Sheet1Clause No.ISO 13485:20037-2 Customer related processes-13485 rev 1Topic In ReviewAudit Question4.2.2Quality manualHow does the QM define customer related processes?4.2.3WI or procedureReview applicable procedures and WIs. Are they consistent with 4.2.3 and 7.2?4.2.4RecordsReview records of reviews. Do the records indicate conformity with clause 7.2.2?5.3Quality PolicyAsk an employee at random what the quality policy is and how it relates to him/her.5.4.1Quality Objectives.What are the quality objectives for the department and what evidence is there to verify they are being met?5.5.1Responsibility and authorityWho has the responsibility to accept/reject contracts from customers? How is this defined?6.2.2Competence awareness and trainingHow is competency defined? Select several individuals at random and verify that their records reflect the job requirements.6.3InfrastructureWhat infrastructure is required by the department and is it available? (Phones, internet access, etc.)4.1General RequirementsWhat Sales/marketing tasks are outsourced? How are they controlled?5.2Customer FocusHow does Top management ensure that customer requirements are determined and are met with the aim of customer satisfaction? See 7.2.1 5.1.a 5.5.2.c 6.1.b 7.2.3 8.2.1. Does the execution of these clauses demonstrate customer focus?.5.5.1Responsibility and authorityHow is the responsibility and authority for accepting/rejecting contracts defined?5.5.2Mgt Rep.How does the Mgt. Rep ensure the promotion of awareness of customer requirements throughout the organization? How are the management representatives duties and responsibilities defined?6.1Provision of resourcesHow does the organization determine and provide for the resources needs to enhance customer satisfaction by meeting customer requirements?7.2.1Determination of requirements related to the productHow does the customer communicate his requirements to the organization? How does the organization determine requirements not specified by the customer, but necessary for intended use? How are applicable statutory/regulatory requirements defined? If the organization goes through a bid/no bid process, how is that accomplished? What additional requirements has the organization invoked?7.2.2Review of requirements related to the productIf the organization generates proposals or bids, how are the requirements communicated? How are the responses reviewed and evaluated? What evidence exists to ensure the organization has the ability to meet the defined requirements? How are changes communicated to the organization?7.2.3Customer communicationWhat channels of communication exist for the customer? How are complaints tracked? What follow up exists to ensure that customer complaint investigations are initiated ? (See 8.5.1) What records of these complaint investigations are maintained?7.3.2Design inputHow do the requirements defined in clause 7.2.1 get communicated to D&D ?7.4.1Purchasing processIf the customer specifies a particular supplier, or material how is this communicated to purchasing?7.4.2Purchasing informationIf the customer specifies particular material/components how is that information conveyed to Purchasing?7.5.1Control of Production and service provisionsHow does the customer convey production and service provisions he wants used on his product such as SPC, and qualifications of personnel?7.5.2Validation of processes for production and service provisionHow does the customer convey special requirements for production and service provisions such as ESD controls, sterilization etc.? How is this monitored?7.5.5Packaging material requirementsHow does the customer convey handling, packing, packaging and shipping requirements?8.2.1FeedbackHow is customer satisfaction monitored and measured? How does the documented procedure for feedback ensure customer complaints are considered as part of the early warning of quality problems?Monitoring and measurement of processesHow are the customer related processes monitored and measured? What corrections and corrective actions have been executed?8.2.4Monitor/measure productHow does the customer specify acceptance criteria and how is this documented? What records are maintained to prove conformity to customer specified requirements?8.4Data analysisHow is data collected and analyzed on the various processes related to customer requirements? What is done with this data? What evidence exists to show that data analysis has resulted in Continual Improvement or preventive action?8.5.1Continual improvementWhat continual improvements have been implemented on customer related processes? Review the documented procedure(s) for issue and implementation of advisory notices. Are they capable of being issued at any time? How are records of customer complaints maintained?8.5.2Corrective actionWhat corrective actions have been implemented on customer related processes?8.5.3Preventive actionWhat preventive actions have been initiated on customer related processes?8-2-1 Feedbcak process -13485 rev 14.2.1General documentationWhat additional documentation/records have been generated for this function, besides those mandated by ISO 13485? Are they in accordance with clause 4.2.3 and 4.2.4?4.2.2Quality manualDoes the feedback process operate as described in the Quality manual?4.2.3Control of documentsReview existing procedures or Work instruction for the feedback process.4.2.4RecordsReview records of the feedback process..5.3Quality PolicyAsk an employee at random, what the quality policy means to him/her?5.4.1Quality objectivesReview the feedback quality objectives. Are they being met?5.5.1Responsibility & AuthorityReview the responsibility & authority for personnel conducting the feed\back process. Is it as defined in clause 5.5.1.?6.2.2Competence, awareness and trainingHow are competency requirements defined for personnel conducting the feedback process? Do the records of personnel performing various tasks of the feedback process (6.2.2.e) match the competency requirements defined in 6.2.2.a.6.3InfrastructureWhat infrastructure is required by the feedback process?5.4.2QMS planningHow does QMS planning direct the feedback process?5.6.2.bManagement review inputsHow is feedback discussed? (5.6.2.b) Are any changes to the feedback process initiated as a result of management review? How are customer complaints addressed?7.2.3Customer communicationHow is customer feedback used to validate feedback (7.2.3.c)?8.1M&M analysis -GeneralWhat statistical techniques are used to monitor and measure feedback?8.2.1FeedbackHow is information relating to customer perception as to whether the organization has met customer requirements monitored? Caution: While customer complaints are often an indicator of low customer satisfaction the absence of such complaints does not necessarily imply high customer satisfaction; and even when customer requirements have been agreed with and fulfilled this does not necessarily ensure high customer satisfaction. See notes 1 and 2 in IS9000-2005, 3.1.4. How are the methods for obtaining and using this information determined? How does the documented procedure for feedback define the early warning of quality problems? How are these early warnings communicated to the preventive and corrective action processes? How is experience from the post production phase factored into the feedback system?8.2.3M&M processesHow is the feedback process defined by the process owner?8.4Data AnalysisWhat feedback data is analyzed and what is done with the analyses?8.5.1Continual improvementHas the feedback process ever resulted in an improvement in any process that would result in improvement of the effectiveness of the QMS? How is this communicated?8.5.2Corrective ActionReview all outstanding CAs against the feedback process since the last audit. What evidence is there that the CAs were effective?8.5.3Preventive ActionHave any PAs been developed regarding feedback? If so, how effective were they?8-3 Control of NC- process 13485 rev 14.2.1General documentationWhat additional documentation/records have been generated for this function, besides those mandated by ISO 13485-2003? Are they in accordance with clause 4.2.3 and 4.2.4?4.2.2Quality manualDoes control of Nonconforming product operate as described in the Quality manual?4.2.3Control of documentsReview existing procedures or Work instruction for control of N/C product.4.2.4RecordsReview records of the control of nonconforming product..5.3Quality PolicyAsk an employee at random, what the quality policy means to him/her?5.4.1Quality objectivesReview quality objectives for N/C product. Are they being met?5.5.1Responsibility & AuthorityReview the responsibility & authority for personnel conducting control of N/C product as defined in clause 5.5.1.6.2.2Competence, awareness and trainingHow are competency requirements defined for personnel performing control of N/C product? Do the records of personnel performing various tasks of the control of N/C product (6.2.2.e) match the competency requirements defined in 6.2.2.a.6.3InfrastructureWhat infrastructure is required by control of N/C product (Storage space etc) & how is this defined?5.6.2Management review inputsIs the control of N/C product discussed as part of Product conformity (5.6.2.c) What changes are initiated as a result of this discussion?7.3.7D&D changesHow does control of N/C product drive D&D changes?7.4.1Purchasing processDoes the control of N/C product influence or impact the selection of suppliers?7.4.3Verification of purchased productReview records of received N/C material. How is acceptance criteria for incoming material defined?7.5.1Production/serviceHow is the rework or repair of N/C product described?8.2.4M&M of productHow is N/C product identified and moved from inspection/test to the N/C product area?8.3Control of N/C productHow is N/C product precluded from unintended use or delivery? What evidence exists to prove reworked/repaired product has been re-verified? What action is taken when N/C product is discovered after delivery or use has started? How does the organization ensure that N/C product accepted by concession only if regulatory requirements are met? What work instructions have been developed for product that must be reworked one or more times? Have these WIs undergone the same the same authorization and approval as the original WI? How has a determination of the adverse effects of rework on the product been documented?8.4Data analysisWhat is done with N/C data?8.5.2Corrective ActionHow does control of N/C product trigger corrective action? Review recent product CAs to ensure the requirement of 8.5.2 have been met.

Sheet44.2.1General documentationWhat additional documentation/records have been generated for this function, besides those mandated by ISO 13485-2003? Are they in accordance with clause 4.2.3 and 4.2.4?4.2.2Quality manualDoes control of Nonconforming product operate as described in the Quality manual?4.2.3Control of documentsReview existing procedures or Work instruction for control of N/C product.4.2.4RecordsReview records of the control of nonconforming product..5.3Quality PolicyAsk an employee at random, what the quality policy means to him/her?5.4.1Quality objectivesReview quality objectives for N/C product. Are they being met?5.5.1Responsibility & AuthorityReview the responsibility & authority for personnel conducting control of N/C product as defined in clause 5.5.1.6.2.2Competence, awareness and trainingHow are competency requirements defined for personnel performing control of N/C product? Do the records of personnel performing various tasks of the control of N/C product (6.2.2.e) match the competency requirements defined in 6.2.2.a.6.3InfrastructureWhat infrastructure is required by control of N/C product (Storage space etc) & how is this defined?5.6.2Management review inputsIs the control of N/C product discussed as part of Product conformity (5.6.2.c) What changes are initiated as a result of this discussion?7.3.7D&D changesHow does control of N/C product drive D&D changes?7.4.1Purchasing processDoes the control of N/C product influence or impact the selection of suppliers?7.4.3Verification of purchased productReview records of received N/C material. How is acceptance criteria for incoming material defined?7.5.1Production/serviceHow is the rework or repair of N/C product described?8.2.4M&M of productHow is N/C product identified and moved from inspection/test to the N/C product area?8.3Control of N/C productHow is N/C product precluded from unintended use or delivery? What evidence exists to prove reworked/repaired product has been re-verified? What action is taken when N/C product is discovered after delivery or use has started? How does the organization ensure that N/C product accepted by concession only if regulatory requirements are met? What work instructions have been developed for product that must be reworked one or more times? Have these WIs undergone the same the same authorization and approval as the original WI? How has a determination of the adverse effects of rework on the product been documented?8.4Data analysisWhat is done with N/C data?8.5.2Corrective ActionHow does control of N/C product trigger corrective action? Review recent product CAs to ensure the requirement of 8.5.2 have been met.