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TRANSCRIPT
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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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• Define cleanliness or conta$ination control
re#uire$ents for pro'ucts that cannot be
cleane' prior to sterilization or use.
• Define cleanliness or conta$ination control
re#uire$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