ISO 13485 Documents With Manual, Procedures, Audit Checklist
D126: DEMO OF ISO 13485:2016 Medical Device Document KitPrice 399 USD Total editable documentation packageComplete editable document tool kit (Quality manual, procedures, exhibits, formats,SOPs, process flow chart, audit checklist, medical device file etc.)Buy: www.Documentationconsultancy.comChapter-1.0 CONTENTS OF ISO 13485:2016 DOCUMENT KIT(More than 125 document files)A. The Total Editable Document kit has 8 main directories as below inMs. Word & Ms. ExcelList of DirectorySr.No.1.Quality Manual2.Procedures3.ExhibitsFormats / TemplatesName of departments4.Document of Details40 Pages in Ms. word19 procedures in Ms. word04 exhibits in Ms. Word61 formats in Ms. Word & Ms. ExcelPurchase (PUR)05 formats in Ms. WordStores (ST)02 formats in Ms. WordDND04 formats in Ms. WordEngineering (ENG)03 formats in Ms. WordMarketing (MKT)05 formats in Ms. WordOperation (OPN)15 formats in Ms. WordServices (SER)03 formats in Ms. WordSystem (SYS)17 formats in Ms. Word & Ms. ExcelTraining (TRG)07 formats in Ms. Word5.Standard Operating Procedures(SOPs)6.Process Flow Chart7.Audit Checklist8.Medical Device File06 SOPs in Ms. word12 process flow charts in Ms. word02 files of more than 900 audit questions21 files in Ms. wordTotal 125 files quick download in editable form by e deliveryTo get more information about ISO 13485 documentation kit Click HereE-mail: sales@globalmanagergroup.comTele: 91-79-2979 5322Page 1 of 14
D126: DEMO OF ISO 13485:2016 Medical Device Document KitPrice 399 USD Total editable documentation packageComplete editable document tool kit (Quality manual, procedures, exhibits, formats,SOPs, process flow chart, audit checklist, medical device file etc.)Buy: www.Documentationconsultancy.comB. ISO 13485:2016 requirementwise documents list:Document NoClause No./Document TitleClause No. 04 Quality Management System4.1QM 014.2PRO/SYS/02General RequirementsQuality manualDocumentation RequirementsProcedure for Document and Data control (Ref Clause 4.2.3)F/SYS/01Master List Cum Distribution List Of DocumentsF/SYS/02Change NotePRO/SYS/03Procedure for Record control (Ref Clause 4.2.4)F/SYS/04Master list of recordsE/SYS/01Exhibit for Documents codification systemGFI/TECH/01/xxMedical device fileClause No. 05 Management Responsibility5.1QM 015.2E/SYS/02/MKT5.3Management commitmentQuality ManualCustomer FocusProcess Approach for MarketingQuality PolicyAnnex IV of Quality Manual5.4PlanningF/SYS/05Quality Objective Monitoring ReportF/SYS/09Continual Improvement ity, Authority and communicationJob Description and SpecificationProcess Approach for Management RepresentativeManagement ReviewProcedure for management Review (Ref Clause 5.6)F/SYS/05Quality Objective Monitoring ReportF/SYS/09Continual Improvement PlanClause No. 06 Resource Management6.1QM 01Provision of ResourcesQuality manualTo get more information about ISO 13485 documentation kit Click HereE-mail: sales@globalmanagergroup.comTele: 91-79-2979 5322Page 2 of 14
D126: DEMO OF ISO 13485:2016 Medical Device Document KitPrice 399 USD Total editable documentation packageComplete editable document tool kit (Quality manual, procedures, exhibits, formats,SOPs, process flow chart, audit checklist, medical device file etc.)Buy: www.Documentationconsultancy.com6.2PRO/SYS/05Human ResourceProcedure for Training (Ref Clause 6.2.2)E/SYS/02/HRDProcess approach for TrainingE/HRD/01Exhibits for Skill requirementsF/TRG/01Training CalendarF/TRG/02Training Need Cum Records SheetF/TRG/03Induction Training ReportF/TRG/04Job Description and SpecificationF/TRG/05Skill MatrixF/TRG/06Training ReportF/TRG/07Skill Matrix for QC PersonnelF/SYS/15Risk analysis sheetF/SYS/16Risk identification sheet6.3E/SYS/02/ENGInfrastructureProcess approach for EngineeringF/ENG/01Breakdown History CardF/ENG/02Preventive Maintenance ScheduleF/ENG/03Equipment Wise preventive maintenance checkpoints6.4PRO/SYS/08Work Environment and contamination controlProcedure for control of monitoring of work environment (Ref Clause 6.4)F/OPN/01Temperature RecordF/OPN/02Validation Of Autoclave By Biological IndicatorF/OPN/03Temperature And Relative Humidity Record (Parentral)F/OPN/04Temperature And Relative Humidity Record (Washing & Sterilization)F/OPN/05Temperature And Relative Humidity Record (Filling and Manufacturing)F/OPN/06Differential Pressure Monitoring Record (Parentral)F/OPN/07Differential Pressure Monitoring Record (Washing & Sterilization)F/OPN/08Differential Pressure Monitoring Record (Ointment)F/OPN/09Temperature & Humidity Monitoring Record – General areaF/OPN/10Microbial Monitoring Of Production Area By Settling Plate MethodF/OPN/11Microbial Monitoring Of Production Area By Settling Plate Method – Ointment preparationF/OPN/12Microbial Monitoring By Swab /Surface Contact Technique – Parenteral in preparation.F/OPN/13Microbial Monitoring – Microbial Testing Of Sterile GarmentsF/OPN/14Testing Of Personnel By Finger DabF/OPN/15Microbial Monitoring By Swab /Surface Contact TechniqueTo get more information about ISO 13485 documentation kit Click HereE-mail: sales@globalmanagergroup.comTele: 91-79-2979 5322Page 3 of 14
D126: DEMO OF ISO 13485:2016 Medical Device Document KitPrice 399 USD Total editable documentation packageComplete editable document tool kit (Quality manual, procedures, exhibits, formats,SOPs, process flow chart, audit checklist, medical device file etc.)Buy: www.Documentationconsultancy.comClause No. 07 Product realization and implementation and operation7.1E/QCD/01Planning Of Product RealizationQuality Plan7.2Customer Related processesE/SYS/02/MKTProcess approach for MarketingF/MKT/01Order form/ confirmationF/MKT/02Customer Complaint reportF/MKT/03Customer Feed Back FormF/MKT/04Medical Practitioner Feedback FormF/MKT/05Customer Property Monitoring RegisterF/SYS/17Communication report7.3E/SYS/02/DNDDesign and DevelopmentProcess Approach for Design and DevelopmentF/DND/01Design and Development PlanF/DND/02Design review meetingF/DND/03Design Verification reportF/DND/04Design Validation rocedure for purchasing (Ref Clause 7.4)Vendor RatingProcess approach for PurchaseF/PUR/01Purchase OrderF/PUR/02Indent cum Incoming inspection reportF/PUR/03Approved Vendor list cum open purchase orderF/PUR/04Supplier Registration formF/PUR/05Open Purchase Order7.57.5.1Production and Service ProvisionControl of Production and Service ProvisionE/SYS/02/PRDProcess approach for ProductionE/SYS/02/QCDProcess approach for Quality ControlE/QCD/01Quality PlanE/SYS/02/STRProcess approach for Stores7.5.2Cleanliness of the productQM 01Quality manualTo get more information about ISO 13485 documentation kit Click HereE-mail: sales@globalmanagergroup.comTele: 91-79-2979 5322Page 4 of 14
D126: DEMO OF ISO 13485:2016 Medical Device Document KitPrice 399 USD Total editable documentation packageComplete editable document tool kit (Quality manual, procedures, exhibits, formats,SOPs, process flow chart, audit checklist, medical device file etc.)Buy: www.Documentationconsultancy.com7.5.3Installation activitiesE/SYS/02/INSProcess approach for Installation and commissioningF/SER/03Installation and commissioning record7.5.4Service activitiesE/SYS/02/SERProcess approach for ServicingF/SER/01Service ReportF/SER/02Repairing card7.5.5Particular requirements for sterile medical devicesPRO/SYS/09Procedure for validation of sterilization process (Ref Clause 7.5.2)7.5.6Validation of Processes for Production and Service ProvisionPRO/SYS/09Procedure for validation of sterilization process (Ref Clause 7.5.2)7.5.7Particular requirements for validation of processes for sterilization and sterilebarrier systemsPRO/SYS/09Procedure for validation of sterilization process (Ref Clause 7.5.2)7.5.8IdentificationPRO/STR/01Procedure for identification of products(Ref Clause 7.5.3.1)7.5.9Identification and TraceabilityPRO/STR/02Procedure for traceability (Ref Clause 7.5.3.2)7.5.10Customer PropertyF/MKT/05Customer Property Monitoring Register7.5.11Preservation of ProductsE/SYS/02/STRProcess approach for Stores7.6Control of Measuring and Monitoring EquipmentPRO/SYS/07Procedure for control of monitoring and measuring equipments (Ref Clause 7.6)F/SYS/03Calibration Status Of Instrument / EquipmentClause No. 08 à Measurement, Analysis and improvement8.1GeneralQM 01Quality manual8.2Monitoring And Measurement8.2.1Feedback8.2.2Customer complaint8.2.3Reporting to regulatory authoritiesPRO/MKT/01Procedure for customer feedbackF/MKT/02Customer Complaint reportF/MKT/03Customer Feed Back FormF/MKT/04Medical Practitioner Feedback FormF/SYS/17Communication reportTo get more information about ISO 13485 documentation kit Click HereE-mail: sales@globalmanagergroup.comTele: 91-79-2979 5322Page 5 of 14
D126: DEMO OF ISO 13485:2016 Medical Device Document KitPrice 399 USD Total editable documentation packageComplete editable document tool kit (Quality manual, procedures, exhibits, formats,SOPs, process flow chart, audit checklist, medical device file etc.)Buy: www.Documentationconsultancy.com8.2.4Internal AuditPRO/SYS/04Procedure for internal audit (Ref Clause 8.2.2)E/SYS/02/QCDProcess approach for Quality ControlF/SYS/06Audit Plan / ScheduleF/SYS/07Internal Audit Non–Conformity ReportF/SYS/08Clausewise Document wise Audit Review Report8.2.5Monitoring and measurement of productE/QCD/01Quality Plan8.2.6Monitoring and measurement of processesPRO/SYS/10Procedure for monitoring and measurement of process (Ref Clause 8.2.3)F/SYS/05Quality objective monitoring reportF/SYS/12Qualitative process monitoring report8.3Control of Non confirming productsPRO/PRD/01Procedure for control of non confirming products (Ref Clause 8.3)E/PRD/01Exhibit for disposal of non confirming products8.4Analysis of DataPRO/SYS/11Procedure for Analysis of data8.5ImprovementPRO/SYS/12Procedure for issue and implementation of advisory notice (Ref Clause 8.5.1)PRO/SYS/06Procedure for corrective and preventive actions (Ref Clause 8.5.2 and 8.5.3)F/SYS/10Corrective Action ReportF/SYS/11Preventive Action ReportMaster Reference GuidelinePRO/SYS/13Procedure for Hazard AnalysisF/SYS/14Hazard AnalysisF/SYS/15Risk analysis sheetF/SYS/16Risk indemnification sheetClause wise audit questionnaireDepartment wise audit questionnairesTo get more information about ISO 13485 documentation kit Click HereE-mail: sales@globalmanagergroup.comTele: 91-79-2979 5322Page 6 of 14
D126: DEMO OF ISO 13485:2016 Medical Device Document KitPrice 399 USD Total editable documentation packageComplete editable document tool kit (Quality manual, procedures, exhibits, formats,SOPs, process flow chart, audit checklist, medical device file etc.)Buy: www.Documentationconsultancy.comPart: C Documentation:Our document kit is having sample documents required for implementation of ISO 13485:2016. Thedocuments are prepared by the highly experienced team of people with rich experience of processimprovement and process enhancement and many companies are certified successfully under ISO13485:2016 with our help. You need to study the document kit and do necessary changes as peryour company need and within 1 week your entire documents are ready as well as your team willgot many ideas for system establishment to reduce the cost and effort with all necessary controlsand your total documents are ready. We had given all type of templates and organization use it asper their need and many organization are certified globally in 1st trial with the help of ourdocuments from any kind of stringent lead appraisal audit.Under this directory many files are made in word Document as per the details listed below. All thedocuments are related to ISO 13485:2016 for and user can edit it in line with their own processes.1. Quality Manual:It covers sample copy of quality manual and requirement wise details for how ISO 13485:2016 isimplemented. It covers sample policy for all process areas, Quality policy and organization structure andstcovers 1 tier of ISO 13485:2016 documents.(A) Table Of ContentsChapterNo.SubjectSection–11.Cover page, table of contents and authorization statement2.Company profile3.Control and distributionSection–24.Quality Management System5.Management Responsibility6.Resource Management7.Product Realization8.Measurement, Analysis And ImprovementAnnexureANX–I List of proceduresANX–II Glossary of termsANX–III Process flow chartANX–IV Quality PolicyANX–V Organization structurePageNo.ISO 13485References1–46–78–9 10 – 1314 – 1718 – 1920 – 2829 – 344.05.06.07.08.0353637 – 383940 2. Procedures (19 Procedures):It covers sample copy of procedures covering all the specific practice areas of 19 processes. Ourprocedures help the organization to make the best system and quick process improvements. All proceduresare as listed below.To get more information about ISO 13485 documentation kit Click HereE-mail: sales@globalmanagergroup.comTele: 91-79-2979 5322Page 7 of 14
D126: DEMO OF ISO 13485:2016 Medical Device Document KitPrice 399 USD Total editable documentation packageComplete editable document tool kit (Quality manual, procedures, exhibits, formats,SOPs, process flow chart, audit checklist, medical device file etc.)Buy: www.Documentationconsultancy.comList of Procedures (19 /STR/02PRO/STR/03Name of ProcedureTotal PageProcedure for Management reviewProcedure for Document and Data ControlProcedure for Control of recordsProcedure for Internal AuditProcedure for TrainingProcedure For Corrective And Preventive ActionProcedure For Control of Monitoring And Measuring EquipmentsProcedure for Control of Monitoring of work environmentProcedure for validation of sterilization processProcedure For Monitoring And Measurement of ProcessesProcedure For Analysis of DataProcedure For Issue And Implementation of Advisory NoticesProcedure For Hazard IdentificationProcedure for customer satisfaction surveyProcedure for PurchasingProcedure for Control of Non–Conforming ProductsProcedure for identification of productsProcedure for traceabilityProcedure for preservationTotal Pages 03070303030404020303020201020502020202553. Exhibits (04 Exhibits):It covers sample copy of guidelines covering all the details and for training to the user toimplement the processes and get detail ideas for process implementation and improvement.List of Exhibits (04 Exhibits)Sr. No.1.2.3.4.Guideline No.E/HRD/01E/PRD/01E/QCD/01E/SYS/01Name of GuidelinesTotal Pages01010101Skill RequirementsDisposal of Non–conforming ProductsQuality PlanDocument codification systemTotal Pages 044. Formats (61 Formats)It covers sample copy of forms required to maintain records as well as establish control and make system inthe organization. The samples given are as a guide and not compulsory to follow and organization is free tochange the same to suit own requirements.List of Formats (61 Formats)Sr. No.Format No.Name of Format1.F/PUR/01Purchase Order2.F/PUR/02Indent cum Incoming inspection report3.F/PUR/03Approved Vendor list cum open purchase order4.F/PUR/04Supplier Registration formTo get more information about ISO 13485 documentation kit Click HereE-mail: sales@globalmanagergroup.comTele: 91-79-2979 5322Page 8 of 14
D126: DEMO OF ISO 13485:2016 Medical Device Document KitPrice 399 USD Total editable documentation packageComplete editable document tool kit (Quality manual, procedures, exhibits, formats,SOPs, process flow chart, audit checklist, medical device file etc.)Buy: www.Documentationconsultancy.com5.F/PUR/05Open Purchase Order6.F/ST/01Daily Stock Statement7.F/ST/02Gate Pass8.F/DND/01Design And Development Plan9.F/DND/02Design Review Minutes Of Meeting10.F/DND/03Design Verification Report11.F/DND/04Design Validation Report12.F/ENG/01Breakdown History Card13.F/ENG/02Preventive Maintenance Schedule14.F/ENG/03Equipment Wise preventive maintenance checkpoints15.F/MKT/01Order form/ confirmation16.F/MKT/02Customer Complaint report17.F/MKT/03Customer Feed Back Form18.F/MKT/04Medical Practitioner Feedback Form19.F/MKT/05Customer Property Monitoring Register20.F/OPN/01Temperature Record21.F/OPN/02Validation Of Autoclave By Biological Indicator22.F/OPN/03Temperature And Relative Humidity Record (Parentral)23.F/OPN/04Temperature And Relative Humidity Record (Washing & Sterilization)24.F/OPN/05Temperature And Relative Humidity Record (Filling and Manufacturing)25.F/OPN/06Differential Pressure Monitoring Record (Parentral)26.F/OPN/07Differential Pressure Monitoring Record (Washing & Sterilization)27.F/OPN/08Differential Pressure Monitoring Record (Ointment)28.F/OPN/09Temperature & Humidity Monitoring Record – General area29.F/OPN/10Microbial Monitoring Of Production Area By Settling Plate Method30.F/OPN/11Microbial Monitoring Of Production Area By Settling Plate Method – Ointmentpreparation31.F/OPN/12Microbial Monitoring By Swab /Surface Contact Technique – Parenteral inpreparation.32.F/OPN/13Microbial Monitoring – Microbial Testing Of Sterile Garments33.F/OPN/14Testing Of Personnel By Finger Dab34.F/OPN/15Microbial Monitoring By Swab /Surface Contact Technique35.F/SER/01Service report36.F/SER/02Repairing card37.F/SER/03Installation commissioning report38.F/SYS/01Master List Cum Distribution List Of Documents39.F/SYS/02Change Note40.F/SYS/03Calibration Status Of Instrument / EquipmentTo get more information about ISO 13485 documentation kit Click HereE-mail: sales@globalmanagergroup.comTele: 91-79-2979 5322Page 9 of 14
D126: DEMO OF ISO 13485:2016 Medical Device Document KitPrice 399 USD Total editable documentation packageComplete editable document tool kit (Quality manual, procedures, exhibits, formats,SOPs, process flow chart, audit checklist, medical device file etc.)Buy: www.Documentationconsultancy.com41.F/SYS/04Master list of records42.F/SYS/05Quality Objective Monitoring Report43.F/SYS/06Audit Plan / Schedule44.F/SYS/07Internal Audit Non–Conformity Report45.F/SYS/08Clausewise Documentwise Audit Review Report46.F/SYS/09Continual Improvement Plan47.F/SYS/10Corrective Action Report48.F/SYS/11Preventive Action Report49.F/SYS/12Qualitative Process Monitoring Report50.F/SYS/13Vendor Rating51.F/SYS/14Hazard Analysis Report52.F/SYS/15Risk analysis sheet53.F/SYS/16Risk indemnification sheet54.F/SYS/17Communication report55.F/TRG/01Training Calendar56.F/TRG/02Training Need Cum Records Sheet57.F/TRG/03Induction Training Report58.F/TRG/04Job Description and Specification59.F/TRG/05Skill Matrix60.F/TRG/06Training Report61.F/TRG/07Skill Matrix for QC Personnel5. Standard Operating Procedures (06 SOPs)It covers sample copy of work instructions to link with significant aspects issues in theorganization. It takes care of all such issues and used as a training guide as well as to establishcontrol and make system in the organization. The samples given are as a guide and notcompulsory to follow and organization is free to change the same to suit own requirements.List of SOPsName of SOPSr. No.SOP No.1.W/OPN/01Measurement Of Temperature And Humidity022.W/OPN/02Validation of Autoclave033.W/OPN/03Microbial Monitoring of Production perature & Humidity Monitoring026.W/OPN/06Clean Room Condition Monitoring034.Monitoring ofLaboratoryTotal PageSterilityRoomandTotal Pages 0219To get more information about ISO 13485 documentation kit Click HereE-mail: sales@globalmanagergroup.comTele: 91-79-2979 5322Page 10 of 14
D126: DEMO OF ISO 13485:2016 Medical Device Document KitPrice 399 USD Total editable documentation packageComplete editable document tool kit (Quality manual, procedures, exhibits, formats,SOPs, process flow chart, audit checklist, medical device file etc
B. ISO 13485:2016 requirementwise documents list: Document No Clause No./Document Title Clause No. 04 Quality Management System 4.1 General Requirements QM 01 Quality manual 4.2 Documentation Requirements PRO/SYS/02 Procedure for Document and Data control (Ref Clause 4.2.3) F/SYS/01 Master List Cum Distribution List Of Documents
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
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.
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 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
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
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
ISO 13485:2016-based Quality Management System by clearing up any misconceptions regarding the standard'srequirements. . ISO 13485 has an additional set of requirements specific to the medical device industry, and it discards some of the requirements of the new ISO 9001. Therefore, compliance with ISO 13485 does not imply
