ISO 13485 Medical Devices Implementation System
R6350,00
Take the stress out of ISO 13485:2016 Medical device compliance implementation, compliance and certification, with our expertly crafted ISO 13485:2016 Implementation products. Designed for businesses of all sizes, these guides and templates make implementing and maintaining ISO 13485:2016 Medical device compliance standards simple, efficient, and affordable.
This package includes:
✔ Comprehensive ISO 13485:2016 Medical device compliance Implementation Guides and Required Documentation.
✔ Fully customizable with no restrictions or copyrights.
✔ Includes 204 essential ISO 13485:2016 documentation, in the following folders:
- Additional HSE Working Documents_v5
- ISO 13485 Implementation Guides
- Quality Management System
- Management Responsibility
- Resource Management
- Product Realization
- Measurement, Analyses and Improvement
✔ Package includes additional recommended ISO 13485:2016 documentation, including:
- Policies
- Procedures
- Safe work method statements
- Safety plans
- Checklists
- Registers
- Reports
- Toolbox talks
- Legal documents
- And much more!
✔ Designed to simplify ISO 13485:2016 Medical device compliance and streamline your business operations.
✔ Backed by 12 years industry expertise and best practices.
Why Choose This Product?
Our ISO 13485:2016 Medical device compliance implementation package is a one-stop solution for achieving compliance and certification with ease. Whether you’re preparing for certification or improving your systems, this package offers unbeatable value, time-saving convenience, and complete peace of mind.
Description
This Package Contains: v5
QMS-08-00 – Procedure – Control of Non-Conforming products & Rework.docx
QMS-08-00 – Procedure – Data analysis.docx
QMS-08-00 – Procedure – Improvement by Preventative Action.docx
QMS-08-00 – Procedure – Improvement regarding corrective action.docx
QMS-08-00 – Procedure – Internal and External Auditing.docx
QMS-08-00 – Procedure – Rework of non-conforming products.docx
QMS-08-00 – Register – Corrective Action (CAR).docx
QMS-08-00 – Register – Equipment Calibration.docx
QMS-08-00 – Register – Meetings, Audits and Management Review Schedule.docx
QMS-08-00 – Report – HSE Non-Conformance_Observation List.docx
QMS-08-00 – Report – Internal Audit Report.docx
QMS-08-00 – Report – Non-conformance and Corrective Action.docx
QMS-08-00 – Report – Parts Non-Conformance Report.docx
QMS-08-00 – Report – Supplier Corrective Action Request.docx
QMS-08-00 – Report – Supplier Performance Monitoring Report.docx
QMS-08-00 – Report – Supplier Quality Assurance Evaluation Report.docx
00. Clause for Clause Summary.docx
00. Company Letterhead – QMS Master Landscape.docx
00. Company Letterhead – QMS Master Portrait.docx
00. ISO 13485_ A Complete Guide to Quality Management in the Medical Device Industry ( PDF Drive ).pdf
00. Plan – Template – Complete.docx
00. Procedure -Template .docx
QMS-04-00 – Register – Management of Change Control.docx
QMS-04-00 – Form – Management of Change Request.docx
QMS-04-00 – OHS Scope.docx
QMS-04-00 – Plan – Management of Change.docx
QMS-04-00 – Procedure – Control of documents, records, data and change control.docx
QMS-04-00 – Procedure – Validation of the implementation and application of computer software.docx
QMS-04-00 – Quality Manual.docx
QMS-04-00 – Register – Control of Documents (ISO9001).docx
QMS-04-00 – Register – Document Storage and Retention.docx
QMS-04-00 – Register – Legal Compliance.docx
QMS-05-00 – Agenda – Management Review Meeting.docx
QMS-05-00 – Agenda – Planning Meeting – Table Format.docx
QMS-05-00 – Agenda – QMS Committee Meeting.docx
QMS-05-00 – Appointment – QMS Manager.docx
QMS-05-00 – Flowchart – HSE Issue Resolution.docx
QMS-05-00 – Flowchart – HSE Non-Conformance Resolution.docx
QMS-05-00 – Form – Job Position Request Description Form.docx
QMS-05-00 – Form – Objectives and Targets Management Plan Template.docx
QMS-05-00 – Legal – Non-Disclosure Agreement (NDA).docx
QMS-05-00 – Legal – Service Level Agreement.docx
QMS-05-00 – Organogram – Company.docx
QMS-05-00 – Policy – Quality Policy Statement.docx
QMS-05-00 – Policy – Quality Policy.docx
QMS-05-00 – Procedure – Leadership, roles, responsibilities and authorities.docx
QMS-05-00 – Procedure – Management Review.docx
QMS-05-00 – Register – Interested Parties.docx
QMS-05-00 – Register – Objectives and targets.docx
QMS-06-00 – Checklist – Resources Monitoring and Measurement.xlsx
QMS-06-00 – Checklist – Supplier Compliance Questionnaire.docx
QMS-06-00 – Form – Employee Training Plan Template.docx
QMS-06-00 – Plan – Supplier_Contractor Management.docx
QMS-06-00 – Procedure – Control of contaminated or potentially contaminated product.docx
QMS-06-00 – Procedure – Induction, Training and Competency.docx
QMS-06-00 – Procedure – Maintenance and Preventative Maintenance activities.docx
QMS-06-00 – Procedure – Monitoring and Control of the Work Environment.docx
QMS-06-00 – Register – Approved Supplier Register.docx
QMS-06-00 – Register – Incident Control.docx
QMS-06-00 – Register – Training – Objectives & Targets Plan.docx
QMS-06-00 – Register – Training – Objectives and Targets.docx
QMS-06-00 – Register – Training – Policy.docx
QMS-06-00 – Register – Training.docx
QMS-06-00 – Report – Employee Evaluation.docx
QMS-06-00 – Training Matrix – resources & Competencies.xlsx
QMS-07-00 – Checklist – Vehicles.docx
QMS-07-00 – Form – Equipment Maintenance Record.docx
QMS-07-00 – Form – Project Change Control Log.docx
QMS-07-00 – Form – Project Change Request.docx
QMS-07-00 – Form – Requisition Form.docx
QMS-07-00 – Form – Supplier Corrective Action Request.docx
QMS-07-00 – Procedure – Calibration.docx
QMS-07-00 – Procedure – Criteria, evaluation and selection of outsourced suppliers & record.docx
QMS-07-00 – Procedure – Design & Development, transfer & record control.docx
QMS-07-00 – Procedure – Medical device installation & verification of installation.docx
QMS-07-00 – Procedure – Monitoring and Measurement of Equipment.docx
QMS-07-00 – Procedure – Preserving the conformity of product.docx
QMS-07-00 – Procedure – Procurement Management.docx
QMS-07-00 – Procedure – Product identification & Tracability.docx
QMS-07-00 – Procedure – Product realization.docx
QMS-07-00 – Procedure – Production and service provision process validation and its records .docx
QMS-07-00 – Procedure – Risk and Opportunity Management.docx
QMS-07-00 – Procedure – Servicing of the medical device and its records.docx
QMS-07-00 – Procedure – Validation of a process for sterilization & sterile barriers systems.docx
QMS-07-00 – Register – Non Conformance.docx
QMS-07-00 – Register – Risk & Opportunities.docx
QMS-07-00 – Report – Customer Satisfactory and feedback.docx
QMS-07-00 – Report – Incident Investigation – Basic.docx
QMS-08-00 – Form – Calibration Record.docx
QMS-08-00 – Monitoring – Improvement Monitoring – Management Review.docx
QMS-08-00 – Monitoring – Products and Services Continual Improvement.docx
QMS-08-00 – Plan – Continual Improvement – Template.docx
QMS-08-00 – Procedure – Communication and Customer feedback.docx
QMS-08-00 – Procedure – Complaint handling.docx
QMS-08-00 – Procedure – Control of Non-Conformance and Corrective Actions.docx
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Working Documentation Pack:
QMS-00-00 – Procedure -Management Reviews.docx
QMS-00-00 – Procedure -Metrological Traceability.docx
QMS-00-00 – Procedure -Personnel Training.docx
QMS-00-00 – Procedure -Personnel.docx
QMS-00-00 – Procedure -Structural.docx
QMS-00-00 – Procedure -Technical Records.docx
QMS-00-00 – Procedure -Validation of Implementation and Application of Computer Software.docx
QMS-00-00 – Register – Equipment Calibration.docx
QMS-00-00 – Report – Parts Non-Conformance.docx
QMS-00-00 – Survey – Customer Satisfactory.docx
QMS-00-00 – Survey – Employee Evaluation.docx
QMS-00-00 – Survey – Supplier Performance Monitoring.docx
QMS-00-00 – Training Matrix – resources & Competencies.xlsx
QMS-00-00 – Form – Calibration Record.docx
QMS-00-00 – Form – Employee Training Plan Template.docx
QMS-00-00 – Form – Equipment Maintenance Record.docx
QMS-00-00 – Form – Project Change Control Log.docx
QMS-00-00 – Form – Project Change Request.docx
QMS-00-00 – Form – Requisition – Form.docx
QMS-00-00 – Form – Supplier Corrective Action Request.docx
QMS-00-00 – Plan – Supplier_Contractor Management.docx
QMS-00-00 – Procedure – Control of Documents, Data and Change Management.docx
QMS-00-00 – Procedure – Ensuring The Validity of Results.docx
QMS-00-00 – Procedure – Evaluation of measurement Uncertainty.docx
QMS-00-00 – Procedure – Handling of Test or Calibration Items.docx
QMS-00-00 – Procedure – Internal & External Auditing .docx
QMS-00-00 – Procedure – Reporting of Results.docx
QMS-00-00 – Procedure – Review of requests, tenders and contracts.docx
QMS-00-00 – Procedure – Sampling.docx
QMS-00-00 – Procedure – Selection, Verification and Validation Methods.docx
QMS-00-00 – Procedure -Calibration and Validation of Analytical Methods .docx
QMS-00-00 – Procedure -Complaint Handling.docx
QMS-00-00 – Procedure -Confidentiality.docx
QMS-00-00 – Procedure -Control of Data and Information Managerment.docx
QMS-00-00 – Procedure -Control of Risks and Opportunities.docx
QMS-00-00 – Procedure -Equipment.docx
QMS-00-00 – Procedure -Externally Provided Products & Services.docx
QMS-00-00 – Procedure -Facilities & Environmental Conditions.docx
QMS-00-00 – Procedure -Impartiality.docx
QMS-00-00 – Procedure -Improvement.docx
QMS-00-00 – Procedure -Internal Audits.docx
