ISO 15378 Documents With Manual Procedures By .
D141: DEMO OF ISO 15378:2017 DOCUMENT KIT for primarypackaging material for medicinal products GMPPrice 899 USDComplete editable ISO 15378:2017 document kit (Manual, procedures,exhibits, process approach, SOPs, formats, audit checklist etc.)Buy: www.Documentationconsultancy.comChapter-1.0 CONTENTS OF ISO 15378:2017 DOCUMENT KITfor primary packaging industry GMP(Morethan 150files)The Total EditableDocumentkit documenthas 7 main directoriesas below.ISO 15378:2017 Editable Document kitSr. No.List of DirectoryDocument of Details1.System Manual2.Procedures3.Exhibits04 exhibits in MS WordFormats43 formats in MS Word / excel4.10 chapter and 04 annexure in MS Word18 procedures in MS WordEngineering (ENG)03 formats in MS WordPurchase (PUR)05 formats in MS WordDND04 formats in MS WordMarketing (MKT)04 formats in MS WordOperation (OPN)01 formats in MS WordStores (STR)02 formats in MS WordSystem (SYS)17 formats in MS Word / ExcelTraining (TRG)07 formats in MS Word5.Process approach12 process approach in MS Word6.Standard operatingprocedures61 standard operating procedure in MSWord7.Maintenance (MNT)03 standard operating procedure in MS WordProduction (PRD)17 standard operating procedure in MS WordQuality Assurance (QA)24 standard operating procedure in MS WordQuality Control (QCD)11 standard operating procedure in MS WordSafety (SFT)03 standard operating procedure in MS WordStores (STR)02 standard operating procedure in MS WordInformation Technology (IT)01 standard operating procedure in MS WordAudit checklistMore than 800 questionsTotal 150 files quick download in editable form by e deliveryTo get more information about ISO 15378:2017 Documentation kit Click Herewww.globalmanagergroup.com E mail sales@globalmanagergroup.com Tele: 91-79-2979 5322Page 1 of 8
D141: DEMO OF ISO 15378:2017 DOCUMENT KIT for primarypackaging material for medicinal products GMPPrice 899 USDComplete editable ISO 15378:2017 document kit (Manual, procedures,exhibits, process approach, SOPs, formats, audit checklist etc.)Buy: www.Documentationconsultancy.comB. Documentation:Our document kit is having sample documents required for ISO 15378:2017 certification aslisted below. You need to study it do necessary changes as per your company need andwithin 4 days your entire editable documents with all necessary details are ready as wellas your team will gotmany ideas for system establishment to reduce the cost and effortwith all necessary controls and your total documentsare ready. We had given all type oftemplates and organization use it as per their need and many organizations are certifiedglobally in 1sttrial with the help of our documents from any kind of stringent lead appraisalaudit.Under this directory further files are made in word document as per the details listedbelow. All the documents are related to ISO 15378:2017 for and user can edit it in line withtheir own processes.1. ISO 15378:2017 Manual:It covers sample copy of ISO 15378:2017 manual. It covers 10 chapter and 04 annexure as wellas list of procedures as well as overview of covers tier1 of ISO 15378:2017 documents.ISO 15378:2017Manual IndexChapterNo.PageNo.SubjectISO 15378:2017ClauseReferenceSection – 11.2.3.Company profileTable of contentsControl and distribution1–21–21–2Section – 2Context of the Organization4.5.6.Understanding the organization and its contextUnderstanding the needs and expectations ofinterested partiesDetermining the scope of the quality managementsystemQuality management system and its ship5.0Leadership & CommitmentPolicyOrganizational roles, responsibilities and authorities5.15.25.31–5Planning6.0Action to address risks and opportunitiesQuality objectives and planning to achieve themPlanning of changes6.16.26.31–2To get more information about ISO 15378:2017 Documentation kit Click Herewww.globalmanagergroup.com E mail sales@globalmanagergroup.com Tele: 91-79-2979 5322Page 2 of 8
D141: DEMO OF ISO 15378:2017 DOCUMENT KIT for primarypackaging material for medicinal products GMPPrice 899 USDComplete editable ISO 15378:2017 document kit (Manual, procedures,exhibits, process approach, SOPs, formats, audit checklist etc.)Buy: ed onal planning and controlRequirements for products and servicesDesign and development of products and servicesControl of externally provided processes, productsand servicesProduction and service provisionRelease of products and servicesControl of nonconforming outputs8.18.28.38.41 – 108.58.68.7Performance evaluation9.0Monitoring, measurement, analysis and evaluationInternal auditManagement rmity and corrective actionContinual IIANX–IIIANX–IVList of Documented informationGlossary of termsCompany activity process flow chartOrganization structure1–21–11–21–1 2. Procedures (18 Procedures):It covers sample copy of mandatory procedures covering all the details of ISO 15378:2017.List of procedure1.2.3.4.5.6.7.8.9.10.Procedure 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 ProcessesTo get more information about ISO 15378:2017 Documentation kit Click Herewww.globalmanagergroup.com E mail sales@globalmanagergroup.com Tele: 91-79-2979 5322Page 3 of 8
D141: DEMO OF ISO 15378:2017 DOCUMENT KIT for primarypackaging material for medicinal products GMPPrice 899 USDComplete editable ISO 15378:2017 document kit (Manual, procedures,exhibits, process approach, SOPs, formats, audit checklist etc.)Buy: 17.18.Procedure For Analysis of DataProcedure For Risk ManagementProcedure for Customer satisfaction surveyProcedure for PurchasingProcedure for Control of Non–Conforming ProductsProcedure for Identification of productsProcedure for TraceabilityProcedure for Preservation3. Exhibits (04 exhibits).It covers sample copy of exhibits covering all the details of ISO 15378:2017.List of exhibits1.2.3.4.Skill RequirementsDisposal of Non–conforming ProductsQuality PlanDocument codification system4. Blank Formats (43 Formats):It covers sample copy of blank forms required to maintain records as well as establish control andmake system. The samples given are as a guide and not compulsory to follow to change thesame to suit own requirements.List of 33.35.Purchase OrderApproved Vendor list cum open purchase orderOpen Purchase OrderGate PassDesign Review Minutes Of MeetingDesign Validation ReportPreventive Maintenance ScheduleOrder form/ confirmationCustomer Feed Back FormMaster List Cum Distribution List Of DocumentsCalibration Status Of Instrument / EquipmentQuality Objective Monitoring ReportInternal Audit Non–Conformity ReportContinual Improvement PlanPreventive Action ReportVendor RatingRisk analysis sheet37.39.41.43.Training CalendarInduction Training ReportSkill MatrixSkill Matrix for QC PersonnelCommunication 34.36.38.40.42.Indent cum Incoming inspection reportSupplier Registration formDaily Stock StatementDesign And Development PlanDesign Verification ReportBreakdown History CardEquipment Wise preventive maintenance checkpointsCustomer Complaint reportCustomer Property Monitoring RegisterChange NoteMaster list of recordsAudit Plan / ScheduleClausewise Documentwise Audit Review ReportCorrective Action ReportQualitative Process Monitoring ReportList of license/certificateRisk indemnification sheetTemperature & Humidity Monitoring Record – GeneralareaTraining Need Cum Records SheetJob Description and SpecificationTraining ReportTo get more information about ISO 15378:2017 Documentation kit Click Herewww.globalmanagergroup.com E mail sales@globalmanagergroup.com Tele: 91-79-2979 5322Page 4 of 8
D141: DEMO OF ISO 15378:2017 DOCUMENT KIT for primarypackaging material for medicinal products GMPPrice 899 USDComplete editable ISO 15378:2017 document kit (Manual, procedures,exhibits, process approach, SOPs, formats, audit checklist etc.)Buy: www.Documentationconsultancy.com5. Process approach (12process approaches):It covers sample copy of process approach covering all the details of ISO 15378:2017.List of process approach1.2.3.4.5.6.7.8.9.10.11.12.Process Flow Chart of Customer ServiceProcess Flow Chart of Design and DevelopmentProcess Flow Chart of DespatchProcess Flow Chart of EngineeringProcess Flow Chart of MarketingProcess Flow Chart of Production Planning and ControlProcess Flow Chart of ProductionProcess Flow Chart of PurchaseProcess Flow Chart of Quality ControlProcess Flow Chart of Risk & OpportunityProcess Flow Chart of StoresProcess Flow Chart of Training6. Standard operating procedures (61SOPs):It covers sample copy of standard operating procedures covering all the details of ISO15378:2017.List of standard operating procedures (SOPs)1.3.Preventive & Breakdown Maintenance ProcessRodent & Fly Control Maintenance Process2.4.5.Packing Process Of Alluminium Collapsible Tubes6.7.9.Operation & Cleaning Of Extrusion PressOperation & Cleaning Of Annealing MachineOperation & Cleaning Of Coating & PrintingMachineSOP for Process For Making Purchases Of RawMaterialsSOP for Operation Of Necking & Bidding MachineSOP for Process For Running Capping MachineSOP for Process For Printing Of Laminated WebSOP for SOPSOP for Receipt and Handling of MarketComplaintsSOP for Handling of market returnsSOP for Deviation and InvestigationSOP for Out of Calibration (OOC)SOP for Generation and Movement of ngSOP for Handling and storage of controlled samplesSOP for Mock recallSOP for Failure investigationSOP for Fundamentals of validation sopSOP for Guidelines for area validation–clean areaSOP for Handling Customer ComplaintSOP for Testing And Approval Of Trimmed TubesSOP for Testing And Approval Of Lacquered TubesSOP for Testing And Approval Of Latex Lined8.10.Cleaning & HousekeepingManufacturing Process of Alluminium Collapsible TubesIn-process Checking Frequency Of Different ParametersOf All ProductsOperation & Cleaning Of Trimming MachineOperation & Cleaning Of Lacquering Machine12.Operation & Cleaning Of Latex Lining Machine14.SOP for Process For Issuing Line Clearance16.18.20.22.SOP for Process Of Washing For CansSOP for Process For Production Of Laminated TubesSOP for Manufacturing Of Plastic BottlesSOP for Control of Version, Archival and Retrieval of Data24.SOP for Product recall26.28.30.32.SOP for Change control systemSOP for Vendor quality auditSOP for Out of specification (OOS)SOP for Rework procedure34.SOP for Printed product label control36.38.40.42.44.46.48.50.52.SOP for Retain samples and its disposalSOP for Batch release of Finished ProductsSOP for Introduction to validationSOP for Re-validationSOP for Validation of HVAC systemSOP for Testing And Approval Of Extruded TubesSOP for Testing and Approval Of Annealed TubesSOP for Testing And Approval Of Coated & Printed TubesSOP for Testing And Approval Of Finished 1.43.45.47.49.51.To get more information about ISO 15378:2017 Documentation kit Click Herewww.globalmanagergroup.com E mail sales@globalmanagergroup.com Tele: 91-79-2979 5322Page 5 of 8
D141: DEMO OF ISO 15378:2017 DOCUMENT KIT for primarypackaging material for medicinal products GMPPrice 899 USDComplete editable ISO 15378:2017 document kit (Manual, procedures,exhibits, process approach, SOPs, formats, audit checklist etc.)Buy: esSOP for Leak Testing In TubesSOP for Leakage Testing Of Laminated TubesSOP for Maintaining Safety Standards In PlantSOP for Receipt of Raw & Packaging MaterialsSOP for IT54.56.58.60.SOP for Testing And Approval Of Laminated TubesSOP for Maintaining Safety Standards In Tool RoomSOP for Maintaining Safety Standards For StorageSOP for Receipt, Storage& Dispatch of Finished Goods7. Audit checklist (more than500 questions)It covers sample audit questions based on all the ISO 15378:2017requirements and GMPimplementation. It helps the auditor to make own audit checklist for quick and perfect auditing toensure all the ISO 15378:2017requirements are fulfilled.Chapter-2.0 ABOUT COMPANYGlobal Manager Groupis a progressive company and promoted by a group of qualifiedengineers and management graduates having rich experience of 25 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 ofindustries and laboratories to achievecompetitiveness, certifications and compliance to international standards and regulations.So far we had more than 1800 clients in more than 45 countries. Our readymadetraining and editable document kit helps the client in making their documents easyand make them complying to related ISOstandard faster.1. Our promoters and engineers have experience of more than 1800 companies globallyfor management training, ISO series consultancy. We had clients in more than 45countries.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 ISO series certification of our clients from reputedcertifying body and branded image and leading name in the market.4. Suggest continual improvement and cost reduction measures as well as highlyinformative training presentations and other products gives payback within 2 monthsagainst our cost.5. So far more than 50000 employees are trained by us in ISOseries certification.6. We had spent more than 60000 man-days (170 man years) in preparing ISOdocuments and training slides.To get more information about ISO 15378:2017 Documentation kit Click Herewww.globalmanagergroup.com E mail sales@globalmanagergroup.com Tele: 91-79-2979 5322Page 6 of 8
D141: DEMO OF ISO 15378:2017 DOCUMENT KIT for primarypackaging material for medicinal products GMPPrice 899 USDComplete editable ISO 15378:2017 document kit (Manual, procedures,exhibits, process approach, SOPs, formats, audit checklist etc.)Buy: www.Documentationconsultancy.comGlobal 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 inany areas of management to make their house in proper manner6. To establish strong internal control with the help of system and use of the latestmanagement techniques.Chapter-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 XP3.2 Features of Document kit:- Contains all necessary documents as listed above and comply with the requirementsof ISO 15378:2017 Standards. 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 15378:2017 Documentation kit Click Herewww.globalmanagergroup.com E mail sales@globalmanagergroup.com Tele: 91-79-2979 5322Page 7 of 8
D141: DEMO OF ISO 15378:2017 DOCUMENT KIT for primarypackaging material for medicinal products GMPPrice 899 USDComplete editable ISO 15378:2017 document kit (Manual, procedures,exhibits, process approach, SOPs, formats, audit checklist 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 preparing theISO 15378:2017documents.2. Take care for all the section and sub sections of ISO 15378:2017 standard helps you inestablishing 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 ISO15378:2017 documents.4. Save much time and cost in document preparation.5. You will get better control in your system due to our proven formats.6. You will get better control in your system due to our proven documents and templatesdeveloped under the guidance of our experts and globally proven consultants havingrich experience of more than 25 years in ISO consultancy.7. Our products are highly sold globally and used by many multinational companies andhad provided total customer satisfaction as well as value for money.8. In preparation of document kits; it is been verified and evaluated at various levels of ourteam and more than 1000 hours are spent in preparation of this product kit.9. Prepared by globally proven team of leading consultantChapter-5.0 METHOD OF ONLINE DELIVERYOn secured completion of purchase we provide user name and password to download theproduct from our ftp server. Thus we are providing instant online delivery of our products touser by sending email of username and password.For Purchase Click HereBUYTo get more information about ISO 15378:2017 Documentation kit Click Herewww.globalmanagergroup.com E mail sales@globalmanagergroup.com Tele: 91-79-2979 5322Page 8 of 8
It covers sample copy of mandatory procedures covering all the details of ISO 15378:2017. List of procedure 1. Procedure for Management review 2. Procedure for Document and Data Control 3. Procedure for Control of records 4. Procedure for Internal Audit 5. Procedure for Training 6. Procedure For Corrective And Preventive Action 7.
ISO 10381-1:2002 da ISO 10381-2:2002 da ISO 10381-3:2001 da ISO 10381-4:2003 da ISO 10381-5:2001 da ISO 10381-6:1993 da ISO 10381-7:2005 ne ISO 10381-8:2006 ne ISO/DIS 18512:2006 ne ISO 5667-13 da ISO 5667-15 da Priprema uzoraka za laboratorijske analize u skladu s normama: HRN ISO 11464:2004 ne ISO 14507:2003 ne ISO/DIS 16720:2005 ne
ISO 10771-1 ISO 16860 ISO 16889 ISO 18413 ISO 23181 ISO 2941 ISO 2942 ISO 2943 ISO 3724 ISO 3968 ISO 4405 ISO 4406 ISO 4407 ISO 16232-7 DIN 51777 PASSION TO PERFORM PASSION TO PERFORM www.mp ltri.com HEADQUARTERS MP Filtri S.p.A. Via 1 Maggio, 3 20060 Pessano con Bornago (MI) Italy 39 02 957
ISO 18400-107, ISO 18400-202, ISO 18400-203 and ISO 18400-206, cancels and replaces the first editions of ISO 10381-1:2002, ISO 10381-4:2003, ISO 10381-5:2005, ISO 10381-6:2009 and ISO 10381-8:2006, which have been structurally and technically revised. The new ISO 18400 series is based on a modular structure and cannot be compared to the ISO 10381
The DIN Standards corresponding to the International Standards referred to in clause 2 and in the bibliog-raphy of the EN are as follows: ISO Standard DIN Standard ISO 225 DIN EN 20225 ISO 724 DIN ISO 724 ISO 898-1 DIN EN ISO 898-1 ISO 3269 DIN EN ISO 3269 ISO 3506-1 DIN EN ISO 3506-1 ISO 4042 DIN
ISO 8402 was published in 1986, with ISO 9000, ISO 9001, ISO 9002, ISO 9003 and ISO 9004 being published in 1987. Further feedback indicated that there was a need to provide users with application guidance for implementing ISO 9001, ISO 9002 and ISO 9003. It was then agreed to re-number ISO 9000 as ISO 9000-1, and to develop ISO 9000-2 as the .
ISO 37120. PAS 181/ISO 37106. PAS 183 – data sharing & IT. PAS 184. PAS 185. a security-minded approach. ISO/IEC 30145 . reference architecture. ISO/IEC . 30146. ISO 37151. ISO 37153. ISO 37156. Data exchange. ISO 37154. ISO 37157. ISO 37158. Monitor and analyse . data. PAS 182/ ISO/IEC 30182. PD 8101. PAS 212. Hypercat. BIM. PAS 184. Role of .
ISO 14644‐1 FEDERAL STANDARD 209E ISO Class English Metric ISO 1 ISO 2 ISO 31 M1.5 ISO 410 M2.5 ISO 5 100 M3.5 ISO 6 1,000 M4.5 ISO 7 10,000 M5.5 ISO 8 100,000 M6.5 ISO 9N/A N/A Standard 209E classifications are out‐of‐date. This standard was officially retired in 2001. Increasing Cleanliness
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