Correspondence Between ISO 13485:2016 And 21 CFR Part 820 .
CorrespondenceBetweenISO 13485:2016 and21 CFR Part 820QMS Requirements10411 Corporate Drive, Suite 102, Pleasant Prairie, WI .com
2Correspondence Between ISO 13485:2016 and 21 CFR 820ISO 13485:2016US FDA Quality System Regulation(QSR - 21 CFR 820)4 Quality Management SystemSubpart A--General Provisions4.1 General RequirementsSec. 820.5 Quality System.4.1.1 The organization shall document a quality managementsystem and maintain its effectiveness in accordance with therequirements of this International Standard and applicableregulatory requirements.Each manufacturer shall establish and maintain a qualitysystem that is appropriate for the specific medical device(s)designed or manufactured, and that meets the requirements ofthis part.The organization shall establish, implement, and maintain anyrequirement, procedure, activity, or arrangement required to bedocumented by this International Standard or applicableregulatory requirements.Subpart B--Quality System RequirementsThe organization shall document the role(s) undertaken by theorganization under the applicable regulatory requirements.NOTE. Roles undertaken by the organization can includemanufacturer, authorized representative, importer, ordistributor.4.1.2 The organization shall:a)b)c)determine the processes needed for the qualitymanagement system and the application of theseprocesses throughout the organization taking intoaccount the roles undertaken by the organization;apply a risk based approach to the control of theappropriate processes needed for the qualitymanagement system;determine the sequence and interaction of theseprocesses.4.1.3 For each quality management system process, theorganization shall:Sec. 820.20 Management Responsibility.(a) Quality Policy. Management with executive responsibilityshall establish its policy and objectives for, and commitmentto, quality. Management with executive responsibility shallensure that the quality policy is understood, implemented, andmaintained at all levels of the organization.(b) Organization. Each manufacturer shall establish andmaintain an adequate organizational structure to ensure thatdevices are designed and produced in accordance with therequirements of this part.(1) Responsibility and Authority. Each manufacturer shallestablish the appropriate responsibility, authority, andinterrelation of all personnel who manage, perform, and assesswork affecting quality, and provide the independence andauthority necessary to perform these tasks.(2) Resources. Each manufacturer shall provide adequateresources, including the assignment of trained personnel, formanagement, performance of work, and assessment activities,including internal quality audits, to meet the requirements ofthis part.a)determine criteria and methods needed to ensurethat both the operation and control of theseprocesses are effective;(3) Management Representative. Management with executiveresponsibility shall appoint, and document such appointmentof, a member of management who, irrespective of otherresponsibilities, shall have established authority over andresponsibility for:b)ensure the availability of resources and informationnecessary to support the operation and monitoring ofthese processes;(i) Ensuring that quality system requirements are effectivelyestablished and effectively maintained in accordance with thispart; andc)implement actions necessary to achieve plannedresults and maintain the effectiveness of theseprocesses;(ii) Reporting on the performance of the quality system tomanagement with executive responsibility for review.d)monitor, measure as appropriate, and analyze theseprocesses;(c) Management Review. Management with executiveresponsibility shall review the suitability and effectiveness ofthe quality system at defined intervals and with sufficientfrequency according to established procedures to ensure thatthe quality system satisfies the requirements of this part andthe manufacturer's established quality policy and objectives.Regulatory Compliance Associates Inc., 10411 Corporate Drive, Suite 102, Pleasant Prairie, WI 53158
3Correspondence Between ISO 13485:2016 and 21 CFR 820ISO 13485:2016e)establish and maintain records needed todemonstrate conformance to this InternationalStandard and compliance with applicable regulatoryrequirements (see 4.2.5).4.1.4 The organization shall manage these qualitymanagement system processes in accordance with therequirements of this International Standard and applicableregulatory requirements. Changes to be made to theseprocesses shall be:a)evaluated for their impact on the qualitymanagement system;b)evaluated for their impact on the medical devicesproduced under this quality management system;c)controlled in accordance with the requirements ofthis International Standard and applicable regulatoryrequirements.US FDA Quality System Regulation(QSR - 21 CFR 820)The dates and results of quality system reviews shall bedocumented.(d) Quality Planning. Each manufacturer shall establish aquality plan which defines the quality practices, resources, andactivities relevant to devices that are designed andmanufactured. The manufacturer shall establish how therequirements for quality will be met.(e) Quality System Procedures. Each manufacturer shallestablish quality system procedures and instructions. Anoutline of the structure of the documentation used in thequality system shall be established where appropriate.4.1.5 When the organization chooses to outsource anyprocess that affects product conformity to requirements, itshall monitor and ensure control over such processes. Theorganization shall retain responsibility of conformity to thisInternational Standard and to customer and applicableregulatory requirements for outsourced processes. Thecontrols shall be proportionate to the risk involved and theability of the external party to meet the requirements inaccordance with 7.4. The controls shall include written qualityagreements.4.1.6 The organization shall document procedures for thevalidation of the application of computer software used in thequality management system. Such software applications shallbe validated prior to initial use and, as appropriate, afterchanges to such software or its application.The specific approach and activities associated with softwarevalidation and revalidation shall be proportionate to the riskassociated with the use of the software.Records of such activities shall be maintained (see 4.2.5).4.2 Documentation RequirementsSubpart A—General Provisions4.2.1 GeneralSec. 820.5 Quality System.The quality management system documentation (see 4.2.4)shall include:Each manufacturer shall establish and maintain a qualitysystem that is appropriate for the specific medical device(s)designed or manufactured, and that meets the requirements ofthis part.a)documented statements of a quality policy andquality objectives;b)a quality manual;Subpart B--Quality System RequirementsSec. 820.20 Management Responsibility.Regulatory Compliance Associates Inc., 10411 Corporate Drive, Suite 102, Pleasant Prairie, WI 53158
4Correspondence Between ISO 13485:2016 and 21 CFR 820ISO 13485:2016c)documented procedures and records required by thisInternational Standard;d)documents, including records, determined by theorganization to be necessary to ensure the effectiveplanning, operation, and control of its processes;e)other documentation specified by applicableregulatory requirements.US FDA Quality System Regulation(QSR - 21 CFR 820)(a) Quality Policy. Management with executive responsibilityshall establish its policy and objectives for, and commitmentto, quality. Management with executive responsibility shallensure that the quality policy is understood, implemented, andmaintained at all levels of the organization.(e) Quality System Procedures. Each manufacturer shallestablish quality system procedures and instructions. Anoutline of the structure of the documentation used in thequality system shall be established where appropriate.Subpart D--Document ControlsSec. 820.40 Document Controls.Each manufacturer shall establish and maintain procedures tocontrol all documents that are required by this part. Theprocedures shall provide for the following:(a) Document Approval and Distribution. Each manufacturershall designate an individual(s) to review for adequacy andapprove prior to issuance all documents established to meetthe requirements of this part. The approval, including the dateand signature of the individual(s) approving the document,shall be documented. Documents established to meet therequirements of this part shall be available at all locations forwhich they are designated, used, or otherwise necessary, andall obsolete documents shall be promptly removed from allpoints of use or otherwise prevented from unintended use.(b) Document Changes. Changes to documents shall bereviewed and approved by an individual(s) in the same functionor organization that performed the original review andapproval, unless specifically designated otherwise. Approvedchanges shall be communicated to the appropriate personnelin a timely manner. Each manufacturer shall maintain recordsof changes to documents. Change records shall include adescription of the change, identification of the affecteddocuments, the signature of the approving individual(s), theapproval date, and when the change becomes effective.4.2.2 Quality ManualSubpart B--Quality System RequirementsThe organization shall document a quality manual thatincludes:Sec. 820.20 Management Responsibility.a)the scope of the quality management system,including details of and justification for any exclusionor non-application;b)the documented procedures for the qualitymanagement system, or reference to them;c)a description of the interaction between theprocesses of the quality management system.(a) Quality Policy. Management with executive responsibilityshall establish its policy and objectives for, and commitmentto, quality. Management with executive responsibility shallensure that the quality policy is understood, implemented, andmaintained at all levels of the organization.(b) Organization. Each manufacturer shall establish andmaintain an adequate organizational structure to ensure thatdevices are designed and produced in accordance with therequirements of this part.Regulatory Compliance Associates Inc., 10411 Corporate Drive, Suite 102, Pleasant Prairie, WI 53158
5Correspondence Between ISO 13485:2016 and 21 CFR 820ISO 13485:2016The quality manual shall outline the structure of thedocumentation used in the quality management system.US FDA Quality System Regulation(QSR - 21 CFR 820)(1) Responsibility and Authority. Each manufacturer shallestablish the appropriate responsibility, authority, andinterrelation of all personnel who manage, perform, and assesswork affecting quality, and provide the independence andauthority necessary to perform these tasks.(2) Resources. Each manufacturer shall provide adequateresources, including the assignment of trained personnel, formanagement, performance of work, and assessment activities,including internal quality audits, to meet the requirements ofthis part.(e) Quality System Procedures. Each manufacturer shallestablish quality system procedures and instructions. Anoutline of the structure of the documentation used in thequality system shall be established where appropriate.4.2.3 Medical Device FileSubpart M--RecordsFor each medical device type or medical device family, theorganization shall establish and maintain one or more fileseither containing or referencing documents generated todemonstrate conformity to the requirement of thisInternational Standard and compliance with applicableregulatory requirements.Sec. 820.181 Device Master Record.Each manufacturer shall maintain device master records(DMR's). Each manufacturer shall ensure that each DMR isprepared and approved in accordance with 820.40. The DMRfor each type of device shall include, or refer to the location of,the following information:The content of the file(s) shall include, but is not limited to:a)general description of the medical device, intendeduse/purpose, and labelling, including any instructionsfor use;b)specifications for product;c)specifications or procedures for manufacturing,packaging, storage, handling and distribution;d)procedures for measuring and monitoring; asappropriate, requirements for installation;e)as appropriate, procedures for servicing.(a) Device specifications including appropriate drawings,composition, formulation, component specifications, andsoftware specifications;(b) Production process specifications including the appropriateequipment specifications, production methods, productionprocedures, and production environment specifications;(c) Quality assurance procedures and specifications includingacceptance criteria and the quality assurance equipment to beused;(d) Packaging and labeling specifications, including methodsand processes used; and(e) Installation, maintenance, and servicing procedures andmethods.Subpart K--Labeling and Packaging ControlSec. 820.120 Device Labeling.Each manufacturer shall establish and maintain procedures tocontrol labeling activities.(a) Label Integrity. Labels shall be printed and applied so as toremain legible and affixed during the customary conditions ofprocessing, storage, handling, distribution, and whereappropriate use.Regulatory Compliance Associates Inc., 10411 Corporate Drive, Suite 102, Pleasant Prairie, WI 53158
6Correspondence Between ISO 13485:2016 and 21 CFR 820ISO 13485:2016US FDA Quality System Regulation(QSR - 21 CFR 820)(b) Labeling Inspection. Labeling shall not be released forstorage or use until a designated individual(s) has examinedthe labeling for accuracy including, where applicable, thecorrect unique device identifier (UDI) or universal product code(UPC), expiration date, control number, storage instructions,handling instructions, and any additional processinginstructions. The release, including the date and signature ofthe individual(s) performing the examination, shall bedocumented in the DHR.(c) Labeling Storage. Each manufacturer shall store labeling ina manner that provides proper identification and is designed toprevent mix-ups.(d) Labeling Operations. Each manufacturer shall controllabeling and packaging operations to prevent labeling mix-ups.The label and labeling used for each production unit, lot, orbatch shall be documented in the DHR.(e) Control Number. Where a control number is required by820.65, that control number shall be on or shall accompany thedevice through distribution.Sec. 820.130 Device Packaging.Each manufacturer shall ensure that device packaging andshipping containers are designed and constructed to protectthe device from alteration or damage during the customaryconditions of processing, storage, handling, and distribution.Subpart L--Handling, Storage, Distribution, and InstallationSec. 820.140 Handling.Each manufacturer shall establish and maintain procedures toensure that mix-ups, damage, deterioration, contamination, orother adverse effects to product do not occur during handling.Sec. 820.150 Storage.(a) Each manufacturer shall establish and maintain proceduresfor the control of storage areas and stock rooms for product toprevent mix-ups, damage, deterioration, contamination, or otheradverse effects pending use or distribution and to ensure thatno obsolete, rejected, or deteriorated product is used ordistributed. When the quality of product deteriorates over time,it shall be stored in a manner to facilitate proper stock rotation,and its condition shall be assessed as appropriate.(b) Each manufacturer shall establish and maintain proceduresthat describe the methods for authorizing receipt from anddispatch to storage areas and stock rooms.Sec. 820.160 Distribution.(a) Each manufacturer shall establish and maintain proceduresfor control and distribution of finished devices to ensure thatRegulatory Compliance Associates Inc., 10411 Corporate Drive, Suite 102, Pleasant Prairie, WI 53158
7Correspondence Between ISO 13485:2016 and 21 CFR 820ISO 13485:2016US FDA Quality System Regulation(QSR - 21 CFR 820)only those devices approved for release are distributed andthat purchase orders are reviewed to ensure that ambiguitiesand errors are resolved before devices are released fordistribution. Where a device's fitness for use or qualitydeteriorates over time, the procedures shall ensure that expireddevices or devices deteriorated beyond acceptable fitness foruse are not distributed.(b) Each manufacturer shall maintain distribution recordswhich include or refer to the location of:(1) The name and address of the initial consignee;(2) The identification and quantity of devices shipped;(3) The date shipped; and(4) Any control number(s) used.Sec. 820.170 Installation.(a) Each manufacturer of a device requiring installation shallestablish and maintain adequate installation and inspectioninstructions, and where appropriate test procedures.Instructions and procedures shall include directions forensuring proper installation so that the device will perform asintended after installation. The manufacturer shall distributethe instructions and procedures with the device or otherwisemake them available to the person(s) installing the device.(b) The person installing the device shall ensure that theinstallation, inspection, and any required testing are performedin accordance with the manufacturer's instructions andprocedures and shall document the inspection and any testresults to demonstrate proper installation.Subpart M--RecordsSec. 820.180 General Requirements.All records required by this part shall be maintained at themanufacturing establishment or other location that isreasonably accessible to responsible officials of themanufacturer and to employees of FDA designated to performinspections. Such records, including those not stored at theinspected establishment, shall be made readily available forreview and copying by FDA employee(s). Such records shall belegible and shall be stored to minimize deterioration and toprevent loss. Those records stored in automated dataprocessing systems shall be backed up.(a) Confidentiality. Records deemed confidential by themanufacturer may be marked to aid FDA in determiningwhether information may be disclosed under the publicinformation regulation in part 20 of this chapter.Regulatory Compliance Associates Inc., 10411 Corporate Drive, Suite 102, Pleasant Prairie, WI 53158
8Correspondence Between ISO 13485:2016 and 21 CFR 820ISO 13485:2016US FDA Quality System Regulation(QSR - 21 CFR 820)(b) Record Retention Period. All records required by this partshall be retained for a period of time equivalent to the designand expected life of the device, but in no case less than 2 yearsfrom the date of release for commercial distribution by themanufacturer.(c) Exceptions. This section does not apply to the reportsrequired by 820.20(c) Management review, 820.22 Qualityaudits, and supplier audit reports used to meet therequirements of 820.50(a) Evaluation of suppliers, contractors,and consultants, but does apply to procedures establishedunder these provisions. Upon request of a designatedemployee of FDA, an employee in management with executiveresponsibility shall certify in writing that the managementreviews and quality audits required under this part, and supplieraudits where applicable, have been performed anddocumented, the dates on which they were performed, and thatany required corrective action has been undertaken.Subpart N--ServicingSec. 820.200 Servicing.(a) Where servicing is a specified requirement, eachmanufacturer shall establish and maintain instructions andprocedures for performing and verifying that the servicingmeets the specified requirements.(b) Each manufacturer shall analyze service reports withappropriate statistical methodology in accordance with820.100.(c) Each manufacturer who
Correspondence Between ISO 13485:2016 and 21 CFR 820 Regulatory Compliance Associates Inc., 10411 Corporate Drive, Suite 102, Pleasant Prairie, WI 53158 5 ISO 13485:2016 US FDA Quality System Regulation (QSR - 21 CFR 820) The quality manual shall outline the structure of the documentation used in the quality management system.
ISO 13485:2016 Annexes Annex A Comparison of content between ISO 13485:2003 and ISO 13485:2016 – comments on changes Annex B Correspondence between ISO 13485:2016 and ISO 9001:2015 – top level clause mapping European Annexes - ZA (AIMD), ZB (MDD) and ZC (IVD) Identifies relationship between the European StandardFile Size: 855KB
The primary international version is ISO 13485:2003. The variant EN ISO 13485:2012 is the latest European harmonized version of ISO 13485; it replaces the prior harmonized version, EN ISO 13485:2003, which is now considered to be obsolete. EN ISO 13485:2012 is applicable only to manufacturers placing devices on the market in Europe.
ISO 13485 clauses 4.2.1, 5.4.1 Annex IX (Chapter I) 03 Quality Manual 9 03 Quality Manual ISO 13485 clauses 4.2.1, 4.2.2 04 Human Resources 10 04 Procedure for Human Resources ISO 13485 clause 6.2 11 04.1 Appendix 1 -Training Program ISO 13485 clause 6.2 12 04.2 Appendix 2 - Training Record ISO 13485 clause 6.2 13 04.3
resulting in the standard now having 10 clauses, where previously there were 8. The 3rd edition of ISO 13485 will keep the current clause structure and a new Annex is proposed for ISO 13485 to provide a clause by clause correlation between the new revisions of ISO 9001 and ISO 13485. The new revisions of both ISO 9001 and ISO 13485 have anFile Size: 375KB
ISO 13485:2016 did NOT follow ISO 9001:2015 into the Higher Level Structure format ISO 9001:2015 now has 7* QS core “Processes” ISO 13485:2016 retains 5* QS core “Processes” Annex B of ISO 13485:2016 provides a handy cross-reference between ISO
ISO 13485 OPPOSED TO ISO 9001 _ As mentioned above, ISO 13485 is based on the structure of ISO 9001, even though it is a stand-alone standard. Despite that both standards are organized in the same way, ISO 13485 excludes ISO 9001 requirements related to continual improvement and customer s
compliance with ISO 13485:2003. They will have to spelle d out clearly any exclusions. Correspondence between ISO 9001:2000 and ISO 13485:2003 and the US Quality System Regulation Prepared by: Ed Kimmelman, Consultant E:mail --- GPA_ED@msn.com Rev: 5 Aug. 2003 PH: 1-302-762-0947 Page 5 .
ISO 9001:2008 –3 instances of the word “risk” ISO 9001:2015 –43 instances of the word “risk” ISO 13485:2003 –4 instances of the word “risk” ISO 13485:2016 –32 instances of the word “risk” “13485 Plus” is a guidance document that was publishe
