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Quality manual

  1. 1. Quality ManualQM-422 Revision 0Page 1 of 23Document owner Quality Manager SignApproved by CEO SignEffective date 01 Jan 2013Revision historyRevision Form # Effective date Description of amendments0 DAF 1 01 Jan 2013 First issue.
  2. 2. Quality ManualQM-422 Revision 0Page 2 of 23Table of contentsClause Title Page1 Purpose and scope2 Normative reference3 Terms and definitions4 Quality management system5 Management responsibility6 Resource management7 Product realization8 Measurement, analysis and improvementNote: The clause numbers above correspond to the ISO 9001 International Standard.
  3. 3. Quality ManualQM-422 Revision 0Page 3 of 231 Purpose and scopeThe quality management system has been established toa) demonstrate INSERT YOUR COMPANY NAME’s ability to consistently provideproduct that meets customer and applicable statutory and regulatory requirements,andb) enhance customer satisfaction through the effective application of the system,including processes for continual improvement of the system and the assurance ofconformity to customer and applicable statutory and regulatory requirements.The scope of INSERT YOUR COMPANY NAME’s quality management system encompassesthe provision of the following products:a)b)c)2 Normative referencesThe following reference is indispensable for the application of this document: ISO 9000,Quality management systems — Fundamentals and vocabulary3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 9000 apply.4 Quality management system4.1 General requirementsINSERT YOUR COMPANY NAME has established, documented, implemented and ismaintaining a quality management system, and continually strives to improve its effectivenessin accordance with the requirements of the ISO 9001 International Standard.INSERT YOUR COMPANY NAME hasa) determined the processes needed for the quality management system and theirapplication throughout the organization,b) determined the sequence and interaction of these processes,c) determined the criteria and methods needed to ensure that both the operation andcontrol of these processes are effective, andd) ensured the availability of resources and information necessary to support theoperation and monitoring of these processes.
  4. 4. Quality ManualQM-422 Revision 0Page 4 of 23INSERT YOUR COMPANY NAME monitors, measures where applicable, analyses andimplements actions necessary to achieve planned results and continual improvement of theseprocesses.Where INSERT YOUR COMPANY NAME chooses to outsource any process that affectsproduct conformity to requirements, it ensures control over such processes via the purchasingprocess.Processes needed for the quality management system referred above include managementactivities, resource management, product realization, measurement, analysis andimprovement, as depicted in Figure 1.Figure 1KeyValue-adding activitiesInformation flowOutputCustomerrequirementsCustomersatisfactionProductProductrealization(Clause 7)Managementresponsibility(Clause 5)Resourcemanagement(Clause 6)Measurement,analysis andimprovement(Clause 8)InputContinual improvement of thequality management system
  5. 5. Quality ManualQM-422 Revision 0Page 5 of 234.2 Documentation requirements4.2.1 GeneralINSERT YOUR COMPANY NAME’s quality management system documentation includes thefollowing:a) Quality Policy,b) Quality Manual,c) Quality Plan,d) KPI Register,e) documented procedures and records required by the ISO 9001 Standard, andf) documents, including records, determined by INSERT YOUR COMPANY NAME to benecessary to ensure the effective planning, operation and control of its processes.4.2.2 Quality manualINSERT YOUR COMPANY NAME has established the Quality Manual that includesa) the scope of the quality management system, including details of and justification forany exclusions,b) references to the documented procedures established for the quality managementsystem, andc) a description of the interaction between the processes of the quality managementsystem.4.2.3 Control of documentsDocuments required by the quality management system are controlled.The Control of Documents Procedure has been established to define the controls neededa) to approve documents for adequacy prior to issue,b) to review and update as necessary and re-approve documents,c) to ensure that changes and the current revision status of documents are identified,d) to ensure that relevant versions of applicable documents are available at points of use,e) to ensure that documents remain legible and readily identifiable,f) to ensure that documents of external origin determined by the organization to benecessary for the planning and operation of the quality management system areidentified and their distribution controlled, andg) to prevent the unintended use of obsolete documents, and to apply suitableidentification to them if they are retained for any purpose.The following records are maintained:a) Documents Register
  6. 6. Quality ManualQM-422 Revision 0Page 6 of 23b) Document Approval Form4.2.4 Control of recordsRecords established to provide evidence of conformity to requirements and of the effectiveoperation of the quality management system are controlled.INSERT YOUR COMPANY NAME has established the Control of Records Procedure todefine the controls needed for thea) identification,b) storage,c) protection,d) retrieval,e) retention, andf) disposition of records.Records are ensured to remain legible, readily identifiable and retrievable.The following records are maintained:a) Records Register.5 Management responsibility5.1 Management commitmentTop management of INSERT YOUR COMPANY NAME provides evidence of its commitmentto the development and implementation of the quality management system and continuallyimproving its effectiveness bya) communicating to the organization the importance of meeting customer as well asstatutory and regulatory requirements,b) establishing the Quality Policy,c) ensuring that quality objectives are established and documented,d) conducting management reviews (Clause 5.6), ande) ensuring the availability of resources (Clause 6).5.2 Customer focusTop management of INSERT YOUR COMPANY NAME ensures that customer requirementsare determined and are met with the aim of enhancing customer satisfaction (see Clauses7.2.1 and 8.2.1).5.3 Quality policy
  7. 7. Quality ManualQM-422 Revision 0Page 7 of 23Top management of INSERT YOUR COMPANY NAME has established a Quality Policy andensures that ita) is appropriate to the purpose of the organization,b) includes a commitment to comply with requirements and continually improve theeffectiveness of the quality management system,c) provides a framework for establishing and reviewing quality objectives,d) is communicated and understood within the organization, ande) is reviewed for continuing suitability.5.4 Planning5.4.1 Quality objectivesTop management of INSERT YOUR COMPANY NAME ensures that quality objectives,including those needed to meet requirements for product (see Clause 7.1 a), are establishedat relevant functions and levels within the organization.The quality objectives are measurable and consistent with the Quality Policy.The quality objectives are documented in the Quality Plan.5.4.2 Quality management system planningTop management of INSERT YOUR COMPANY NAME ensures thata) the planning of the quality management system is carried out in order to meet therequirements given in Clause 4.1, as well as the quality objectives, andb) the integrity of the quality management system is maintained when changes to thequality management system are planned and implemented.5.5 Responsibility, authority and communication5.5.1 Responsibility and authorityTop management of INSERT YOUR COMPANY NAME ensures that responsibilities andauthorities are defined and communicated within the organization.Such information is contained in the following documents:a) Organization Chart,b) Job Descriptions,c) Quality Manual,d) Quality Plan,e) KPI Register, andf) Documented procedures.
  8. 8. Quality ManualQM-422 Revision 0Page 8 of 235.5.2 Management representativeTop management of INSERT YOUR COMPANY NAME has appointed a member of theorganizations management who, irrespective of other responsibilities, is responsible and hasauthority ina) ensuring that processes needed for the quality management system are established,implemented and maintained,b) reporting to top management on the performance of the quality management systemand any need for improvement, andc) ensuring the promotion of awareness of customer requirements throughout theorganization.The responsibility of the management representative includes liaison with external parties onmatters relating to the quality management system.The Management Representative is designated in the Organization Chart.5.5.3 Internal communicationTop management of INSERT YOUR COMPANY NAME ensures that appropriatecommunication processes are established within the organization.Apart from electronic communications,a) the Management Representative convenes monthly quality meetings with allDepartment Managers and internal auditors to discuss the effectiveness of the qualitymanagement system, andb) the Department Managers respectively convene monthly quality meetings with theirdepartment personnel to discuss the effectiveness of the quality management system.The following records are maintained:a) Quality Meeting Minutes5.6 Management review5.6.1 GeneralTop management of INSERT YOUR COMPANY NAME reviews the quality managementsystem annually to ensure its continuing suitability, adequacy and effectiveness.This review includes assessing opportunities for improvement and the need for changes to thequality management system, including the quality policy and quality objectives.Records from these management reviews are maintained (see Clause 4.2.4).
  9. 9. Quality ManualQM-422 Revision 0Page 9 of 235.6.2 Review inputThe Management Representative is responsible for providing the following inputs for themanagement reviews:a) results of audits,b) customer feedback,c) process performance and product conformity,d) status of preventive and corrective actions,e) follow-up actions from previous management reviews,f) changes that could affect the quality management system, andg) recommendations for improvement.5.6.3 Review outputThe output from the management reviews include any decisions and actions related toa) improvement of the effectiveness of the quality management system and itsprocesses,b) improvement of product related to customer requirements, andc) resource needs.6 Resource management6.1 Provision of resourcesTop management of INSERT YOUR COMPANY NAME has determined and provided theresources needed toa) implement and maintain the quality management system and continually improve itseffectiveness, andb) enhance customer satisfaction by meeting customer requirements.6.2 Human resources6.2.1 GeneralINSERT YOUR COMPANY NAME’s personnel performing work affecting conformity toproduct requirements are competent on the basis of appropriate education, training, skills andexperience.6.2.2 Competence, training and awarenessINSERT YOUR COMPANY NAMEa) determines the necessary competence for personnel performing work affectingconformity to product requirements,
  10. 10. Quality ManualQM-422 Revision 0Page 10 of 23b) where applicable, provides training or take other actions to achieve the necessarycompetence,c) evaluates the effectiveness of the actions taken,d) ensures that its personnel are aware of the relevance and importance of their activitiesand how they contribute to the achievement of the quality objectives, ande) maintains appropriate records of education, training, skills and experience (see Clause4.2.4).Employees’ performance, including those assigned with specific QMS functions such as theManagement Representative and internal auditors are appraised at least annually by theirrespective superiors.Identified competency gaps are filled through training or other suitable means.Effectiveness of the actions taken are monitored and subsequently evaluated in the nextperformance appraisal.The following records are maintained:a) Job Descriptions,b) Qualifications and work experience records,c) Performance Appraisals,d) Training records, ande) Other relevant HR records.6.3 InfrastructureINSERT YOUR COMPANY NAME has determined, provided and maintained the followinginfrastructure needed to achieve conformity to product requirements:a) buildings, workspace and associated utilities,a) process equipment (both hardware and software), andb) supporting services (such as transport, communication or information systems).Records of maintenance activities are maintained (see Clause 4.2.4).6.4 Work environmentINSERT YOUR COMPANY NAME has determined and provided a suitable and conducivework environment needed to achieve conformity to product requirements.7 Product realization7.1 Planning of product realizationINSERT YOUR COMPANY NAME has planned and developed the processes needed forproduct realization.
  11. 11. Quality ManualQM-422 Revision 0Page 11 of 23Planning of product realization is consistent with the requirements of the other processes ofthe quality management system (see Clause 4.1).In planning product realization, the INSERT YOUR COMPANY NAME determines thefollowing, as appropriate:a) quality objectives and requirements for the product,b) the need to establish processes and documents, and to provide resources specific tothe product,c) required verification, validation, monitoring, measurement, inspection and test activitiesspecific to the product and the criteria for product acceptance, andd) records needed to provide evidence that the realization processes and resultingproduct meet requirements (see Clause 4.2.4).The output of this planning is documented in the Quality Plan. Figure 2 depicts the productrealization process flow:Figure 27.2 Customer-related processes7.2.1 Determination of requirements related to the productINSERT YOUR COMPANY NAME has determineda) requirements specified by the customer, including the requirements for delivery andpost-delivery activities,b) requirements not stated by the customer but necessary for specified or intended use,where known,c) statutory and regulatory requirements applicable to the product, andProcess AProcess BProcess CProcess DStart/Stop
  12. 12. Quality ManualQM-422 Revision 0Page 12 of 23d) any additional requirements considered necessary by the organization.The following records are maintained:a) xb) x7.2.2 Review of requirements related to the productINSERT YOUR COMPANY NAME reviews the requirements related to the product. Thisreview is conducted prior to INSERT YOUR COMPANY NAME’s commitment to supply aproduct to the customer and ensures thata) product requirements are defined,b) contract or order requirements differing from those previously expressed are resolved,andc) the organization has the ability to meet the defined requirements.Records of the results of the review and actions arising from the review are maintained (seeClause 4.2.4).Where the customer provides no documented statement of requirement, the customerrequirements are confirmed by INSERT YOUR COMPANY NAME before acceptance.Where product requirements are changed, INSERT YOUR COMPANY NAME ensures thatrelevant documents are amended and that relevant personnel are made aware of the changedrequirements.The following records are maintained:a) xb) x7.2.3 Customer communicationINSERT YOUR COMPANY NAME determines and implements effective arrangements forcommunicating with customers in relation toa) product information,b) enquiries, contracts or order handling, including amendments, andc) customer feedback, including customer complaints.7.3 Design and developmentINSERT YOUR COMPANY NAME does not engage in any product design and developmentactivities.
  13. 13. Quality ManualQM-422 Revision 0Page 13 of 23OR (choose one and delete the other)7.3 Design and development7.3.1 Design and development planningINSERT YOUR COMPANY NAME plans and controls the design and development of productvia the Design & Development Plan.During the design and development planning, INSERT YOUR COMPANY NAME determinesa) the design and development stages,b) the review, verification and validation that are appropriate to each design anddevelopment stage, andc) the responsibilities and authorities for design and development.INSERT YOUR COMPANY NAME manages the interfaces between different groups involvedin design and development to ensure effective communication and clear assignment ofresponsibility.Planning output is updated, as appropriate, as the design and development progresses.7.3.2 Design and development inputsInputs relating to product requirements are determined and records maintained (see Clause4.2.4). These inputs includea) functional and performance requirements,b) applicable statutory and regulatory requirements,c) where applicable, information derived from previous similar designs, andd) other requirements essential for design and development.The inputs are reviewed for adequacy and requirements are ensured to be complete,unambiguous and not in conflict with each other.7.3.3 Design and development outputsThe outputs of design and development are in a form suitable for verification against thedesign and development input and are approved prior to release.Design and development outputsa) meet the input requirements for design and development,b) provide appropriate information for purchasing, production and service provision,c) contain or reference product acceptance criteria, andd) specify the characteristics of the product that are essential for its safe and proper use.
  14. 14. Quality ManualQM-422 Revision 0Page 14 of 23Information for production and service provision include details for the preservation of product.7.3.4 Design and development reviewAt suitable stages, systematic reviews of design and development are performed inaccordance with planned arrangements (see Clause 7.3.1)a) to evaluate the ability of the results of design and development to meet requirements,andb) to identify any problems and propose necessary actions.Participants in such reviews include representatives of functions concerned with the designand development stage(s) being reviewed.Records of the results of the reviews and any necessary actions are maintained (see Clause4.2.4).7.3.5 Design and development verificationVerification is performed in accordance with planned arrangements (see Clause 7.3.1) toensure that the design and development outputs have met the design and development inputrequirements.Records of the results of the verification and any necessary actions are maintained (seeClause 4.2.4).7.3.6 Design and development validationDesign and development validation is performed in accordance with planned arrangements(see Clause 7.3.1) to ensure that the resulting product is capable of meeting the requirementsfor the specified application or intended use, where known.Wherever practicable, validation is completed prior to the delivery or implementation of theproduct.Records of the results of validation and any necessary actions are maintained (see Clause4.2.4).7.3.7 Control of design and development changesDesign and development changes are identified.The changes are reviewed, verified and validated, as appropriate, and approved beforeimplementation.The review of design and development changes includes evaluation of the effect of thechanges on constituent parts and products already delivered.
  15. 15. Quality ManualQM-422 Revision 0Page 15 of 23Records of the results of the review of changes and any necessary actions are maintained(see Clause 4.2.4).7.4 Purchasing7.4.1 Purchasing processINSERT YOUR COMPANY NAME ensures that purchased product conforms to specifiedpurchase requirements. The type and extent of control applied to the supplier and thepurchased product are dependent upon the effect of the purchased product on subsequentproduct realization or the final product.INSERT YOUR COMPANY NAME evaluates and select suppliers based on their ability tosupply product in accordance with its requirements. Criteria for selection, evaluation and re-evaluation are established.Records of the results of evaluations and any necessary actions arising from the evaluationare maintained (see 4.2.4).The following records are maintained:a) Purchase requisitions,b) Request for quotations,c) Supplier brochures,d) Supplier quotations,e) Purchase orders, andf) Delivery orders.7.4.2 Purchasing informationPurchasing information describes the product to be purchased, including, where appropriate,a) requirements for approval of product, procedures, processes and equipment,b) requirements for qualification of personnel, andc) quality management system requirements.INSERT YOUR COMPANY NAME ensures the adequacy of specified purchase requirementsprior to their communication to the supplier.7.4.3 Verification of purchased productINSERT YOUR COMPANY NAME establishes and implements inspection activities necessaryfor ensuring that purchased product meets specified purchase requirements.Where INSERT YOUR COMPANY NAME or its customer intends to perform verification at thesuppliers premises, it shall state the intended verification arrangements and method ofproduct release in the purchasing information.
  16. 16. Quality ManualQM-422 Revision 0Page 16 of 237.5 Production and service provision7.5.1 Control of production and service provisionINSERT YOUR COMPANY NAME plans and carries out production and service provisionunder controlled conditions via the Production & Service Provision Plan.Controlled conditions shall include, as applicable,a) the availability of information that describes the characteristics of the product,b) the availability of work instructions, as necessary,c) the use of suitable equipment,d) the availability and use of monitoring and measuring equipment,e) the implementation of monitoring and measurement, andf) the implementation of product release, delivery and post-delivery activities.The following records are maintained:a) xb) x7.5.2 Validation of processes for production and service provisionINSERT YOUR COMPANY NAME does not engage in any validation of processes forproduction and service provision because all resulting outputs can be verified by subsequentmonitoring or measurement.OR (choose one and delete the other)INSERT YOUR COMPANY NAME validates any processes for production and serviceprovision where the resulting output cannot be verified by subsequent monitoring ormeasurement and, as a consequence, deficiencies become apparent only after the product isin use or the service has been delivered.Validation demonstrates the ability of these processes to achieve planned results.INSERT YOUR COMPANY NAME establishes arrangements for these processes including,as applicable,a) defined criteria for review and approval of the processes,b) approval of equipment and qualification of personnel,c) use of specific methods and procedures,d) requirements for records (see Clause 4.2.4), ande) revalidation.7.5.3 Identification and traceability
  17. 17. Quality ManualQM-422 Revision 0Page 17 of 23Where appropriate, INSERT YOUR COMPANY NAME identifies the product by suitablemeans throughout product realization.INSERT YOUR COMPANY NAME identifies the product status with respect to monitoring andmeasurement requirements throughout product realization.INSERT YOUR COMPANY NAME controls the unique identification of the product andmaintains its records (see Clause 4.2.4).7.5.4 Customer propertyINSERT YOUR COMPANY NAME exercises care with customer property while it is under itscontrol or use.INSERT YOUR COMPANY NAME identifies, verifies, protects and safeguards customerproperty provided for use or incorporation into the product.If any customer property is lost, damaged or otherwise found to be unsuitable for use,INSERT YOUR COMPANY NAME reports this to the customer and maintains relevant records(see Clause 4.2.4).Note: Customer property includes intellectual property, personal or corporate data.7.5.5 Preservation of productINSERT YOUR COMPANY NAME preserves the product during internal processing anddelivery to the intended destination in order to maintain conformity to requirements.As applicable, preservation includes identification, handling, packaging, storage andprotection.Preservation also applies to the constituent parts of a product.7.6 Control of monitoring and measuring equipmentINSERT YOUR COMPANY NAME determines the monitoring and measurement to beundertaken and the monitoring and measuring equipment needed to provide evidence ofconformity of product to determined requirements.INSERT YOUR COMPANY NAME establishes processes to ensure that monitoring andmeasurement can be carried out and are carried out in a manner that is consistent with themonitoring and measurement requirements.Where necessary to ensure valid results, measuring equipment area) be calibrated or verified, or both, at specified intervals, or prior to use, againstmeasurement standards traceable to international or national measurement standards;
  18. 18. Quality ManualQM-422 Revision 0Page 18 of 23where no such standards exist, the basis used for calibration or verification shall berecorded (see Clause 4.2.4);b) be adjusted or re-adjusted as necessary;c) have identification in order to determine its calibration status;d) be safeguarded from adjustments that would invalidate the measurement result;e) be protected from damage and deterioration during handling, maintenance andstorage.In addition, INSERT YOUR COMPANY NAME assesses and records the validity of theprevious measuring results when the equipment is found not to conform to requirements. Insuch cases, INSERT YOUR COMPANY NAME takes appropriate action on the equipmentand any product affected.Records of the results of calibration and verification are maintained (see Clause 4.2.4).When used in the monitoring and measurement of specified requirements, the ability ofcomputer software to satisfy the intended application is confirmed. This is undertaken prior toinitial use and reconfirmed as necessary.Confirmation of the ability of computer software to satisfy the intended application typicallyincludes its verification and configuration management to maintain its suitability for use.The following records are maintained:a) xb) x8 Measurement, analysis and improvement8.1 GeneralINSERT YOUR COMPANY NAME plans and implements the monitoring, measurement,analysis and improvement processes neededa) to demonstrate conformity to product requirements,b) to ensure conformity of the quality management system, andc) to continually improve the effectiveness of the quality management system.This includes determination of applicable methods, including statistical techniques, and theextent of their use.8.2 Monitoring and measurement8.2.1 Customer satisfaction
  19. 19. Quality ManualQM-422 Revision 0Page 19 of 23As one of the measurements of the performance of the quality management system, INSERTYOUR COMPANY NAME monitors information relating to customer perception as to whetherINSERT YOUR COMPANY NAME has met customer requirements.INSERT YOUR COMPANY NAME plans and implements an annual Customer SatisfactionSurvey where relevant questions regarding INSERT YOUR COMPANY NAME’s products inrelation to the customers’ experience are asked and customers’ comments and suggestionsare sought.8.2.2 Internal auditINSERT YOUR COMPANY NAME conducts internal audits annually to determine whether thequality management systema) conforms to the planned arrangements (see Clause 7.1), to the requirements of theISO 9001 Standard and to the quality management system requirements establishedby INSERT YOUR COMPANY NAME, andb) is effectively implemented and maintained.An audit programme is planned, taking into consideration the status and importance of theprocesses and areas to be audited, as well as the results of previous audits. The audit criteria,scope, frequency and methods are defined.The selection of auditors and conduct of audits ensures objectivity and impartiality of theaudit process. Auditors do not audit their own work.The Internal Audit Procedure has been established to define the responsibilities andrequirements for planning and conducting audits, establishing records and reporting results.Records of the audits and their results are maintained (see 4.2.4).The management responsible for the area being audited shall ensure that any necessarycorrections and corrective actions are taken without undue delay to eliminate detectednonconformities and their causes.Follow-up activities include the verification of the actions taken and the reporting of verificationresults (see 8.5.2).The following records are maintained:a) Internal Audit Schedule,b) Audit Plans, andc) ISO 9001 Audit Checklist.8.2.3 Monitoring and measurement of processes
  20. 20. Quality ManualQM-422 Revision 0Page 20 of 23Suitable key performance indicators (KPI) have been established to monitor and, whereapplicable, measure the quality management system processes.These key performance indicators (KPI) demonstrate the ability of the processes to achieveplanned results. When planned results are not achieved, correction and corrective action aretaken, as appropriate.The key performance indicators (KPI) are maintained in the KPI Register.8.2.4 Monitoring and measurement of productINSERT YOUR COMPANY NAME monitors and measures the characteristics of the productto verify that product requirements have been met.This is carried out at appropriate stages of the product realization process in accordance withthe planned arrangements (see Clause 7.1).Evidence of conformity with the acceptance criteria is maintained and records are ensured toindicate the person(s) authorizing release of product for delivery to the customer (see Clause4.2.4).The release of product and delivery of service to the customer does not proceed until theplanned arrangements (see Clause 7.1) have been satisfactorily completed, unless otherwiseapproved by a relevant authority and, where applicable, by the customer.The following records are maintained:a) xb) x8.3 Control of nonconforming productINSERT YOUR COMPANY NAME ensures that product which does not conform to productrequirements is identified and controlled to prevent its unintended use or delivery.A procedure has been established to define the controls and related responsibilities andauthorities for dealing with nonconforming products and documented in the Quality Plan.Where applicable, INSERT YOUR COMPANY NAME deals with nonconforming product byone or more of the following ways:a) by taking action to eliminate the detected nonconformity;b) by authorizing its use, release or acceptance under concession by a relevant authorityand, where applicable, by the customer;c) by taking action to preclude its original intended use or application;d) by taking action appropriate to the effects, or potential effects, of the nonconformitywhen nonconforming product is detected after delivery or use has started.
  21. 21. Quality ManualQM-422 Revision 0Page 21 of 23When nonconforming product is corrected it is subject to re-verification to demonstrateconformity to the requirements.Records of the nature of nonconformities and any subsequent actions taken, includingconcessions obtained, are maintained (see Clause 4.2.4).The following records are maintained:a) Nonconforming Product Form.8.4 Analysis of dataINSERT YOUR COMPANY NAME determines, collects and analyses appropriate data todemonstrate the suitability and effectiveness of the quality management system and toevaluate where continual improvement of the effectiveness of the quality management systemcan be made.Methods of the analysis of data include, where appropriate:a) Trend Chart - used to detect trends and unusual activities within the data set,b) Pareto Chart Analysis - used to analyze the different components that make up thedata value in a descending order, with the cumulative percentage line superimposedon it,c) SWOT Analysis - used to analyze process strengths, weaknesses, opportunities andthreats based on the characteristics of the data set,d) Arithmetic average or mean - used to identify the average performance value of thedata set,e) Median - used to identify the actual middle value of the data set,f) Mode - used to identify the most frequent value occurring within the data set,g) Range - used to determine the value between the lowest and highest values in thedata set,h) Cause and Effect Analysis - used to analyze the causes and effects of a given dataset,i) Risk Analysis - used to identify potential risks, andj) Other analysis methods, as appropriate.The analysis of data provides information relating toa) customer satisfaction (see Clause 8.2.1),b) conformity to product requirements (see Clause 8.2.4),a) characteristics and trends of processes and products, including opportunities forpreventive action (see 8.2.3 and 8.2.4),andb) suppliers (see Clause 7.4).The following records are maintained:
  22. 22. Quality ManualQM-422 Revision 0Page 22 of 23a) KPI Reports.8.5 Improvement8.5.1 Continual improvementINSERT YOUR COMPANY NAME continually improves the effectiveness of the qualitymanagement system through the use of the Quality Policy, quality objectives, audit results,analysis of data, corrective and preventive actions and management review.8.5.2 Corrective actionINSERT YOUR COMPANY NAME takes action to eliminate the causes of nonconformities inorder to prevent recurrence.Corrective actions are appropriate to the effects of the nonconformities encountered.The Corrective & Preventive Action Procedure has been established to define requirementsfora) reviewing nonconformities (including customer complaints),b) determining the causes of nonconformities,c) evaluating the need for action to ensure that nonconformities do not recur,d) determining and implementing action needed,e) records of the results of action taken (see Clause 4.2.4), andf) reviewing the effectiveness of the corrective action taken.The following records are maintained:a) CAPA Request, andb) CAPA Register.8.5.3 Preventive actionINSERT YOUR COMPANY NAME determines action to eliminate the causes of potentialnonconformities in order to prevent their occurrence.Preventive actions are appropriate to the effects of the potential problems.The Corrective & Preventive Action Procedure has been established to define requirementsfora) determining potential nonconformities and their causes,b) evaluating the need for action to prevent occurrence of nonconformities,c) determining and implementing action needed,d) records of results of action taken (see Clause 4.2.4), ande) reviewing the effectiveness of the preventive action taken.
  23. 23. Quality ManualQM-422 Revision 0Page 23 of 23The following records are maintained:a) CAPA Request, andb) CAPA Register.