The document provides a Gantt chart for implementing a quality management system that complies with ISO 13485:2016 standards at a client site over 3 phases from June to August 2020. Key activities include project initiation and planning, updating quality documents and procedures, implementing a data management system, and conducting management reviews. The project aims to refine business processes, implement risk analysis, and track metrics to ensure the quality policy and objectives are achieved.
The document provides a Gantt chart for implementing a quality management system that complies with ISO 13485:2016 standards at a client site over 3 phases from June to August 2020. Key activities include project initiation and planning, updating quality documents and procedures, implementing a data management system, and conducting management reviews. The project aims to refine business processes, implement risk analysis, and track metrics to ensure the quality policy and objectives are achieved.
The document provides a Gantt chart for implementing a quality management system that complies with ISO 13485:2016 standards at a client site over 3 phases from June to August 2020. Key activities include project initiation and planning, updating quality documents and procedures, implementing a data management system, and conducting management reviews. The project aims to refine business processes, implement risk analysis, and track metrics to ensure the quality policy and objectives are achieved.
The document provides a Gantt chart for implementing a quality management system that complies with ISO 13485:2016 standards at a client site over 3 phases from June to August 2020. Key activities include project initiation and planning, updating quality documents and procedures, implementing a data management system, and conducting management reviews. The project aims to refine business processes, implement risk analysis, and track metrics to ensure the quality policy and objectives are achieved.
Project Team Member- '-- Type : T - Training , C - Consulting, A - Assessment/Audit
Jun-20 Jul-20 Aug-20
Sl. No Activity Deliverables Mandays Type 1 2 3 4 1 2 3 4 1 2 3 4
Phase 1 : Project Initiation, Planning
C 1 Project Kickoff Initiation of Project plan discussion
C 2 Plant Tour Shop Floor Familiarization 1
C A. Form Steering Committee 3 Form Leadership Team B. Form Core Team C. Form Expanded Team
Conduct discovery analysis to understand current systems & C
Discovery Analysis & 4 Review Implementation Plan & update inline with Gap Implementation Plan Assessment 1 ISO 13485 Awareness T 5 Awareness Session inline with Standard requirements Session
b. Present benchmarks c. Set strategic imperatives C d. Review measurable assignment Define QMS Policy and e. Assign members to gather measurable 1 Objectives, Result measurable 3 f. Assign members to define processes and process measurable g. Establishing Strategic policy and objectives h. The means of achieving Quality objectives are to be decided with goals and targets i. Establishing the Data Management System. Draft ISO 13485 :2016 Gantt Chart
Project Manager: '-- Revision no. 00
Project Team Member- '-- Type : T - Training , C - Consulting, A - Assessment/Audit
Jun-20 Jul-20 Aug-20
Sl. No Activity Deliverables Mandays Type 1 2 3 4 1 2 3 4 1 2 3 4
All processes to be identified, QMS Procedures to be rewritten, new
procedures developed, which will help to break departmental C barriers and to start with process approach 1. Identify and Documenting the processes and carrying out the Documentation Support - Process Mapping Refining business processes, 2. Identify and track the deliverables for each identified process QMS Procedures, Process and data tracking Mapping vide Turtle Diagram 8 3. Training for the process owners for Mapping and documentation 8 assigning responsibility, of relevant processes - Turtle Diagram measurable & working on 4. Assigning responsibility & measurable & start working on Quality Manual, & discussion Quality Manual with top management 5. Software Validation System 6. Medical Device File 7. Sterelisation Systems 8. Process Validation Systems
1. Meeting the adequacy requirement of ISO 13485:2016 (Level 1 &
2) C Reviewing business processes 2. Review of all Business Process in line with measurable and turtle 3 along with linking of WI & diagram 3 Formats 3. WI made available in necessary places and unnecessary WI's removed. 4. Review the adequacy of WI's.
Reviewing Quality Manual
C and business processes Review of the Level 1 / 2 / 3 / 4 documents in line with measurable 4 2 documentation along with WI and turtle diagram at Client's end & formats
C 5 Risk Analysis Conduct risk analysis for all processes and context 2
C Release business processes for 1. Improvement in Business Processes measurable 6 1 implementation 2. Elimination of non value added activities
PHASE 2 COMPLETION Draft ISO 13485 :2016 Gantt Chart
Project Manager: '-- Revision no. 00
Project Team Member- '-- Type : T - Training , C - Consulting, A - Assessment/Audit
Jun-20 Jul-20 Aug-20
Sl. No Activity Deliverables Mandays Type 1 2 3 4 1 2 3 4 1 2 3 4
PHASE 3 : Data management system and Management review system
1 BMS data collection start Customer expectations are identified with customer focus 3 C QOS data collection completion & preparation of 1. Processes alligned to achieve the Policy quality policy ( linking of 2 2. Business processes to be controlled for achieving Policy are 2 C quality policy to result identified and quantified. measurables to process measurables )
Tracking of result measurables and process 3 measurables to ensure Achievement of result quantifiers 2 T&C business processes implementation
1. First management review conducted after first internal audit
2. Top management takes decision on continual improvement 7 Management review projects 1 C 3. Organisation gets ready for readiness review & Preassesment audit for ISO 13485:2016
PHASE 3 COMPLETION PHASE 4: INTERNAL AUDIT Qualified internal auditors to be developed, who are capable of 1 Internal audit training 3 T auditing the company's QMS for effectiveness Non conformities, which are barriers for achieving process 2 Internal audit measurables and not meeting the system will be identified with 2 A improvement points where ever possible. Causal Analysis & Implementation of Corrective NCR's closed effectively, ensuring achievement of process 3 2 C actions for NCRs from measurables / satisfying system requirements. Internal Audit Continual improvement points to be identified to enhance 4 Management review 1 C business performance PHASE 4 COMPLETION Draft ISO 13485 :2016 Gantt Chart
Project Manager: '-- Revision no. 00
Project Team Member- '-- Type : T - Training , C - Consulting, A - Assessment/Audit
Jun-20 Jul-20 Aug-20
Sl. No Activity Deliverables Mandays Type 1 2 3 4 1 2 3 4 1 2 3 4
PHASE 5: CERTIFICATION 1 Pre - assessment audit - Causal Analysis & Implementation of corrective 2 - 1 C actions for the Pre assessment Audit Points Ensure that no major NC's present in the system to facilitate 3 Final Implementation Review 1 C registration 4 Registration audit Certification for IATF 16949: 2016
