IL SISTEMADI GESTIONE QUALITÀA ….pdf · ILSISTEMADI GESTIONE QUALITÀA...

IL SISTEMA DI GESTIONE QUALITÀ A

SUPPORTO DELLA CERTIFICAZIONE

DEI DISPOSITIVI MEDICI

- LINEE ESSENZIALI

SSFA / dic - 2016

- LINEE ESSENZIALI

Marco Delbò – [email protected] - +393387210330

1

a cura di: MARCO DELBÒ[email protected] / +39 338 7210330

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


MARCATURA CE: QUADRO LEGISLATIVO

DIRETTIVA 93/42/CEE DEL CONSIGLIO del 14 giugno 1993

concernente i dispositivi medici

M1 Direttiva 98/79/CE del Parlamento europeo e del Consiglio del 27

Modificata da:

Recepita DL46/97

3

Marco Delbò – [email protected] - +393387210330 +7

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 2007


CHANGES - UPCOMING NEW MD REGULATION

DIRETTIVA 93/42/CEE M5

NEW MDR (Medical Device Regulation)

Verrà sostituita da:

4


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 2016

FAQCouncil 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

Marcatura CE: quadro legislativoCHANGES - UPCOMING NEW MD REGULATION

Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009

This is based on the consolidated version of the Medical DevicesRegulation (MDR) that has been adopted by the EuropeanParliament and the Member States in June 2016. This text has beendescribed by one of the stakeholders as ‘Tentatively AgreedConsolidated Compromise Text’, which illustrates the delicatenature of this document. There is a small possibility that somechanges are made by the European Commission’s Legal Serviceswhen this compromise gets a final review for legal inconsistencies.In general it can be expected that most, if not all of therequirements in this version will be in the final version that will bepublished at the beginning of 2017.

5



CHANGES - UPCOMING NEW MD REGULATION

NEW MDR (Medical Device Regulation)

modalità di transizione:

6


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.

MARCATURA CE: PROCESSO

La marcatura CE di un Dispositivo Medico:

è un processo complesso

7


con varie alternative

va correttamente pianificato

MARCATURA CE: PROCESSO: È UN MD?

1: è un dispositivo medico?

non è sempre scontato classificare

8


scontato classificare un prodotto come 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;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; 9


MDD - COUNCIL DIRECTIVE 93/42/EEC M5

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, 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

10


Medical device regulation –negotiated text 27 June 2016 DRAFT


1: è un dispositivo medico?

Poi ci sono le complicazioni:

accessorio

11


SI

NO FORSE

accessorio

+12

MARCATURA CE: PROCESSO: CLASSIFICAZIONE

2: decidere la classificazione

I Is Im IIa IIb III

III III+ AnimalTissue + Pharma

12


Regole di classificazione modificate dalla nuova Medical Device Regulation

III III

Ir

Tissue + Pharma

Previsti alcuni cambi di classe

MARCATURA CE: PROCESSO: ITER DI CERTIFICAZIONE

Iter di Certificazione:

varie alternative per CE

All.

VIIAll.

VAll.

IIAll.

IIIAll.

IV

13


nelle varie combinazioni

VII V II III IV

secondo la classe e le priorità aziendali

nuova Medical Device Regulation :cambieranno gli allegati di riferimento, ma il principio rimarrà lo stesso

All.

VI

MARCATURA CE: SGQ

Sistema Gestione Qualità

All.

V

All.

II All.

VIcompleto

14


secondo la classe e le priorità aziendali

nuova Medical Device Regulation :cambieranno gli allegati di riferimento, ma il principio rimarrà lo stesso

VIcompletoescl. DD Escl. DD e Prod

Possono essere

obbligatori

MARCATURA CE: SGQ

SGQ: come supportarlo?

poco

EN ISO 9001 Serve?

SINO

Utile?

15


GMP Serve?

NObuona base di partenza

SISI

Utile?

MARCATURA CE: SGQ

SGQ: come supportarlo?

è la norma di

EN ISO 13485 Serve?

SISINon obblig

Utile?

16


norma di riferimento

SISISI

obbligatorio

Si presume la conformità ai requisiti per i sistemi di qualità che applicano le corrispondenti norme armonizzate

MARCATURA CE: SGQ - EN ISO 13485 OVERVIEW

EN 46001:1997 +46002

(EN) ISO 13485:1996 +13488

(EN) ISO 13485:2003

17


(EN) ISO 13485:2003/AC:2007

EN ISO 13485:2012 +allegato Z NORMA ARMONIZZATA

(EN) ISO 13485:2016 01/03/2016

three-year transition period > 28/02/2019

SARA’ NORMA ARMONIZZATA

No new ISO 13485:2003 certificates issued in final year of transition


Non ancora tradotta

21 set 2016

18


In attesa di approvazione di nuovo CORRIGENDUM che modifica allegati Z della ISO13485:2016

MARCATURA CE: SGQ

EN ISO 13485:2016 �� EN ISO 9001:2015

Struttura NON più condivisa

19


Struttura NON più condivisa

Le norme non saranno in contrasto, ma non più allineate

MARCATURA CE: SGQ

EN ISO 13485 �� GMP

≠ = Struttura NON condivisa

Management review

Produzione e controlli

calibrazioni

20


vigilance

Scelte basate su RiskManagement, meno prescrittive

Ad es: classe cleanroom, validazioni ster. e non sterility test

Training, qualifica

ATTITUDINE

Le aziende GMP parlano la stessa lingua, hanno la giusta mentalità

MARCATURA CE: SGQ

EN ISO 13485 �� GMP

≠ general differences:

pharma is strictly regulated with clear indications, based on GMP guidelines and Pharmacopoeia

21


MD more flexible, based on risk management and applicable standards; more options based on company decisions

MARCATURA CE: SGQ

Estensione da GMP a EN ISO 13485

right attitude, correct approach

correct structure generally in place (i.e.: vigilance)

IMPLEMENTED PROCEDURES generally suitable: manufacturing, validations, controls,

22


suitable: manufacturing, validations, controls, calibration, environmental controls, job descriptions and training, management of deviations

MARCATURA CE: SGQ

Estensione da GMP a EN ISO 13485

approach to apply the pharma rules for medical devices, resulting in overcomplicated and often misleading processes

main differences: TF management, risk

23


main differences: TF management, risk management, vigilance, CAPA management, internal audit, D&D and certification process, management review

MARCATURA CE: SGQ – QUANDO CERTIFICARSI?

Finchè non ho il CE non vendo

Finchè non produco non posso chiedere il CE

FRETTA

Prima di audit di certificazione:


24

Prima di audit di certificazione:

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)


25

anche pilota (prodotti rappresentativi)

Se voglio certificare protesi sterili e suostrumentario non sterile

Ideale entrambi iprodotti



Almeno un esempio di applicazione dei processi, ad es:

Almeno un lot di produzione

Almeno un Riesame direzione


26

Almeno un Riesame direzione

Almeno un ciclo V.I.I.

Almeno un piano per PMS

Almeno un progetto (se applicabile)

MARCATURA CE: SGQ – CHI SI DEVE AUDITARE?

Legal manufacturer

Fornitori critici, ad es:

sterilizzazione

filling

A meno che non siano certificati

ISO 13485 o

Tutte le location applicabili


27

filling

Etichettatura / packaging

Materie prime critiche (es: ac. Ialuronico, principiattivi, tessuti d’origine animale, etc.)

Processi in outsourcing (es: DD, Vigilance, etc.)

ISO 13485 o GMP

MARCATURA CE: SGQ – CHI SI DEVE AUDITARE?

OBL

Virtual manufacturer:


28

Virtual manufacturer:

Deve dimostrare competenza e avere i FT

MARCATURA CE: SGQ – COSA SI DEVE AUDITARE?

CERTIFICAZIONE

Fornitori critici / scopo / allegati

Implementati tutti i processi

Stage 1: si verifica che l’azienda sia pronta


29

Stage 2: audit completo

SORVEGLIANZA

Almeno annuale

+ UAV (Verifiche NON annunciate)

MARCATURA CE: SGQ – COSA SI DEVE AUDITARE?

CERTIFICAZIONE

Se non già certificatiAnche processi in outsourcing

Tutti i processi, tutti i punti della ISO13485

i Fascicoli Tecnici


30

i Fascicoli Tecnici

SORVEGLIANZA

processi, FT, punti della ISO13485, a campione

Sempre: Responsabilità Direzione, VII, NC, CAPA, Vigilance

MARCATURA CE: SGQ – DURATA CERTIFICATI

CERTIFICAZIONE ISO 13485

Max 3 ANNI

Non oltre transizione nuova edizione


31

Marcatura CE (annex V, II, III)

Max 5 ANNI

Non oltre transizione nuovo regolamento

MARCATURA CE: SGQ – DURATA VISITA

Proporzionale alle dimensioni (numero dipendenti, FTE)

+ increasing factors

- Decreasing factors Processi ripetitivi


32

Molte NC

Shift

ripetitivi

Processi non

applicabili

Molti processi

SGQ maturo

con poche NC

Processi comples

si

interprete

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)


33

Dispositivi border line: classificazione non accettata da NB (classe / non è Disp. Medico)


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)


34

Visita ai fornitori: contratto non disponibile; nessuna produzione in corso ( o nessun prodotto simile da prendere ad esempio)

ne scoprono di nuovi durante audit)


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


35

Riesame Direzione: NON è una valutazione, non copre tutti i punti (es: nuovi requisiti regolatori)

qualificato o non correttamente documentate

Non è pianificata PMS

Fornitori critici non qualificati (anche consulenti)


ERRORI PRINCIPALI – attitudine errata

qual è il giusto approccio del fabbricante?


36


EN ISO 13485:2016 – differenze principali della nuova edizione

general changes

Many additions

Some new requirements

37


Some new requirements

Some expansion & clarification

Increased clarity of interrelationshipbetween clauses and requirements


EN ISO 13485:2016

1 Scope

2 Normative references

3 Terms and definitions

changes

does not align with the new ISO 9001:2015 changes

standard’s numbering and clauses:

38


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)


EN ISO 13485:2016

1 Scope

2 Normative references

3 Terms and definitions

changes

risk-based approach to control QMS processes

emphasis on understanding of, and adherence, to

39


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.


EN ISO 13485:2016

4 Quality management system4.1 General requirements

4.2 Documentation requirements

4.2.1 General

4.2.2 Quality manual

4.2.3 Medical device file4.2.3 Medical device file

4.2.4 Control of documents

4.2.5 Control of records

40



EN ISO 13485:2016

4 Quality management system4.1 General requirements

4.2 Documentation requirements

4.2.1 General

4.2.2 Quality manual

4.2.3 Medical device file

changes

risk-based approach to control QMS processes (+ outsourced)

Roles to be documented to meet regulatory requirements (i.e., specifying the legal manufacturer, defining processes, and identifying records to be kept to meet regulatory requirements)

4.2.3 Medical device file

4.2.4 Control of documents

4.2.5 Control of records

41


software used for the QMS to be validated prior to initial use and after any change

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


EN ISO 13485:20165 Management responsibility5.1 Management commitment5.2 Customer focus5.3 Quality policy5.4 Planning5.4.1 Quality objectives5.4.2 Quality management system planning5.4.2 Quality management system planning5.5 Responsibility, authority and communication5.5.1 Responsibility and authority5.5.2 Management representative5.5.3 Internal communication5.6 Management review5.6.1 General5.6.2 Review input5.6.3 Review output 42



EN ISO 13485:2016

EN ISO 13485:20165 Management responsibility5.1 Management commitment5.2 Customer focus5.3 Quality policy5.4 Planning5.4.1 Quality objectives5.4.2 Quality management system planning

changes

Increased emphasis on regulatory requirements

Responsibilities and authority documented, including the 5.4.2 Quality management system planning5.5 Responsibility, authority and communication5.5.1 Responsibility and authority5.5.2 Management representative5.5.3 Internal communication5.6 Management review5.6.1 General5.6.2 Review input5.6.3 Review output

43


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


EN ISO 13485:20166 Resource management6.1 Provision of resources6.2 Human resources6.3 Infrastructure6.4 Work environment and contamination control6.4 Work environment and contamination control6.4.1 Work environment6.4.2 Contamination control

44



EN ISO 13485:20166 Resource management6.1 Provision of resources6.2 Human resources6.3 Infrastructure6.4 Work environment and contamination control

changes

Documented processes required to establish competence, provide training and ensure quality awareness throughout the organization

emphasis on defining, maintaining, and updating the 6.4 Work environment and contamination control6.4.1 Work environment6.4.2 Contamination control

45


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



changes

emphasis on maintenance-related activities of production, control, work env, monitor and measurement equipment - companies must have clearly documented

6.4 Work environment and contamination control6.4.1 Work environment6.4.2 Contamination control

46


equipment - companies must have clearly documented procedures to specify how those activities are being performed.

new requirement to handle orders in a streamlined way to prevent mix-ups



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 14644 (air cleanliness classification 6.4 Work environment and contamination control6.4.1 Work environment6.4.2 Contamination control

47


adds a reference to ISO 14644 (air cleanliness classification and monitoring) and ISO 14698 (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.

planned arrangements for controlling (potentially) contaminated product in order to prevent contamination of work environment, personnel, or product


EN ISO 13485:2016 §7.1

7 Product realization7.1 Planning of product realization

changes

document how risk-management activities are being handled

48


Planned processes for verification, validation, monitoring, measurement, inspection, test activities, handling, storage, distribution, and traceability

Documented risk management throughout development-planning activities

+3


EN ISO 13485:2016 §7.2

7 Product realization� 7.2 Customer-related processes� 7.2.1 Determination of requirements related to product

� 7.2.2 Review of requirements related to product

� 7.2.3 Communication� 7.2.3 Communication

49



EN ISO 13485:2016 §7.2

7 Product realization� 7.2 Customer-related processes� 7.2.1 Determination of requirements related to product

� 7.2.2 Review of requirements related to product

� 7.2.3 Communication

changes

Manufacturers must determine whether there is a need for user training to ensure specified performance and safe use of the medical device + any user training identified is available or planned to be available…� 7.2.3 Communication

50


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)

+3

available or planned to be available…


EN ISO 13485:2016 §7.3

7 Product realization� 7.3 Design and development� 7.3.1 General

� 7.3.2 Design and development planning

� 7.3.3 Design and development inputs� 7.3.3 Design and development inputs

� 7.3.4 Design and development outputs

� 7.3.5 Design and development review

� 7.3.6 Design and development verification

� 7.3.7 Design and development validation

� 7.3.8 Design and development transfer

� 7.3.9 Control of design and development changes

� 7.3.10 Design and development files 51



EN ISO 13485:2016 §7.3



� 7.3.3 Design and development inputs

changes

requirement to update documents with DD progress and to ensure traceability of outputs to inputs� 7.3.3 Design and development 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

inputs must include usability - standards,- and should be verified and validated. Outputs must be in a form suitable for verification against inputs

+3


EN ISO 13485:2016 §7.3




changes

verification and validation plan must be documented, including methods, criteria for acceptance, failure, justification for sample sizes selected� 7.3.3 Design and development inputs









verification and validation of connections and interfaces

Validation must be conducted on final production units (representative product) or documented equivalent devices

+4

verification + validation of user instructionsrequired, including review of failure modes


EN ISO 13485:2016 §7.3




changes

DD Transfer: new clause

requires a documented plan for design transfer to � 7.3.3 Design and development inputs









requires a documented plan for design transfer to another facility or outsourcing partner. should include plans for supplier quality and capability, manufacturing personnel capability and training, manufacturing process and process validation, materials, manufacturing tools and methods, work environment, installation, and service

+2


EN ISO 13485:2016 §7.3




changesDD Changes and Files: new subclause, more detail

link to risk management and product realizationadded, + detail regarding determining significance of change� 7.3.3 Design and development inputs









change

+4

requirements to control changes, documentation to be kept, approval requirements, reports and testing to justify changes, etc

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


EN ISO 13485:2016 §7.4

7 Product realization

�7.4 Purchasing�7.4.1 Purchasing process�7.4.2 Purchasing information�7.4.2 Purchasing information�7.4.3 Verification of purchased product

56



EN ISO 13485:2016 §7.4


�7.4 Purchasing�7.4.1 Purchasing process�7.4.2 Purchasing information

changes

Criteria for evaluation and selection of suppliersincludes performance and risk

Supplier performance monitoring as part of re-evaluation process, additional record requirements�7.4.2 Purchasing information�7.4.3 Verification of purchased product

57


evaluation process, additional record requirements

+5

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


EN ISO 13485:2016 §7.5


� 7.5 Production and service provision� 7.5.1 Control of production and service provision� 7.5.2 Cleanliness of product� 7.5.3 Installation activities� 7.5.4 Servicing activities� 7.5.5 Particular requirements for sterile medical devices� 7.5.5 Particular requirements for sterile medical devices� 7.5.6 Validation of processes for production and service provision� 7.5.7 Particular requirements for validation of processes for

sterilization and� sterile barrier systems� 7.5.8 Identification� 7.5.9 Traceability� 7.5.10 Customer property� 7.5.11 Preservation of product


58


EN ISO 13485:2016 §7.5


� 7.5 Production and service provision� 7.5.1 Control of production and service provision� 7.5.2 Cleanliness of product� 7.5.3 Installation activities� 7.5.4 Servicing activities� 7.5.5 Particular requirements for sterile medical devices

changes

Production / service to be planned, monitored, and controlled to ensure products conforms to specifications

Cleanliness: adds contamination control

Servicing: activity records to be analyzed to determine if should be considered and

� 7.5.5 Particular requirements for sterile medical devices� 7.5.6 Validation of processes for production and service provision� 7.5.7 Particular requirements for validation of processes for



if events in the field should be considered and reported as complaints, or used to improve the product as part of design inputs

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 and validation of software after changes (risk based)

59


EN ISO 13485:2016 §7.5


� 7.5 Production and service provision� 7.5.1 Control of production and service provision� 7.5.2 Cleanliness of product� 7.5.3 Installation activities� 7.5.4 Servicing activities� 7.5.5 Particular requirements for sterile medical devices

changes

Validation of sterilization and sterile barriers

Validation required prior to implementation / Changes+ Document results, conclusions, actions� 7.5.5 Particular requirements for sterile medical devices� 7.5.6 Validation of processes for production and service provision� 7.5.7 Particular requirements for validation of processes for



UDI (where required by regulations)

60

procedures for separation of returned products fromconforming product

shipping conditions and their impact on product and package integrity, including management of sterile device packaging, to be assessed


EN ISO 13485:2016 §7.6

� 7.6 Control of monitoring and measuring equipment

changes

Requirements for the validation of the application of software used for monitoring and measurement of


61

software used for monitoring and measurement of requirements. Risk based approach required.


EN ISO 13485:2016 §8� 8 Measurement, analysis and improvement� 8.1 General� 8.2 Monitoring and measurement� 8.2.1 Feedback� 8.2.2 Complaint handling� 8.2.3 Reporting to regulatory authorities� 8.2.4 Internal audit� 8.2.5 Monitoring and measurement of processes� 8.2.5 Monitoring and measurement of processes� 8.2.6 Monitoring and measurement of product� 8.3 Control of nonconforming product� 8.3.1 General� 8.3.2 Actions in response to nonconforming product detected before delivery� 8.3.3 Actions in response to nonconforming product detected after delivery� 8.3.4 Rework� 8.4 Analysis of data� 8.5 Improvement� 8.5.1 General� 8.5.2 Corrective action� 8.5.3 Preventive action


62


EN ISO 13485:2016 §8� 8 Measurement, analysis and improvement� 8.1 General� 8.2 Monitoring and measurement� 8.2.1 Feedback� 8.2.2 Complaint handling� 8.2.3 Reporting to regulatory authorities� 8.2.4 Internal audit� 8.2.5 Monitoring and measurement of processes

changes

Feedback procedures --> input to risk management and improvement process. Clause strengthened

Complaint handling & Reporting to regulatoryauthorities (New Clauses)� 8.2.5 Monitoring and measurement of processes� 8.2.6 Monitoring and measurement of product� 8.3 Control of nonconforming product� 8.3.1 General� 8.3.2 Actions in response to nonconforming product detected before delivery� 8.3.3 Actions in response to nonconforming product detected after delivery� 8.3.4 Rework� 8.4 Analysis of data� 8.5 Improvement� 8.5.1 General� 8.5.2 Corrective action� 8.5.3 Preventive action


63

authorities (New Clauses)

Monitoring and Measurement of Product: Records now must identify the test equipment used to perform measurement activities

NC products: + details in respect of controls, concessions, records (Clause restructured)

Verify that CAPA does not have an adverse effect; actions to be taken without undue delay


EN ISO 13485:2016 ANNEXESAnnex 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


EN ISO 13485:2016 transizione

Cosa fare?


65

+1


EN ISO 13485:2016 transizioneCosa fare?

- Study the standard- gap analysis of current QMS Vs. new

requirements- Prepare transition plan, with timescales- Factor any additional resources & costs - 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

APPROFONDIMENTI:

Thank you for your attention

Any questions?Any questions?

67


IL SISTEMADI GESTIONE QUALITÀA ….pdf · ILSISTEMADI GESTIONE QUALITÀA...

Documents

Transcript of IL SISTEMADI GESTIONE QUALITÀA ….pdf · ILSISTEMADI GESTIONE QUALITÀA...