Title:AS9100D QualityManualRevision Date.:05/04/2018Page 1 of 22The Quality Policy of Monroe Engineering is defined in the following statement:Monroe Engineering is committed to customer satisfaction; westrive for Continuous Improvement in our products and ourpeople.The policies under which Monroe Engineering will operate its’ quality system are containedwithin the quality manual. The quality system is designed to and operates with the requirementsof ISO 9001:2015 and where contractually required AS9100 Rev D. Requirements specificallyfor AS9100 are identified in bold throughout this quality manual. The quality manual issuedand controlled by Monroe Engineering defines the quality system that is effective across alldisciplines and at all levels within the company. If you have any questions concerning thecurrent status of this manual, please contact the Management Representative at MonroeEngineering 2990 Technology Dr. Rochester Hills, Michigan 48309.
Revision DateMarch 24,2017April 20, 2017Revision sectionAll quality manualApril 21, 2017June 15, 2017July 7, 2017Interaction ofProcesses to Level BInteraction ofprocesses & section4.3 scope, Org ChartSections 4.2 & 4.4.2Sections 4.2 & 9.3May 4, 2018IOPMay 30, 2017Section 4.3NotesUpdated manual to ISO9001:2015 &AS9100 Rev DUpdated Section references tocoincide with AS9100 Rev DUpdated IOP to Level BChanged exclusions and addedprocess owners, Defined Org ChartAdded Interested PartiesAdded Interested Parties toManagement Review and added biannual scheduleAdded updated IOP Document
Organizational Chart for Monroe EngineeringMonroe Corporate StaffMonroe Engineering StaffCEOPresidentGeneralManagerPurchasing /CustomerServiceSalesPhones & OrderEntryCFOQualityManager / MRSupervisor ofOperationsShipping &ReceivingWarehouseEmployeesAccountsPayable /Receivable
44.1Context of the OrganizationUnderstanding the organization and its contextMonroe Engineering has determined the external and internal issues that are relevant to the purpose andstrategic direction to achieve the quality management system (QMS) desired. The QMS information will bemonitored and reviewed.4.2Understanding the needs and expectations of interested partiesMonroe Engineering will consistently provide products and services that meet customer and applicablestatutory and regulatory requirements. To do this we shall determine, monitor and review informationconcerning during the Management Review (see 9.3):a). the interested parties relevant to the QMS; andb). the requirements of the interested parties relevant to the QMS.4.3Determining the scope of the QMSThis quality manual applies to all activities within Monroe Engineering as a manufacturer and distributor ofclamps, knobs, handles, plungers, leveling pads, hinges, and boosters. At this time, Monroe Engineeringexcludes design (8.3), the customer supplies all design work. Post-delivery activities sections 8.5.5 g & h areexcluded because we do not have technical documentation or have control over work done outside ourcompany. If we determine in the future to add design and/or post-delivery activity, we will update our qualitymanagement system to include these sections of the ISO9001 / AS9100 standard.4.4Quality management system and its processes4.4.1Monroe Engineering has established, implemented, maintained and continually improves theirquality management system including their processes and interactions in accordance with theAS9100D requirements.The QMS shall also address customer and applicable statutory and regulator QMSrequirements.Monroe Engineering has determined the processes needed for their QMS and their applicationthroughout and shall:a). determine the inputs required and expected outputs from their processes;b). determine the sequence and interaction of processes;c). determine and apply the criteria and methods needed to ensure the effective operationand control of their processes;d). determine the resources needed for their processes and ensure their availability;e). assign the responsibilities and authorities for the processes;f). address the risks and opportunities determined by the requirements;g). evaluate the processes and implement any changes needed to ensure the processesachieve their intended results;h). improve their processes and the QMS.4.4.2Monroe Engineering shall:a). maintain documented information to support the operation of its processes; andb). retain documented information to ensure processes are being carried out as planned.Documented information includes A general description of relevant interested parties; The scope of the QMS, including boundaries and applicability; A description of the processes need for the QMS and their application throughout ourcompany;
55.1The sequence and interaction of these processes; andAssignment of the responsibilities and authorities for these processes.LeadershipLeadership and commitment5.1.1Top management of Monroe Engineering is committed to the QMS by:a). taking accountability for the effectiveness of the QMS;b). the quality policy and objectives are established for the QMS and are compatible with thecontext and strategic direction;c). ensuring the integration of the QMS into the business processes;d). promote the use of the process approach and risk-based thinking;e). the QMS resources are available;f). communicating the effectiveness to the QMS;g). ensure the QMS achieves its intended results;h). engaging, directing and supporting persons to contribute to the effectiveness of the QMS;i). promote improvement;j). supporting management roles to demonstrate their leadership as it applies to their area ofresponsibility.5.1.2Customer focusTop management shall demonstrate leadership and commitment with respect to customer focus byensuring that:a). determine, understand and consistently meet customer and applicable statutory andregulatory requirements;b). determine and address the risks and opportunities that can affect conformity of productsand services and the ability to enhance customer satisfaction; andc). maintain the focus of enhancing customer satisfaction; andd). product and service conformity and on-time delivery performance are measuredand appropriate action is taken if planned results are not, or will not be, achieved.5.2Policy5.2.1 Establishing the quality policyTop management has established, implemented and maintained a quality policy that:a). is appropriate to the purpose and context of Monroe Engineering and supports ourstrategic direction;b). provided a framework for setting quality objectives;c). includes a commitment to satisfy applicable requirements; andd). includes a commitment to continual improve its QMS.5.2.2 Communicating the quality policyThe quality policy shall:a). is available and maintained as documented information;b). is communicated, understood and applied within the organization; andc). is available to relevant parties, as appropriate.5.3Organizational roles, responsibilities and authoritiesTop management ensures responsibilities and authorities for relevant roles are assigned,communicated and understood.Top management has assigned responsibility and authority for:a). ensuring the QMS conforms to the requirements of AS9100D;b). ensuring the processes are delivering their intended outputs;c). reporting on the performance of the QMS and on opportunities for improvement;d). ensuring the promotion of customer focus throughout Monroe Engineering; ande). ensuring the integrity of the QMS is maintained when changes to the QMS are plannedand implemented.
Top management has appointed the Director of Quality, who has the responsibility andauthority for oversight of the QMS as the management representative (MR). The MR has theorganizational freedom and unrestricted access to top management to resolve qualitymanagement issues.66.1PlanningActions to address risks and opportunities6.1.1Our QMS has determined the risks and opportunities that need to be addressed to:a). give assurance the QMS has achieve its intended results;b). enhance desirable effects;c). prevent or reduce undesired effects; andd). achieve improvement.6.1.2The organization shall plan:a). actions to address these risks and opportunities;b). how to;1). Integrate and implement the actions into its QMS processes; and2). Evaluate the effectiveness of these actions.Actions taken to address risks and opportunities shall be proportionate to the potential impact onthe conformity of products and services.6.2Quality objectives and planning to achieve them6.2.1Monroe Engineering has established quality objectives at relevant functions, levels and processesneeded for the QMS.The quality objectives shall:a). be consistent with the quality policy;b). be measurable;c). take into account applicable requirements;d). be relevant to conformity of products and services and to enhancement of customersatisfaction;e).be monitored;f). be communicated; andg). be updated as appropriate.Quality objectives are maintained as documented information.6.2.2When planning how to achieve our quality objectives we shall determine:a). what will be done;b). what resources will be required;c). who will be responsible;d). when it will be completed; ande). how the results will be evaluated.6.3PlanningWhen changes are made to our QMS they are planned. We shall consider:a). the purpose of the changes and their potential consequences;b). the integrity of the QMS;c). the availability of resources; andd). the allocation or reallocation of responsibilities and authorities.77.1SupportResources7.1.1GeneralWe have determined and provided the resources needed for the establishment,
implementation, maintenance and continual improvement of the QMS.MONROE ENGINEERING shall consider:a). the capabilities of, and constraints on, existing internal resources; andb). what needs to be obtained from external providers.7.1.2PeopleWe have determined and provided the people necessary for the effective implementation ofits QMS and for the operation and control of its processes.7.1.3InfrastructureThe infrastructure (can include buildings, associated utilities, equipment, transportation resources,information and communication technology) is maintained for the operation of its processes and toachieve conformity of products and services.7.1.4Environment for the operation of processesThe environment is maintained for the operation of its processes and to achieve conformityof products and services. (A suitable environment can be a combination of human andphysical factors such as: social, psychological, physical)7.1.5Monitoring and measuring resources126.96.36.199GeneralThe resources needed to ensure valid and reliable results when monitoring ormeasuring is used to verify the conformity of products and services torequirements are provided.We ensure that the resources provided:a). are suitable for the specific type of monitoring and measurement activitiesbeing undertaken; andb). are maintained to ensure their continuing fitness for their purpose.Documented information is retained as evidence of fitness for purpose of themonitoring and measurement resources.188.8.131.52.1.6Measurement traceabilityWhen measurement traceability is a requirement or considered to be an essentialpart of providing confidence in the validity of measurement results, measuringequipment shall be:a). calibrated or verified, or both, at specified intervals or prior to use, againstmeasurement standards traceable to international or national measurementstandards; when no such standards exist, the basis used for calibration orverification shall be retained as documented information;b). identified in order to determine their status; andc). safeguarded from adjustments, damage or deterioration that would invalidatethe calibration status and subsequent measurement results.We have a process for the recall of monitoring and measuring equipment requiringcalibration or verification. A register of the monitoring and measuring equipmentincludes the equipment type, unique identification, location and the calibration orverification method, frequency and acceptance criteria. Calibration or verificationof monitoring and measuring equipment shall be carried out under suitableenvironmental conditions.We determine if the validity of previous measurement results has been adverselyaffected when measuring equipment if found to be unfit for its intended purpose,and shall take appropriate action as necessary.Organizational knowledge (is knowledge specific to Monroe Engineering)We have determined the knowledge necessary for the operation of our processes and toachieve conformity of products and services. This knowledge will be maintained and madeavailable to the extent necessary. When addressing changing needs and trends, we shall
consider its current knowledge and determine how to acquire or access any necessaryadditional knowledge and required updates.7.2CompetenceMonroe Engineering shall:a). determine the necessary competence of person(s) doing work under itscontrol that affects the performance and effectiveness of the QMS;b). ensure these persons are competent on the basis of appropriate education,training, or experience and a periodic review occurs;c). where applicable, take actions to acquire the necessary competence, andevaluate the effectiveness of the actions taken; andd). retain documented information as evidence of competence.7.3AwarenessMonroe Engineering shall ensure persons doing work under our control are aware of:a). the quality policy;b). relevant quality objectives;c). their contribution to the effectiveness of the QMS, including the benefits ofimproved performance;d). the implications of not conforming with the QMS requirements;e). relevant QMS documented information and changes thereto;f). their contribution to product or service conformity;g). their contribution to product safety; andh). the importance of ethical behavior.7.4CommunicationMonroe Engineering shall determine the internal and external (feedback) communications relevant tothe QMS, including:a). on what it will communicate;b). when to communicate;c). with whom to communicate;d). how to communicate; ande). who communicates.7.5Documented Information7.5.1 GeneralMonroe Engineering’s QMS shall include:a). documented information required by AS9100D; andb).documented information determined by Monroe Engineering as being necessaryfor the effectiveness of the QMS.7.5.2Creating and updatingWhen documented information is created or updated, we ensure appropriate:a). identification and description;b). format and media; andc). review and approval for suitability and adequacy.7.5.3Control of documented information184.108.40.206 Documented information required by our QMS and AS9100D shall be controlledto ensure:a). it is available and suitable for use, where and when needed; andb). it is adequately protected.
220.127.116.11 For control of documented information, we shall address the followingactivities, as applicable:a). distribution, access, retrieval and use;b). storage and preservation, including preservation of legibility;c). control of changes;d). retention and disposition; ande). prevention of the unintended use of obsolete documented information byremoval or by application of suitable identification or controls if kept for anypurpose.External documented information determined to be necessary for the planning andoperation of the QMS shall be identified as appropriate, and be controlled.Documented information retained as evidence of conformity shall be protected fromunintended alterations.When documented information is managed electronically, data protectionprocesses shall be defined.88.1OperationsOperational planning and controlWe shall plan, implement and control the processes needed to meet the requirements for theprovision of products and services, and to implement the actions determined by:a). determining the requirements for the products and services;NOTE: Determination of requirements for the products and services should includeconsideration of: Personal and product safety; Producibility and inspectability; Reliability, availability, and maintainability; Suitability of parts and materials used in the product; Selection and development of embedded software; Product obsolescence; Prevention, detention, and removal of foreign objects; Handling, packaging, and preservation; Recycling or final disposal of the product at the end of its life.b). establishing criteria for1). the processes;2). the acceptance of products and services;NOTE: According to the nature of the product and depending on the specifiedrequirements, statistical techniques can be used to support: Design verification; Process control; Selection and verification of key characteristics; Process capability measurements; Statistical process control; Design of experiments; Verification; Failure mode, effects, and criticality analysis.c). determining the resources needed to achieve conformity to the product and servicerequirements and to meet on-time delivery of products and services;d). implementing control of the processes in accordance with the criteria; ande). determining, maintaining and retaining documented information to the extent necessary:1). To have confidence that the processes have been carried out as planned;2). To demonstrate the conformity of products and services to their requirements.f). determining the processes and controls needed to manage critical items, includingproduction process controls when key characteristics have been identified;g). engaging representatives of affected organization functions for operational
planning and control;h). determining the process and resources to support the use and maintenance of theproducts and services;i). determining the products and services to be obtained from external providers;j). establishing the controls needed to prevent the delivery of nonconformingproducts and services to the customer.As appropriate, customer requirements, and products and services, we planned andmanage product and service provision in a structured and controlled manner including scheduledevents performed in a planned sequence to meet requirements at acceptable risk, within resource andschedule constraints.The output of this planning shall be suitable for our operations.We shall control planned changes and review the consequences of unintended changes, takingaction to mitigate any adverse effects, as necessary. We will ensure outsource processes arecontrolled.We have established, implemented, and maintained a process to plan and control thetemporary or permanent transfer of work, to ensure the continuing conformity of thework to requirements. The process shall ensure that work transfer impacts and risksare managed.8.1.1 Operational Risk ManagementWe have planned, implemented, and control a process for managing operational risksto the achievement of applicable requirements, which includes as appropriate toMonroe Engineering and the products and services:a). assignment of responsibilities for operational risk management;b). definition of risk assessment criteria;c). identification, assessment, and communication of risks throughout operations;d). identification, implementation, and management of actions to mitigate risks thatexceed the defined risk acceptance criteria;e). acceptance of risks remaining after implementation of mitigating actions.8.1.2 Configuration ManagementWe have planned, implemented and control the configuration management process asappropriate to our company and its products and services in order to ensure theidentification and control of physical and functional attributes throughout the productlifecycle. This process shall:a). control product identity and traceability to requirements, including the implementation ofidentified changes;b). ensure documented information is consistent with the actual attributes of the productsand services.8.1.3 Product SafetyMonroe Engineering has planned, implemented and controls the pr