IL SISTEMA DI GESTIONE QUALITÀ A - LINEE ESSENZIALI SUPPORTO DELLA CERTIFICAZIONE DEI DISPOSITIVI MEDICI. SSFA / dic-2016

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1 SSFA / dic-2016 IL SISTEMA DI GESTIONE QUALITÀ A SUPPORTO DELLA CERTIFICAZIONE DEI DISPOSITIVI MEDICI - LINEE ESSENZIALI 1 Marco Delbò segreteriamd@gmail.com

2 a cura di: MARCO DELBÒ / Independent Medical Devices Professional Microbiologist Consultant: Regulatory Affairs and Quality Assurance; Certification of Medical Devices; Risk Analysis; Technical Files preparation; CE marking of MD; Quality Systems Certification, Canadian Regulations CMDCAS; FDA 510k; ISO 9001; ISO 13485; Internal Audit Auditor Team Leader: ISO 9001; ISO 13485; CE marking; Canadian Regulations CMDCAS; Unannounced Audits 2 Marco Delbò segreteriamd@gmail.com

3 MARCATURA CE: QUADRO LEGISLATIVO DIRETTIVA 93/42/CEE DEL CONSIGLIO del 14 giugno 1993 concernente i dispositivi medici Modificata da: Recepita DL 46/97 M1 Direttiva 98/79/CE del Parlamento europeo e del Consiglio del 27 ottobre 1998 M2 Direttiva 2000/70/CE del Parlamento europeo e del Consiglio del 16 novembre 2000 M3 Direttiva 2001/104/CE del Parlamento europeo e del Consiglio del 7 dicembre 2001 M4 Regolamento (CE) n. 1882/2003 del Parlamento europeo e del Consiglio del 29 settembre 2003 M5 Direttiva 2007/47/CE del Parlamento europeo e del Consiglio del 5 settembre Marco Delbò segreteriamd@gmail.com

4 MARCATURA CE: QUADRO LEGISLATIVO CHANGES - UPCOMING NEW MD REGULATION DIRETTIVA 93/42/CEE M5 Verrà sostituita da: NEW MDR (Medical Device Regulation) Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 Brussels, 27 June Marco Delbò segreteriamd@gmail.com

5 Marcatura CE: quadro legislativo FAQ CHANGES - UPCOMING NEW MD REGULATION Council of the European Union Brussels, 27 June 2016 Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 This is based on the consolidated version of the Medical Devices Regulation (MDR) that has been adopted by the European Parliament and the Member States in June This text has been described by one of the stakeholders as Tentatively Agreed Consolidated Compromise Text, which illustrates the delicate nature of this document. There is a small possibility that some changes are made by the European Commission s Legal Services when this compromise gets a final review for legal inconsistencies. In general it can be expected that most, if not all of the requirements in this version will be in the final version that will be published at the beginning of Marco Delbò segreteriamd@gmail.com

6 MARCATURA CE: QUADRO LEGISLATIVO CHANGES - UPCOMING NEW MD REGULATION NEW MDR (Medical Device Regulation) modalità di transizione: After publication, there will be a three-year transition period. (early 2020??) certificates issued prior to final implementation will have a maximum validity of five years. all CE Mark certifications issued before implementation of the new regulations will automatically expire four years after the new regulations come into force. 6 Marco Delbò segreteriamd@gmail.com

7 MARCATURA CE: PROCESSO La marcatura CE di un Dispositivo Medico: è un processo complesso con varie alternative va correttamente pianificato 7 Marco Delbò segreteriamd@gmail.com

8 MARCATURA CE: PROCESSO: È UN MD? 1: è un dispositivo medico? non è sempre scontato classificare un prodotto come MD 8 Marco Delbò segreteriamd@gmail.com

9 MARCATURA CE: PROCESSO: È UN MD? 1: è un dispositivo medico? «dispositivo medico»: qualunque strumento, apparecchio, impianto, software, sostanza o altro prodotto, utilizzato da solo o in combinazione, compreso il software destinato dal fabbricante ad essere impiegato specificamente con finalità diagnostiche e/o terapeutiche e necessario al corretto funzionamento del dispositivo, destinato dal fabbricante ad essere impiegato sull uomo a fini di: diagnosi, prevenzione, controllo, terapia o attenuazione di una malattia; diagnosi, controllo, terapia, attenuazione o compensazione di una ferita o di un handicap; studio, sostituzione o modifica dell'anatomia o di un processo fisiologico; intervento sul concepimento, la cui azione principale voluta nel o sul corpo umano non sia conseguita con mezzi farmacologici né immunologici né mediante metabolismo, ma la cui funzione possa essere assistita da questi mezzi; MDD - COUNCIL DIRECTIVE 93/42/EEC M5 9 Marco Delbò segreteriamd@gmail.com

10 MARCATURA CE: PROCESSO: È UN MD? 1: è un dispositivo medico? medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific medical purposes of: diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability, investigation, replacement or modification of the anatomy or of a physiological or pathological process or state, providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means. Products specifically intended for the cleaning, disinfection or sterilisation of medical devices and devices for the purpose of control or support of conception shall be considered medical devices Medical device regulation negotiated text 27 June 2016 DRAFT Marco Delbò segreteriamd@gmail.com

11 MARCATURA CE: PROCESSO: È UN MD? 1: è un dispositivo medico? Poi ci sono le complicazioni: accessorio SI NO FORSE 11 Marco Delbò

12 MARCATURA CE: PROCESSO: CLASSIFICAZIONE 2: decidere la classificazione I Is Im IIa IIb III III + Animal Tissue III + Pharma Regole di classificazione modificate dalla nuova Medical Device Regulation Previsti alcuni cambi di classe Ir 12 Marco Delbò segreteriamd@gmail.com

13 MARCATURA CE: PROCESSO: ITER DI CERTIFICAZIONE Iter di Certificazione: varie alternative per CE All. All. All. All. All. VII V II III IV nelle varie combinazioni secondo la classe e le priorità aziendali All. VI nuova Medical Device Regulation : cambieranno gli allegati di riferimento, ma il principio rimarrà lo stesso 13 Marco Delbò segreteriamd@gmail.com

14 MARCATURA CE: SGQ Sistema Gestione Qualità All. V escl. DD All. II completo All. VI Escl. DD e Prod secondo la classe e le priorità aziendali nuova Medical Device Regulation : cambieranno gli allegati di riferimento, ma il principio rimarrà lo stesso Possono essere obbligatori 14 Marco Delbò segreteriamd@gmail.com

15 MARCATURA CE: SGQ SGQ: come supportarlo? EN ISO 9001 Serve? Utile? NO SI poco GMP Serve? Utile? NO SI SI buona base di partenza 15 Marco Delbò

16 MARCATURA CE: SGQ SGQ: come supportarlo? EN ISO Serve? Non obblig atorio Utile? SISI SI è la norma di riferim ento Si presume la conformità ai requisiti per i sistemi di qualità che applicano le corrispondenti norme armonizzate 16 Marco Delbò segreteriamd@gmail.com

17 MARCATURA CE: SGQ - EN ISO OVERVIEW EN 46001: (EN) ISO 13485: (EN) ISO 13485:2003 (EN) ISO 13485:2003/AC:2007 EN ISO 13485:2012 +allegato Z NORMA ARMONIZZATA (EN) ISO 13485: /03/2016 three-year transition period > 28/02/2019 SARA NORMA ARMONIZZATA No new ISO 13485:2003 certificates issued in final year of transition Marco Delbò segreteriamd@gmail.com

18 MARCATURA CE: SGQ - EN ISO OVERVIEW 21 set 2016 Non ancora tradotta In attesa di approvazione di nuovo CORRIGENDUM che modifica allegati Z della ISO13485: Marco Delbò segreteriamd@gmail.com

19 MARCATURA CE: SGQ EN ISO 13485:2016 EN ISO 9001:2015 Struttura NON più condivisa Le norme non saranno in contrasto, ma non più allineate 19 Marco Delbò

20 MARCATURA CE: SGQ EN ISO GMP = Struttura NON condivisa Produzione e controlli Management review vigilance calibrazioni Training, qualifica Scelte basate su Risk Management, meno prescrittive Ad es: classe clean room, validazioni ster. e non sterility test ATTITUDINE Le aziende GMP parlano la stessa lingua, hanno la giusta mentalità Marco Delbò segreteriamd@gmail.com

21 MARCATURA CE: SGQ EN ISO GMP general differences: pharma is strictly regulated with clear indications, based on GMP guidelines and Pharmacopoeia MD more flexible, based on risk management and applicable standards; more options based on company decisions 21 Marco Delbò

22 MARCATURA CE: SGQ Estensione da GMP a EN ISO right attitude, correct approach correct structure generally in place (i.e.: vigilance) IMPLEMENTED PROCEDURES generally suitable: manufacturing, validations, controls, calibration, environmental controls, job descriptions and training, management of deviations 22 Marco Delbò segreteriamd@gmail.com

23 MARCATURA CE: SGQ Estensione da GMP a EN ISO approach to apply the pharma rules for medical devices, resulting in overcomplicated and often misleading processes main differences: TF management, risk management, vigilance, CAPA management, internal audit, D&D and certification process, management review 23 Marco Delbò segreteriamd@gmail.com

24 MARCATURA CE: SGQ QUANDO CERTIFICARSI? Finchè non ho il CE non vendo FRETTA Finchè non produco non posso chiedere il CE Prima di audit di certificazione: Almeno un paio di mesi di dati, di applicazione del SGQ 24 Marco Delbò

25 MARCATURA CE: SGQ QUANDO CERTIFICARSI? Almeno un paio di mesi di dati, di applicazione del SGQ Almeno un esempio di applicazione dei processi, ad es: Almeno un lot di produzione anche pilota (prodotti rappresentativi) Se voglio certificare protesi sterili e suo strumentario non sterile Ideale entrambi i prodotti 25 Marco Delbò segreteriamd@gmail.com

26 MARCATURA CE: SGQ QUANDO CERTIFICARSI? Almeno un paio di mesi di dati, di applicazione del SGQ Almeno un esempio di applicazione dei processi, ad es: Almeno un lot di produzione Almeno un Riesame direzione Almeno un ciclo V.I.I. Almeno un piano per PMS Almeno un progetto (se applicabile) 26 Marco Delbò

27 MARCATURA CE: SGQ CHI SI DEVE AUDITARE? Legal manufacturer Tutte le location applicabili Fornitori critici, ad es: sterilizzazione filling Etichettatura / packaging A meno che non siano certificati ISO o GMP Materie prime critiche (es: ac. Ialuronico, principi attivi, tessuti d origine animale, etc.) Processi in outsourcing (es: DD, Vigilance, etc.) 27 Marco Delbò segreteriamd@gmail.com

28 MARCATURA CE: SGQ CHI SI DEVE AUDITARE? OBL Virtual manufacturer: Deve dimostrare competenza e avere i FT 28 Marco Delbò segreteriamd@gmail.com

29 MARCATURA CE: SGQ COSA SI DEVE AUDITARE? CERTIFICAZIONE Stage 1: si verifica che l azienda sia pronta Implementati tutti i processi Stage 2: audit completo Fornitori critici / scopo / allegati SORVEGLIANZA Almeno annuale + UAV (Verifiche NON annunciate) 29 Marco Delbò segreteriamd@gmail.com

30 MARCATURA CE: SGQ COSA SI DEVE AUDITARE? CERTIFICAZIONE Tutti i processi, tutti i punti della ISO13485 Anche processi in outsourcing Se non già certificati i Fascicoli Tecnici SORVEGLIANZA processi, FT, punti della ISO13485, a campione Sempre: Responsabilità Direzione, VII, NC, CAPA, Vigilance 30 Marco Delbò segreteriamd@gmail.com

31 MARCATURA CE: SGQ DURATA CERTIFICATI CERTIFICAZIONE ISO Max 3 ANNI Non oltre transizione nuova edizione Marcatura CE (annex V, II, III) Max 5 ANNI Non oltre transizione nuovo regolamento 31 Marco Delbò segreteriamd@gmail.com

32 MARCATURA CE: SGQ DURATA VISITA Proporzionale alle dimensioni (numero dipendenti, FTE) + increasing factors - Decreasing factors Processi ripetitivi Processi comples si Molte NC interpre te Shift Molti processi SGQ maturo con poche NC Processi non applicabili 32 Marco Delbò segreteriamd@gmail.com

33 MARCATURA CE: SGQ VITA VISSUTA ERRORI PRINCIPALI strategia errata Scelta errata del NB (non è NB o non copre la famiglia di prodotto da certificare, o l allegato) Scelto Allegato errato (o non applicabile o inutile) Dispositivi border line: classificazione non accettata da NB (classe / non è Disp. Medico) 33 Marco Delbò segreteriamd@gmail.com

34 MARCATURA CE: SGQ VITA VISSUTA ERRORI PRINCIPALI preparazione errata Azienda non pronta (SGQ non ancora completato, nessuna produzione, nessun batch record) Fornitori critici /location : elenco incompleto (se ne scoprono di nuovi durante audit) Visita ai fornitori: contratto non disponibile; nessuna produzione in corso ( o nessun prodotto simile da prendere ad esempio) 34 Marco Delbò segreteriamd@gmail.com

35 MARCATURA CE: SGQ VITA VISSUTA ERRORI PRINCIPALI preparazione errata Risk management: non c è collegamento tra SGQ e Analisi dei Rischi VII non eseguite, o eseguite da personale non qualificato o non correttamente documentate Riesame Direzione: NON è una valutazione, non copre tutti i punti (es: nuovi requisiti regolatori) Non è pianificata PMS Fornitori critici non qualificati (anche consulenti) 35 Marco Delbò segreteriamd@gmail.com

36 MARCATURA CE: SGQ VITA VISSUTA ERRORI PRINCIPALI attitudine errata qual è il giusto approccio del fabbricante? 36 Marco Delbò

37 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485:2016 differenze principali della nuova edizione general changes Many additions Some new requirements Some expansion & clarification Increased clarity of interrelationship between clauses and requirements 37 Marco Delbò segreteriamd@gmail.com

38 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: Scope 2 Normative references 3 Terms and definitions changes does not align with the new ISO 9001:2015 changes standard s numbering and clauses: - new clauses and sub-clauses have been added - In order to work with (MDSAP) NC-grading, (sub)clauses required formatting facilitate global alignment (i.e. MDSAP) allow organizations to be involved in different stages of the product life-cycle (extended scope) 38 Marco Delbò segreteriamd@gmail.com

39 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: Scope 2 Normative references 3 Terms and definitions changes risk-based approach to control QMS processes emphasis on understanding of, and adherence, to international regulatory requirements a number of definitions that were added, i.e.: clinical evaluation, complaint, distributor, importer, lifecycle, manufacturer, medical device family, performance evaluation, postmarket surveillance, purchased product, risk, risk management and sterile barrier system. 39 Marco Delbò segreteriamd@gmail.com

40 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: Quality management system 4.1 General requirements 4.2 Documentation requirements General Quality manual Medical device file Control of documents Control of records 40 Marco Delbò segreteriamd@gmail.com

41 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: Quality management system changes 4.1 risk-based General requirements approach to control QMS processes (+ outsourced) 4.2 Documentation requirements Roles to be documented to meet regulatory requirements (i.e., General specifying the legal manufacturer, defining processes, and identifying Quality records manual to be kept to meet regulatory requirements) Medical device file software Control used of documents for the QMS to be validated prior to initial use and after any change Control of records Medical Device File (similar to a technical file) for regulatory purposes, and the establishment of methods to protect confidential health information + Detailed list of items (a-f) to be included to meet regulatory requirements 41 Marco Delbò segreteriamd@gmail.com

42 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: Management responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning Quality objectives Quality management system planning 5.5 Responsibility, authority and communication Responsibility and authority Management representative Internal communication 5.6 Management review General Review input Review output 42 Marco Delbò segreteriamd@gmail.com

43 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485:2016 EN ISO 13485:2016 changes 5 Management responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Increased Quality policy emphasis on regulatory requirements 5.4 Planning Quality objectives Quality management system planning 5.5 Responsibility, authority and communication Responsibility and authority Management representative Internal communication 5.6 Management review Responsibilities and authority documented, including the interrelation of personnel affecting quality and liaison with external parties and regulatory authorities Input and output requirements have been added to maintain the suitability and adequacy of the QMS General Review input Review output 43 Marco Delbò segreteriamd@gmail.com

44 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: Resource management 6.1 Provision of resources 6.2 Human resources 6.3 Infrastructure 6.4 Work environment and contamination control Work environment Contamination control 44 Marco Delbò segreteriamd@gmail.com

45 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: Resource management 6.1 Provision of resources 6.2 Human resources 6.3 Infrastructure changes Documented processes required to establish competence, provide training and ensure quality awareness throughout the organization 6.4 Work environment and contamination control emphasis on defining, maintaining, and updating the competence of personnel involved with quality system compliance and regulatory requirements. required to evaluate effectiveness of any training commensurate with the risks associated with the work individuals perform Work environment Contamination control 45 Marco Delbò segreteriamd@gmail.com

46 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: Resource management 6.1 Provision of resources 6.2 Human resources 6.3 Infrastructure changes emphasis on maintenance-related activities of production, control, work env, monitor and measurement equipment - companies must have clearly documented procedures to specify how those activities are being performed. 6.4 Work environment and contamination control Work environment Contamination control new requirement to handle orders in a streamlined way to prevent mix-ups 46 Marco Delbò segreteriamd@gmail.com

47 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: Resource management 6.1 Provision of resources 6.2 Human resources 6.3 Infrastructure changes control of work environment by specifying requirements for health, cleanliness, and clothing of personnel involved in production activities to prevent cross-contamination adds a reference to ISO (air cleanliness classification and monitoring) and ISO (cleanrooms and associated control environments). Manufacturers must consider conditions such as noise, temperature, humidity, lighting, and adequate infrastructure for manufacturing, inspection, storage, and distribution areas. 6.4 Work environment and contamination control Work environment Contamination control planned arrangements for controlling (potentially) contaminated product in order to prevent contamination of work environment, personnel, or product 47 Marco Delbò segreteriamd@gmail.com

48 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: Product realization 7.1 Planning of product realization changes document how risk-management activities are being handled Planned processes for verification, validation, monitoring, measurement, inspection, test activities, handling, storage, distribution, and traceability Documented risk management throughout developmentplanning activities 48 Marco Delbò segreteriamd@gmail.com

49 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: Product realization 7.2 Customer-related processes Determination of requirements related to product Review of requirements related to product Communication 49 Marco Delbò segreteriamd@gmail.com

50 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: Product realization Manufacturers must determine whether there is a need for user training Determination to ensure of requirements specified performance related to product and safe use of the medical Review of device requirements + any user related training to product identified is available Communication or planned to be available 7.2 Customer-related processes changes Manufacturers must ensure that applicable regulatory requirements are met as part of the product review requirements documented arrangements must be in place for communicating with regulatory authorities ( product information, regulatory inquiries, complaints, and advisory notices) Marco Delbò segreteriamd@gmail.com

51 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: Product realization 7.3 Design and development General Design and development planning Design and development inputs Design and development outputs Design and development review Design and development verification Design and development validation Design and development transfer Control of design and development changes Design and development files 51 Marco Delbò segreteriamd@gmail.com

52 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: Product realization 7.3 Design and development General Design and development planning Design and development inputs changes requirement to update documents with DD progress and to ensure traceability of outputs to inputs competence of personnel in design and development activities must be defined and demonstrated, and a review by a specialist (independent reviewer) is now required Design and development outputs Design and development review Design and development verification Design and development validation Design and development transfer inputs must include usability - standards,- and should be verified and validated. Outputs must be in a form suitable for verification against inputs Control of design and development changes Design and development files Marco Delbò segreteriamd@gmail.com

53 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: Product realization 7.3 Design and development verification and validation plan must be documented, General including methods, criteria for acceptance, failure, Design and development planning justification for sample sizes selected Design and development inputs Design and development outputs Design and development review Design and development verification Design and development validation Design and development transfer Control of design and development changes Design and development files Marco Delbò segreteriamd@gmail.com changes verification and validation of connections and interfaces Validation must be conducted on final production units (representative product) or documented equivalent devices verification + validation of user instructions required, including review of failure modes 53 +4

54 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: Product realization 7.3 Design and development DD Transfer: new clause General Design and development planning changes requires a documented plan for design transfer to Design and development inputs another Design facility and or outsourcing development partner. outputs should include plans for supplier quality and capability, Design and development review manufacturing personnel capability and training, manufacturing process Design and process and development validation, materials, verificationmanufacturing tools and methods, Design work and environment, development installation, validationand service Design and development transfer Control of design and development changes Design and development files 54 Marco Delbò segreteriamd@gmail.com

55 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: Product realization DD Changes and Files: new subclause, 7.3 Design more and development detail General Design and development planning Design and development inputs changes link to risk management and product realization added, + detail regarding determining significance of change Design and development outputs requirements to control changes, documentation to be kept, approval requirements, reports and testing to justify changes, etc Design and development review Design and development verification Design and development validation DD files to be maintained for each medical device type /family. must include or reference records to demonstrate conformity to the requirements for D&D, and records to justify changes Design and development transfer Control of design and development changes Design and development files Marco Delbò segreteriamd@gmail.com

56 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: Product realization 7.4 Purchasing Purchasing process Purchasing information Verification of purchased product 56 Marco Delbò segreteriamd@gmail.com

57 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: Product realization 7.4 Purchasing Purchasing process Purchasing information changes Criteria for evaluation and selection of suppliers includes performance and risk Supplier performance monitoring as part of re- evaluation process, additional record requirements Verification of purchased product Purchasing information to include, as applicable, product specifications Suppliers to agree to prior notification of changes Verification of processes based on risks and results of evaluations and reevaluations; link to change control Marco Delbò segreteriamd@gmail.com

58 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: Product realization 7.5 Production and service provision Control of production and service provision Cleanliness of product Installation activities Servicing activities Particular requirements for sterile medical devices Validation of processes for production and service provision Particular requirements for validation of processes for sterilization and sterile barrier systems Identification Traceability Customer property Preservation of product 58 Marco Delbò segreteriamd@gmail.com

59 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: Product realization changes Production 7.5 Production / service and to service be planned, provision monitored, and Control of production and service provision controlled to ensure products conforms to specifications Cleanliness of product Installation activities Servicing activities Cleanliness: adds contamination control Servicing: activity records to be analyzed to determine Particular requirements for sterile medical devices if events Validation in the of processes field should for production be considered and service provision and Particular requirements for validation of processes for sterilization and product sterile barrier as systems part of design inputs Identification Traceability Customer property Preservation of product reported as complaints, or used to improve the Validation: Processes must be validated where output cannot be, or is not, verified. + need for procedures. Statistical techniques applied and rationale for sample sizes must be documented, including approval of changes 59 and validation of software after changes (risk based) Marco Delbò segreteriamd@gmail.com

60 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: Product realization changes 7.5 Production and service provision Validation Control of sterilization production and service and provision sterile barriers Cleanliness of product Installation activities Servicing activities Validation required prior to implementation / Changes + Document results, conclusions, actions Particular requirements for sterile medical devices Validation of processes for production and service provision Particular requirements for validation of processes for UDI sterilization (whereand required by regulations) sterile barrier systems Identification conforming Traceability product Customer property Preservation of product procedures for separation of returned products from shipping conditions and their impact on product and package integrity, including management of sterile device packaging, to be assessed Marco Delbò segreteriamd@gmail.com

61 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: changes 7.6 Control of monitoring and measuring equipment Requirements for the validation of the application of software used for monitoring and measurement of requirements. Risk based approach required. 61 Marco Delbò segreteriamd@gmail.com

62 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: Measurement, analysis and improvement 8.1 General 8.2 Monitoring and measurement Feedback Complaint handling Reporting to regulatory authorities Internal audit Monitoring and measurement of processes Monitoring and measurement of product 8.3 Control of nonconforming product General Actions in response to nonconforming product detected before delivery Actions in response to nonconforming product detected after delivery Rework 8.4 Analysis of data 8.5 Improvement General Corrective action Preventive action 62 Marco Delbò segreteriamd@gmail.com

63 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485: Measurement, analysis and improvement 8.1 General 8.2 Monitoring and measurement Feedback Complaint handling Reporting to regulatory authorities Internal audit authorities Monitoring (New and measurement Clauses) of processes Monitoring and measurement of product 8.3 Control of nonconforming product General changes Feedback procedures --> input to risk management and improvement process. Clause strengthened Complaint handling & Reporting to regulatory Monitoring and Measurement of Product: Records now must identify the test equipment used to Actions in response to nonconforming product detected before delivery perform Actions measurement in response to nonconforming activities product detected after delivery Rework NC products: + details in respect of controls, 8.4 Analysis of data concessions, 8.5 Improvement records (Clause restructured) General Corrective action Preventive action Verify that CAPA does not have an adverse effect; actions to be taken without undue delay Marco Delbò segreteriamd@gmail.com

64 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485:2016 ANNEXES Annex A (informative) Comparison of content between ISO 13485:2003 and ISO 13485:2016 Annex B (informative) Correspondence between ISO 13485:2016 and ISO 9001:2015 Annex Z under revision (solo EN) European Annexes - ZA (AIMD), ZB (MDD) and ZC (IVD) Identifies relationship between the European Standard (EN ISO 13485:2016) and Conformity Assessment Requirements of the respective EU Medical Device Directives via each conformity assessment route for each directive 64 Marco Delbò segreteriamd@gmail.com

65 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485:2016 transizione Cosa fare? 65 Marco Delbò segreteriamd@gmail.com

66 MARCATURA CE: SGQ - EN ISO OVERVIEW EN ISO 13485:2016 transizione Cosa fare? - Study the standard - gap analysis of current QMS Vs. new requirements - Prepare transition plan, with timescales - Factor any additional resources & costs into budgets - Review staff awareness / knowledge and determine training required - Compile project / implementation plan - Look out for additional help, information and resources 66 Marco Delbò segreteriamd@gmail.com

67 APPROFONDIMENTI: Thank you for your attention Any questions? 67 Marco Delbò