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4. Systemic requirements

4.1 Organizational requirements

4.1.1 Establish a QMS.

• Develop a QMS for your organization.

• Meet all applicable ISO 14!" re#uire$ents.

• Meet all applicable regulatory re#uire$ents.

• Docu$ent your organization%s QMS.

• I$ple$ent your organization%s QMS.

• &arry out all re#uire' QMS activities.

• &arry out all re#uire' ISO 14!" activities.

• &arry out all re#uire' regulatory activities.

• (ollo) all re#uire' QMS proce'ures.

• (ollo) all re#uire' ISO 14!" proce'ures.

• (ollo) all re#uire' regulatory proce'ures.

• *pply all re#uire' QMS arrange$ents.

• *pply all re#uire' ISO 14!" arrange$ents.

• *pply all re#uire' regulatory arrange$ents.

• Maintain your organization%s QMS.

4.1.+ &larify structure.

• &onsi'er the roles that regulators e,pect you to perfor$.

• Deter$ine the processes that your organization%s QMS nee's.

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• &larify ho) QMS processes are applie' throughout your

organization.

• *pply a ris- base' approach to your organization%s QMS

processes.

4.1. Support processes.

• Support each QMS process.

• Support QMS process operations.

• Support QMS process $onitoring.

• Support QMS process $easuring.

• Support QMS process analysis.

• Support QMS process recor' -eeping.

4.1.4 Manage changes.

• Manage your QMS processes.

• &o$ply )ith ISO 14!" process $anage$ent re#uire$ents.

• Manage changes to your organization%s QMS processes.

• &o$ply )ith regulatory process $anage$ent re#uire$ents.

• &o$ply )ith regulatory change control re#uire$ents.

4.1." &ontrol outsourcing.

• Monitor outsource' processes that affect pro'uct confor$ity.

• &ontrol outsource' processes that affect pro'uct confor$ity.

4.1. /ali'ate soft)are.

• Develop a proce'ure to vali'ate an' revali'ate your QMS soft)are.

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• Develop an approach that is proportional to the ris- that is being

ta-en.

• 0se your proce'ure to vali'ate an' revali'ate soft)are

applications.

• /ali'ate co$puter soft)are applications for their inten'e' use.

• /ali'ate soft)are )henever its inten'e' use changes as

appropriate2.

• Maintain a recor' of your soft)are vali'ation an' revali'ation

activities.

4.+ Docu$entation requirements

4.+.1 Establish #uality 'ocu$ents.

4.+.1.1 &larify 'ocu$entation re#uire$ents.

• &onsi'er your 'ocu$entation re#uire$ents.

• Inclu'e all re#uire' 'ocu$ents an' recor's.

• Inclu'e the 'ocu$ents an' recor's that regulations

re#uire.

• Inclu'e the 'ocu$ents an' recor's that ISO 14!" +31"

re#uires.

• Inclu'e the 'ocu$ents an' recor's that your organization

re#uires.

4.+.1.+ &larify file $anage$ent re#uire$ents.

• Establish a file for each $e'ical 'evice or fa$ily of $e'ical'evices.

• Maintain a file for each $e'ical 'evice or fa$ily of $e'ical

'evices.

4.+.+ Develop a #uality $anual.

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• repare a #uality $anual for your QMS.

• Define the scope of your organization%s QMS.

• Outline the structure of your QMS 'ocu$entation.

• Inclu'e your QMS proce'ures or refer to the$.

• Describe ho) your QMS processes interact.

4.+. &ontrol #uality 'ocu$ents.

• Establish a proce'ure to control QMS 'ocu$ents.

• Docu$ent your QMS 'ocu$ent control proce'ure.

• I$ple$ent your QMS 'ocu$ent control proce'ure.

4.+.4 Maintain #uality recor's.

• Establish recor's for your organization%s QMS.

• Develop proce'ures to control QMS recor's.

• Docu$ent your recor' control proce'ures.

• I$ple$ent your recor' control proce'ures.

• Define $etho's to protect QMS health recor's.

". Management requirements

".1 Commitment requirements.

• De$onstrate your ongoing co$$it$ent.

• Support the 'evelop$ent of your QMS.

• Support the i$ple$entation of your QMS.

• Support the $aintenance of your QMS.

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".+ E,ternal requirements.

• Ensure that e,ternal re#uire$ents are 'eter$ine'.

• Ensure that e,ternal re#uire$ents are being $et.

". Policy requirements.

• lan your #uality policy.

• Draft your #uality policy.

• *pply your #uality policy.

• 5evie) your #uality policy.

".4 Planning requirements

".4.1 Establish #uality ob6ectives.

• Establish #uality ob6ectives for your organization.

• Set ob6ectives nee'e' to $eet pro'uct re#uire$ents.

• Set ob6ectives nee'e' to $eet regulatory re#uire$ents.

".4.+ &arry out #uality planning.

• lan ho) you%re going to 'evelop your QMS.

• lan ho) you%re going to 'ocu$ent your QMS.

• lan ho) you%re going to structure your QMS.

• lan ho) you%re going to $anage your QMS.

• lan ho) you%re going to $onitor your QMS.

• lan ho) you%re going to control your QMS.

• lan ho) you%re going to i$ple$ent your QMS.

• lan ho) you%re going to $aintain your QMS.

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"." Managerial requirements

".".1 &larify responsibility an' authority.

• Define QMS responsibilities an' authorities.

• Docu$ent QMS responsibilities an' authorities.

• Define ho) QMS personnel are interrelate'.

".".+ *ppoint $anage$ent representative.

• *ppoint a $e$ber of $anage$ent to oversee your QMS.

• 7ive $anage$ent representative authority an' responsibility.

• *ssign authority an' responsibility for 'ocu$enting your QMS.

• *ssign authority an' responsibility for reporting to top

$anage$ent.

• *ssign authority an' responsibility for pro$oting corporate

a)areness.

".". Establish internal co$$unications.

• Establish appropriate internal co$$unication processes.

• Encourage co$$unication about the effectiveness of your QMS.

". Review requirements

"..1 erfor$ regular $anage$ent revie)s.

• Sche'ule your revie)s at planne' intervals.

• Docu$ent your QMS revie) re#uire$ents.

• 5evie) your QMS at planne' intervals.

• 8eep a recor' of $anage$ent revie)s.

"..+ E,a$ine $anage$ent revie) inputs.

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• E,a$ine infor$ation about your QMS inputs2.

• E,a$ine previous $anage$ent revie)s.

• E,a$ine the results of previous au'its.

• E,a$ine pro'uct confor$ity infor$ation.

• E,a$ine process perfor$ance fee'bac-.

• E,a$ine corrective an' preventive actions.

• E,a$ine reco$$en'ations for i$prove$ent.

• E,a$ine fee'bac- about re#uire$ents fro$ !.+.12.

• E,a$ine ne) or revise' regulatory re#uire$ents.

• E,a$ine changes that coul' affect your QMS.

".. 7enerate $anage$ent revie) outputs.

• 7enerate your $anage$ent revie) outputs.

• 7enerate 'ecisions an' actions to i$prove your QMS.

• 7enerate 'ecisions an' actions to enhance your pro'ucts.

• 7enerate 'ecisions an' actions to 'eal )ith regulatory changes.

• 7enerate 'ecisions an' actions to a''ress relevant resource

nee's.

• Establish a recor' of your $anage$ent revie)s.

. Resource requirements.1 Allocation requirements.

• Deter$ine the resources that your QMS nee's.

• rovi'e the resources that your QMS nee's.

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• rovi'e the resources nee'e' to i$ple$ent your QMS.

• rovi'e the resources nee'e' to $eet regulatory re#uire$ents.

• rovi'e the resources nee'e' to $eet custo$er re#uire$ents.

.+ Personnel requirements

.+.1 Ensure the co$petence of )or-ers.

• I'entify personnel )ho can affect pro'uct safety or perfor$ance.

• I'entify )or- that can affect pro'uct safety or perfor$ance.

• Ma-e sure that these )or-ers are co$petent.

.+.+ Meet all co$petence re#uire$ents.

• Establish a process to $anage the co$petence of $e'ical

'evice )or-ers.

• 0se your process to $anage the co$petence of $e'ical 'evice

)or-ers.

• I'entify suitable $etho's for evaluating training an' a)areness

activities.

• Maintain recor's that 'ocu$ent the co$petence of $e'ical 'evice

)or-ers.

. Infrastructure requirements

..1 Docu$ent the infrastructure that you nee'.

• Docu$ent the infrastructure that your QMS nee's.

• rovi'e the infrastructure that your QMS nee's.

• rovi'e the buil'ings an' utilities that your organization nee's.

• rovi'e the )or-spaces an' e#uip$ent that your organization

nee's.

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• rovi'e the support services that your organization nee's.

• Maintain the infrastructure that your QMS nee's.

..+ Docu$ent your $aintenance re#uire$ents.

• I'entify $aintenance activities that $ay affect pro'uct safety or

perfor$ance.

• Establish $aintenance re#uire$ents for these $aintenance

activities.

• Docu$ent $aintenance re#uire$ents for these $aintenance

activities.

• Docu$ent $aintenance re#uire$ents for e#uip$ent asappropriate2.

• Maintain e#uip$ent in accor'ance )ith your $aintenance

re#uire$ents.

.4 Environment requirements

.4.1 Define your $e'ical 'evice )or- environ$ent.

.4.1.1 Docu$ent your $e'ical 'evice environ$ent.

• I'entify the )or- environ$ent nee'e' to $eet pro'uct

re#uire$ents.

• Docu$ent the )or- environ$ent nee'e' to $eet pro'uct

re#uire$ents.

• Establish the )or- environ$ent nee'e' to $eet pro'uct

re#uire$ents.

.4.1.+ Docu$ent your environ$ental re#uire$ents.

• I'entify )or- environ$ents that affect pro'uct safety or

perfor$ance.

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• Docu$ent your re#uire$ents for these )or-

environ$ents.

• I'entify the environ$ental con'itions that affect ho) )or-

is perfor$e'.

• I'entify )or-ing con'itions that affect pro'uct safety or

perfor$ance.

• Docu$ent proce'ures to $onitor an' control )or-ing

con'itions.

.4.1. Docu$ent your cleanliness e,pectations.

• I'entify personnel )ho coul' affect pro'uct safety or

perfor$ance.

• I'entify those )ho co$e into contact )ith relate' )or-

environ$ents.

• Establish suitable health9 cleanliness9 an' clothing

re#uire$ents.

.4.1.4 Docu$ent your conta$ination controls.

• Establish arrange$ents to control pro'ucts that coul' beconta$inate'.

• Docu$ent arrange$ents to control pro'ucts that coul' be

conta$inate'.

.4.+ Define your sterile $e'ical 'evice environ$ent.

• Establish )or- environ$ent re#uire$ents for sterile $e'ical

'evices.

• &o$ply )ith your )or- environ$ent re#uire$ents for $e'ical

'evices.

:. Realization requirements

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:.1 Planning requirements.

• lan the processes you nee' to realize pro'ucts.

• Develop the processes that you nee' to realize pro'ucts.

• Develop a ris- $anage$ent process for pro'uct realization.

• lan ho) you%re going to realize each pro'uct.

• (or$ulate #uality ob6ectives for your pro'uct.

• &larify specific pro'uct realization re#uire$ents.

• 7enerate pro'uct realization planning outputs.

• Establish recor's of pro'uct realization activities.

:.+ Customer requirements

:.+.1 Deter$ine pro'uct re#uire$ents.

• &larify your pro'uct re#uire$ents.

• I'entify re#uire$ents specifie' by your custo$ers.

• I'entify re#uire$ents 'ictate' by your pro'uct%s inten'e' use.

• I'entify re#uire$ents i$pose' by your regulatory bo'ies.

• I'entify re#uire$ents 'efine' by your organization.

:.+.+ 5evie) your pro'uct re#uire$ents.

• Evaluate pro'uct re#uire$ents before you accept or'ers.

• 5evie) pro'uct re#uire$ents before you supply pro'ucts.

• /erify pro'uct re#uire$ents before you agree to accept or'ers.

• &onfir$ that pro'uct re#uire$ents can be $et before you

procee'.

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• Maintain a recor' of your pro'uct re#uire$ent revie)s.

:.+. &o$$unicate pro'uct re#uire$ents.

:.+..1 &o$$unicate )ith custo$ers.

• Establish arrange$ents to co$$unicate )ith custo$ers.

• Docu$ent your custo$er co$$unication arrange$ents.

:.+..+ &o$$unicate )ith regulators.

• Establish arrange$ents to co$$unicate )ith regulatory

authorities.

:. Develoment requirements

:..1 repare 'esign an' 'evelop$ent proce'ures.

• Establish proce'ures for 'esign an' 'evelop$ent.

• Docu$ent proce'ures for 'esign an' 'evelop$ent.

:..+ Organize 'esign an' 'evelop$ent activities.

• lan the 'esign an' 'evelop$ent of your pro'ucts.

• Docu$ent your pro'uct 'esign an' 'evelop$ent plans.

• Maintain your 'esign an' 'evelop$ent planning 'ocu$ents.

• &ontrol the 'esign an' 'evelop$ent of your pro'ucts.

:.. Deter$ine 'esign an' 'evelop$ent inputs.

• Deter$ine pro'uct 'esign an' 'evelop$ent inputs.

• 5evie) your pro'uct 'esign an' 'evelop$ent inputs.

• *pprove your pro'uct 'esign an' 'evelop$ent inputs.

• Maintain a recor' of 'esign an' 'evelop$ent inputs.

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:..4 7enerate 'esign an' 'evelop$ent outputs.

• 7enerate suitable 'esign an' 'evelop$ent outputs.

• /erify your pro'uct 'esign an' 'evelop$ent outputs.

• *pprove your pro'uct 'esign an' 'evelop$ent outputs.

• Maintain recor's of 'esign an' 'evelop$ent outputs.

:.." &arry out 'esign an' 'evelop$ent revie)s.

• lan your organization%s 'esign an' 'evelop$ent revie)s.

• erfor$ revie)s in accor'ance )ith planne' arrange$ents.

• Maintain recor's of your 'esign an' 'evelop$ent revie)s.

:.. erfor$ 'esign an' 'evelop$ent verifications.

• lan your 'esign an' 'evelop$ent verification activities.

• Docu$ent your 'esign an' 'evelop$ent verification plans.

• erfor$ verifications in accor'ance )ith planne' arrange$ents.

• 8eep recor's of your 'esign an' 'evelop$ent verification

activities.

:..: &on'uct 'esign an' 'evelop$ent vali'ations.

• lan your organization%s 'esign an' 'evelop$ent

vali'ation activities.

• Docu$ent your organization%s 'esign an' 'evelop$ent vali'ation

plans.

• erfor$ vali'ations in accor'ance )ith your planne'

arrange$ents.

• 8eep recor's of 'esign an' 'evelop$ent vali'ation activities.

:..! lan 'esign an' 'evelop$ent transfers.

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• lan pro'uct 'esign an' 'evelop$ent transfers.

• Docu$ent 'esign an' 'evelop$ent transfer plans.

• 0se your plans an' proce'ures to $a-e transfers.

• 8eep recor's of 'esign an' 'evelop$ent transfers.

:..; &ontrol 'esign an' 'evelop$ent changes.

:..;.1 Establish control of your changes.

• Establish processes to control 'esign an' 'evelop$ent

changes.

• 0se processes to control changes that affect your $e'ical'evices.

:..;.+ I'entify an' recor' your changes.

• I'entify 'esign an' 'evelop$ent changes.

• *pprove changes before you i$ple$ent the$.

• 5ecor' 'esign an' 'evelop$ent changes.

:..;. 5evie) an' evaluate your changes.

• 5evie) an' evaluate 'esign an' 'evelop$ent changes.

• 5evie) an' evaluate the effect changes coul' have.

:..;.4 Maintain a recor' of your revie)s.

• 5ecor' results of your revie) of 'esign an' 'evelop$ent

changes.

:..13 Maintain 'esign an' 'evelop$ent files.

• Maintain a 'esign an' 'evelop$ent file for each 'evice or fa$ily of

'evices.

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• Inclu'e or reference recor's that 'ocu$ent co$pliance an'

changes.

:.4 Purc!asing requirements

:.4.1 Manage purchasing process.

:.4.1.1 repare purchase proce'ures.

• Establish proce'ures to control pro'uct purchases.

• Docu$ent proce'ures to control pro'uct purchases.

:.4.1.+ &ontrol selection of suppliers.

• lan the selection an' evaluation of your suppliers.

• Establish supplier selection an' evaluation criteria.

• Evaluate an' select your organization%s suppliers.

• *pprove suppliers that $eet your selection an'

evaluation criteria.

• *pprove suppliers that $eet or can $eet all relevant

re#uire$ents.

:.4.1. Monitor supplier perfor$ance.

• lan ho) you%re going to $onitor supplier perfor$ance.

• Monitor the perfor$ance of your organization%s suppliers.

• 0se $onitoring results to re

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• lan your organization%s pro'uct purchases.

• 5evie) purchase re#uire$ents before sharing the$.

• Maintain your organization%s purchasing 'ocu$ents an' recor's.

:.4. /erify purchase' pro'ucts.

• Develop $etho's an' activities to verify purchase' pro'ucts.

• Ma-e arrange$ents to verify the pro'ucts you plan to purchase.

• /erify that your purchase' pro'ucts $eet purchase re#uire$ents.

• &onsi'er )hat to 'o )hen changes are $a'e to purchase'

pro'ucts.

• Establish an' $aintain a recor' of purchase' pro'uct

verifications.

:." Pro"uction requirements

:.".1 &ontrol $e'ical 'evice pro'uction an' service provision.

:.".1.1 lan an' perfor$ pro'uction an' service provision.

• lan your pro'uction an' service provision activities.

• &arry out pro'uction an' service provision activities.

• Monitor pro'uction an' service provision activities.

• &ontrol pro'uction an' service provision activities.

:.".1.+ &larify cleanliness9 installation9 an' servicing e,pectations.

:.".1.+.1 Define re#uire$ents for cleanliness or conta$ination

controls.

• Define cleanliness or conta$ination control

re#uire$ents for pro'ucts that you clean

prior to sterilization or use.

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re#uire$ents for pro'ucts that cannot be

cleane' prior to sterilization or use.


re#uire$ents for pro'ucts supplie' non

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:.".1. Maintain a recor' of sterilization process para$eters.

• Establish a recor' of your sterilization process para$eters.

• 5ecor' sterilization para$eters for each batch of $e'ical

'evices.

:.".+ /ali'ate processes use' for pro'uction an' service provision.

:.".+.1 /ali'ate processes an' soft)are if outputs aren%t being

verifie'.

• I'entify processes that generate outputs that are

not or cannot be verifie' by subse#uent $onitoring

an' $easure$ent until it%s too late.

• Establish proce'ures to vali'ate pro'uction an'

service 'elivery processes an' soft)are applications

that coul' affect your pro'ucts an' services.

• Develop plans to vali'ate pro'uction an' service

'elivery processes that generate outputs that are

not or cannot be verifie' until it%s too late.

• /ali'ate processes an' soft)are applications that

coul' generate output 'eficiencies an' coul' affectyour pro'ucts an' services.

:.".+.+ /ali'ate sterilization processes an' pro'uct pac-aging

processes.

• repare proce'ures for vali'ating sterilization processes.

• Docu$ent your sterilization process vali'ation

proce'ures.

• repare proce'ures to vali'ate pac-aging for sterile barrier

syste$s.

• Docu$ent your pac-aging process vali'ation proce'ures.

:.". I'entify $e'ical 'evice pro'ucts an' establish traceability.

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:."..1 reserve pro'uct i'entity throughout pro'uct realization.

• repare proce'ures an' syste$s to control i'entify of

$e'ical 'evices.

• Establish proce'ures to $aintain i'entify 'uring pro'uctrealization.

• Docu$ent your pro'uct i'entification syste$s an'

proce'ures.

:."..+ Establish suitable traceability proce'ures an' recor's.

:."..+.1 Establish suitable pro'uct traceability proce'ures.

• &larify your pro'uct traceability re#uire$ents.

• Establish your pro'uct traceability proce'ures.

• Maintain a recor' of your traceability activities.

:."..+.+ Establish suitable recor's for i$plantable 'evices.

• Establish traceability recor's for i$plantable

$e'ical 'evices.

• E,pect suppliers an' 'istributors to have

traceability recor's.

:.".. Maintain pro'uct status throughout pro'uct realization.

• I'entify the status of $e'ical 'evices throughout pro'uct

realization.

• Maintain the status of $e'ical 'evices throughout pro'uct

realization.

• 0se status infor$ation to control the 'isposition of $e'ical

'evices.

:.".4 rotect property supplie' for $e'ical 'evices by custo$ers.

http://www.praxiom.com/iso-definition-2005.htm#Traceabilityhttp://www.praxiom.com/iso-13485-definitions.htm#3.6_Implantable_medical_devicehttp://www.praxiom.com/iso-13485-definitions.htm#3.6_Implantable_medical_devicehttp://www.praxiom.com/iso-13485-definitions.htm#3.11_Medical_devicehttp://www.praxiom.com/iso-definition-2005.htm#Traceabilityhttp://www.praxiom.com/iso-13485-definitions.htm#3.6_Implantable_medical_devicehttp://www.praxiom.com/iso-13485-definitions.htm#3.6_Implantable_medical_devicehttp://www.praxiom.com/iso-13485-definitions.htm#3.11_Medical_device

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• I'entify property supplie' by custo$ers to be use' by $e'ical

'evices.

• /erify property supplie' by custo$ers to be use' by your $e'ical

'evices.

• Safeguar' property supplie' by custo$ers to be use' by $e'ical

'evices.

• Maintain a recor' of custo$er property that is lost9 'a$age'9 or

unsuitable.

• 5eport lost9 'a$age'9 or unsuitable custo$er property to your

custo$ers.

:."." reserve $e'ical 'evice pro'ucts an' co$ponents.

:.".".1 Develop proce'ures to preserve pro'uct confor$ity.

• Establish proce'ures to preserve the confor$ity of

pro'ucts.

• Docu$ent an' $aintain your pro'uct preservation

proce'ures.

• 0se your proce'ures to preserve the confor$ity ofpro'ucts.

:.".".+ revent pro'uct 'a$age9 alteration9 an' conta$ination.

• revent $e'ical 'evice 'a$age9 alteration9 an'

conta$ination.

• rotect pro'ucts )hen e,pose' to hazar's an' e,pecte'

con'itions.

:. Measurement requirements

• I'entify $onitoring an' $easure$ent re#uire$ents.

• Select suitable $onitoring an' $easure$ent e#uip$ent.

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• Establish your $onitoring an' $easure$ent proce'ures.

• repare calibration an' verification plans an' proce'ures.

• rotect your $onitoring an' $easure$ent e#uip$ent.

• /ali'ate your $onitoring an' $easure$ent soft)are.

• *pply your $onitoring an' $easure$ent proce'ures.

!. Reme"ial requirements

!.1 lanning re#uire$ents

• lan $onitoring9 $easure$ent9 an' analytical processes..

• lan ho) $onitoring $etho's )ill be use' ensure confor$ity an'

effectiveness.

• lan ho) $easure$ent )ill be use' to ensure confor$ity an'

effectiveness.

• lan ho) analytics )ill be use' to ensure confor$ity an'

effectiveness.

!.+ 5esearch re#uire$ents

!.+.1 Establish suitable fee'bac- $etho's an' proce'ures.

!.+.1.1 Develop fee'bac- $etho's an' gather infor$ation.

• Establish fee'bac- $etho's an' proce'ures.

• Establish custo$er fee'bac- $etho's an' proce'ures.

• Establish pro'uction fee'bac- $etho's an'

proce'ures.

• E,a$ine the infor$ation you have gathere'.

• 0se your fee'bac- to $easure QMS effectiveness.

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• 0se your fee'bac- to facilitate ris- $anage$ent.

• 0se your fee'bac- to support pro'uct realization.

!.+.1.+ Investigate co$plaints9 ta-e action9 an' report results.

!.+.1.+.1 Develop an' 'ocu$ent co$plaint han'ling

proce'ures.

• Establish your co$plaint han'ling proce'ures.

• Docu$ent your co$plaint han'ling proce'ures.

• Docu$ent relate' responsibilities an'

re#uire$ents.

!.+.1.+.+ Develop an' 'ocu$ent co$plaint reporting

proce'ures.

• Establish proce'ures for reporting co$plaints to

regulators.

• 5eport co$plaints to regulators )hen a'verse

events occur.

• Maintain a recor' of your regulatory reports an'notifications.

!.+.+ lan an' perfor$ internal au'its at planne' intervals.

• lan your organization%s internal au'it progra$.

• &arry out your internal au'its at planne' intervals.

• Maintain a recor' of au'it plans an' perfor$ance.

• Eli$inate all 'etecte' nonconfor$ities an' causes.

• (ollo)

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• Establish suitable $etho's to $onitor an' $easure each QMS

process.

• I$ple$ent suitable $etho's to $onitor an' $easure each QMS

process.

• Deter$ine )hether or not each QMS process is achieving

planne' results.

• =a-e re$e'ial action )henever processes fail to achieve planne'

results.

!.+.4 Monitor an' $easure $e'ical 'evice characteristics.

!.+.4.1 /erify that all $e'ical 'evice re#uire$ents are being $et.

• Monitor an' $easure your organization%s pro'uct

characteristics.

• Establish a recor' of pro'uct $onitoring an' $easure$ent

activities.

• &o$plete all planne' arrange$ents before you release your

pro'ucts.

!.+.4.+ 8eep a recor' of i$plantable 'evice testers an' inspectors.

• Establish a recor' of i$plantable $e'ical 'evice testing

an' inspection.

• I'entify the people )ho test or inspect i$plantable

$e'ical 'evices.

!. ro'uct re#uire$ents

!..1 revent uninten'e' 'elivery or use of nonconfor$ing pro'ucts.

• &larify ho) you inten' to prevent uninten'e' pro'uct 'elivery or

use.

• revent the uninten'e' 'elivery or use of your nonconfor$ing

pro'ucts.

http://www.praxiom.com/iso-13485-definitions.htm#3.6_Implantable_medical_devicehttp://www.praxiom.com/iso-13485-definitions.htm#3.6_Implantable_medical_device

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• Establish a recor' of your organization%s nonconfor$ing pro'uct

activities.

!..+ Deal )ith pre

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• &larify ho) pro'uct re)or- shoul' be recor'e'.

!.4 *nalytical re#uire$ents

• &onsi'er ho) you plan to evaluate your QMS.

• Establish proce'ures to evaluate your QMS.

• 7ather infor$ation an' 'ata about your QMS.

• *nalyze infor$ation an' 'ata about your QMS.

!." I$prove$ent re#uire$ents

!.".1 =a-e action to change QMS an' pro'ucts.

• I'entify any changes that $ust be $a'e.

• I'entify changes that $aintain QMS suitability an' effectiveness.

• I'entify changes that $aintain pro'uct safety an' perfor$ance.

• Ma-e any changes that $ust be $a'e.

!.".+ =a-e action to correct actual nonconfor$ities.

• Docu$ent a corrective action proce'ure.

• Specify ho) actual proble$s )ill be investigate'.

• Specify ho) corrective actions )ill be 'evelope'.

• Specify ho) corrective actions )ill be verifie'.

• Specify ho) corrective action )ill be ta-en.

• Specify ho) corrective action )ill be revie)e'.

• I$ple$ent your corrective action proce'ure.

• Maintain recor's of corrective action ta-en.

!.". =a-e action to prevent potential nonconfor$ities.

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• Docu$ent a preventive action proce'ure.

• Specify ho) potential proble$s )ill be investigate'.

• Specify ho) preventive actions )ill be 'evelope'.

• Specify ho) preventive actions )ill be verifie'.

• Specify ho) preventive action )ill be ta-en.

• Specify ho) preventive action )ill be revie)e'.

• I$ple$ent your preventive action proce'ure.

• Maintain recor's of preventive action ta-en.

*lso see ISO 14;:1 5is- Manage$ent Stan'ar' for Me'ical Devices in lain

English2.
http://www.praxiom.com/iso-14971.htmhttp://www.praxiom.com/iso-14971.htmhttp://www.praxiom.com/iso-14971.htm

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13485 2015