Table of Contents INTRODUCTION... 4 COMMON REQUIREMENTS... 5 1. SCOPE... 7 1.1 DESCRIPTION OF ORGANIZATION... 7 1.2 SCOPE OF CERTIFICATION... 7 1.3 THIRD PARTY CERTIFICATION... 7 2. REFERENCES... 8 3. TERMS & DEFINITIONS... 9 3.1 DESCRIPTION... 9 3.2 IMPLEMENTATION AND MAINTENANCE... 9 4. INTEGRATED MANAGEMENT SYSTEM... 10 4.1 GENERAL REQUIREMENTS... 10 4.1.1 Integrated Management System Manual... 11 4.1.2 Document and Data Control... 11 4.1.3 Control of Records... 11 5. CORPORATE POLICIES... 12 5.1 GENERAL... 12 5.2 CORPORATE POLICY STATEMENT... 12 6. SYSTEM PLANNING... 13 6.1 OCCUPATIONAL HAZARDS AND ENVIRONMENTAL ASPECTS... 13 6.2 LEGAL AND OTHER REQUIREMENTS... 13 6.3 OBJECTIVES, TARGETS & PROGRAMMES... 13 6.3.1 Quality Objectives and Targets... 13 6.3.2 Environmental Objectives and Targets... 14 6.3.3 Occupational Health & Safety Objectives and Targets... 14 6.3.4 Quality, Environmental and OHSAS Management Programs... 14 6.4 INTEGRATED MANAGEMENT SYSTEM... 14 6.4.1 Management System Planning... 14 6.4.2 Outsourced Processes... 14 6.5 RESPONSIBILITY & AUTHORITY... 15 6.5.1 Management Commitment... 15 6.5.2 Customer Focus... 15 6.5.3 Responsibility & Authority... 15 6.5.4 Management Representative... 17 6.5.5 Communication & Participation... 17 6.6 PROVISION OF RESOURCES... 17 6.7 HUMAN RESOURCES... 17 6.7.1 General... 17 6.7.2 Competence, Awareness & Training... 18 6.8 INFRASTRUCTURE... 18 6.9 WORK ENVIRONMENT... 18 7. OPERATIONAL PLANNING & CONTROL... 19 7.1 PRODUCT REALIZATION PLANNING... 19 7.2 CUSTOMER RELATED PROCESSES... 19 7.2.1 Determination of Requirements Related to Product... 19 7.2.2 Review of Requirements Related to Product... 19 7.2.3 Customer Communication... 20 www.iso9001help.co.uk 2013 P a g e 2 of 36
7.3 DESIGN & DEVELOPMENT... 20 7.3.1 Planning... 20 7.3.2 Input... 20 7.3.3 Output... 20 7.3.4 Review... 20 7.3.5 Verification... 21 7.3.6 Validation... 21 7.3.7 Control of Design & Development Changes... 21 7.4 PURCHASING... 21 7.4.1 Purchasing Process... 21 7.4.2 Purchasing Information... 21 7.4.3 Verification of Purchased Product... 22 7.5 PRODUCTION & SERVICE PROVISION... 22 7.5.1 Control of Production & Service Provision... 22 7.5.2 Validation of Processes for Production & Service Provision... 22 7.5.3 Identification & Traceability... 22 7.5.4 Customer Property... 22 7.5.5 Preservation of Product... 23 7.6 CONTROL OF MONITORING & MEASURING EQUIPMENT... 23 7.7 OPERATIONAL CONTROL OF ENVIRONMENTAL AND HEALTH & SAFETY... 23 8. ASSESSMENT & EVALUATION... 25 8.1 GENERAL... 25 8.2 MONITORING & MEASUREMENT... 25 8.2.1 Customer Satisfaction... 25 8.2.2 Internal Audit... 25 8.2.3 Process Monitoring & Measurement... 26 8.2.4 Product Monitoring & Measurement... 26 8.2.5 Evaluation of Compliance... 27 8.3 CONTROL OF NON-CONFORMANCES... 27 8.3.1 Control of Non-conforming Products... 27 8.3.2 Accident & Incident Investigation... 27 8.3.3 Control of Emergency Situations... 27 8.4 ANALYSIS OF DATA... 28 9. CONTINUAL IMPROVEMENT... 29 9.1 GENERAL... 29 9.2 CORRECTIVE ACTION... 29 9.3 PREVENTIVE ACTION... 30 10. MANAGEMENT REVIEW... 31 10.1 GENERAL... 31 10.2 REVIEW INPUT... 31 10.3 REVIEW OUTPUT... 31 APPENDICES... 32 A.1 ABBREVIATIONS & ACRONYMS... 32 A.2 SEQUENCE & INTERACTION OF IMS PROCESSES... 33 A.3 LIST OF KEY MANAGEMENT SYSTEM DOCUMENTS... 34 Operational Procedures... 34 Forms & Records... 34 Checklists... 35 A.4 ORGANIZATION CHART... 36 www.iso9001help.co.uk 2013 P a g e 3 of 36
Common Requirements Your Company s integrated management system shares common requirements that are stipulated by international standard ISO 9001:2008, ISO 14001:2004 and BS OHSAS 18001:2007. The table shown below cross refers these common requirements to the section headings found in this document: ISO 9001 ISO 14001 OHSAS 18001 4 Integrated Management System Clause Clause Clause 4.1 General Requirements 4.1 4.1 4.1 4.1.1 Integrated Management System Manual 4.2.1 & 4.2.2 4.4.4 4.4.4 4.1.2 Document and Data Control 4.2.3 4.4.5 4.4.5 4.1.3 Control of Records 4.2.4 4.5.4 4.5.4 5 Corporate Policies 5.1 General 5.3 4.2 4.2 5.2 Policy Statement 5.3 4.2 4.2 6 System Planning 6.1 Occupational Hazards and Environmental Aspects 7.2.1 4.3.1 4.3.1 6.2 Legal and Other Requirements 7.2.1 4.3.2 4.3.2 6.3 Objectives, Targets and Programmes 5.4.1 4.3.3 4.3.3 6.4.1 Management System Planning 5.4.2 4.4.7 4.4.7 6.4.2 Outsourced Processes 4.1 4.1 4.1 6.5.1 Management Commitment 5.1 4.2 & 4.4.1 4.2 & 4.4.1 6.5.2 Customer Focus 5.2 4.3.1, 4.3.2 & 5.6 4.3.1, 4.3.2 & 5.6 6.5.3 Responsibility and Authority 5.5.1 4.4.1 4.4.1 6.5.4 Management Representative 5.5.2 4.4.1 4.4.1 6.5.5 Communication and Participation 5.5.3 4.4.3 4.4.3 6.6 Provision of Resources 6.1 4.4.1 & 4.4.2 4.4.1 & 4.4.2 6.7.1 Human Resources General 6.2.1 4.4.2 4.4.2 6.7.2 Competence, Awareness & Training 6.2.2 4.4.2 4.4.2 6.8 Infrastructure 6.3 4.4.1 4.4.1 6.9 Work Environment 6.4 4.4.1 & 4.4.2 4.4.1 & 4.4.2 7 Operational Planning & Control 7.1 Product Realization Planning 7.1 4.4.6 4.4.6 7.2.1 Determination of Product Requirements 7.2.1 4.3.2 4.3.2 7.2.2 Review of Product Requirements 7.2.2 4.3.1 4.3.1 7.2.3 Customer Communication 7.2.3 & 5.5.3 4.4.3 4.4.3 7.3.1 Design Development Planning 7.3.1 4.4.6 4.4.6 www.iso9001help.co.uk 2013 P a g e 5 of 36
7.3.2 Design Development Input 7.3.2 4.4.6 4.4.6 7.3.3 Design Development Output 7.3.3 4.4.6 4.4.6 7.3.4 Design Development Review 7.3.4 4.4.6 4.4.6 7.3.5 Design Development Verification 7.3.5 4.4.6 4.4.6 7.3.6 Design Development Validation 7.3.6 4.4.6 4.4.6 7.3.7 Design Development Changes 7.3.7 4.4.6 4.4.6 7.4.1 Purchasing Process 7.4.1 4.4.6 4.4.6 7.4.2 Purchasing Information 7.4.2 4.4.6 4.4.6 7.4.3 Verification of Purchased Product 7.4.3 4.4.6 4.4.6 7.5.1 Control of Production & Service Provision 7.5.1 4.4.6 4.4.6 7.5.2 Validation of Processes 7.5.2 4.4.6 4.4.6 7.5.3 Identification & Traceability 7.5.3 4.4.6 4.4.6 7.5.4 Customer Property 7.5.4 4.4.6 4.4.6 7.5.5 Preservation of Product 7.5.5 4.4.6 4.4.6 7.6 Monitoring & Measuring Equipment 7.6 4.5.1 4.5.1 7.7 Operational Control of EH&S 7 4.4.6 4.4.6 8 Assessment & Evaluation 8.1 General 8.1 4.5.1 4.5.1 8.2.1 Customer Satisfaction 8.2.1 N/A N/A 8.2.2 Internal Audit 8.2.2 4.5.5 4.5.5 8.2.3 Process Monitoring & Measurement 8.2.3 4.5.1 & 4.5.2 4.5.1 & 4.5.2 8.2.4 Product Monitoring & Measurement 8.2.4 4.5.1 & 4.5.2 4.5.1 & 4.5.2 8.2.5 Evaluation of Compliance 8.2.2 4.5.2 4.5.2 8.3.1 Control of Non-conforming Products 8.3 4.5.3 4.5.3 8.3.2 Accident & Incident Investigation 8.3 4.5.3 4.5.2 8.3.3 Control of Emergency Situations 8.3 4.4.7 4.4.7 8.4 Analysis of Data 8.4 4.5.3 4.5.3 9 Continual Improvement 9.1 General 8.5.1 4.5.3 4.5.2 9.2 Corrective Action 8.5.2 4.5.3 4.5.2 9.3 Preventive Action 8.5.3 4.5.3 4.5.2 10 Management Review 10.1 General 5.6.1 4.6 4.6 10.2 Input 5.6.2 4.6 4.6 10.3 Output 5.6.3 4.6 4.6 www.iso9001help.co.uk 2013 P a g e 6 of 36
5. Corporate Policies 5.1 General Top management ensures that our corporate policies are established communicated to all employees at all levels of the organization through documented training, regular communication and reinforcement during annual employee performance reviews. The policy statements act as a compass by providing the direction and framework for establishing key corporate level performance measures and related improvement objectives and targets. The Managing Director <amend as appropriate> has overall responsibility for defining, documenting, implementing and reviewing our corporate policies in consultation with the management teams and other personnel, or their representatives. The policy statements encompass elements of the integrated management system including quality, environmental and health and safety commitments. The policies are reviewed at least annually, as part of the management review programme, or at a frequency dictated by other requirements. 5.2 Policy Statement Your Company is committed to an operating philosophy based on openness in communication, integrity in serving our customers, fairness and concern for our employees and responsibility to the communities within which we operate. Our vision is to exceed customer expectations for quality, safety, sustainability, cost, delivery and value. Additionally, we are dedicated to creating a profitable business culture that is based on the following principles: CUSTOMER Customer needs are paramount and represent the highest priority within our business. Our obligation is to proactively seek out and define customer needs while addressing all requests expeditiously without creating false expectations. COMMUNITY AND THE ENVIRONMENT Your Company is committed to supporting the communities within which we operate. We believe in the practice of social responsibility and encourage similar behavior in our employees and suppliers. We support the conservation of the physical environment and the prevention of pollution at our facilities. We proactively comply with all applicable safety, environmental, legal and regulatory requirements to which we subscribe. PEOPLE Your Company is also committed to equality in employment opportunity and rewards, embracing wholeheartedly the cultural diversity within the communities we call home. Our employees welfare and interests are foremost throughout all aspects of our business and how we conduct our affairs. Your Company is committed to: QUALITY Creating and nurturing an environment of success based on honesty and integrity Equitable sharing in the success of the company Empowerment through training and communication Individual growth and equal opportunity Designing and providing a safe and secure work environment Beginning with a clear definition of customer expectations, we strive to consistently meet or exceed them. We adhere to all applicable standards and customer specific requirements and endeavor to provide processes that ensure we achieve this in order to build a robust and world class business. BUSINESS PROCESS We establish and employ metrics that are used to measure our performance against core objectives that cover operational parameters such as health and safety, quality, the environment, materials management, and customer satisfaction. We continually improve effectiveness and efficiency by monitoring our objectives through internal auditing, analyzing data, reviewing performance and implementing corrective and preventive actions. www.iso9001help.co.uk 2013 P a g e 12 of 36
6. System Planning 6.1 Occupational Hazards and Environmental Aspects Your Company identifies environmental aspects and impacts as well as health and safety hazards pertaining to its business operations and customer requirements. This process is managed using the Identification, Evaluation and Control Procedure (OP03). The subsequent output from this process takes account of the severity of pertinent environmental aspects as well as health and safety hazards, and the company s ability to influence them, in order to determine which are the most significant. The aspects that present significant impacts or hazards are considered and become subject to risk management and/or corrective or preventive action where appropriate. The integrated management system is structured to identify and manage these aspects in order to control or limit potential impacts and risks that may affect our organization. Supporting documentation: Ref. Title & Description ISO 9001 ISO 14001 OHSAS 18001 OP03 Identification, Evaluation and Control Procedure 7.2.1 4.3.1 4.3.1 6.2 Legal and Other Requirements Top management reviews all relevant environmental legislation using the NETRegs service www.netregs.gov.uk provided online by the Environment Agency and has identified all relevant legal requirements. Legal requirements are reviewed on a regular basis with assistance from the automatic emails received from NETRegs whenever legislation is updated or is newly published. Top management also reviews relevant health and safety regulations and guidance using the Health and Safety Executive website www.hse.gov.uk/guidance/index.htm. The management review meeting attendees ensure that applicable environmental aspects and health and safety hazards are identified and are understood in terms of customer requirements and current legislation. Supporting documentation: Ref. Title & Description ISO 9001 ISO 14001 OHSAS 18001 OP04 Legal & Other Requirements Procedure 5.2 4.3.2 4.3.2 6.3 Objectives, Targets & Programmes Your Company sets out its objectives and targets on a regular basis within the management review minutes where details of program dates and responsibilities are defined. Improvements in quality, environmental and health and safety performance are incremental and in keeping with the size and complexity of the company. When setting objectives and targets, the company ensures that they are consistent with the corporate policies and the significant environmental aspects or health and safety hazards. In addition, technological options, financial, operational and business requirements are considered. In order to determine whether or not the objectives and targets are being met, they are measured; and where practical, to allow progress to be monitored, metrics are gathered and analyzed. 6.3.1 Quality Objectives and Targets On the basis of the set integrated policies and in connection with application of the integrated management system principles, Your Company sets quality objectives that are specified in the register of objectives. All employees are responsible for fulfillment of the integrated policies and subsequent objectives. Managers of all departments are obliged to develop general objectives into objectives applicable to their departments and employees. Implement the IMS Enhance customer satisfacation Develop employee competence Gain certification and compliance to ISO 9001, 14001 & OHSAS 18001 across the organization Implement systems to record and analyze customer complaints and reduce complaints by 10% each year Undertake system awareness training for all employees www.iso9001help.co.uk 2013 P a g e 13 of 36
6.3.2 Environmental Objectives and Targets Objectives and targets are set as a means of ensuring that the aims of our environmental policy are achieved. The environmental objectives and targets for those impacts and issues considered to be significant, as well as those for which, though not evaluated as being significant, the company deems it appropriate to have an objective and target, have been set after evaluation and consideration of legal and other requirements, technological options, cost benefit considerations and relevant view of interested parties. Identify environmental programmes Achieve the environmental objectives and targets Acheive the actions outlined in the environmental programme Objectives are measured and refined targets are met 6.3.3 Occupational Health & Safety Objectives and Targets When determining and reviewing objectives of occupational health and safety, Your Company takes into account the identified dangers and associated levels of risk, to which employees are exposed to. These risks are considered along with legal and other requirements of the organization, technological capacities and financial, operating and business requirements and opinion of engaged parties. The set objectives and target values are consistent with the corporate integrated policies and with the liability to increase the standard of employee protection. Where possible, the objectives and target values are quantified and responsibilities for the fulfillment of the objectives are determined. Increase awareness of bahavioural safety Define and set performance benchmarks Regular employee training and review sessions concering risk Use industry benchmarks to drive improvement programmes 6.3.4 Quality, Environmental and OHSAS Management Programs Programs for achieving objectives and targets are defined and documented through the continual improvement process. These programs define the principal actions to be taken, those responsible for undertaking those actions and the scheduled times for their implementation and completion. Continual improvement projects are developed and coordinated by the Management Representative and relevant department managers. Supporting documentation: Ref. Title & Description ISO 9001 ISO 14001 OHSAS 18001 OP05 Objective, Targets & Programmes Procedure 5.4 4.3.3 4.3.3 6.4 Integrated Management System 6.4.1 Management System Planning The integrated management system is planned and implemented in order to meet our corporate QEH&S objectives and the requirements of ISO 9001, 14001 and OHSAS 18001. The planning process involves establishing and communicating our policies, objectives and associated operational procedures. This document constitutes our overall plan for establishing, maintaining and improving the integrated management system. For each instance of management system planning, the output is documented accordingly and changes are conducted in a controlled manner. The management review and the internal audit processes ensure the integrity of the IMS is maintained when significant changes are planned which may affect key processes. 6.4.2 Outsourced Processes Where Your Company identifies the requirement to outsource any process, or part thereof, that affects conformity with requirements; Your Company identifies control requirements such as; the competence of personnel, the provision of product conformity certificates, contract documentation, specific job files, etc. The controls identified do www.iso9001help.co.uk 2013 P a g e 14 of 36
A.2 Sequence & Interaction of IMS Processes MANAGEMENT PROCESSES CUSTOMER RELATED PROCESSES SUPPORT PROCESSES Integrated Management System Communication & Participation Set Objectives & Targets Provide Resources & Infrastructure Customer, Market, Stakeholder & Legal Requirements Training & Competence Maintain Facilities & Equipment Identify Aspects & Hazards Quote Order Calibrate Equipment Identify Legal & Other Requirements Control Risks & Impacts Determine Roles & Responsibilties Contract Review Product & Process Planning Document & Data Control Emergency Planning Control Records Design & Development Supplier Selection & Evaluation ASSESSMENT PROCESSES ASSESSMENT PROCESSES Evaluation of Compliance Incoming Inpsection, Handling & Storage Production Processes Continual Improvement Internal Auditing Corrective Action Nonconformities & Incident Control Storage, Dispatch & Delivery Preventive Action Customer Satisfaction Analyze IMS Process Data Customer, Market & Stakeholder Feedback Management Review Product & Process Monitoring www.iso9001help.co.uk 2013 P a g e 33 of 36
A.3 List of Key Management System Documents Operational Procedures Procedure No. Title & Description OP01 Document & Data Control Procedure OP02 Control of Records Procedure OP03 Identification, Evaluation and Control Procedure OP04 Legal & Other Requirements Procedure OP05 Objective, Targets & Programmes Procedure OP06 Communication & Participation Procedure OP07 Competence, Awareness & Training Procedure OP08 Facilities Management Procedure OP09 Product Realization & Planning Procedure OP10 Contract Review Procedure OP11 Design & Development Control Procedure OP12 Purchasing Procedure OP13 Production & Service Provision Procedure OP14 Control of Monitoring & Measuring Equipment Procedure OP15 Operation Control Procedure OP16 Customer Satisfaction Procedure OP17 Internal Audit Procedure OP18 Inspection, Testing & Checking Procedure OP19 Non-conforming Product Procedure OP20 Accident & Incident Investigation Procedure OP21 Emergency Preparedness & Response Procedure OP22 Analysis of Data Procedure OP23 Continual Improvement Procedure OP24 Corrective & Preventive Action Procedure OP25 Management Review Procedure Forms & Records Form No. Title & Description F01-1 Master Document Index F01-2 Document Issue Sheet F01-3 Document Change Request F02-1 Master Quality Record Index F03-1 Environmental Aspect & Impact Assessment Register F03-2 Health & Safety Risk Assessment F04-1 Register of Applicable Legislation and Other Requirements F05-1 QEH&S Targets & Management Programme F07-1 Competency Review Form F07-2 Training Attendance Form F07-3 Training Evaluation Form F08-1 Equipment Maintenance & Service Log www.iso9001help.co.uk 2013 P a g e 34 of 36
Form No. Title & Description F10-1 Contract Review Checklist F11-1 Design Change Request F11-2 Design Change Request Log F12-1 Supplier Evaluation F12-2 Approved Supplier Index F13-1 Production Control Plan F13-2 Customer Property Log F14-1 Controlled Equipment Log F14-2 Calibration Log F14-3 Software Validation Log F16-1 Customer Satisfaction Survey F16-2 Customer Complaint & Feedback Log F17-1 Internal Audit Schedule F17-2 Internal Audit Assignment F17-3 Internal Audit Report F17-4 Internal Audit Feedback F18-1 Receiving Inspection Log F18-2 Final Inspection Log F18-3 Inspection & Test Report F19-1 Nonconformity Report F19-2 Nonconformity Report Log F20-1 Accident & Incident Report F20-2 Accident & Incident Investigation Form F23-1 Improvement Activity Form F24-1 Corrective Action Request F24-2 Preventive Action Request F24-3 CAPA Request Log F25-1 Management Review Agenda & Minutes Checklists Checklist No. CL17-1 CL17-2 CL17-3 Title & Description ISO 9001 Internal Audit Checklist ISO 14001 Internal Audit Checklist OHSAS 18001 Internal Audit Checklist www.iso9001help.co.uk 2013 P a g e 35 of 36