ISO 13485/13488/CMDCAS

Accelerate's Steps for ISO13485 / ISO13488 / CMDCAS Process

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 -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)