ISO9001 Internal Audit ReportQuality Management System Audit Checklist(a cumulative audit report/summary and management summary)Intelex Audit Report #LEAD AUDITORDEPARTMENT CONTACT INFORMATION/AUDIT PLANNINGAUDIT DATE (RANGE)Name: (Contact)Department:AUDITORSEmail:Locations Sampled:Phone:Audit Scope/Criteria:(e.g., area(s) being audited, applicable clauses from ISO 9001, applicable Administrative Directive requirements, state or federal regulations, etc.)TOFax:FINDINGSSUMMARY OF AUDIT RESULTSMAJORAudit Summary:MinorSystem Strength:CommentSystem Weakness:CLAUSETYPE OF EXPECTATIONEXPECTATION DEFINEDSYSTEM TRAILAUDITOR COMMENTSFINDINGIntelex NC # & CA #Relationship with ISO 9001:2008DocumentedProvenRecordedThis is what the standard is requesting we document, define, prove, and/or record. A description of the types of expectations (shown to the left) is embedded electronically in the cell for each expectation as a comment. (Italics tends to identify a note or summary of what is being covered somewhere else.)This is where we note the location of the answer to the EXPECTATION in our system. Grayed out boxes do not require a response, as they will be addressed in the sections referenced. When the SYSTEM TRAIL entry is BOLD ITALIC, this is a required record for the records control procedure addressed in 4.2.4.Evidence reviewed and/or issues identified.(black font is comment/evidentiary, blue is opportunity for improvement, and red is a nonconformance [issue that must be resolved])CommentMinorMAJORNC#CA#General questions during all auditaDo you know your Quality Policy? What does it mean?What are the organization quality objectives?How do you contribute to meeting organizations quality objectives?Who is the ISO Management Representative?Do you think you have received adequate training?4.2.1 Documentation Requirements4.2.2 Quality ManualaDoes the Organization have a documented Quality Manual?Does the organization have stated Quality Policy & Objectives?Does the organization have the 6 required procedures stated by the standard?What other additional Documents does the organization provide to show effective planning, operation & control of its processes?Does the quality manual describe the scope of the QMS?Does the quality Manual describe the interaction between processes?Does the quality Manual identify exclusions, if any?4.2.3 Control of DocumentsaDoes the organizations Document Control procedure address the following:- Approval of documents- Review of documents- Revision control of documents- proper identification controls of documents- reapproval of documents, as necessary- control of external documents- control of obsolete documents to prevent unintended use. If so, how?Does the organization have a Master Document list? If so how is it controlled & managed?Does the Master Document List identify all the organizations documents with accurate information?Does the Master Document List include external documents?4.2.4 Control of RecordsaaDoes the organization have a documented Records control procedure that addresses the following?- identification controls for records- strorage requirements for records- protection requirements for records- retreival/access controls for records- retention policy for records- define disposition of records after their intended useAre the records legible & identifiable?Do the records have proper revision controls?Does the organization has a records control list? If so, does it address all the required controls for records?5.1 Management CommitmentaDoes the organization have an established Quality Policy?Does the organization have a established Quality Objectives?How does the organization provide effective communication of customer, statutory & regulatory requirements?Does the management conduct Management review meetings?Does the organization provide resources for effective operation of its processes?5.3 Quality PolicyaIs the documented quality policy appropriate for the purpose of the organization?Does the quality policy include a commitment to comply with requirements?Does the quality policy include a commitment to continual improvement?5.4 PlanningaDid the organization establish documented quality objectives, including product-related ones, at all relevant functions and levels?Are the quality objectives measurable & consistant with the quality policy?What QMS planning activities are used to establish the following:- identify processes needed- determine sequence & interaction of processes- methods and criteria needed to show effective operation & control- availability of resources & information ncecessary for support operations- monitor, measure & analyze processes- implement actions necessary to achieve planned results and continual improvement- establish controls for outsourced processesHow does the organization plan to maintain the integrity of the QMS when changes occur?5.5 Responsibility, authority and communicationaaHow are responsibilities & authorities estblished within the organization? Does it have an ORG chart?Did the organization appoint an Management Representative?What kind of responsibilities & authority does the Management Representative has in achieving the following:- establish, implement & maintain processes needed for effective QMS- report to management on the performance of the QMS & any improvements necessary- promote awareness of customer requirements throughout the organizationWhat kind of communication channels are established regarding the effectiveness of the QMS?5.6 Management ReviewaaAre Management Reviews conducted at planned intervals to ensure the continued suitability, adequecy & effectiveness of its QMS?Are records of Management Review minutes maintained?Does the Management reviews take into account of the following?- results of previous audits- customer feedback/complaints- process performance (Objectives) & product conformity (NCR's)- status of corrective & preventive actions (CA/PA's)- follow-up actions from previous management reviews- changes that could affect the QMS- recommendations/opportunities for improvementDoes the result of Management Reviews provide the following:- improvement of the effectiveness of the QMS & its processes- improvement of product/service in relation to its customers- address resource needs6.0 Resource Management6.1 Provision of ResourcesaAre the resources needed to implement, maintain & continually improve the effectiveness of the QMS & its processes determined & being provided?Are resources needed to enhance customer satisfaction determined & being provided?6.2 Human ResourcesaaIs the competence of the personnel affecting quality of the product/service determined in relation to their education, training, skills and experience?Are the personnel affecting quality are being provided with training?Is the training effective? How is it evaluated?Does staff understand the importance of their training and how their activities contribute to the quality objectives of the organization?Are records of education, training, skills & experience properly maintained and readily available?6.3 Infrastructure6.4 Work EnvironmentaaAre necessary infrastructure (buildings; work space & associated utilities; equipment - both hardware & software; supporting services - transportation, communicationsetc) provided & maintained to ensure product/service conformity to requirements?Does the organization determine & manage the work environment (conditions such as lighting, ventilation, clealinesses of work spaces...etc) necessary to achieve conformity of product/service requirements?7.0 Product Realization7.1 Product PlanningaaAre the processes needed for product/service realization identified, planned, developed & implemented?Are product related Quality Objectives established?Are the following identified, established & implemented in relation to the product/service:- processes- resources- documents- verifications, validations, monitoring, Inspection & test activities- criteria for acceptanceAre the product/service specific records identified, established & maintained (per 4.2.4)?5.2 Customer Focus7.2 Customer Related ProcessesaaHow does the organization determine customer requirements, including delivery & post-delivery requirements?How does the organization address unstated customer requirements?How does the organization determine statutory, regulatory & any other additional requirements determined by the organization?Are all product/service requirements identified, reviewed & confirmed prior to acceptance of order/contract?Does the organizations ability to fullfill the customer requirements established?Show that relevant documents are amended & communicated to all involved parties when product/service requirements have changed after acceptance of order/contract?Are proper records of reviews, changes & customer communication maintained?When the customer provides no documented statement of requirement, does the organization confirm the requirements before acceptance?Are proper communication channels established for handling customer feedback & customer compliants?7.3 Design7.3.1 Design & development planningaaDoes the organization has established plan & controls for design & development?Does the design & development plan identify the design changes?Does the design & development plan identify reviews, verifications & validations required at each stage?Does the design & development plan identify the roles, responsibilities & authority?Does the design plan establish effective communication plan?7.3.2 Design & development inputsaaAre the design inputs identified & records maintained?Does design inputs include the following:- functional & performance requirements- statuatory & regulatory requirements- inputs ffrom previous similar designs, where applicable- any other essectial requirements as neededAre the design inputs reviewed for adequecy (requirements are complete, unambiguous and not in conflict with each other)?7.3.3 Design & development outputsaaAre the design outputs reviewed & verified to meet design inputs?Are the design outputs approved prior to release?Does the design outputs show appropriate information for purchasing, production and/or service, as applicable?Does the design outputs provide appropriate reference to product acceptance criteria?Does the design outputs specify the characteristics of the product that are essential for its safe & proper use?7.3.4 Design & development reviewaaAre systematic design reviews being conducted at planned stages?Does the design reviews evaluate the ability of the results to meet requirements?Does the design reviews identify problems & propose necessary actions?Are appropriate personnel involved in the design reviews? (representatives of functions & stackholders)Are the records of design reviews properly maintained?7.3.5 Design & development verificationaaAre design verificaton activities planned & conducted at appropriate stages?Does the design verification ensure that outputs met design requirements?Are the records of verificaion & any necessary actions properly maintained?7.3.6 Design & development validationaaAre design validation activities planned & conducted at appropriate stages?Does the design validation ensure that the product/service met its intended purpose?Where applicable, is the design validation conducted & performed prior to its delivery or implementation?Are the records of validation & any necessary actions properly maintained?7.3.7 Design & development changesaaAre design changes reviewed, verified/validated and approved before implementation?Does the review of design changes include its effect on constituent parts and product already delivered?Are the records of the results of design changes and any necessary actions properly maintained?7.4 PurchasingaaWhat type and extent of controls does the organization has over its suppliers?Does the organization has controls established for any outsourced processes or products?Is supplier evaluation criteria established? How often are suppliers evaluated?Are records maintained on supplier evaluations?Does the purchaing information describe the product/service to be purchased?Does the purchasing information describe the following:- requirements for approval of product/service, procedures, processes and equipment?- requirements for qualification of personnel?- requirements of Quality Management System? (such as a purchasing procedure or policies)How does the organization verify the adequecy of the purchasing requirements prior to communicating them to supplier?What kind of inspection or other activities are established to verify that the purchased product meets the purchasing requirements?If product verification is carried out at supplier's premises, how does the organization verify the arrangements & method of product release?7.5 Production and Service provision7.5.1 Control of production and service provisionaDoes the organization has the available information that describes the characteristics of the product/service?Does the organization have the necessary work instruction needed to carryout production and service provsion?Does the organization use suitable equipment for carrying out production and service provision?Does the organization use & maintain measuring & monitoring equipment where needed?How does the organization control the release, delivery and post-delivery activities?7.5.2 Validation of processes for production and service provisionaaDoes the organization have any special processes where the output of the process cannot be verified by subsequent monitoring or measurement?If so, how does the organization address the following:- validation of such processes to achieve planned results- defined criteria for review and approval of those processes- approval of equipment or personnel related to those processes- use of methods and procedures for those processes- any requirements for records- revalidation of those processes when changes occur to those processesAre proper records maintained including records of revalidation of any such processes?7.5.3 Identification and traceabilityaaWhere necessary, does the organizaton address traceability requirements?Is the product/service identified using suitable means throughout its realization process?Is the product status identified with respect to monitoring and measurement requirements?Where traceability is a requirement, are proper records maintained?7.5.4 Customer propertyaaDoes the organization identify customer property while it is under the organization's control or use?How is the customer property safegaurded & protected while it is under the organization's control or use?If any customer property is lost, damaged or otherwise found to be unsuitable for use, how is this reported to the customer?How are records maintained in relation to handling of customer property?7.5.5 Preservation of productHow does the organization handle the preservation requirments of the product/service (or its constituent parts) during its internal processing & delivery?Does the preservation process address the following:- identification methods of the product/service- handling methods of the product/service- packaging requirements for the product/service- storage requirements for the product/service- protection requirments for the product/service7.6 Control of monitoring and measuring devicesaaDoes the organization use monitoring & measuring devices to prove evidence of conformity?Does the organization establish processes to enable performance of monitoring & measuring activities that are consistent with the monitoring & measuring requirments?Does the organization identify the calibration needs for these measuring & monitoring devices?Does the organization establish the criteria & frequency of calibration for these measuring & monitoring devices?Are the calibration requirements/methods traceable to a known International or national standard?If there is no known standard, how does the organization perform calibration of such devices?Are the measuring or monitoring equipment adjusted or re-adjusted as necessary?What kind of controls are in place to safegaurd adjustments that would invalidate the measurement result?How can the calibration status of these devices be identified? (Is there a calibration log or a calibration sticker on these devices?)How are these calibrated devices protected from damage and deterioration during handling, maintenance and storage?Are the calibration results verified & recorded? Are the records properly maintained?When a device is found to be out-of calibration, how does the organization assess & record the validity of the previous measuring results?How type of actions does the organization take on any equipment or product when a out-of-calibration situation occurs with the measuring device that is used?When using computer software as part of the measuring & monitoring activities, is the ability of this application confirmed prior to initial use and reconfirmed as necessary?8.0 Measurement, analysis & improvement8.1 GeneralaHow does the organizaton demonstrate the following:- conformity of product/service- conformity to Quality Management System- continually improve the effectiveness of the Quality Management System8.2 Monitoring and measurement8.2.1 Customer satisfactionWhat methods does the organization use to collect customer perception? How does it use that information?8.2.2 Internal auditsaaDoes the organization has an internal audit procedure? Does the Internal audit procedure define roles, responsibilities & authority for planning, conducting audits, & reporting audit results?Are internal audits conducted at planned intervals to determine the effectiveness of the QMS?Does the internal audit criteria include status, importance & results of previous audits of the audit area?Does the audits define the following: Audit criteria, scope, audit frequency & audit methods?Are the audits conducted in a manner that ensures impartiality and objectivity?Are the audit records properly maintained?Does the audit area take appropriate actions in a timely manner when nonconformities are identified?Does follow-up activities of the audit include verification of actions? Are the results of these verification recorded?8.2.3 Monitoring and measurement of processesaWhat methods does the organization have in place to measure & monitor their processes?Does the organization take necessary corrective actions when its processes are found not to achieve planned results?8.2.4 Monitoring and measurement of productsaaHow does the organization measure & monitor product/service characteristics?Does the organization identify the appropriate stages for monitoring & measuring of product/service?Does the organization maintain proper records to show evidence of conformity of the product/service?Does the organization ensure that all monitoring & measuring activities are completed before the product is released?8.3 Control of Nonconforming productaaHow does the organization identify & segregate nonconforming material?What measures/controls does the organization have to prevent unintended use or delivery of onconforming product?Does the organization define the responsibilities and authorities in relation to dealing with nonconforming product?Does the organization perform the following:- take action when nonconformace is detected- authorize its use, release or acceptance under concession by relevant authority- take action to preclude its original intended use or applicationAre proper records for nonconformances maintained including for any subsequent actions taken?Does the organization reverify product/service once the nonconformance is corrected?How does the organization deal if nonconformance is detected after the product/service is delivered?8.4 Analysis of DataDoes the organization collect & analyze appropriate data to demonstrate the suitability & effectiveness of the QMS?How does the organization utilize this data to evaluate continual improvement in the effectiveness of the QMS?Does the organization collect and analyze data in relation to the follwoing:- Customer satisfaction- conformity of product/service requirements- characteristics and trends of processes & products- suppliers8.5 Improvement8.5.1 Continual ImprovementaDoes the organization use Quality policy, objectives, audit results, analysis of data, management reviews, corrective and preventive actions to continually improve the effectiveness of the QMS?8.5.2 Corrective actionaaDoes the organization have a corrective action procedure?Does the procedure address how to handle the following:- review nonconformities including customer complaints- determine the cause of nonconformities (root cause analysis)- evaluate the need for action to prevent reoccurance- determine and implement necessary actions- maintain records of results of the action taken- review corrective action takenDoes the procedure describe the responsibilities & authorities in relation to the corrective action process?Are the corrective actions performed in a timely manner?Are the results of the corrective actions verified & approved by proper authority before they are closed?8.5.3 Preventive actionaaDoes the organization have a preventive action procedure?Does the procedure address how to handle the following:- determine potential nonconformities and their causes- evaluate the need for action to prevent occurance- determine and implement necessary actions- maintain records of results of the action taken- review preventive action takenDoes the procedure describe the responsibilities & authorities in relation to the preventive action process?Are the preventive actions performed in a timely manner?Are the results of the preventive actions verified & approved by proper authority before they are closed?1.2(Application & exclusions) See 4.2.2a .4.1(Establish, document, implement, maintain & continually improve the effectiveness of the quality management system [QMS]) See 4.2.2b, 4.2.2c & 5.4.2a.4.1a(ID & apply processes needed for the QMS) See 4.2.1c, 4.2.1d, 4.2.2b, 4.2.3, 4.2.4, 5.4.2a, 7.1, 7.1b, 7.5.2c, 7.6, 8.2.2, 8.3, 8.5.2 & 8.5.3.4.1b(Sequence & interaction of processes) See 4.2.2a, 4.2.2c, 5.4.2a, 7.1, 7.1b, 7.3.1a, 7.3.1b & 7.5.2c.4.1c(Criteria & methods for operation & control of processes) See 4.2.1d, 5.4.2a, 7.1c, 7.5.1d, 7.5.1e, 7.5.2 & 7.5.5.4.1d(Resource & information availability) See 4.2.3d, 5.4.2a, 5.6.3c, 6.1a, 6.2.1, 6.2.2a, 6.3, 6.4, 7.1b, 7.3.1, 7.3.3b, 7.5.1a & 7.5.1b.4.1e(Monitor, measure & analyze processes) See 5.4.2a, 5.6.1, 6.2.2c, 7.3.5, 7.3.6, 7.5.1d, 7.5.2e, 7.6a, 8.2.1, 8.2.2, 8.2.3, 8.2.4, & 8.4.4.1f(Actions needed to achieve planned results & continual improvement of the processes are implemented) See 5.4.2a, 6.2.2b, 6.3, 6.4, 7.3.4, 7.5.1, 8.5.1, 8.5.2d & 8.5.3c.4.1aShow that outsourced processes that affect product conformity requirements are identified in the quality management system and that control is maintained over those processes. (May be defined as part of a plan [5.4.2a] or through the purchasing process [7.4].)4.2.1a(Documented statement of a quality policy & quality objectives) See 5.3a-c & 5.4.1.4.2.1b(Documented quality manual) See 4.2.2.4.2.1c & 4.1a(Documented procedures per ISO9001:2000 identified & applied) See 4.2.3, 4.2.4, 8.2.2, 8.3, 8.5.2 & 8.5.3 for minimum procedure requirements and 4.2.2b for the need to acknowledge them in the quality manual.4.2.1d, 4.1a & 4.1caShow that the QMS documentation includes documents needed by the company to ensure effective planning, operation & control of its processes. (If any are procedures, see 4.2.2b.)4.2.1e(Records required by ISO9001:2000) See 5.6.1, 6.2.2e, 7.1d, 7.2.2, 7.3.2, 7.3.4, 7.3.5, 7.3.6, 7.3.7, 7.4.1, 7.5.2d, 7.5.3, 7.5.4, 7.6, 8.2.2, 8.2.4, 8.3, 8.5.2e & 8.5.3d.4.2.2a & 4.2.1baaShow that there is a documented quality manual that includes the scope of the QMS.4.2.2a, 1.2 & 4.1baaShow that the documented quality manual includes details of/justification for any section 7 exclusions.4.2.2a, 1.2 & 4.1baaShow that the documented quality manual only excludes requirements from section 7 of ISO9001:2000 that cannot be applied due to the nature of the business.4.2.2b, 4.1, 4.1a, 4.2.1b, 4.2.1c & 4.2.1daaThe documented quality manual includes or references the procedures called for by ISO 9001:2000 and those needed by the company to effectively plan, operate and control its processes.4.2.2c, 4.1, 4.1b & 4.2.1baaThe documented quality manual includes a description of the interaction between the processes of the QMS and how the sequence and interaction of these processes are used to maintain & continually improve the effectiveness of the QMS in relation to ISO9001:2000.4.2.3a, 4.1a & 4.2.1caaShow that QMS documents are approved for adequacy prior to issue per a documented procedure.4.2.3b, 4.1a & 4.2.1caaShow that QMS documents are reviewed per a documented procedure.4.2.3b, 4.1a & 4.2.1caaShow that QMS documents are updated, as necessary, per a documented procedure.4.2.3b, 4.1a, 4.2.1c & 5.4.2baaShow that changed QMS documents are re-approved, per a documented procedure, ensuring that the integrity of the QMS is maintained when the changes are implemented.4.2.3c, 4.1a & 4.2.1caaShow that QMS document changes are identified per a documented procedure.4.2.3c, 4.1a & 4.2.1caaShow that the current revision status of QMS documents is identified per a documented procedure.4.2.3d, 4.1a, 4.1d & 4.2.1caaShow that relevant versions of QMS documents are available at the point of use per a documented procedure.4.2.3e, 4.1a & 4.2.1caaShow that the document control procedure for QMS documents ensures that QMS documents remain legible & readily identifiable.4.2.3f, 4.1a & 4.2.1caaShow that the document control procedure ensures that documents of external origin (related to the QMS) are identified.4.2.3f, 4.1a & 4.2.1caaShow that the document control procedure ensures that the distribution of documents of external origin (related to the QMS) are controlled.4.2.3g, 4.1a & 4.2.1caaShow that obsolete QMS documents are prevented from unintended use per a documented procedure.4.2.3g, 4.1a & 4.2.1caaShow that obsolete QMS documents, retained for any purpose, are suitably identified to prevent unintended use per a documented procedure.4.2.4aShow that records remain legible.4.2.4aShow that records are readily identifiable.4.2.4aShow that records are retrievable.4.2.4, 4.1a & 4.2.1caaShow that a documented procedure defines the controls needed for the identification of records need to provide evidence of conformity to requirements and the effective operation of the system.4.2.4, 4.1a & 4.2.1caaShow that a documented procedure defines the controls needed for the storage of records.4.2.4, 4.1a & 4.2.1caaShow that a documented procedure defines the controls needed for the protection of records.4.2.4, 4.1a & 4.2.1caaShow that a documented procedure defines the controls needed for the retrieval of records.4.2.4, 4.1a & 4.2.1caaShow that a documented procedure defines the controls needed for the retention time of records.4.2.4, 4.1a & 4.2.1caaShow that a documented procedure defines the controls needed for the disposition of records.5.1aaShow that the importance of meeting customer, statutory & regulatory requirements is communicated internally. Mainly supported by determinations made at 7.2.1, 7.3.2, 7.3.3 & 7.3.7.5.1b(Established quality policy) See 5.3a-c.5.1c(Established quality objectives) See 5.4.1.5.1d(Management reviews are conducted) See 5.6.1.5.1e(Ensure the availability of resources) See 5.6.3c, 6.1, 6.2.2b, 6.3 & 6.4.5.2(Customer requirements determined & met) See 7.2.1, 7.2.2, 7.3.2, 7.3.3a, 7.3.3d, 7.3.5, 7.3.6, 7.3.7 & 8.2.1.5.3a, 4.2.1a & 5.1baaShow that the documented quality policy is appropriate to the purpose of the organization.5.3b, 4.2.1a & 5.1baaShow that the documented quality policy includes a commitment to comply with requirements.5.3b, 4.2.1a & 5.1baaShow that the quality policy includes a commitment to continually improve the effectiveness of the QMS.5.3c, 4.2.1a & 5.1baaShow that the documented quality policy provides a framework for establishing & reviewing the objectives.5.3d(Quality policy communicated & understood) See 5.5.3 & 6.2.2d.5.3e(Reviewed for continuing suitability) See 5.6.1.5.4.1, 4.2.1a & 5.1caaShow that documented quality objectives, including product-related ones, have been established at relevant functions and levels in the company.5.4.1aShow that quality objectives are measurable.5.4.1aShow that quality objectives are consistent with the quality policy.5.4.2a, 4.1 & 4.1aaShow that QMS planning is used to identify the processes needed for the QMS and the application of those processes throughout the organization.5.4.2a, 4.1 & 4.1baShow that QMS planning is used to determine the sequence & interaction of the processes of the QMS.5.4.2a, 4.1 & 4.1caShow that QMS planning is used to determine the criteria and methods needed to show that process operation & control is effective.5.4.2a, 4.1 & 4.1daShow that QMS planning is used to ensure the availability of resources & information necessary to support process operation & monitoring.5.4.2a, 4.1 & 4.1eaShow that QMS planning includes consideration of methods for monitoring, measuring & analyzing the processes of the QMS.5.4.2a, 4.1 & 4.1faShow that QMS planning involves the implementation of those actions needed to achieve planned results & continual improvement.5.4.2a & 4.1 (overall & for outsourcing)aShow that QMS planning identifies the controls implemented for outsourced processes that affect product conformity to requirements.5.4.2baShow that QMS changes are planned to ensure that the integrity of the QMS is maintained as the plan is implemented. (also, see 4.2.3b).5.5.1aShow that responsibilities & authorities are defined and communicated.5.5.2aShow that a member of management has been appointed to the position of management representative.5.5.2aaShow that the management representative is responsible for and has the authority to ensure that the processes needed for the QMS are established, implemented & maintained.5.5.2baShow that the management representative is responsible for and has the authority to report to top management on the performance of the QMS and any need for improvement.5.5.2caShow that the management representative is responsible for and has the authority to ensure that awareness of customer requirements is promoted throughout the organization.5.5.3 & 5.3daShow that communication processes have been established and are taking place regarding the effectiveness of the QMS and the need for personnel to understand the quality policy.5.6.1 & 5.1daShow that management review is conducted at planned intervals.5.6.1, 4.1e & 5.3eaShow that management review assesses (analyzes) the continuing suitability, adequacy & effectiveness of the QMS, quality policy & quality objectives.5.6.1aShow that management review assesses opportunities for improvement.5.6.1aShow that management review assesses the need for changes to the QMS, quality policy & quality objectives.5.6.1 & 4.2.1eaShow that management review records are established.5.6.1 & 4.2.4aShow that management review records are maintained per the records control procedure (called for in 4.2.4).5.6.2aaShow that management review inputs include information on the results of audits.5.6.2baShow that management review inputs include information on customer feedback.5.6.2caShow that management review inputs include information on process performance and product conformity.5.6.2daShow that management review inputs include information on the status of preventive & corrective action. May be the review called for in 8.5.2f & 8.5.2e.5.6.2eaShow that management review inputs include information on follow-up actions form previous management reviews.5.6.2faShow that management review inputs include information on changes that could affect the QMS.5.6.2gaShow that management review inputs include information on recommendations for improvement.5.6.3aaShow that outputs from management review include any decisions and actions related to improvement of the effectiveness of the QMS & its processes.5.6.3baShow that outputs from management review include any decisions and actions related to product improvements (especially those related to customer requirements).5.6.3c, 4.1d & 5.1eaShow that outputs from management review include any decisions and actions related to resource needs.6.1a, 4.1d & 5.1eaShow that the resources needed to implement, maintain & continually improve the effectiveness of the QMS and its processes have been determined and are being provided for.6.1b & 5.1eaShow that the resources needed to enhance customer satisfaction by meeting customer requirements have been determined and are being provided for.6.2.1 & 4.1daShow that personnel performing work affecting quality are competent as it relates to appropriate education, training, skills and/or experience. (Show there is a system.)6.2.2a & 4.1daShow that the competence for personnel performing work affecting quality has been determined as it relates to appropriate education, training, skills and/or experience. (Show it has been broken down effectively - in our case by position.)6.2.2b, 4.1f & 5.1eaShow that training and/or other actions taken to satisfy the need for competence has been or is being provided. (Show you have implemented the plan.)6.2.2c & 4.1eaShow that the effectiveness of training or other actions taken to satisfy the need for competence is evaluated. (Show it is effective.)6.2.2daShow that personnel are aware of the relevance and importance of their activities as part of training.6.2.2d & 5.3daShow that personnel are aware of (understand) the quality policy and objectives and how they (personnel) contribute to the achievement of the objectives.6.2.2e & 4.2.1eaShow that the records of education, training, skills and/or experience are established.6.2.2e & 4.2.4aShow that the records of education, training, skills and/or experience are being maintained per the records control procedure (called for in 4.2.4).6.3a, 4.1d, 4.1f & 5.1eaShow that the building, workspace and associated utilities needed to achieve product conformity to requirements have been determined, provided for, and are being maintained.6.3b, 4.1d, 4.1f & 5.1eaShow that the process equipment (hardware & software) needed to achieve product conformity to requirements have been determined, provided for, and are being maintained.6.3c, 4.1d, 4.1f & 5.1eaShow that the supporting services needed to achieve product conformity to requirements have been determined, provided for, and are being maintained.6.4, 4.1d, 4.1f & 5.1eaShow that the work environment needed to achieve product conformity has been determined and is being managed.7.1, 4.1a & 4.1baShow that the processes needed for product realization are identified, planned, developed & implemented throughout the company.7.1aaShow that product-related quality objectives and requirements have been determined.7.1b, 4.1a, 4.1b & 4.1daShow that product-specific processes, documents & resources have been determined and are implemented throughout the organization.7.1c & 4.1caShow that product-specific verifications, validations, monitoring, inspections & test have been determined.7.1c & 4.1caShow that criteria for product acceptance associated with product-specific verifications, validations, monitoring, inspections & test have been determined.7.1d & 4.2.1eaShow that process realization records (validation or qualification as applicable) have been determined.7.1d & 4.2.4aShow that records providing evidence of the product's ability to fulfill the plan are being maintained per the records control procedure (called for in 4.2.4).7.1aShow that planning outputs are in a form suitable for the company's method of operations.7.2.1a, 5.1a & 5.2aShow that requirements specified by the customer, including delivery & post-delivery requirements, are determined. Can involve or be facilitated by design and development inputs (7.3.2) if and when a quote or order includes design and development.7.2.1b, 5.1a & 5.2aShow that requirements not stated by the customer, but necessary for specified or intended use (where known) are determined. Can involve or be facilitated by design and development inputs (7.3.2) if and when a quote or order includes design and development.7.2.1c, 5.1a & 5.2aShow that product related regulatory and/or legal requirements are determined. Can involve or be facilitated by design and development inputs (7.3.2) if and when quote or order includes design and development.7.2.1d, 5.1a & 5.2aShow that any additional requirements identified by the company are determined. Can involve or be facilitated by design and development inputs (7.3.2) if and when quote or order includes design and development.7.2.2aaShow that product requirements are defined at quotation, contract/order acceptance and the acceptance of amendments to the contract/order. Could involve the review for adequacy for design and development inputs (see 7.3.2).7.2.2baShow that product requirements differing from those previously expressed are resolved for quotes, contract/orders and/or amendments to contracts/orders. If design and development inputs are involved, this would encompass resolving requirements that are incomplete, ambiguous, or in conflict with each other (see 7.3.2).7.2.2caShow that the organization has the ability (currently or is planning to obtain it) to meet customer requirements before submitting a quote, accepting a contract/order or accepting an amendment.7.2.2, 4.2.1e & 5.2aShow that the results (records) of product requirement reviews, conducted prior to submitting a quotation are in place and include any actions arising from the review. Could involve the review for adequacy for design and development inputs (see 7.3.2 & 7.3.4).7.2.2, 4.2.1e & 5.2aShow that the results (records) of product requirement reviews, conducted prior to the acceptance of a contract/order, are in place and include any actions arising from the review. Could involve the review for adequacy for design and development inputs (see 7.3.2 & 7.3.4).7.2.2, 4.2.1e & 5.2aShow that the results (records) of product requirement reviews, conducted prior to the acceptance of changes to a contract/order, are in place and include any actions arising from the review. Could involve the review for adequacy for design and development inputs and/or changes (see 7.3.2, 7.3.4 and/or 7.3.7).7.2.2 & 4.2.4aShow that the quote, contract/order & amendment records are maintained per the records control procedure (called for in 4.2.4).7.2.2 & 5.2aShow that customer requirements are confirmed before acceptance when the customer does not provide a documented statement of requirements.7.2.2 & 5.2aShow that relevant documents are amended when product requirements have changed, after acceptance of the contract/order.7.2.2aShow that relevant personnel are made aware of changed requirements when product requirements have changed, after acceptance of the contract/order.7.2.3aaShow that effective arrangements for customer communication relating to product information has been determined and is implemented.7.2.3baShow that effective arrangements for customer communication relating to inquiries, contracts/order handling (including amendments) has been determined and is implemented.7.2.3caShow that effective arrangements for customer communication relating to customer feedback (including customer complaints) has been determined and is implemented. Should be considered to serve as data to be analyzed (see 8.2.1 & 8.4a).7.3.1 & 4.1daShow that there is a plan and controls for design & development.7.3.1a & 4.1baShow that the design & development plan determines the design & development stages.7.3.1b & 4.1baShow that the design & development plan determines reviews, verifications, validations appropriate to each stage.7.3.1caShow that the design & development plan determines the responsibilities & authorities for design & development.7.3.1aShow that effective communication and clear assignment of responsibility occurs as a result of managing interfaces between the different parties involved with the design and development.7.3.1aShow that planning outputs are updated, as appropriate, as the design and development progresses.7.3.2 & 5.2aShow that inputs relating to product requirements have been determined and are recorded. Determination considerations included in 7.2.1 could be applicable if a quote or order is involved.7.3.2 & 4.2.1eaShow input records are defined. Determination considerations included in 7.2.1 could be applicable if a quote or order is involved.7.3.2 & 4.2.4aShow that input records are maintained per the records control procedure (called for in 4.2.4).7.3.2a, 5.1a & 5.2aShow that inputs include functional & performance requirements. Determination considerations included in 7.2.1 could be applicable if a quote or order is involved.7.3.2b, 5.1a & 5.2aShow that inputs include statutory & regulatory requirements (as applicable). Determination considerations included in 7.2.1 could be applicable if a quote or order is involved.7.3.2c, 5.1a & 5.2aShow that inputs from previous similar designs are included, where applicable. Determination considerations included in 7.2.1 could be applicable if a quote or order is involved.7.3.2d, 5.1a & 5.2aShow that inputs based upon other requirements essential for design and development are included. Determination considerations included in 7.2.1 could be applicable if a quote or order is involved.7.3.2aShow that inputs are reviewed for adequacy. May be relative to acceptance of a quote or order (7.2.2) if the product or service is being designed and/or developed.7.3.2aShow that requirements are complete, unambiguous and not in conflict with each other. Determination considerations included in 7.2.1 could be applicable if a quote or order is involved.7.3.3aShow that design and development outputs are provided in a form that enables verification against inputs.7.3.3aShow that design and development outputs are approved prior to release.7.3.3a & 5.2aShow that design and development outputs meet input requirements.7.3.3b, 4.1d & 5.1aaShow that design and development outputs provide appropriate information for purchasing.7.3.3b, 4.1d & 5.1aaShow that design and development outputs provide appropriate information for production.7.3.3b, 4.1d & 5.1aaShow that design and development outputs provide appropriate information for service provision.7.3.3c & 5.1aaShow that design and development outputs contain or reference product acceptance criteria.7.3.3d, 5.1a & 5.2aShow that design and development outputs specify the characteristics of the product that are essential to its safe and proper use.7.3.4 & 4.1faShow that systematic reviews of design and development are performed in accordance with planned arrangements, at suitable stages.7.3.4a & 4.1faShow that design and development reviews evaluate the ability of the results of design and development to meet requirements.7.3.4b & 4.1faShow that design and development reviews identify any problems and propose necessary actions.7.3.4aShow that participants in these reviews include representatives of functions concerned with the stage being reviewed.7.3.4 & 4.2.1eaShow that the results of design and development reviews and any necessary actions are recorded. If a quote or order are involved, this may be the same thing as an record of the quote or order (see 7.2.2).7.3.4 & 4.2.4aShow that design and development review records are maintained per the records control procedure (called for in 4.2.4).7.3.5 & 4.1eaShow that design and development verification is performed in accordance with planned arrangements.7.3.5, 4.1e & 5.2aShow that design and development verification ensures that outputs have met input requirements.7.3.5 & 4.2.1eaShow that the results of verification and any necessary actions are recorded.7.3.5 & 4.2.4aShow that design and development verification records are maintained per the records control procedure (called for in 4.2.4).7.3.6 & 4.1eaShow that design and development validation is performed in accordance with planned arrangements.7.3.6, 4.1e & 5.2aShow that design and development validation ensures that the resulting product is capable of meeting the requirements for the specified application or intended use, where known.7.3.6aShow that, where practicable, validation is completed before delivery or implementation.7.3.6 & 4.2.1eaShow that the results of validation and any necessary actions are recorded.7.3.6 & 4.2.4aShow that design validation records are maintained per the records control procedure (called for in 4.2.4).7.3.7 & 4.2.1eaShow that design and development changes are identified and recorded. If a change to an order is involved, this may be the same thing as an record of the changed order (see 7.2.2).7.3.7 & 4.2.4aShow that design and development change records are maintained per the records control procedure (called for in 4.2.4).7.3.7, 5.1a & 5.2aShow that changes are reviewed, verified/validated (as appropriate) and approved before implementation.7.3.7, 5.1a & 5.2aShow that the review of the change includes an evaluation of the effect of the change on constituent parts and product already delivered.7.3.7 & 4.2.1eaShow that the results of reviews associated with design and development changes and any necessary actions arising from the changes are recorded.7.3.7 & 4.2.4aShow that the records of changes are maintained per the records control procedure (called for in 4.2.4).7.4.1 & 4.1aShow that the type and extent of control over a supplier is dependent upon the effect of that product on product realization or the final product, including any controls needed for outsourced processes or products.7.4.1aShow that the type and extent of control applied to the purchased product is dependent upon the effect of that product on product realization or the final product.7.4.1aShow that suppliers are evaluated and selected using established criteria.7.4.1aShow that suppliers are re-evaluated using established criteria.7.4.1 & 4.2.1eaShow that the evaluations (including re-evaluations) and any actions arising from the evaluations are maintained per the records control procedure.7.4.1 & 4.2.4aShow that records of evaluations, including any actions arising from the evaluation are maintained (called for in 4.2.4).7.4.2aShow that purchasing information describes the product to be purchased.7.4.2aaWhere appropriate, show where purchasing information describes requirements for approval of product, procedures, processes and equipment.7.4.2baWhere appropriate, show where purchasing information describes requirements for qualification of personnel.7.4.2caWhere appropriate, show where purchasing information describes applicable quality management system requirements.7.4.2aShow that adequacy of specified purchase requirements is ensured prior to communicating those requirements to the supplier.7.4.3aShow that inspection or other activities (supplier audits, review of test data, etc.) necessary for ensuring that purchased product meets specified purchase requirements have been established and are implemented. (Remember: any form of measuring and monitoring of product has to comply with requirements associated with section 8.2.4 of the standard!)7.4.3aShow that verification arrangements for customer or company imposed source inspections and the method of product release is included in the purchasing information.7.5.1a, 4.1d & 4.1faShow that information that describes product characteristics is available, as applicable.7.5.1b, 4.1d & 4.1faShow that work instructions needed to plan and carry out production and service provision are available, as necessary.7.5.1c & 4.1faShow that equipment suitable for carrying out production and service provision is in use, as applicable.7.5.1d, 7.5.1e, 7.6, 4.1c, 4.1e & 4.1faShow that the monitoring & measurement to be undertaken and the devices to be used have been determined (implemented) and that the devices needed are available for production and service provision, as applicable.7.5.1f & 4.1faShow that release, delivery & post delivery activities for production and service provision have been implemented, as applicable.7.5.2Show that arrangements for validation of processes for production or service provision, where the resulting output cannot be verified by subsequent monitoring & measurement activities, include:7.5.2a & 4.1caDefined criteria for review of these processes.7.5.2a & 4.1caDefined criteria for approval of these processes.7.5.2b & 4.1caThe approval of the equipment used for these processes.7.5.2b & 4.1caThe qualification of personnel performing these processes.7.5.2c, 4.1a, 4.1b & 4.1caShow that specific methods and procedures for process validation are identified and their application is determined throughout the company.7.5.2d, 4.1c & 4.2.1eaRecords reflecting that these processes have been reviewed and approved.7.5.2d, 4.1c & 4.2.1eaRecords reflecting that equipment used in these processes have approved.7.5.2d, 4.1c & 4.2.1eaRecords reflecting that personnel are qualified to perform these processes.7.5.2e, 4,1c, 4.1e, 4.2.1e & 7.5.2daArrangements for revalidation, including records showing that revalidation is happening.7.5.2d & 4.2.4aShow that the validation/revalidation records listed above are maintained per the records control procedure (called for in 4.2.4).7.5.3aShow that product has been identified by suitable means throughout product realization, where appropriate.7.5.3aShow that product status with respect to monitoring and measurement requirements is identified.7.5.3 & 4.2.1eaaShow that traceability of the product is maintained, including records, where traceability is required.7.5.3 & 4.2.4aShow that traceability records, where traceability is required are maintained per the records control procedure (called for in 4.2.4).7.5.4aShow that customer property is identified while it is under the company's control or being used by the company.7.5.4aShow that customer property is verified while it is under the company's control or being used by the company.7.5.4aShow that customer property is protected while it is under the company's control or being used by the company.7.5.4aShow that customer property is safeguarded while it is under the company's control or being used by the company.7.5.4aShow that customer property that is lost, damaged or otherwise found to be unsuitable for use is reported to the customer.7.5.4 & 4.2.1eaShow that a record is maintained when lost, damaged or otherwise unsuitable customer property is reported to the customer.7.5.4 & 4.2.4aShow that the reported loss, damage or otherwise unsuitable customer property record is maintained per the records control procedure (called for in 4.2.4).7.5.5 & 4.1caShow that identification methods preserve the conformity of product from processing to delivery, including any constituent parts of a product.7.5.5 & 4.1caShow that handling methods preserve the conformity of product from processing to delivery, including any constituent parts of a product.7.5.5 & 4.1caShow that packaging methods preserve the conformity of product from processing to delivery, including any constituent parts of a product.7.5.5 & 4.1caShow that storage methods preserve the conformity of product from processing to delivery, including any constituent parts of a product.7.5.5 & 4.1caShow that protection methods preserve the conformity of product from processing to delivery, including any constituent parts of a product.7.6, 7.5.1d & 7.5.1eaShow that the monitoring & measurement to be undertaken and the devices to be used have been determined.7.6 & 4.1aaShow that processes to ensure that monitoring and measurement can be and are carried out in a manner that is consistent with requirements have been established.7.6a & 4.1eaShow that measuring equipment is calibrated or verified at specified intervals or prior to use.7.6a & 4.1eaShow that measuring equipment is calibrated or verified against standards that are traceable to national or international standards.7.6a & 4.2.1eaShow that the basis for calibration or verification is recorded when there is no standard for a calibration or verification performed.7.6a & 4.2.4aShow that records of the basis for calibration or verification, when there is no standard for a calibration or verification performed, are maintained per the records control procedure (called for in 4.2.4).7.6baShow that measuring equipment is adjusted or re-adjusted as necessary.7.6caShow that the calibration status of measuring equipment is identifiable.7.6daShow that measurement equipment is safeguarded from adjustments that would invalidate the measurement result.7.6eaShow that measurement equipment is protected from damage or deterioration during handling, maintenance & storage.7.6aShow that the validity of previous measuring results is assessed when the measuring equipment is found not to conform to requirements (fails calibration or verification).7.6 & 4.2.1eaShow that the assessment of the validity of previous measuring results is recorded, when the measuring equipment is found not to conform to requirements (fails calibration or verification).7.6 & 4.2.4aShow that assessment records associated with measuring equipment that is found not to conform to requirements (fails calibration or verification) are maintained per the records control procedure (called for in 4.2.4).7.6aShow that appropriate action is taken with measuring equipment and any affected product, when the measuring equipment is found not to conform to requirements.7.6 & 4.2.1eaShow that the results of calibration and verification are recorded.7.6 & 4.2.4aShow that calibration and verification records are maintained per the records control procedure (called for in 4.2.4).7.6aShow that software associated with monitoring & measurement activities is confirmed prior to use & reconfirmed as necessary.8.1a(plan & implement monitoring, measurement, analysis & improvement processes to demonstrate product conformity) See 8.2.1, 8.2.4, 8.4b, 8.5.2 & 8.5.3.8.1b(plan & implement monitoring, measurement, analysis & improvement processes to ensure conformity of the QMS) See 8.2.1, 8.2.2, 8.2.3, 8.3, 8.4a, 8.4b, 8.4c, 8.4d, 8.5.1, 8.5.2 & 8.5.3.8.1c(plan & implement monitoring, measurement, analysis & improvement processes to continually improve the effectiveness of the QMS) See 8.2.1, 8.2.2, 8.2.3, 8.4a, 8.4b, 8.4c, 8.4d, 8.5.1, 8.5.2 & 8.5.3.8.1aApplicable methods (including statistical techniques) and the extent of their use are determined.8.2.1, 4.1e, 7.2.3c, 8.1a, 8.1b & 8.1caShow that methods for obtaining information relating to customer perception (are customer's satisfied with how we met requirements) are determined.8.2.1, 4.1e, 5.2, 8.1a, 8.1b & 8.1caShow that methods for using information relating to customer perception (are customer's satisfied with how we met requirements) are determined.8.2.2, 4.1a, 4.2.1c, 8.1b & 8.1caShow that audits are conducted at planned intervals.8.2.2, 4.1a, 4.1e, 4.2.1c, 8.1b & 8.1caShow how the audits are used to determine whether the QMS conforms to planned arrangements.8.2.2, 4.1a, 4.1e, 4.2.1c, 8.1b & 8.1caShow how the audits are used to determine whether the QMS conforms to the requirements of ISO9001:2000.8.2.2, 4.1a, 4.1e, 4.2.1c, 8.1b & 8.1caShow how the audits are used to determine whether the QMS conforms requirements imposed by the organization on itself.8.2.2, 4.1a, 4.1e, 4.2.1c, 8.1b & 8.1caShow how the audits are used to determine whether the QMS is effectively implemented & maintained.8.2.2, 8.1b & 8.1caShow that the audit program plan takes into consideration status (how the area is doing), importance (If the area breaks down it will have a significant impact) and previous audit results.8.2.2, 8.1b & 8.1caShow that audit criteria is defined.8.2.2, 8.1b & 8.1caShow that audit scope is defined.8.2.2, 8.1b & 8.1caShow that audit frequency is defined.8.2.2, 8.1b & 8.1caShow that audit methods are defined.8.2.2, 8.1b & 8.1caShow that auditors are selected in a manner that ensures objectivity, impartiality and that they do not audit their own work.8.2.2, 8.1b & 8.1caShow that audits are conducted in a manner that ensures objectivity and impartiality.8.2.2, 4.1a, 4.2.1c, 8.1b & 8.1caaShow that the responsibility and requirements for planning and conducting audits is defined in a documented procedure.8.2.2, 4.1a, 4.2.1c, 8.1b & 8.1caaShow that the responsibility and requirements for reporting and recording the results of audits (including maintenance of those records) is defined in a documented procedure.8.2.2, 4.2.1e, 8.1b & 8.1caShow that the results of audits are recorded.8.2.2, 8.1b & 8.1caShow that action is taken by area management, without undue delay, to eliminate any detected nonconformities and their causes.8.2.2, 4.2.1e, 8.1b & 8.1caaShow that follow-up activities include the verification of actions taken and that the results of this verification are recorded.8.2.2 & 4.2.4aShow that records (audit results & follow-up verification) are maintained per the records control procedure (called for in 4.2.4).8.2.3, 4.1e, 8.1b & 8.1caShow that suitable and applicable methods for monitoring & measuring QMS processes are in place and demonstrating the ability of theses processes to achieve planned results.8.2.3, 8.1b & 8.1caShow that correction and corrective action are taken, as appropriate, to ensure conformity of the product when planned results are not achieved.8.2.4, 4.1e & 8.1aaShow that product characteristics related to product requirements are monitored and measured.8.2.4, 4.1e & 8.1aaShow that appropriate stages for monitoring and measuring product characteristics are identified and fulfilled.8.2.4 & 4.2.1eaShow that records reflect evidence of conformity to acceptance criteria and indicate the person's) authorizing release of the product.8.2.4 & 4.2.4aShow that records associated with monitoring and measurement of product are maintained per the records control procedure (called for in 4.2.4).8.2.4aShow that all applicable product related monitoring & measuring activities have been completed before release/delivery unless otherwise approved by a relevant authority.8.3 & 8.1bcaShow that nonconforming product is identified in a manner that prevents unintended use or delivery.8.3 & 8.1bcaShow that nonconforming product is controlled in a manner that prevents unintended use or delivery.8.3, 4.1a, 4.2.1c & 8.1baaShow that controls for dealing with nonconforming product are defined in a documented procedure.8.3, 4.1a, 4.2.1c & 8.1baaShow that responsibilities and authorities related to controls for dealing with nonconforming product are defined in a documented procedure.8.3 & 8.1bcEvidence that reflects that nonconforming product was dealt with in one or more of the following ways:8.3a & 8.1baShow that action was taken to eliminate the detected nonconformity, as applicable.8.3b & 8.1baShow that relevant authority(s) authorized use-as-is (UAI), release or acceptance under concession, as applicable.8.3c & 8.1baShow that action was taken to preclude its original intended use or application, as applicable.8.3, 4.2.1e & 8.1baShow that the nature of nonconformities & any subsequent actions taken, including concessions obtained, are recorded.8.3, 4.2.4 & 8.1baShow that nonconformance records are maintained per the records control procedure (called for in 4.2.4).8.3 & 8.1baShow that corrected nonconforming product is re-verified.8.3 & 8.1baShow that action appropriate to the effects or potential effects of nonconforming product is taken when the nonconformance is detected after delivery or use has started.8.4a, 4.1e, 7.2.3c, 8.1b & 8.1caShow that data relating to customer satisfaction has been determined, is collected and analyzed to demonstrate the suitability & effectiveness of the QMS and to evaluate where continual improvement opportunities can be realized. Be sure that the data generated from measuring, monitoring & other relevant sources is included, where applicable.8.4b, 4.1e, 8.1a, 8.1b & 8.1caShow that data reflecting conformity to product requirements has been determined, is collected and analyzed to demonstrate the suitability & effectiveness of the QMS and to evaluate where continual improvement opportunities can be realized. Be sure that the data generated from measuring, monitoring & other relevant sources is included, where applicable.8.4c, 4.1e, 8.1b & 8.1caShow that data associated with characteristics and trends of processes & products have been determined, is collected and analyzed to demonstrate the suitability & effectiveness of the QMS and to evaluate where continual improvement/preventive action opportunities can be realized. Be sure that the data generated from measuring, monitoring & other relevant sources is included, where applicable.8.4d, 4.1e, 8.1b & 8.1caShow that supplier data has been determined, is collected and analyzed to demonstrate the suitability & effectiveness of the QMS and to evaluate where continual improvement opportunities can be realized. Be sure that the data generated from measuring, monitoring & other relevant sources is included, where applicable.8.5.1, 4.1f, 8.1b & 8.1caShow examples of how the policy, objectives, audit results, analysis of data, corrective & preventive actions are used to continually improve the effectiveness of the QMS.8.5.2a, 4.1a, 4.2.1c, 8.1a, 8.1b & 8.1caaShow that nonconformities (including customer complaints) are reviewed as defined in a documented procedure.8.5.2b, 4.1a, 4.2.1c, 8.1a, 8.1b & 8.1caaShow that the causes of nonconformities are determined as defined in a documented procedure.8.5.2c, 4.1a, 4.2.1c, 8.1a, 8.1b & 8.1caaShow that the need for action to ensure that nonconformities do not recur is evaluated as defined in a documented procedure.8.5.2d, 4.1a, 4.1f, 4.2.1c, 8.1a, 8.1b & 8.1caaShow that the action needed to take corrective action is determined and implemented as defined in a documented procedure.8.5.2e, 4.1a, 4.2.1c, 4.2.1e, 8.1a, 8.1b & 8.1caaShow that the results of any action taken is recorded.8.5.2e & 4.2.4aShow that corrective action records are maintained per the records control procedure (called for in 4.2.4).8.5.2f, 4.1a, 4.2.1c, 8.1a, 8.1b & 8.1caaShow that the corrective action taken is reviewed as defined in a documented procedure. May be accomplished as part of Management Review (see 5.6.2d).8.5.3a, 4.1a, 4.2.1c, 8.1a, 8.1b & 8.1caaShow that potential nonconformities and their causes are determined per a documented procedure.8.5.3b, 4.1a, 4.2.1c, 8.1a, 8.1b & 8.1caaShow that the need for preventive action is evaluated per a documented procedure.8.5.3c, 4.1a, 4.1f, 4.2.1c, 8.1a, 8.1b & 8.1caaShow that the action needed to take preventive action is determined and implemented per a documented procedure.8.5.3d, 4.1a, 4.2.1c, 4.2.1e, 8.1a, 8.1b & 8.1caaShow that the results of any action taken is recorded.8.5.3d & 4.2.4aShow that preventive action records are maintained per the records control procedure (called for in 4.2.4).8.5.3e, 4.1a, 4.2.1c, 8.1a, 8.1b & 8.1caaShow that the preventive action taken is reviewed as defined in a documented procedure. May be accomplished as part of Management Review (see 5.6.2d).

&L&F COD-FRM-009&CRevision: 4 08/23/10&R&P of &NThe ISOGUY Says: When the System Trail is BOLD ITALIC, this is a record needing to be control per the records control procedure called for in 4.2.4.The ISOGUY Says: When the System Trail is BOLD ITALIC, this is a record needing to be control per the records control procedure called for in 4.2.4.The ISOGUY Says: When the SYSTEM TRAIL entry is BOLD ITALIC, this is a record needing to be control per the records control procedure called for in 4.2.4.The ISOGUY Says: When the SYSTEM TRAIL entry is BOLD ITALIC, this is a record needing to be control per the records control procedure called for in 4.2.4.The ISOGUY Says: When the SYSTEM TRAIL entry is BOLD ITALIC, this is a record needing to be control per the records control procedure called for in 4.2.4.The ISOGUY Says: When the SYSTEM TRAIL entry is BOLD ITALIC, this is a record needing to be control per the records control procedure called for in 4.2.4.The ISOGUY Says: When the SYSTEM TRAIL entry is BOLD ITALIC, this is a record needing to be control per the records control procedure called for in 4.2.4.The ISOGUY Says: When the SYSTEM TRAIL entry is BOLD ITALIC, this is a record needing to be control per the records control procedure called for in 4.2.4.The ISOGUY Says: When the SYSTEM TRAIL entry is BOLD ITALIC, this is a record needing to be control per the records control procedure called for in 4.2.4.The ISOGUY Says: When the SYSTEM TRAIL entry is BOLD ITALIC, this is a record needing to be control per the records control procedure called for in 4.2.4.The ISOGUY Says: When the SYSTEM TRAIL entry is BOLD ITALIC, this is a record needing to be control per the records control procedure called for in 4.2.4.The ISOGUY Says: When the SYSTEM TRAIL entry is BOLD ITALIC, this is a record needing to be control per the records control procedure called for in 4.2.4.The ISOGUY Says: When the SYSTEM TRAIL entry is BOLD ITALIC, this is a record needing to be control per the records control procedure called for in 4.2.4.ISOGUY Says: The Date Range can be the start to finish date for an audit of the entire system or may be based upon management review dates. In other words, the Date Range from the last management review until the next one.ISO Guy Says: A MAJOR nonconformance means there is something that is really wrong or broken that needs attention and/or will take quite a bit of effort to resolve.ISO Guy Says: A minor nonconformance is something that is not severe, but must be resolved as it is a problem.ISO Guy Says: A comment is an opportunity for improvement due to a concern where there was not enough evidence to say there was a nonconformance or something could use a little help to make it better, and/or positive feedback. Any action taken would be preventive in nature and could be used to take credit for preventive action.The ISOGUY Says: Documented is something that has to be defined in a documented procedure and/or documented because it is required (i.e., documented policy, quality manual, etc.).The ISOGUY Says: Proven is something needing to be shown as happening or having already occurred. The difference between proven and recorded is recorded means a record of proof has to be maintained. Also, there are some cases where the proof involves the development of process documents to ensure the "effective planning, operation, and control" of the company's processes.The ISOGUY Says: Recorded means we not only have to prove it, but have to maintain a record of that proof.The ISOGUY Says: When the SYSTEM TRAIL entry is BOLD ITALIC, this is a record needing to be control per the records control procedure called for in 4.2.4.ISO Guy Says: A comment is an opportunity for improvement due to a concern where there was not enough evidence to say there was a nonconformance or something could use a little help to make it better, and/or positive feedback. Any action taken would be preventive in nature and could be used to take credit for preventive action.ISO Guy Says: A minor nonconformance is something that is not severe, but must be resolved as it is a problem.ISO Guy Says: A MAJOR nonconformance means there is something that is really wrong or broken that needs attention and/or will take quite a bit of effort to resolve.