BS EN ISO 13485:2016 pdf free.Medical devices—Qualitymanagement systems —Requirements for regulatorypurposes.
This European Standard has been prepared under a Commission ‘s standardization request M/O23 toprovide one voluntary means of conforming to requirements of Council Directive 93/42/EEC of 14 June1993 concerning medical devices [OJ L169].
Once this European Standard is cited in the Official Journal of the European Union under Directive93/42/EEC(as amended) and has been implemented as a national standard in at least one MemberState, compliance with the normative clauses of this European Standard given in Tables ZB.1,ZB.2 andZB.3 confer, within the limits of the scope of this European Standard, a presumption of conformity withthe requirements on a manufacturer’s quality system as given in Annexes ll,v and Vl of that Directiveand associated EFTA regulations. This AnnexZB explains to which requirements,under whichconditions and to what extent presumption of conformity can be claimed.
EN ISO 13485:2016 provides requirements for a quality system applicable to medical devices. Becausethis standard describes a quality system that is connected in part or in whole to the conformityassessment requirements of 93/42/EEC (as amended), it is not meaningful to link individual clauses ofthe standard to specific Essential Requirements. Compliance with all the normative clauses in ENISO 13485 will ensure that a process is in place to address quality system aspects related to medicaldevices, which are included in the conformity assessment annexes of the Directive.However, becausethis is an adoption of an international standard, intended to be applicable in jurisdictions all over theworld,it is not the primary goal of the standard to cover exactly the European quality systemrequirements.Therefore, for all of the quality system requirements, conformity is not entirely achievedby complying only with the requirements specified in this standard.Manufacturers and conformityassessment bodies will need to feed the quality system requirements in the applicable Annex of theDirective into the processes provided by the standard.Explanation on the correspondence of thestandard and the requirements of the Directive is included in Tables ZB.1,ZB.2 and ZB.3.
The Conformity Assessment Annexes ll, V and Vl of the Directive include description of the regulatoryprocess and activities undertaken by the Notified Body,which both are outside of the scope of thisEuropean Standard and therefore not covered by this European Standard. Furthermore,therequirements of the Directive refer to an application to a Notified Body, not to the requirement for aquality system as such.Accordingly, coverage of legal requirements can only be presumed to the extentlisted in Tables ZB.1,ZB.2 and ZB.3 in an application to a Notified Body:
contains the necessary quality system documentation;has been reviewed and approved by a Notified Body,
and the undertakings listed in the application are correctly executed by the manufacturer.BS EN ISO 13485 pdf download.