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ISO 13485: Module 3. Complete Ready-to-Use Documentation Templates Package

3.8%491410
ISO 13485: Module 3. Complete Ready-to-Use Documentation Templates Package
We offer you to familiarize yourself with a free example of the process:
"PR-07 CUSTOMER COMPLAINT MANAGEMENT"

Process Modeling Methods:

  • Textual
  • Tabular (RACI chart)
  • Flowchart-based (graphical): BPMN, IDEF0
 491410 935.78$ 899.78$

List of Management System Documents
ISO 13485 «Medical devices. Quality Management Systems. Requirements for regulatory purposes»

TOTAL more than 90 documents (processes, procedures, maps together with forms)
Quality Manual (system guide + 11 forms):
F01/QM-01 Process Interaction Scheme
F02/QM-01 SWOT Analysis
F03/QM-01 Protocol of Expectations and Needs of Interested Parties
F04/QM-01 Quality Policy
F05/QM-01 Quality Objectives
F06/QM-01 Organizational Structure
F07/QM-01 System Responsibility Matrix
F08/QM-01 Risk Management Map (general)
F09/QM-01 Annual Quality System Program
F10/QM-01 Register of Indicators and Criteria for QMS
F11/QM-01 General List of All QMS Documents
Orders:
On the Development of the ISO 13485 System
On the Establishment of the Risk Management Group
On the Implementation of the ISO 13485 System
Processes (descriptions + KPI + KPI monitoring maps + KPI Dashboard):
PR-01 Order Acceptance Process
PR-02 Customer Satisfaction Evaluation Process
PR-03 Design of New Types of Products
PR-04 Procurement Management
PR-05 Production Management
PR-06 Inventory Management
PR-07 Customer Complaint Management
PR-08 Documented Information Management
PR-09 Nonconforming Product Management
PR-10 Product Monitoring and Measurement
PR-11 Process Nonconformity Management
PR-12 Knowledge Base Management
PR-13 Measuring Equipment Management
PR-14 Customer Satisfaction Monitoring
PR-15 Work Environment Management
PR-16 Equipment Management
PR-17 Information Systems Management
PR-18 Data Analysis and Monitoring
PR-19 Internal Audit Management
PR-20 Personnel Management
PR-21 Sending Information to External Counterparties by E-mail
PR-22 Top Management Processes
PR-23 Strategy Management
PR-24 Risk Management
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