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CE Marking (Medical Devices)  

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CE Marking (Medical Devices) Steps for Certification

Step 1
Prepare Implementation Plan and Detailed Schedule Accelerate & Clients
ACCELERATE
 + Prepare plan for the Quality System Development
(Accelerate will work with Client)
Step 2
Gap Assessment
ACCELERATE
 + Perform the Gap Assessment to Identify GAPS between the standard and what exist.
(Accelerate will prepare the report)
Step 3
Training (Auditors)
ACCELERATE
 + Train the Internal Auditors and Process Owners to the Standard.
Upon passing the exam, process owner taking training will get qualified as Internal Auditor
and Lead Auditor Accelerate will issue certificate.
Step 4
Implementation Training
ACCELERATE
 + Train process owners to Implementation Process.
(Accelerate will perform the activity)
ISO will issue certificate on passing exam.
Step 5
Quality Policy (Define & Document)
Accelerate & Client
ACCELERATE
 + Define Quality Policy to internal and external customers.
(Accelerate will prepare Quality Policy working with Client
Step 6
Quality Objectives
(Define & Document)
Accelerate & Client
ACCELERATE
 + Define Quality Objective with reference to Quality Policy.
(Accelerate will prepare working with Client)
Step 7
Measurement Analysis & Improvement
(Define & Document)
ACCELERATE
 + Define Measurement Analysis Process for continuous improvement.
(Accelerate will prepare working with Client)
Step 8
Quality Planning (Define & Document)
ACCELERATE
 + Define Quality Planning Process.
(Accelerate will prepare working with Client)
Step 9
Executive Management Training
ACCELERATE
 + Train Executive Management for the process for Conducting Management Review.
(Accelerate will issue certificate)
Step 10
Documentation of Data Control

Hazard Analysis and Risk Assessment
-Development of a consistent
approval process
ACCELERATE

 + Define Documentation and Data Control Process for development
and Management of Documentation Control System.
(Accelerate will develop, works with Client, which include infrastructure for Documentation Control)
Step 11
Level I (Quality Manual)
ACCELERATE
 + Prepare Quality Manual.
Document the Company Policy in the manual for compliance to the standard.
(Accelerate will prepare for Client)
Step 12
Level II (Standard Operating Procedures)
ACCELERATE
 + Define the process and the interaction between the processes.
Document each process in compliance with the standard.
(Accelerate will prepare with Client)
Step 13
Level III (Work Instructions) Draft
Accelerate & Client
ACCELERATE
 + Document the processes in detail if needed.
(Accelerate will work with Client)
Step 14
Level I (Quality Manual)
Approval/Sign-Off Client
ACCELERATE
 + Have Top Management sign the Quality Manual.
(Client works with Accelerate)
Step 15
Level II (SOP)
Approval/Sign-Off
Client & Accelerate
ACCELERATE
 + Have all procedures approved by process owners and concerned functions.
(Client works with Accelerate)
Step 16
Level III (Work Instructions)
Approval/Sign-Off
Client & Accelerate
ACCELERATE
 + Have work instruction signed-off by concerned functions.
(Client works with Accelerate)
Step 17
First Internal Audit (by qualified Internal Auditors) Client & Accelerate
ACCELERATE
 + Perform first Internal Audit. This audit will be conducted by independent Internal Certified Auditors. (Client will perform with support from Accelerate)
Step 18
Corrective & Preventive Actions, customer, vendor, quality Client & Accelerate
ACCELERATE
 + Do close loop corrective and preventive action for all issues including issues from Internal Audit (STEP 17). (Client will perform with  Accelerate)
Step 19
First Management Review (Performed by Management Rep. & Executive Mgmt.)
ACCELERATE
 + Conduct Management Review as per Management Review procedures. (Client works with Accelerate)
Step 20
Second Internal Audit (By Qualified Internal Auditors)
Accelerate & Client
ACCELERATE
 + Perform second Internal by Certified Internal Auditors (same as STEP 17). (Client works with Accelerate)
Step 21
Corrective & Preventive Action for 2nd Internal Audit
Accelerate & Client
ACCELERATE
 + Perform close loop corrective and preventive action (Same as STEP 18). (Client works with Accelerate)
Step 22
Second Management Review (By Executive Mgmt.) Client & Accelerate
ACCELERATE
 + Perform Management Review as per Management Review Procedure (same as STEP 19).
(Client works with Accelerate)
Step 23
Registrar Pre-Assessment (Optional Activity) Registrar Client & Accelerate
ACCELERATE
 + Registrar (an independent certifying body) to perform Pre-Assessment (Accelerate will support)
Step 24
Corrective & Preventive Actions to registrar finding Accelerate & Client
ACCELERATE
 + Do close loop corrective actions (same as STEP 18 & 21) (Client works with Accelerate)
Step 25
Accelerate Documentation Review
ACCELERATE
 + Accelerate Review the complete system for compliance to standard.
Step 26
Accelerate Assessment
ACCELERATE
 + Accelerate perform audit for identifying issues to related Implementation.
Step 27
Corrective & Preventive Actions
ACCELERATE
 + Do close loop corrective & preventive action for all issues raised (STEP 25 & 26)(Accelerate works with Client)
Step 28
Final Registration Audit
ACCELERATE
 + Registrar perform the final Registration Audit. (Accelerate will support)
Step 29
Prepare action plan for registrar finding
ACCELERATE
 + Submit Action Plan & close Registrar Findings.. (Accelerate works with Client)
Step 30
Client Certified
ACCELERATE
 + Accelerate Registered Client in Accelerate Database as "Certified"
Step 31
Maintaining Upgrade & Training
ACCELERATE
 + Accelerate will provide. (If desired)
 

Useful Links

 FDA-CGMP

HACCP

Quality University

Safety-Web 

 

*  based on Gap Assessment and if company follow  all recommendations

 

Note: Quality University mark is a Registered Trade Mark of Quality University and should not be used without written approval of Quality University.
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