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.
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Environmental input comprises the standard
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help protect the environment and respond to
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The health and safety management input meets
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enhance opportunities, control occupational
hazards and manage all aspects of health and
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EHQMS Manual & Policy Document
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with socio-economic needs.
ISO 9001:2015, ISO 14001:2015 & OHSAS 18001:2007
EHQMS Manual & Policy Document
Double click here to insert your organization’s name or logo.
ISO 9001:2015, ISO 14001:2015 & OHSAS 18001:2007
INTRODUCTION ............................................................................................................................................... 5
2
REFERENCES & DEFINITIONS......................................................................................................................... 6
3
COMMON REQUIREMENTS ............................................................................................................................ 7
4
ABOUT OUR ORGANIZATION ......................................................................................................................10
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4.2
RELEVANT INTERESTED PARTIES................................................................................................................................................. 11
4.3
INTEGRATED MANAGEMENT SYSTEM........................................................................................................................................ 11
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EHQMS Scope ................................................................................................................................................................ 11
4.3.2
EHQMS Processes......................................................................................................................................................... 12
4.3.3
Outsourced Processes ................................................................................................................................................ 12
4.3.4
Documented Information .......................................................................................................................................... 12
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4.3.1
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LEADERSHIP & GOVERNANCE.....................................................................................................................14 LEADERSHIP & COMMITMENT ................................................................................................................................................... 14
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5.1
EHQMS Management ................................................................................................................................................. 14
5.1.2
Customer Focus ............................................................................................................................................................. 15
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5.1.1
CORPORATE POLICIES ................................................................................................................................................................. 15
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5.2
Establishing & Communicating .............................................................................................................................. 15
5.2.2
Policy Statement ........................................................................................................................................................... 16
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5.2.1
ROLE, RESPONSIBILITIES & AUTHORITIES ................................................................................................................................. 17
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5.3
Top Management ......................................................................................................................................................... 17
5.3.2
IMS Manager .................................................................................................................................................................. 17
5.3.3
Department Managers ............................................................................................................................................... 18
5.3.4
Employees ....................................................................................................................................................................... 18
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5.3.1
5.4
COMMUNICATION ....................................................................................................................................................................... 18 Internal Communication ............................................................................................................................................ 18
5.4.2
External Communication ........................................................................................................................................... 19
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5.4.1
EHQMS PLANNING ........................................................................................................................................20 GENERAL....................................................................................................................................................................................... 20 Risks & Opportunities ................................................................................................................................................. 20
6.1.2
Environmental Impacts ............................................................................................................................................... 21
6.1.3
Occupational Hazards ................................................................................................................................................. 22
6.1.4
Compliance Obligations ............................................................................................................................................ 23
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6.1.1
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6.1
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6
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ORGANIZATIONAL CONTEXT...................................................................................................................................................... 10
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4.1
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6.2
EHQMS OBJECTIVES.................................................................................................................................................................. 24
6.2.1
Objectives ........................................................................................................................................................................ 24
6.2.2
Objectives & Planning to Achieve Them ............................................................................................................. 25
6.3 7
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Table of Contents
PLANNING FOR CHANGE ............................................................................................................................................................ 26
SUPPORT .........................................................................................................................................................28
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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
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7.1.1
OPERATIONAL PLANNING & CONTROL.................................................................................................................................... 33
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8.1
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PRODUCT & SERVICE DEVELOPMENT ........................................................................................................33 Environmental Management ................................................................................................................................... 33
8.1.2
Quality Management .................................................................................................................................................. 33
8.1.3
Health & Safety Management ................................................................................................................................. 34
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DETERMINING REQUIREMENTS FOR PRODUCTS ...................................................................................................................... 34
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8.2
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8.1.1
Customer Communication ........................................................................................................................................ 34
8.2.2
Determining Requirements ...................................................................................................................................... 35
8.2.3
Reviewing Requirements ........................................................................................................................................... 35
8.2.4
Changes in Requirements ......................................................................................................................................... 35
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8.2.1
DESIGN & DEVELOPMENT.......................................................................................................................................................... 36 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
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CONTROL OF SUPPLIERS & EXTERNAL PROCESSES ................................................................................................................. 38
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8.3.1
General.............................................................................................................................................................................. 38
8.4.2
Purchasing Controls .................................................................................................................................................... 39
8.4.3
Purchasing Information .............................................................................................................................................. 39
8.5
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8.4.1
PRODUCTION & SERVICE PROVISION ....................................................................................................................................... 40
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8
RESOURCES .................................................................................................................................................................................. 28
Identification & Traceability ..................................................................................................................................... 40 rd
3 Party Property.......................................................................................................................................................... 41 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
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8.5.4
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8.5.3
Control of Production & Service Provision ........................................................................................................ 40
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8.5.1 8.5.2
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PERFORMANCE EVALUATION .....................................................................................................................45 9.1
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7.1
ISO 9001:2015, ISO 14001:2015 & OHSAS 18001:2007
MONITORING, MEASUREMENT, ANALYSIS & EVALUATION ................................................................................................... 45
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General.............................................................................................................................................................................. 45
9.1.2
Customer Satisfaction ................................................................................................................................................. 45
9.1.3
Analysis & Evaluation .................................................................................................................................................. 46
9.1.4
Evaluation of Compliance.......................................................................................................................................... 46
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9.1.1
INTERNAL AUDIT.......................................................................................................................................................................... 47
9.3
MANAGEMENT REVIEW .............................................................................................................................................................. 48
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9.2
General.............................................................................................................................................................................. 48
9.3.2
Inputs................................................................................................................................................................................. 48
9.3.3
Outputs ............................................................................................................................................................................. 49
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9.3.1
10
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ISO 9001:2015, ISO 14001:2015 & OHSAS 18001:2007
IMPROVEMENT ..........................................................................................................................................50 GENERAL....................................................................................................................................................................................... 50
10.2
NON-CONFORMITY & CORRECTIVE ACTION ........................................................................................................................... 50
10.3
IMPROVEMENT ............................................................................................................................................................................. 51
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APPENDICES ...........................................................................................................................................................52 SEQUENCE & INTERACTION OF EHQMS PROCESSES ............................................................................................................ 52
A.2
ORGANIZATION CHART .............................................................................................................................................................. 53
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A.1
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ISO 9001:2015, ISO 14001:2015 & OHSAS 18001:2007
3 Common Requirements
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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
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18001:2007 are also detailed. The table shown below cross refers these common requirements to the section
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headings found in this document:
EHQMS Manual Heading
BS EN ISO 9001:2015
4.0
About our Organization
4.0
4.1
Organizational Context
4.1
4.2
Relevant Interested Parties
4.2
4.3.1
EHQMS Scope
4.3
4.3.2
EHQMS Processes
4.4
4.3.4
Documented Information
7.5
4.3.4.1
Management System Documents
4.3.4.2
Creating and Updating
4.3.4.3
Controlling Documented Information
5.0
Leadership & Governance
5.1
Leadership and Commitment
5.1.1
EHQMS Management
5.1.2
Customer Focus
5.2
Corporate Policies
5.2.1
Establishing & Communicating
5.2.2
Policy Statement
5.3
Roles, Responsibilities and Authorities
5.4
Communication
5.4.1 5.4.2
4.1
4.2
4.3.2
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4.0
4.1
4.1
7.5
4.4.4
7.5.1
7.5.1
4.4.4
7.5.2
7.5.2
4.4.4
7.5.3
7.5.3
4.4.5 & 4.5.4
5.0
5.0
4.4.1
5.1
5.1
4.4.1
5.1.1
5.1
4.4.1
5.1.2
N/a
N/a
5.2
5.2
4.2
5.2.1
5.2
4.2
5.2.2
5.2
4.2
5.3
5.3
4.4.1
7.4
7.4.1
4.4.3
Internal Communication
7.4
7.4.2
4.4.3.2
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
Environmental Aspects
6.1.2
6.1.2
N/a
Occupational Hazards
N/a
N/a
4.3.1
Compliance Obligations
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4.1
4.3.2
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6.1.3
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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6.1.3
6.2
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4.0
4.4
6.1.4
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OHSAS 18001:2007
4.3
6.1.3
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BS EN ISO 14001:2015
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Section No.
6.1.2
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ISO/OHSAS Standard Clause Ref.
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Environmental, Health & Safety and Quality Management System
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ISO 9001:2015, ISO 14001:2015 & OHSAS 18001:2007
4 About Our Organization
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4.1 Organizational Context
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Your organization is committed to determining our position in the marketplace and understanding how
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relevant factors arising from legal, political, economic, social and technological issues influence our strategic
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direction and which define our organizational context.
Your organization identifies, analyzes, monitors and
Figure 1 External Interested Parties
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reviews factors that may affect our ability to satisfy
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our customers and stakeholders, as well as; factors that may adversely affect the stability and integrity
Consumers
of our processes and our management system. with our strategy, whilst taking account of relevant,
Regulators
influential,
internal
and
external
factors;
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External Influences
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Community
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organization collates and analyzes information
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pertinent to those influential factors to identify
Shareholders
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issues that have the potential to be affected by our activities, products and services. Similarly, we
Legislators
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Media
deliver products, services or activities. Your organization collates, assesses and reviews information about these relevant influential factors
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to ensure that a continual understanding of each factor and its affects is derived and maintained in order to
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develop our contextual intelligence. To facilitate the understanding of our context, Top management
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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
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documents where appropriate.
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The output from this activity is evident as an input to the consideration of risks and opportunities, and the
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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
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18001:2007 do not require our organizational context to be maintained as documented information, we
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maintain and retain; in addition to this document, the following documented information that also describes
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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.
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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 analysis provides our organization with framework for measuring our market and growth potential according
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to external political, economic, social, technological, legal and environmental factors.
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4.2 Relevant Interested Parties
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Your organization recognizes that we have a unique set of interested parties whose needs and expectations
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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
Owners/shareholders
Profitability & growth
Employees
Shared values & security
Suppliers
Beneficial relationships
Regulatory & statutory
Compliance & reporting
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Quality, price & logistics
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Distributors & retailers
Figure 2 Internal Interested Parties
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Price, reliability & value
Employees
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Customers
Management Teams
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Needs & Expectations
To ensure that our products and processes continue
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to meet all relevant requirements, we identify and
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Interested Parties
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those shown in the table below.
Unions
Internal Influences
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assess the potential impact of any relevant needs and
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expectations that may be elicited from interested
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parties.
Contractors & Suppliers
Shareholders
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convert
their
relevant
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parties;
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aligned to deliver the requirements of our interested needs
and
Board of Directors
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expectations into requirements which become inputs to our EHQMS, and our product and service designs.
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4.3 Integrated Management System EHQMS Scope
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4.3.1
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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
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our context, compliance obligations, the life cycle of our products and activities, our authority and ability to
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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-
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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.
Document Ref.
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the position and direction of our organization, business propositions and other ideas. Similarly, PESTLE
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ISO 9001:2015, ISO 14001:2015 & OHSAS 18001:2007
5 Leadership & Governance
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5.1 Leadership & Commitment EHQMS Management
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5.1.1
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Top management provides positive leadership for implementing and maintaining our EHQMS, including the
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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
Top
management
ensures
that
all
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authorities, and methods of communication to ensure the safe and effective performance. necessary
Figure 3: Leadership PDCA Cycle
resources, responsibilities and accountabilities are
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allocated for the continual improvement of the
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EHQMS. Refer to Appendix A.2 for a copy of our
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Organization Chart. Top management have appointed the IMS Manager
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and organizational resources, including the services
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to ensure that the necessary financial, technological of specialists and competent HSE advisors, are available to implement monitor and maintain the
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EHQMS.
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Cross-functional committees that comprise various
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organizational levels, functions and work areas are established to support the management of the
Leadership
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EHQMS. The Cross-functional committees oversee
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the implementation of improvement plans. The Cross-functional committees report to the IMS Manager.
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Your organization’s governance structure provides
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necessary support for creating and establishing processes that are important for achieving our
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EHQMS objectives, targets and policies by using the
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PDCA approach shown in Figure 3 opposite.
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Governance
activities
include
the
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related to the lifecycle of our processes and products. This includes defining the appropriate responsibilities,
systematic
• 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.
verification of EHQMS effectiveness by undertaking internal audits and analyzing performance data,
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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
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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: 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.
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1.
In addition, our corporate policies, objectives and targets are communicated and deployed throughout the
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business via individual, team and department performance objectives which are established and discussed during employee performance reviews.
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Customer Focus
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5.1.2
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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
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maintained by setting objectives related to levels of customer satisfaction at management review meetings.
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Top management also ensures that customer requirements are understood and met. Customer requirements
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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
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continually monitored and measured to identify opportunities for improvement. We continually look for ways
5.2 Corporate Policies Establishing & Communicating
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5.2.1
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to interact directly with our customers to ensure that we focus on their unique needs and expectations.
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Your organization’s corporate policies act as a compass by providing the direction and framework for
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establishing key business performance measures, as well as related objectives and targets. Top management
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ensures that our corporate policies are established and documented, and that the policies are available to all interested parties via our website.
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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
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policies are reviewed at least annually, as part of the formal management review programme or at a The changing needs and expectations of relevant interested parties, Section 4.2;
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1.
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frequency determined by: 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.
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2.
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 methods deemed appropriate.
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ISO 9001:2015, ISO 14001:2015 & OHSAS 18001:2007
6 EHQMS Planning
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6.1 General
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In order for our organization to have a successful EHQMS, we consider and manage the risks and
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opportunities relating to our stakeholders, and our external and internal context. This process uses the
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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
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opportunities and takes action to ensure that our EHQMS meets its intended outcomes, manages external
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environmental conditions and achieves continual improvement. Figure 4 Sources of Risk & Opportunity
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Quality issues, environmental aspects and H&S hazards
Actions
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be addressed
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Mitigation
opportunities to
Compliance obligations
Prevent undesired effects Promote opportunities Continual improvement
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Organizational context and interested parties expectations
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Intended outcomes
Risks and
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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
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take advantage of opportunities. Action is taken in a variety of ways using our EHQMS system processes via
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management reviews, setting objectives, targets and policies, operational control or emergency preparedness
6.1.1
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planning, supplier evaluation, and other appropriate processes.
Risks & Opportunities
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The aim of risk and opportunity management within your organization is to ensure that organizational
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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
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for incorporating risk based thinking in to our organization's culture. This includes the establishment of risk
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management procedures and processes to ensure the effective risk and opportunity management principles 1.
Providing sufficient resources to carry out risk and opportunity management activities; Assigning responsibilities and authorities for risk and opportunity management activities;
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2.
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are undertaken throughout the lifecycle of our EHQMS, our products, services, and activities by:
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3.
Reviewing information and results from audits and risk and opportunity management activities.
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The scope of your organization’s risk and opportunity management process is communicated by the Control
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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
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10 Improvement
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10.1 General
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The IMS Manager uses a range of the performance evaluation tools highlighted in Section 9 to make
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recommendations may emerge from the review groups and from findings raised in internal audits.
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recommendations for improvement and to achieve the intended outcomes of our EHQMS. For example, In order to determine and select opportunities for improvement or to implement any necessary actions to
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meet the requirements of customers and relevant interested parties, or to enhance customer satisfaction,
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your organization drives improvement via the analysis of relevant data. The data inputs for the improvement process include: 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;
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10. Internal and external audit results;
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11. Corrective action and non-conformance rates;
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12. Data from process and product characteristics and their trends. Your organization also ensures that opportunities for improvement from daily feedback on operational
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performance are evaluated by the IMS Manager as appropriate. Changes are typically implemented through
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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.
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The overall effectiveness of continual improvement program (including corrective actions taken as well as the
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overall progress towards achieving corporate level improvement objectives) is assessed through our
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management review process.
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10.2 Non-conformity & Corrective Action
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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-
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conformity using the Non-conformance Report and together with process owners, they consider the root-
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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.
Document Ref.
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EHQMS Manual & Policy Document
Double click here to insert your organization’s name or logo.
ISO 9001:2015, ISO 14001:2015 & OHSAS 18001:2007
Appendices Sequence & Interaction of EHQMS Processes
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