ISO 9001-14001:2015 Small Business Package Contents

ISO 9001-14001:2015 Small Business PackageContentsCombined EMS-QMS Manual * Procedures & Work Instructions describing QMS and EMS System Processes Forms, Attachments, Registers and Tables referenced by the Procedures(5) PowerPoint Presentations Requirements of ISO 9001.2015 Presentation Materials* Requirements of ISO 14001.2015 Presentation Materials ISO 9001.2015 Employee Training Presentation Materials ISO 14001.2015 Employee Training Presentation Materials Integrating ISO 9001-14001 Training PresentationISO 9001.2015 & ISO 14001.2015 Gap Analysis Checklists*ISO 9001.2015 & ISO 14001.2015 Internal Audit Checklists*ISO 9001 & ISO 14001 Employee Newsletters*Sample Included

ISO 9001:2015QUALITY MANAGEMENT SYSTEM*****ISO 14001:2015ENVIRONMENTAL MANAGEMENT SYSTEM*****QMS - EMS MANUALYour Company NameStreet AddressCity, State ZipCustomize with yourcompany's name andLogo

INSERT COMPANY NAME/LOGO HEREQuality and Environmental ManualIntroductionYour Company developed and implemented an integrated Quality and EnvironmentalManagement System in order to document the company’s best business practices, bettersatisfy the requirements and expectations of its customers, enhance its environmentalperformance and improve the overall management of the company.To fully understand the organization and its context, Your Company determined the externaland internal issues that are relevant and that affect its ability to achieve the intended resultsof the Integrated Management System (IMS).Your Company meets the requirements of the international standard ISO 9001:2015. Thesystem addresses the design, development, production, installation, and servicing of thecompany’s products. It incorporates the process approach where consistent and predictableresults are achieved more effectively and efficiently when activities are understood andmanaged as interrelated processes.Your Company meets the requirements of the international standard ISO 14001:2015. Thesystem addresses the management of environmental aspects, compliance obligations, theactions to address risks and opportunities. The management of the interactive processesprovides for the achievement of continual improvement and focus on efforts leading to theprevention of undesirable outcomes.This process approach provides for the management of the integrated management systemand its processes through the application of a “Plan-Do-Check-Act” methodology and afocus on “Risk-Based-Thinking” leading to the prevention of undesirable outcomes.The manual is divided into sections that correlate to the clauses of ISO 9001:2015 and ISO14001:2015. The manual describes the Integrated Management System, delineatesauthorities, inter relationships and responsibilities of the personnel responsible within thesystem. The manual also provides the documented information with procedures orreferences for all activities comprising the management system that ensures the complianceto the necessary requirements of the standards.This manual is used internally to guide the company’s employees through the variousrequirements of the ISO quality and environmental standards that must be met andmaintained in order to ensure environmental performance, customer satisfaction, andcontinual improvement and provide the necessary instructions that create an empoweredwork force. This manual is used externally to introduce our Integrated Management Systemto our customers and other external organizations or interested parties. The manual is alsoused to familiarize them with the controls that have been implemented and to assure themthat the integrity of the Management System is maintained and focused on customersatisfaction and continuous improvement. The IMS manual is approved by a topmanagement representative.President:Date:IMS-001 Rev A Quality and Environmental ManualApproved by: Date:Page 4 of 20

INSERT COMPANY NAME/LOGO HEREQuality and Environmental ManualSection 04Document informationa. Distribution control listAs required with procedure P-750 for Control of documented information.Quality and Environmental Manual latest revision: Letter:Date of Issue: Issued by:The status of the manual and/or description of changes are provided in the revision statuspage of this manual.Controlled copies are issued to:Copy No. 1PresidentVice PresidentCopy No 2Treasurer / Bookkeeper / AccountantAdministrative OfficerCopy No. 3Quality ManagerIMS Team / Quality-Environmental TeamIMS team leader / Quality team leader / Environmental team leaderCopy No. 4Operations ManagerTechnical ManagerMaterials ManagerCopy No. 5Human Resources ManagerEducation / Training OfficerThe master copy is held by the IMS team leader.This manual is issued and controlled by the IMS team leader.All matters or inquiries relating to its contents or usage are to be referred to that individual.It is the responsibility of all holders of the above controlled copies to: Ensure that this manual is read by and available to the personnel under their control. Ensure that superseded pages are returned to the IMS team leader.Uncontrolled copies of this manual will be identified with the word "uncontrolled" in boldletters across this pageIMS-001 Rev A Quality and Environmental ManualApproved by: Date:Page 6 of 20

Includes relevant forms and flow diagramsINSERT COMPANY NAME/LOGO HEREQuality and Environmental ManualFor example, the FD-810-001 Process Flow Diagram represents each step in themanufacturing process and includes other relevant factors associated with the steps.Process Flow1Sources ofMaterials2Hauling,Transportation3 - ExistingOperations andProduction3. a - NewProductionRelevant FactorsRaw materials, productsand other components arepurchased and receivedApproved suppliers,Incoming inspectionsPersonnel - ManpowerEquipment -TrucksManpower – LaborersMachines – AutomationQuality control –Operator self-inspect(x) New MachinesManpower – LaborersTraining – machines,maintenanceOperator self-inspect,4. Products,services fordeliveryProducts, Subassemblies, Components.ServicingSales and Marketing5. Deliveries tocustomersManpower - DriversEquipment –TrucksPermits6. Income - Invoice forproducts/servicesdeliveredIMS-001 Rev A Quality and Environmental ManualApproved by: Date:Page 12 of 20

INSERT COMPANY NAME/LOGO HEREQuality and Environmental ManualSection 04Documented information – Form F-750-001List of Documented Information for IMS Manual Section 04This master list for Procedures provides the responsibility, approval date, and revision status for the documents.A latest copy of each Procedure and Instruction is included in the applicable section of the manual. The IMS designation indicates an Integrated Management System Manual.The P designation indicates Procedures.The WI designation indicates Work Instructions.The number following the document numbers listed in the Document column below identifies the section of the standard that the documentis associated with.Doc. #DescriptionResponsibilityQuality Management SystemIMS-001QMS-EMS Manual – Document InformationPresidentManual Section 04 – Context of the OrganizationP-400Organizational contextPresidentManual Section 05 – LeadershipP-500LeadershipPresidentManual Section 06 – PlanningP-600Planning for the IMSIMS team leaderP-610QMS – Risk management planningIMS team leaderP-612EMS – Risk management planningIMS team leaderWI-622-001Environmental program – WaterTechnical services managerWI-622-002Environmental program – AirTechnical services managerIMS-001-A Quality and Environmental ManualPage 13 of 13Approved by: Date:ApprovedateRevisedateRevisedate

INSERT COMPANY NAME/LOGO HEREQuality and Environmental ManualSection 20Records Documentation Matrix – Form F-750-002This section of the IMS Manual contains the Records Documentation Matrix.In support of the process approach, the last column indicates where in the IMS the documents are used.A sample of the latest attachment, form, register and flow diagram is included.Doc #Description of document1st Rev.DateLast Rev.DateUsed with Manual, Procedure, InstructionAttachmentsA-520-001Quality PolicyP. 8ManualIMS-001 / P-500 / P-740A-520-002Environmental PolicyP.9ManualIMS-001 / P-500 / P-740A-530-001Organization ChartP. 10ManualIMS-001 / P-500 / P-600 / P-740A-600-001PDCA guidelinesP-400 / P-600 / P-740A-600-002Aspects and impacts guidelinesP-612 / P-740A-620-001Objectives and targets guidelinesP-612A-800-001Operational controls guidelinesP-815FormsF-440-001IMS-Process identification worksheetP-400 / P-600 / P-810 / P-851F-610-001Risk and opportunity worksheetP-610 / P-740 / P-1010F-612-001Initial environmental review worksheetP-612 / P-815 / P-911F-614-001Risk management worksheetP-612 / P-740 / P-815 / P-911 / P-911F-615-001Environmental program planning worksheetP-612 / P-815F-620-001Quality objectives planning recordP-610F-620-002Environmental objectives planning recordP-612 / P-911IMS-001-A Quality and Environmental ManualPage 16 of 16Approved by: Date:

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The requirements of ISO 9001:2015 are described in 7 clauses or sectionsSection 4 - Context of the OrganizationSection 5 - LeadershipSection 6 - Planning for the Quality Management SystemSection 7 - SupportSection 8 - OperationSection 9 - Performance EvaluationSection 10 - Improvement4

This example of the process-based model is similar to the one included inthe standard (Figure 1).The seven clauses are all found on the process model.Leadership, Planning for the QMS, Operations, and Performance evaluationform a cycle that is influenced by the Context of the organization andSupport processes aimed at improvementThe most important input to this cycle is customer and other relevantinterested parties requirements.The output of the cycle is customer satisfaction and continual improvementof the quality system.The standard is organized around this model.7

The adoption of a quality management system ought to be a strategicdecision for an organization.A robust quality management system can help an organization to improve itsoverall performance and forms an integral component of sustainabledevelopment initiatives.9

Evaluate your current quality system:Many of the requirements of the standard are addressed by practices already inplace.These practices may or may not be described in documented information.Other requirements of the standard may not be addressed at all and these needto be implemented and documented.The standard is designed to bring control and consistency to your processes.Documenting the processes is part of this control.It helps ensure that people are doing the same thing, to get consistent results.The documented information may take the shape of a Document Pyramid andincludeAn Operations Manual:a top level document that describes briefly what you have in place to meet thestandard.Procedures:describe what is done, for example the overall procedure for purchasing ortraining. What is included in the process?Work Instructions:detailed documents that describe how to perform a process, for example how tofill out a purchase order etc.Forms: to provide the evidence that the system is in place.10

Again -- Remember that for the QMS you only need to consider the issuesthat are relevant to the QMS.To completely understand the needs and expectations of interested parties,Your Company identifies the relevant interested parties, determines,monitors and reviews the requirements that are relevant to the QMS.Their expectations and needs and the impact or potential impact on theability to consistently provide products and services that meet customer andapplicable statutory and regulatory requirements are considered.Interested parties may be customers, owners, and people in theorganization, suppliers, unions, bankers, partners or society that may includecompetitors or opposing pressure groups.16