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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.)Buy: www.Documentationconsultancy.com6. Process Flow ChartList of Process flow chartsSr.No.1.2.3.4.5.Process flowchart DE/SYS/02/MKT6. E/SYS/02/MR7. E/SYS/02/PRD8. E/SYS/02/PUR9. E/SYS/02/QCD10. E/SYS/02/STR11. E/SYS/02/INS12. E/SYS/02/STRName of Process Flow ChartsProcess approach for DespatchProcess approach for Design and DevelopmentProcess approach for EngineeringProcess approach for TrainingProcess approach for MarketingProcess approach for Management RepresentativeProcess approach for ProductionProcess approach for PurchaseProcess approach for Quality ControlProcess approach for StoresProcess approach for Installation and CommissioningProcess approach for ServicingTotal Pages Total Page020403030502020404040303397. ISO 13485:2016 audit questionnaire (02 files of more than 900 Questions)There covers audit questions based on ISO 13485:2016 requirements as well as for Clausewisequestions and department wise question. It will be very good tool for the auditors to make auditQuestionnaire / clause wise audit Questionnaire while auditing and make effectiveness inauditing.8. ISO 13485:2016 medical devices file (21 files)There covers medical devices technical files for ISO 13485:2016.To get more information about ISO 13485 documentation kit Click HereE-mail: sales@globalmanagergroup.comTele: 91-79-2979 5322Page 11 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.comChapter-2.0 ABOUT COMPANYGlobal manager group is a progressive company and promoted by a group of qualifiedengineers and management graduates having rich experience of 20 years in ISOconsultancy and management areas. The company serves the global customers throughon-site and off-site modes of service delivery systems. We offer a full range of consultingservices geared towards helping all types of organizations to achieve competitiveness,certifications and compliance to international standards and regulations. So far we hadmore than 1800 clients in more than 45 countries. Our readymade training andeditable document kit helps the client in making their documents easy and makethem complying to related standard faster with the establishment of best processes.It helps the organization to make the best system with process improvementconcepts and helps the organization to get best performances in terms of reductionin costing, efforts and get the things done timely with Quality product. Thus it helpsthe organization to give full value for money and pay back of our product is lessthan 2 month.1. Our promoters and engineers have experience of more than 1800 companies globally formanagement training, ISO consultancy, process improvement concept implementation andISO series consultancy. We had clients in more than 45 countries.2. Highly qualified 50 team members (M.B.A., Degree engineers) and owner is having richprofessional experience (since 1991).3. We have 100% success rate for global standards certification including ISO of our clientsfrom reputed certifying body and branded image and leading name in the market.4. Suggest continual improvement and cost reduction measures as well as highly informativetraining presentations and other products gives payback within 2 months against our cost.5. So far more than 50000 employees are trained by us in ISO series certification in last 20years.6. We had spent more than 10000 man-days (30 man years) in preparing ISO documents,management kits and training slides.7. Our product gives lot of opportunity for process improvements and gives full benefits to theusers.Global Manager Group is committed for:1.2.3.4.5.Personal involvement & commitment from first dayOptimum chargesProfessional approachHard work and update the knowledge of team membersStrengthening clients by system establishment and providing best training materials in anyareas of management to make their house in proper manner6. To establish strong internal control with the help of system and use of the latestmanagement techniquesTo get more information about ISO 13485 documentation kit Click HereE-mail: sales@globalmanagergroup.comTele: 91-79-2979 5322Page 12 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.comChapter-3.0 USER FUNCTION3.1 Hardware and Software RequirementsA. Hardware: Our document kit can be better performed with the help of P3 and above computerswith a minimum 10 GB hard disk space. For better visual impact of the power point Document you may keep the setting ofcolour image at high colour.B. Software used in Document kit Documents written in Ms Office 2003 and window xp programs. You are thereforerequired to have office 2003 or above with window xp and later.3.2 Features of Document kit:- Contains all necessary documents as listed above and comply with the requirementsof ISO 13485:2016 guidelines for product and services development technical report. Written in Plain English It will save much time in typing and preparation of documents alone. User-friendly and easy to learn. Developed under the guidance of experienced experts. Provides model of a Management system that is simple and free from excessivepaperwork.To get more information about ISO 13485 documentation kit Click HereE-mail: sales@globalmanagergroup.comTele: 91-79-2979 5322Page 13 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.comChapter-4.0 BENEFITS OF USING OUR DOCUMENT KIT1. By using these documents, you can save a lot of your precious time while preparingyour company to the ISO 13485:2016 documents.2. Take care for all the section and sub sections of ISO 13485:2016 guidelines andhelps you in establishing better system.3. Document kit enables you to change the contents and print as many copies as youneed. The user can modify the documents as per their industry and create own ISO13485:2016 documents for their organization4. Readymade templates and sample documents are available which can reduce yourtime in document preparation5. Save much time and cost in document preparation6. The audit questions helps in making perfect audit checklist7. You will get better control in your system due to our proven formats and templatesFor Purchase Click HereBUYTo get more information about ISO 13485 documentation kit Click HereE-mail: sales@globalmanagergroup.comTele: 91-79-2979 5322Page 14 of 14

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/