ISO 13485:2016

Definition of the term (“What is ISO 13485:2016?”)

ISO 13485:2016 is an in­ter­na­tio­nal­ly re­co­gni­zed stan­dard de­ve­lo­ped spe­ci­fi­cal­ly for the me­di­cal de­vice in­dus­try. It sets out the re­qui­re­ments for a qua­li­ty ma­nage­ment sys­tem (QMS) that en­su­res the con­sis­tent de­sign, de­ve­lo­p­ment, pro­duc­tion, in­stal­la­ti­on and de­li­very of me­di­cal de­vices that are safe and ef­fec­ti­ve for their in­ten­ded purpose.

What are the main features of ISO 13485:2016?

  • Cus­to­mer ori­en­ta­ti­on: ISO 13485:2016 fo­cu­ses on cus­to­mer sa­tis­fac­tion and en­su­res that me­di­cal de­vice ma­nu­fac­tu­r­ers prio­ri­ti­ze the needs and ex­pec­ta­ti­ons of their customers. 
  • Risk ma­nage­ment: Risk ma­nage­ment is an in­te­gral part of ISO 13485:2016. Ma­nu­fac­tu­r­ers must iden­ti­fy and mi­ti­ga­te risks as­so­cia­ted with their me­di­cal de­vices du­ring the pro­duct lifecycle. 
  • Re­gu­la­to­ry Com­pli­ance: Com­pli­ance with re­le­vant re­gu­la­to­ry re­qui­re­ments is a key aspect of ISO 13485:2016. This en­su­res that me­di­cal de­vices com­ply with le­gal and safe­ty standards. 
  • Con­ti­nuous im­pro­ve­ment: The stan­dard pro­mo­tes a cul­tu­re of con­ti­nuous im­pro­ve­ment and en­cou­ra­ges or­ga­niza­ti­ons to con­ti­nuous­ly im­pro­ve their pro­ces­ses and products.

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Our di­gi­tiza­ti­on so­lu­ti­ons pri­ma­ri­ly ad­dress do­cu­ment-ba­sed pro­ces­ses in ma­nu­fac­tu­ring, pro­duc­tion and qua­li­ty ma­nage­ment. The ba­sis of the dls | eQMS is a ho­li­stic ECM/DMS sys­tem. The ECM/DMS sys­tem can be con­nec­ted to your exis­ting ERP sys­tem (e.g. SAP) and thus map al­most all do­cu­ment-ba­sed pro­ces­ses in the company.

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What are the benefits of the ISO 13485:2016 certification?

  • Im­pro­ved pro­duct qua­li­ty: By com­ply­ing with ISO 13485:2016, me­di­cal de­vice ma­nu­fac­tu­r­ers can im­pro­ve the over­all qua­li­ty of their pro­ducts, lea­ding to in­creased pa­ti­ent safety. 
  • Ac­cess to the glo­bal mar­ket: The ISO 13485:2016 cer­ti­fi­ca­ti­on is re­co­gni­zed world­wi­de and fa­ci­li­ta­tes mar­ket ac­cess for me­di­cal de­vice ma­nu­fac­tu­r­ers in va­rious regions. 
  • Re­gu­la­to­ry Com­pli­ance: Mee­ting the re­qui­re­ments of ISO 13485:2016 brings an or­ga­niza­ti­on into com­pli­ance with re­gu­la­to­ry stan­dards and re­du­ces the risk of le­gal issues.

How can ISO 13485:2016 be implemented?

  • Launch: To suc­cessful­ly im­ple­ment ISO 13485:2016 or­ga­niza­ti­ons should start by un­der­stan­ding the standard’s re­qui­re­ments and per­forming a gap analysis. 
  • Do­cu­men­ta­ti­on: Do­cu­men­ting pro­ces­ses and pro­ce­du­res is a cri­ti­cal step toward com­pli­ance with ISO 13485:2016. This helps to en­su­re trans­pa­ren­cy and traceability. 
  • Trai­ning and awa­re­ness-rai­sing: Em­ployees must be trai­ned and in­for­med about the qua­li­ty ma­nage­ment sys­tem to en­su­re ef­fec­ti­ve implementation.


ISO 13485:2016 is an im­portant stan­dard for the me­di­cal de­vice in­dus­try that em­pha­si­zes qua­li­ty, safe­ty and re­gu­la­to­ry com­pli­ance. By ad­op­ting and im­ple­men­ting this stan­dard, or­ga­niza­ti­ons can im­pro­ve the qua­li­ty of their pro­ducts, gain ac­cess to glo­bal mar­kets and en­su­re pa­ti­ent safety.

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Frequently Asked Questions (FAQs)

What is ISO 13485:2016?
ISO 13485:2016 is an in­ter­na­tio­nal stan­dard for the me­di­cal de­vice in­dus­try that spe­ci­fies re­qui­re­ments for a qua­li­ty ma­nage­ment system.

How can ISO 13485:2016 be­ne­fit my or­ga­niza­ti­on?
ISO 13485:2016 cer­ti­fi­ca­ti­on can im­pro­ve pro­duct qua­li­ty, pro­vi­de ac­cess to the glo­bal mar­ket and en­su­re re­gu­la­to­ry compliance.

What is the role of risk ma­nage­ment in ISO 13485:2016?
Risk ma­nage­ment is an in­te­gral part of ISO 13485:2016 and re­qui­res or­ga­niza­ti­ons to iden­ti­fy and mi­ti­ga­te risks as­so­cia­ted with their me­di­cal devices.

How do I start with the im­ple­men­ta­ti­on of ISO 13485:2016?
Be­gin by un­der­stan­ding the re­qui­re­ments of the stan­dard, per­forming a gap ana­ly­sis, and do­cu­men­ting your processes.

Is ISO 13485:2016 re­co­gni­zed world­wi­de?
Yes, ISO 13485:2016 is re­co­gni­zed glo­bal­ly and fa­ci­li­ta­tes mar­ket ac­cess for me­di­cal de­vice manufacturers.

What is the most re­cent ISO 13485 stan­dard?
The la­test edi­ti­on of the stan­dard was pu­blished in 2016, which gave the ISO stan­dard its de­si­gna­ti­on ISO 13485:2016.

What are the ch­an­ges in ISO 13485:2016 from its pre­de­ces­sors? 
The fun­da­men­tal ch­an­ges in the 2016 ver­si­on com­pared to its pre­de­ces­sors are in the pro­duct safe­ty of me­di­cal IT. In this con­text, the stan­dard pre­scri­bes se­cu­ri­ty pre­cau­ti­ons for the sto­rage of pa­ti­ent-re­la­ted data and thus also ad­dres­ses aspects of data pro­tec­tion. It falls un­der the sec­tion of le­gis­la­ti­on and is used to com­ply with the Eu­ro­pean Di­rec­ti­ve on Me­di­cal De­vices, 93/42/EEC.

Why is chap­ter 4 of ISO 13485:2016 so im­portant?
Chap­ter 4 sta­tes that the or­ga­niza­ti­on must have a qua­li­ty ma­nage­ment sys­tem and main­tain its ef­fec­ti­ve­ness. A risk-ba­sed ap­proach is al­ways ap­pli­ed to con­trol the qua­li­ty of the pro­ces­ses. If soft­ware is used as sec­tion of qua­li­ty ma­nage­ment, it must be va­li­da­ted be­fo­re im­ple­men­ta­ti­on. The ac­ti­vi­ties as­so­cia­ted with va­li­da­ti­on and re­va­li­da­ti­on must be pro­por­tio­na­te to the risk as­so­cia­ted with the use of the soft­ware. The ac­ti­vi­ties have to be do­cu­men­ted ac­cor­din­gly and the qua­li­ty ma­nage­ment re­qui­res to con­trol the pre­pared do­cu­ments as well.

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