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ISO 13485 Awareness Training

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Principle Benefts How to Apply

Customer Focus

Organisations existbecause of customersand for meeting

customer needs andexpectations

Increased RevenueIncreased loyaltyRepeat business

Market Opportunities

Researching andunderstanding customerneeds

Communicating

Leadership

Unity of purpose anddirection of the OrgCreate maintain

environment! Fullyinvolved in achievingob"ectives

#eople $ill understandrole of leaders and getmotivated to$ards

achieving ob"ectives

%stablishing! vision!policy! ob"ectives!providing resources!

environment and act$ith responsibility andaccountablility

Involvement of #eople

#eople at all levels areessence of the org and

their full involvementenables them to be usedin achieving ob"ectives

Motivated! committedand involved people and

being accountable fortheir o$n performance

Understanding theimportance of people

contribution and roleand freely sharingkno$ledge andexperience

#rocess &pproach

& desired result is

achieved moree'ciently $hen

Improved! consistent

and predictable results

(e)ning the activities

necessary to obtain adesired result

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Principle Benefts How to Apply

*ystems &pproach to Management

Identifying!understanding andmanaging interrelated

processes as a systemfor e+ectiveness ande'ciency in achievingthe ob"ectives

Integration andalignment of the systemthat $ill best achieve

the desired results&bility to focus on e+orton the key processes$ithin the system

*tructuring a system toachieve the orgob"ectives in e+ectively

and e'ciently andimproving systemthrough measurementand evaluation

Factual &pproach to (ecision Making

%+ective decisions are

based on the analysis ofdata and information

Informed decisions

based on fact &bility torevie$! challenge andchange

Making factual data

accessible to those $honeed it and analysingusing valid methods

Continual Improvement

Continually improvingthe org overall

performance

#erformance advantageand increasing org

capabilities

,raining in the methodsand tools of continual

improvement andestablishingrelationships thatbalance short term gains$ith long termconsiderations

Mutually -ene)cial *upplier RelationshipsOrg and suppliers are Increased ability to Identifying and selecting

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Introduction

,he I*O ./012 title page says3

I4,%R4&,IO4&L *,&4(&R( Medical devices 56uality management systems 5 Re7uirements for

regulatory #urposes

It $as released in year 899/ to address the speci)cneeds for 7uality management systems fororgani:ations in the medical devices industry

,he standard is published by I*O! the InternationalOrgani:ation for *tandardi:ation! and is availablethrough 4ational *tandards -odies

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6M* Certi)cation

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Introduction

,he I*O ./0123899/ *tandard relates to 7uality managementsystems in the )eld of Medical (evices! including I;(

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Introduction

The text o ISO 13485:!!3 h"s #een "ppro$e% #y &'( on 4 )"n*"ry

!1 "s " '( ISO 13485:!1 witho*t "ny +o%ifc"tion ,he con@icting

national standards $ere $ithdra$n until august 89.8 from the member stats

of the %U

&lthough I*O ./012 certi)cation is voluntary! obtaining certi)cation allo$s you

to meet the 7uality system re7uirements of the %uropean Medical (evice

(irective

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Introduction

,he conformity of Medical (evices and InGvitro (iagnosticMedical (evice according to %uropean Union (irectivesA/B08B%%C! A9B/12B%%C and A1BAB%%C +*st #e

"ssesse% #eore s"le is per+itte%

,he preferred method to prove conformity is thecertifcation o the Quality Management SystemaccordingI*O ./012 and I*O .0A. by a Notifed Body ,he result of

a positive assessment is the certifc"te o conor+ity"llowin, the &' +"r-and the permission to sell themedical device in the %uropean Union

Compliance $ith I*O ./012 is often seen as the )rst step

in achieving compliance $ith %uropean regulatoryre7uirements

http://en.wikipedia.org/wiki/CE_markhttp://en.wikipedia.org/wiki/CE_mark

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Country Regulator%g MER&! F(&! &4;I*&

No Global Harmonised

Organisation as of now

4oti)ed -odies

%g UL! *H*! -*I! -I*

Medical (eviceCompanies

Medical (evices Certi)cation

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Relationships $ith Medical (evices (irectives

Compliance $ith I*O ./012 does not provide a presumption of

conformity $ith all the aspects of the 7uality systems of the Medical

(evices (irectives

It is important that the organi:ation and the 4oti)ed -ody i%entiy

the re,*l"tory re.*ire+ents th"t "re not co$ere% #y the

st"n%"r%

%4 I*O ./012389.8 provides a frame$ork to enable a manufacturer

to meet some of the 7uality system re7uirements for an %C

(eclaration of Conformity

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,he exclusions that arepermitted

Directive 90/385/EEC Directive 93/42/EEC Directive 98/79/EC

For Anne 2! noe"l#sion are $ermitted

For Anne %%! noe"l#sion are $ermitted

For Anne %%% and %&! noe"l#sion are $ermitted

For Anne 5! e"l#sionof 7'3 of (N %)O 13485is $ermitted

For Anne &! e"l#sionof 7'3 from (N %)O13485 is $ermitted

For Anne &%%!e"l#sion of 7'3 from(N %)O 13485 is$ermitted

For Anne &%! e"l#sionof 7'3! 7'5'1 and 7'5'2from (N %)O 13485 are$ermitted

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e a ons ps $ e ca ev ces(irectives

&nnex 8 and &nnex 2 of (irective A9B/12B%%C&nnex II! ; and ;I of (irective A/B08B%%C&nnex III! I; and ;II of (irective A1BAB%C include

description of the regulatory process and activities

undertaken by the 4oti)ed -ody! $hich both areoutside of the scope of %4 I*O ./012! and therefore notcovered by the standard

,herefore a manufacturer or a 4oti)ed -ody has to takeadditional provisions to ensure conformity and claim or

certify conformance $ith the &nnexes of the Medical(irectives

,he legal re7uirements must be examined! applied andveri)ed one by one and the solutions adopted mustbecome part of the 6M* in the meaning of the (irective

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Relation $ith otherstandards

In 89.8! the %uropean Union issued ne$versions of %4 I*O .0A. on medical device riskmanagement

%4 I*O .0A.389.8 primarily a+ects the %ssentialRe7uirements G the impact is especially on M((

&nnex I

%4 I*O ./012389.8 the conformity assessmentpathG the impact is especially on M(( &nnex II

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Relation $ith otherstandards In addition! I*O ./012 is closely aligned to other

management standards such as I*O A999! I*O .099.

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Relation $ith other standards

I*O A99938992 contains the DFundamentals and ;ocabulary of 6uality

Management *ystems

is indispensable in the application of I*O ./0123899/!

it introduces the user to the concepts behind the managementsystems and speci)es the terminology used

additional and speci)c D,erms and (e)nitions are also given inChapter / of the I*O ./0123899/ *tandard

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Overvie$

*ection .3 *cope

,alks about the standard and ho$ it applies to

organi:ations

*ection 83 4ormative Reference

References another document that should be

used along $ith the standard

*ection /3 ,erms and (e)nitions

Hives de)nitions related to medical devices

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(e)nitions

(ocument Records Medical (evice #rocess

#rocedure &ctive Medical (evice ;eri)cation

;alidation Implantable Medical (evice 6uality

Competence Correction Labelling Improvement

Continual Continuous Customer Complaint

&dvisory 4otice Corrective &ction #reventive&ction

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Overvie$

The -ey sections o ISO13485

*ection 09 6uality Management *ystem Re7uirements

*ection 29 Management Responsibility

*ection J9 Resource Management

*ection 9 #roduct Reali:ation

*ection 19 Measurement! &nalysis! and Improvement

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6uality Management *ystem0.

4.1 General requirements

Implementation and maintenance of an e+ective 6M* toprovide medical devices meeting customer and regulatoryre7uirements

%nsure control of outsourced processes

4.2 Documentation requirements

Khat is to be done and by $hom! $hen! $here! and ho$ it

is to be done! $hat materials! e7uipment and documentsare to be used!

Eo$ an activity is to be monitored and measured!

(esign Eistory File! ,echnical File! Complaint File! devicerecords! etc

Any excl*sions/ 0Section only2

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2 ManagementResponsibility

5.1 Management commitment

Is demonstrated by actions ensuring processes operate

as an e+ective net$ork of interrelated processes

5.2 ustomer !ocus ensure customer re7uirements are understood

5.3 "ualit# $olic#

%stablishes commitment to3 7uality continuinge+ectiveness of the 7uality management systemmeeting customer and regulatory re7uirements

*hould be revie$ed periodically for continued applicability

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6uality #olicy

,o deliver products and services that consistentlymeet and exceed our customers? expectations in

7uality! reliability! safety and trust! by implementingand practicing an e+ective 7uality management system

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2 Management

Responsibility

5.4 %lanning

Incl*%es:

setting 7uality ob"ectives associated targets for thequalit# management s#stem &4( for me&ical&e'ices ( relate& ser'ices

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2 ManagementResponsibility

5.5 ,es$onsi)ilit#- autorit# an&communication

%xamples demonstrating Responsibility

&uthority3 documented position descriptions! includingresponsibilities and authorities

organi:ation charts

can be included in documented procedures or@o$charts

Independence must be demonstrated for certainactivities

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2 ManagementResponsibility

5.5 ,es$onsi)ilit#- autorit# an&communicationKithin an e+ective 7ualitymanagement system communications must be3

encouraged clear and understandable

biGdirectional

at all levels of the organi:ation

open and active'x"+ples: Internal audits! external assessments!management revie$s! bulletin boards! allemployee meetings! suggestion boxes! etc

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2 ManagementResponsibility

5./ Management ,e'iew

#eriodic assessment of the 6M* for continued suitability!ade7uacy and e+ectiveness

Inp*ts incl*%e:

a= results of audits!b= customer feedback!

c= process performance and product conformity!

d= status of preventive and corrective actions!

e= follo$ Gup actions from previous management revie$s!

f= changes that could a+ect the 7uality managementsystem!

g= recommendations for improvement! and

h= ne$ or revised regulatory re7uirements

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2 Management Responsibility

5./ Management ,e'iew

O*tp*ts incl*%e:

a= agenda

b= attendance recordc= presentation materials

d= improvements needed to maintain thee+ectiveness of the 7uality management systemand its processes

e= improvement of product related to customerre7uirements

f= resource needs

g= statement of conclusion the e+ectiveness of the7uality management system

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J Resource Management

/.1 %ro'ision o! resources

eso*rces c"n #e:

people

infrastructure $ork environment

information

suppliers and partners

natural resources

)nancial resources

A%e.*"te reso*rces "re prere.*isite to "neecti$e 67S

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J Resource Management

/.2 0uman ,esources

#ersonnel performing $ork a+ecting product7uality and device safety and e+ectiveness must

be competent6uali)cations include3

%ducation

%xperience

*kills %FF%C,I;% ,raining

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J Resource Management

/.3 In!rastructure

Incl*%es:

-uildings

Kork space Utilities

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J Resource Management

/.4 or n'ironment

,he most signi)cant factors $ithin the $orkenvironment that can a+ect product 7uality are3

process e7uipment! established $ork environment

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#roduct Reali:ation

.1 %lanning o! $ro&uct reali+ation

D#roduct reali:ation describes the processesstarting $ith

planning determination of customer re7uirements customer communication design and development

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#roduct Reali:ation

.1 %lanning o! $ro&uct reali+ation

,he organi:ation shall determine 3

product 7uality ob"ectives re7uirements de)nition of medical device lifetime

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#roduct Reali:ation

.2 ustomer6relate& $rocesses

Focus is on product and services to be supplied,his includes re7uirements related to the

product3 design inputBoutput for ne$ product development!

customer delivery expectations vs deliveryschedules

customer feedback communications relative toorders placed or product delivered

regulatory or legal re7uirements

design related factors included in customer orders

unspeci)ed customer expectations

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#roduct Reali:ation

.2 ustomer6relate& $rocesses

Revie$ of product re7uirements prior tocommitting to supply3

product re7uirements de)ned documented resolution of contractBorder discrepancies ensure ability to meet de)ned re7uirements

Revie$ of postGmarketing product performance additional product information

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#roduct Reali:ation

.3 Design an& &e'elo$ment

%stablished procedures describing design processes and &LLdesign activities3

goals and ob"ectives of the design and development program

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#roduct Reali:ation.3 Design an& &e'elo$ment

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#roduct Reali:ation

.3 Design an& &e'elo$ment

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&"se St*%y: Hospit"l $s=Ho+e >se

For several years &dvanced (evices has been sellinga patient monitor for use in the hospitals Recentlyone of their salespeople suggested marketing thepatient monitor for home use since patients are

spending less and less time in the hospital

Kill home use change the design input Khy or $hynot

Considerations3 User less skilled! no medical training

Users impaired #oor vision! poor manual dexterity

User environment di+erent electromagnetic interferencefrom ,;! cell phones! etc

Multiple users! etc

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#roduct Reali:ation

.3 Design an& &e'elo$ment

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#roduct Reali:ation

.3 Design an& &e'elo$ment

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#roduct Reali:ation

.3 Design an& &e'elo$ment

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#roduct Reali:ation.3 Design an& &e'elo$ment

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#roduct Reali:ation

.3 Design an& &e'elo$ment

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#roduct Reali:ation

.3 Design an& &e'elo$ment

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#roduct Reali:ation

.3 Design an& &e'elo$ment

&ontrol o %esi,n "n% %e$elop+ent ch"n,es

#roduct design may re7uire change or modi)cation for manyreasons

Change can happen during or after the design phase

Changes may result from3 design revie$ design veri)cation or validation omissions or errors during the design phase $hich have been identi)ed

after$ards

di'culties in manufacturing! installation andBor servicing risk management activities! re7uests from the customer or supplier! changes re7uired for corrective or preventive action changes needed to address safety! regulatory! or other re7uirements improvements to function or performance

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#roduct Reali:ation

=3

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#roduct Reali:ation

.4 %urcasing

*upplier selection and control consists of3 establishing criteria

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#roduct Reali:ation

.4 %urcasing

P*rch"sin, inor+"tion describes the product

to be purchased in su'cient detail! such as3 technical information and speci)cations! test and acceptance re7uirements! 7uality re7uirements for products! services! andoutsourced processes!

environmental re7uirements

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#roduct Reali:ation

.4 %urcasing P*rch"sin, inor+"tion

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#roduct Reali:ation

.4 %urcasing

Cerifc"tion o p*rch"se% pro%*ct to ensure speci)edre7uirements are met3

receiving Inspection

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#roduct Reali:ation

.5 %ro&uction an& ser'ice $ro'ision

&ontrol o pro%*ction "n% ser$ice re7uires controlle&con&itions and includes many aspects3

infrastructure

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#roduct Reali:ation

.5 %ro&uction an& ser'ice $ro'ision

C"li%"tion o processes or pro%*ction Dser$ice is re7uired $here the resulting outputcannot be veri)edN

de)ned criteria for revie$ and approval ofprocesses

approval of e7uipment and$ersonnelquali:cation

use of speci)c methods and procedures criteria for revalidation soft$are used in automated processes 7>STbe validated

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#roduct Reali:ation

2 #roduction and service provision

C"li%"tion o processes or pro%*ction D ser$ice

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#roduct Reali:ation

.5 %ro&uction an& ser'ice $ro'ision

I%entifc"tion is re7uired throughout theproduct reali:ation process It includes3

ra$ materials

components )nished medical devices

,his facilitates fault diagnosis in the event of7uality problems is a preGre7uisites fortraceabilityN

#rovisions for identifying segregating returnedmedical device from conforming product must

also be establishedN

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#roduct Reali:ation

.5 %ro&uction an& ser'ice $ro'ision Tr"ce"#ility means the ability to trace the history orlocation of a product or activity by recorded identi)cation3

for$ard to customers

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#roduct Reali:ation

.5 %ro&uction an& ser'ice $ro'ision

&*sto+er property $ithin the context of the standard isde)ned as property or assets o$ned by the customer andunder control of the organi:ation

%xamples of such property are3 ra$ materials or components supplied for inclusion in

product

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#roduct Reali:ation

.5 %ro&uction an& ser'ice $ro'ision

Preser$"tion o pro%*ct applies throughout theproduct reali:ation processes and includesstorage! handling! transportation and delivery

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#roduct Reali:ation

./ ontrol o! monitoring an& measuring &e'ices

,he standard explicitly refers to monitoring and measuringdevices! incl*%in, sotw"re ,o ensure valid results!instruments shall be3

calibrated or veri)ed at speci)ed intervals

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1 Measurement! analysis andimprovement

8=1 ener"lMonitoring and measurement processes are re7uired to3

ensure product conformance

ensure conformance of the 6M*

maintain e+ectiveness of the 6M*

8= 7onitorin, "n% 7e"s*re+ent Eee%#"c- as key performance indicators of the 6M* include3

customer related information! postGmarket surveillance! etc=

internal external audit results monitoring and measurement of processes

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1 Measurement! analysis andimprovement

8=3 &ontrol o nonconor+in, pro%*ct

,his includes nonconforming product occurring in the

organi:ation?s o$n facilities as $ell as to nonconforming

product recei$e% or %eli$ere% by the organi:ation

determine product

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1 Measurement! analysis andimprovement

8.4 Anal#sis o! &ata

,his includes determination! collection! andanalysis of appropriate data to demonstrate the

suitability and e+ectiveness of the 6M* and

to evaluate if improvement of the 6M*e+ectiveness can be made

,his encompasses supplier performance! productconformance! trends of processes products!feedback! etc

,he results of these activities should feed intomanagement revie$s as $ell considered for riskmanagement activities

,hey also serve to identify opportunities forpreventive actions

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1 Measurement! analysis andimprovement

8.5 Im$ro'ement

,his again covers a broad scope3

continued suitability and e+ectiveness of the

6M* documented complaint investigations andresulting actions

product advisory notices

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1 Measurement! analysis andimprovement

8.5 Im$ro'ement

&orrecti$e "ction is intended to eliminatenonconformities $ith the intent to prevent recurrence(onconor+ities +"y #e i%entife%:

in the 6M*

on the product

in manufacturing processes

in metrology

$ith training environmental conditions

control of e7uipment

$ith suppliers! etc

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1 Measurement! analysis andimprovement

8.5 Im$ro'ement

;ecti'e correcti$e "ction includes the follo$ing3 clear and accurate identi)cation of the nonconformity

a+ected process

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1 Measurement! analysis andimprovement

8.5 Im$ro'ement

Pre$enti$e "ction is initiated to address$otential nonconformities *ources to considerinclude information data from3

receiving and incoming inspection products re7uiring re$ork! re"ect or yield data customer feedback and $arranty claims! process measurements! identi)cation of results that are out Gof trend but

not out of speci)cation! suppliers performance! service reports and concessionsBdeviations

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Conclusion

It is important to bear in mind that3 I*O standards are updated periodically Q revisions and

updates do occur and

I*O ./012 is due for an update in the next fe$ years

&s 7uality system standards are updated! you mustensure that 6M* must keeps up $ith those updates in

order the manufactures remain in compliance

# f

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ISO 13485 #enefts

&ccess to markets that recogni:e or re7uire thecerti)cation including Canada and %urope

Implementing a 6uality Management *ystem! in general!helps to motivate sta+ and provide a better de)nition of

roles and key responsibilities Reduce operational costs by highlighting process

de)ciencies and improving e'ciency

Increase customer satisfaction by consistently delivering7uality products and systematically addressing complaints

#roven commitment to 7uality through an internationallyrecogni:ed standard

&dds transparency to the $ay complaints! surveillance orproduct recalls are handled

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,hank you N