


10 Improvement 10.1 General

The IMS Manager uses a range of the performance evaluation tools highlighted in Section 9 to make

recommendations for improvement and to achieve the intended outcomes of our EHQMS. For example,

recommendations may emerge from the review groups and from findings raised in internal audits.

In order to determine and select opportunities for improvement or to implement any necessary actions to

meet the requirements of customers and relevant interested parties, or to enhance customer satisfaction,

your organization drives improvement via the analysis of relevant data. The data inputs for the improvement

process include:

1. Risk and opportunity evaluations;

2. Assessment of the changing needs and expectations of interested parties;

3. The conformity of existing products and services;

4. The effectiveness of our EHQMS;

5. Supplier performance;

6. Environmental performance;

7. Reducing adverse environmental impacts;

8. Increasing beneficial impacts and opportunities;

9. Levels of customer satisfaction, including complaints and feedback;

10. Internal and external audit results;

11. Corrective action and non-conformance rates;

12. Data from process and product characteristics and their trends.

Your organization also ensures that opportunities for improvement from daily feedback on operational

performance are evaluated by the IMS Manager as appropriate. Changes are typically implemented through

the corrective action system. Opportunities for improvement from analysis of longer-term data and trends

are evaluated and implemented through the management review process and are prioritized with respect to

their relevance for achieving our quality and environmental objectives.

The overall effectiveness of continual improvement program (including corrective actions taken as well as the

overall progress towards achieving corporate level improvement objectives) is assessed through our

management review process.

10.2 Non-conformity & Corrective Action

All non-conformities are reported to the IMS Manager in order that an investigation can be initiated using

the Control of Non-conformity & Corrective Action Procedure. The appropriate manager documents the non-

conformity using the Non-conformance Report and together with process owners, they consider the root-

cause of the non-conformity.

Where necessary, other competent parties are consulted to identify the root cause and plan appropriate

action. The IMS Manager records the non-conformance together with any agreed corrective action within the

EHQMS Action Tracker. The results of the corrective action are recorded within the Corrective Action Report. Sample

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ISO 9001:2015, ISO 14001:2015 & OHSAS 18001:2007


Appendices A.1 Sequence & Interaction of EHQMS Processes

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