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ISO 9001-14001:2015 All In One Certification 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 9001.2015 & ISO 14001.2015 Internal Auditor Training MaterialsISO 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
INSERT COMPANY NAME/LOGO HEREISO 9001:2015 Quality Management Systems - The Gap Analysis ChecklistThis gap analysis checklist is prepared for use in evaluating your Quality Management System (QMS) against the requirements of ISO9001:2015. Each requirement is expressed as a question that the user (auditor / assessor) can use to evaluate your QMS capabilities.You will need to have a copy of the ISO 9001:2015 standard to use along with this checklist so that you can refer to the requirements and theclarification sections of Annex A.After you have prepared an audit schedule, and assigned responsibility to your auditors for different areas or processes to audit, copy eachsection of the checklist for the auditors working with that section. As you work through the checklist take notes on what is in place, and whatneeds to be developed. Reference the procedures or other documents that you have reviewed and that will provide information for the newQMS. Take notes on the status of the documents; will they need to be revised for the new system, or can they be used as is? Also note whereprocesses are in place, but documentation is needed. Focus on what is in place, and what needs to be developed.While you do want to know if procedures and processes are being complied with, compliance is not your main focus for this audit. Rememberthat the final outcome of this audit should be a list of things that your company needs to do to comply with ISO QUALITY MANAGEMENT SYSTEMCurrentlyCompliantin PlaceYes / NoIf No - %CompletedItemsNeededCONTEXT OF THE ORGANIZATIONThis clause introduces two sub-clauses relating to the context of the organization, (1) understanding the organization and its context and (2)understanding the needs and expectations of interested parties. Together they require that you determine the issues and requirements thatcan impact on the planning of the QMS. In addition the scope of the QMS and the QMS processes along with their applicability andinteractions need to be determined.4.1Understanding the organization and its contextHas your company determined the external andinternal issues that are relevant to your purposeand strategic direction?Have you considered the relevant issues thataffect your ability to achieve the intended resultsof the Quality Management System (QMS)?Audit conducted by: Date: toCopyright Standards-Stores.comPage 1 of 40
INSERT COMPANY NAME/LOGO HEREISO 9001:2015 Quality Management Systems - The Gap Analysis ChecklistHow do you monitor and review the informationrelated to the external and internal issues?4.2Understanding the needs and expectations of interested partiesWith consideration given to their impact orpotential impact on your company’s ability toconsistently provide products and services thatmeet customer and applicable statutory andregulatory requirements, have you determined: The interested parties relevant to the QMS? The requirements of these interested partiesthat are relevant to the QMS?How do you monitor and review the informationabout the interested parties and their relevantrequirements?4.3Determining the scope of the quality management systemTo establish the scope of the QMS, has yourcompany determined the boundaries andapplicability of the QMS?When determining the scope of the QMS, haveyou considered the: External and internal issues (per 4.1)? Requirements of relevant interested parties(per 4.2)? The products and services of your company?When a requirement of ISO 9001:2015 can beapplied, has your company applied theAudit conducted by: Date: toCopyright Standards-Stores.comPage 2 of 40
INSERT COMPANY NAME/LOGO HEREISO 9001:2015 Quality Management Systems - The Gap Analysis Checklistrequirement?When requirements cannot be applied, and inorder to claim conformity to ISO 9001:2015, howdo you determine if your ability or responsibilityto ensure conformity of products and servicesare not affected?Is the scope of the QMS available andmaintained as documented information?In the scope of the QMS, have you stated theproducts and services covered by the QMS?Has your company provided justification for anyinstance where a requirement of the standardcannot be applied?4.44.4.1Quality management system and its processesHas your company obtained the current versionof the ISO 9001:2015 international standard?As required by the standard, have youestablished, documented implemented,maintained and continually improved the QMS?Have you determined the processes needed forthe QMS, their interactions and applicationsthroughout your company?For the QMS processes have you determined: Inputs required and the outputs expected fromthe processes? Sequence and interaction of the processes? Criteria, methods, including measurementsAudit conducted by: Date: toCopyright Standards-Stores.comPage 3 of 40
INSERT COMPANY NAME/LOGO HEREISO 14001:2015 Environmental Management Systems - The Gap Analysis ChecklistThis gap analysis checklist is prepared for use in evaluating your Environmental Management System (EMS) against the requirements ofISO 14001:2015. Each requirement is expressed as a question that the user (auditor / assessor) can use to evaluate your EMS capabilities.You will need to have a copy of the ISO 14001:2015 standard to use along with this checklist so that you can refer to the requirements andthe guidance sections of Annex A.After you have prepared an audit schedule, and assigned responsibility to your auditors for different areas or processes to audit, copy eachsection of the checklist for the auditors working with that section. As you work through the checklist take notes on what is in place, and whatneeds to be developed. Reference the procedures or other documents that you have reviewed and that will provide information for the newEMS. Take notes on the status of the documents; will they need to be revised for the new system, or can they be used as is? Also notewhere processes are in place, but documentation is needed. Focus on what is in place, and what needs to be developed.While you do want to know if procedures and processes are being complied with, compliance is not your main focus for this audit. Rememberthat the final outcome of this audit should be a list of things that your company needs to do to comply with ISO 4ENVIRONMENTAL MANAGEMENT SYSTEMSCurrentlyCompliantIf No - %Itemsin PlaceYes / NoCompletedNeededCONTEXT OF THE ORGANIZATIONThis clause introduces two sub-clauses relating to the context of the organization, (1) understanding the organization and its context and(2) understanding the needs and expectations of interested parties. Together they require that you determine the issues and requirementsthat can impact on the planning of the EMS. In addition the scope of the EMS needs to be determined and the EnvironmentalManagement System established, implemented, maintained and continually improved.4.1Understanding the organization and its contextHas your company determined the external andinternal issues that affect your ability to achieve theintended outcomes of the Environmental ManagementSystem (EMS)?Have you included such issues as environmentalconditions being affected by or capable of affectingAudit conducted by: Date: toCopyright ISO 14001StorePage 1 of 23
INSERT COMPANY NAME/LOGO HEREISO 14001:2015 Environmental Management Systems - The Gap Analysis Checklistyour company?4.2Understanding the needs and expectations of interested partiesHas your company determined: The interested parties that are relevant to the EMS? The requirements (relevant needs andexpectations) of these interested parties? The requirements that become complianceobligations?4.3Determining the scope of the environmental management systemTo establish the scope of the EMS, has your companydetermined the boundaries and applicability of theEMS?When determining the scope of the EMS, have youconsidered: The external and internal issues (per 4.1)? The compliance obligations relevant interestedparties (per 4.2)? Your organizational units, functions and physicalboundaries? The activities, products and services of yourcompany? Your authority and ability to exercise control andinfluence?Within the defined scope of the EMS, have youincluded all your activities, products and services inAudit conducted by: Date: toCopyright ISO 14001StorePage 2 of 23
INSERT COMPANY NAME/LOGO HEREISO 14001:2015 Environmental Management Systems - The Gap Analysis Checklistthe EMS?Is the scope of the EMS available and maintained asdocumented information?4.4Environmental management systemHas your company obtained the current version of theISO 14001:2015 international standard?As required by the standard, have you established,documented implemented, maintained and continuallyimproved the EMS?Have you determined the processes needed for theEMS and their interactions throughout the company?When establishing and maintaining the EMS, haveyou considered the knowledge gained from: Your understanding of the organization and itscontext (per 4.1)? Your understanding of the needs and expectationsof interested parties (per 4.2)?5LEADERSHIPThis clause requires that your top management demonstrates leadership and commitment with respect to the EMS. This section also askstop management to establish, implement and maintain an environmental policy that is appropriate to your company and to ensure that theresponsibilities and authorities for relevant roles are assigned and communicated.5.1Leadership and commitmentHas top management demonstrated leadership andcommitment with respect to the EMS by: Taking accountability of the effectiveness of theAudit conducted by: Date: toCopyright ISO 14001StorePage 3 of 23
INSERT COMPANY NAME/LOGO HEREISO 9001:2015 Quality Management Systems - The Internal Audit ChecklistThis checklist is based on the information provided in the ISO 9001:2015 international standard. The checklist is best used bytrained and practicing auditors to evaluate or assess Quality Management Systems requirements based on the standard.You will see questions on the checklist that refer to the standard and for each clause provisions are made for additional questions.The auditors are expected to use a great deal of discretion and therefore must be careful and thoughtful prior to establishing adeficiency against a requirement. Evidence for visible top management leadership, commitment and quality management actionmust be looked for.The bold numbers and tittles used in the first two columns of the checklist indicate the “Requirements” and may be referred to onnonconformity reports prepared by the auditor.During assessment of each requirement, auditors record the status of the evaluation by indicating in the right hand column aYes - for Acceptable Condition or No - for Deficient ITY MANAGEMENT SYSTEM44.1OBSERVATIONS / COMMENTSSTATUSCONTEXT OF THE ORGANIZATIONUnderstanding the organization and its contextHas your company determined the external andinternal issues that are relevant to your purpose andstrategic direction?Have you considered the relevant issues that affectyour ability to achieve the intended results of theQuality Management System (QMS)?How do you monitor and review the informationrelated to the external and internal issues?Audit conducted by: Date: to Copyright ISO 9001StorePage 1 of 44
INSERT COMPANY NAME/LOGO HEREISO 9001:2015 Quality Management Systems - The Internal Audit ChecklistAdditional Questions4.2Understanding the needs and expectations of interested partiesWith consideration given to their impact or potentialimpact on your company’s ability to consistentlyprovide products and services that meet customer andapplicable statutory and regulatory requirements,have you determined: The interested parties that are relevant to the QMS? The requirements of these interested parties thatare relevant to the QMS?How do you monitor and review the information aboutthe interested parties and their relevant requirements?Additional Questions4.3Determining the scope of the quality management systemTo establish the scope of the QMS, has your companydetermined the boundaries and applicability of theQMS?When determining the scope of the QMS, have youconsidered the: External and internal issues (per 4.1)? Requirements of relevant interested parties (per4.2)?Audit conducted by: Date: to Copyright ISO 9001StorePage 2 of 44
INSERT COMPANY NAME/LOGO HEREISO 9001:2015 Quality Management Systems - The Internal Audit Checklist The products and services of your company?When a requirement of ISO 9001:2015 can beapplied, has your company applied the requirement?When requirements cannot be applied, and in order toclaim conformity to ISO 9001:2015, how do youdetermine if your ability or responsibility to ensureconformity of products and services are not affected?Is the scope of the QMS available and maintained asdocumented information?In the scope of the QMS, have you stated theproducts and services covered by the QMS?Has your company provided justification for anyinstance where a requirement of the standard cannotbe applied?Additional Questions4.44.4.1Quality management system and its processesHas your company obtained the current version of theISO 9001:2015 international standard?As required by the standard, have you established,documented implemented, maintained and continuallyimproved the QMS?Have you determined the processes needed for theQMS, their interactions and applications throughoutAudit conducted by: Date: to Copyright ISO 9001StorePage 3 of 44
INSERT COMPANY NAME/LOGO HEREISO 14001:2015 Environmental Management Systems - Internal Audit ChecklistThis internal audit checklist based on the information provided in the Sept 2015 release of the ISO 14001:2015 international standard is usedto audit the Environmental Management System in all types of organizationsBelow are the lists the audit questions relevant to each sub-clause of the ISO 14001:2015 standard.The bold numbers and tittles used in the first two columns indicate the “Requirements”. The numbers and titles may be referred to in the auditreport prepared by the auditor.During assessment of each requirement, auditors record the status of the evaluation by indicating in the right hand column aYes - for Acceptable Condition or No - for Deficient it conducted by: Date: to Copyright 2015 14000StorePage 1 of 2
INSERT COMPANY NAME/LOGO HEREISO 14001:2015 Environmental Management Systems - Internal Audit Checklist---ENVIRONMENTAL MANAGEMENT SYSTEMS4CONTEXT OF THE ORGANIZATION4.1OBSERVATIONS / COMMENTSSTATUSUnderstanding the organization and its contextHas your company determined the external andinternal issues that affect your ability to achieve theintended outcomes of the EnvironmentalManagement System (EMS)?Have you included such issues as environmentalconditions being affected by or capable of affectingyour company?Additional Questions4.2Understanding the needs and expectations of interested partiesHas your company determined: The interested parties that are relevant to theEMS? The requirements (relevant needs andexpectations) of these interested parties? The requirements that become complianceobligations?Audit conducted by: Date: to Copyright 2015 14000StorePage 2 of 2
ISO 9001.2015 & ISO 14001.2015 Internal Audit Checklists* ISO 9001.2015 & ISO 14001.2015 Internal Auditor Training Materials . ISO 9001 & ISO 14001 Employee Newsletters *Sample Included. . This gap analysis checklist is prepared for use in evaluating your Quality Management System (QMS) against the requirements of ISO
