“Sy. Download The Report eD ‘control of change Do the organization conduct review and contol changes for prstueton or service provision to ensue continuing conformaty with requirements? ‘oes the organization retain documented information describing he rests of the review of changes, the person(s authorizing the change and any necessary Release of products and services "Has the organization implemented planned arvangemmens at appropiate stage, to verity thatthe product and service requirements have Been 8? ster the planned arrangements satstactority completed o approved bythe felevant authority and as applicable by he customer? oes the organization retain the documented information onthe saan of| roduts and services and includes information relating to the evidence of conformity with the acceptance entra; Wocesbsy ofthe person authorizing he release? ‘contol of nonconforming outputs ‘oes the organization ensure thatthe outputs which donot conform to hei requirements are dented and contoed to prevent thelr unintended us or dativery? [she action appropriate to the nature ofthe nonconformity ands efect onthe ‘o the organization als consider nonconforming product and services detected alter delivery of products, during and after the provision of services? ‘When non conforming products and services ae detected does the organization take corretion ation andlor segregation, containment, return or suspension of ‘he provision of product &services andor informing obtaining authorization for aceptance under concession? a ‘Does the organization retain documented information tha descrites he onconformiy; describes the actions take: describes any concession obtained dentist euthorty deciding the action in respect ofthe nenconformity? Performance evaluation Monitoring, measurement, analysis, and evaluation coneral Did the organization plan how to monte, measure, analyze and evaluate its as? id the organization plan how to monitor QMS performance and effectiveness? id the organization gure out what needs tobe monitored and sleet methods? Did the organization determine its QMS monitoring requirements? oes the organization select monitoring methods at ean produc vali ests? Did the organizntion establish when monitoring should be done and who should owe Di the organization plan how to measure QMS performance and eifectivencss?ion available that defines the characteristics Are there any documented inform: ofthe product, services or activities tobe performed and the results to be achieved? veasuring resources avalable? Ae they being ‘Are any suitable monitoring a S| asec? 4 | Are monitoring and measuring activities being performed at appropriate stages? 5 | arecompetent persons Gncuding qwalifiation) being appointed? ¢¢_ | ste infrastructure and environment being used suitable for operation of processes? 7 | asthe organization implemented any actions to prevent human error? asthe organization implemented any release, delivery and post delivery, © aciities? ‘Where resulting output cannot be verified by subsequent monitoring or 9 | measurement, has the organization conducted validation ad periodic revalidation of the process for production and service provision? as Identification and traceability asthe organization used any suitable means to identify output when its * | necessary to ensure the conformity of produits and services? Has the status of outputs with respeet to monitoring and measuring requirements {roughout the production and service provision being identified by the organization? Has the organization controlled the unique identification ofthe outputs when traceability isa requirement? as the organization retain the documented information necessary to enable ‘aceability, when traceability is a requirement? °S | property belonging to customers or external providers 3 When property belonging to customers or external providers is under the 41. | organization’ control or being used by the organization, does the organization exercise adequate care? 2 | Does the organization identify, verify, protect and safeguard customers! or external providers’ property? ‘When the property or the customer or external provider Is lost, damaged or | otherwise, fount tobe unsuitable for use, does the organization report this to the customer or external provider? Does the organization retain documented {information on what has occurred? Preservation. 4 | Peesthe organization preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements? Postelivery activities 85 Does the organization meet requirements for post delivery activities associated. with the product and services? In determining the extent of post delivery activities does the organization 2 | considers the statutory & regulatory requirements the potential undesired consequences associated with its product and services; customer requirement & ‘feedback; nature, use and intended lifetime of its product and services?