ISO 13485 Standard and Certification Steps

100% Success Rate 60-90 days*.       Lowest Cost	Frequently Asked Questions about ISO 13485	Key Steps for ISO 13485 Certification	Online Training Link (Quality University)
	What is ISO 13485? ISO 13485 is international standard for the Quality Management System for the medical device industry. When was ISO 13485 released? ISO 13485 was released in 2003. What is the latest standard for ISO 13485? The latest version is ISO 13485 2016. Who needs to get ISO 13485 certified? ISO 13485 is a volunteer standard but can be mandated by the customer as a condition for doing business. What is the benefit of achieving ISO 13485 certification? The key benefits of ISO 13485 are quality improvement, a vital factor in doing business within the medical device industry. This in turn will increase company reputation and widen business opportunities. What is the time duration required for a company to achieve ISO 13485 certification? ISO 13485 certification can be achieved in as little as 90 days depending upon the company commitment. What are the certification steps? Please refer to http://accelcert.com/iso13485.html for the steps to certification. Where can I get help with consulting? Please visit http://www.accelcert.com for assistance with consulting. Where can I get help to achieve ISO 13485 certification with a written guarantee? ISO Accelerate Group offers written guarantee certification services with the condition your company will comply with recommendations. Where can I get training for ISO 13485? ISO Accelerate Group offers online, onsite, and customized training. Please visit http://www.accelcert.com for more information. Where can I get online training and certification? Quality University provides online training and certification. For more information, follow this link: http://www.qualityuniversity.com My company is ISO 13485 certified. Where can I get help to upgrade to ISO 13485? Please visit http://www.accelcert.com for more information. Where can I get the cost information for ISO 13485 consulting? Please contact Accelcert at 1-888-476-9103 for specific quotes. Where can I get the cost information for ISO 13485 certification? Please contact Accelcert at 1-888-476-9103 for specific quotes.   *The above information is provided for the better understanding of the specific standard, certification process, consulting, and training resources. We do recommend that you or your company should refer to the latest standards and verify information and/or contact the resources listed, or as applicable.	Step 1 Prepare ISO 13485 Implementation Plan and Detailed Schedule Accelerate & Clients ACCELERATE + Prepare plan for the ISO 13485 Quality System Development (Accelerate will work with Client) Step 2 ISO 13485 Gap Assessment ACCELERATE + Perform the ISO 13485 Gap Assessment to Identify GAPS between the standard and what exist. (Accelerate will prepare the report) Step 3 ISO 13485 Training (Auditors) ACCELERATE + Train the ISO 13485 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 ISO 13485 Implementation Training ACCELERATE + Train process owners to ISO 13485 Implementation Process. (Accelerate will perform the activity) ISO will issue certificate on passing exam. Step 5 ISO 13485 Quality Policy (Define & Document) Accelerate & Client ACCELERATE + Define ISO 13485 Quality Policy to internal and external customers. (Accelerate will prepare Quality Policy working with Client Step 6 ISO 13485 Quality Objectives (Define & Document) Accelerate & Client ACCELERATE + Define ISO 13485 Quality Objective with reference to Quality Policy. (Accelerate will prepare working with Client) Step 7 ISO 13485 Measurement Analysis & Improvement (Define & Document) ACCELERATE + Define ISO 13485 Measurement Analysis Process for continuous improvement. (Accelerate will prepare working with Client) Step 8 ISO 13485 Quality Planning (Define & Document) ACCELERATE + Define ISO 13485 Quality Planning Process. (Accelerate will prepare working with Client) Step 9 ISO 13485 Executive Management Training ACCELERATE + Train ISO 13485 Executive Management for the process for Conducting Management Review. (Accelerate will issue certificate) Step 10 ISO 13485 Documentation of Data Control -Development of a consistent approval process ACCELERATE + Define ISO 13485 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 ISO 13485 Level I (Quality Manual) ACCELERATE + Prepare ISO 13485  Quality Manual. Document the Company Policy in the manual for compliance to the standard. (Accelerate will prepare for Client) Step 12 ISO 13485 Level II (Standard Operating Procedures) ACCELERATE + Define the ISO 13485 process and the interaction between the processes. Document each process in compliance with the standard. (Accelerate will prepare with Client) Step 13 ISO 13485 Level III (Work Instructions) Draft Accelerate & Client ACCELERATE + Document the ISO 13485 processes in detail if needed. (Accelerate will work with Client) Step 14 ISO 13485 Level I (Quality Manual) Approval/Sign-Off Client ACCELERATE + Have Top Management sign the ISO 13485 Quality Manual. (Client works with Accelerate) Step 15 ISO 13485 Level II (SOP) Approval/Sign-Off Client & Accelerate ACCELERATE + Have all ISO 13485 procedures approved by process owners and concerned functions. (Client works with Accelerate) Step 16 ISO 13485 Level III (Work Instructions) Approval/Sign-Off Client & Accelerate ACCELERATE + Have ISO 13485 work instruction signed-off by concerned functions. (Client works with Accelerate) Step 17 First ISO 13485 Internal Audit (by qualified Internal Auditors) Client & Accelerate ACCELERATE + Perform first ISO 13485 Internal Audit. This audit will be conducted by independent Internal Certified Auditors. (Client will perform with support from Accelerate) Step 18 ISO 13485 Corrective & Preventive Actions, customer, vendor, quality Client & Accelerate ACCELERATE + Do close loop ISO 13485 corrective and preventive action for all issues including issues from Internal Audit (STEP 17). (Client will perform with  Accelerate) Step 19 First ISO 13485 Management Review (Performed by Management Rep. & Executive Mgmt.) ACCELERATE + Conduct ISO 13485 Management Review as per Management Review procedures. (Client works with Accelerate) Step 20 Second ISO 13485 Internal Audit (By Qualified Internal Auditors) Accelerate & Client ACCELERATE + Perform second ISO 13485 Internal by Certified Internal Auditors (same as STEP 17). (Client works with Accelerate) Step 21 ISO 13485 Corrective & Preventive Action for 2nd Internal Audit Accelerate & Client ACCELERATE + Perform close loop ISO 13485 corrective and preventive action (Same as STEP 18). (Client works with Accelerate) Step 22 ISO 13485 Second Management Review (By Executive Mgmt.) Client & Accelerate ACCELERATE + Perform ISO 13485 Management Review as per Management Review Procedure (same as STEP 19). (Client works with Accelerate) Step 23 Registrar ISO 13485 Pre-Assessment (Optional Activity) Registrar Client & Accelerate ACCELERATE + Registrar (an independent certifying body) to perform ISO 13485 Pre-Assessment (Accelerate will support) Step 24 ISO 13485 Corrective & Preventive Actions to registrar finding Accelerate & Client ACCELERATE + Do close loop ISO 13485 corrective actions (same as STEP 18 & 21) (Client works with Accelerate) Step 25 Accelerate ISO 13485 Documentation Review ACCELERATE + Accelerate Review the complete ISO 13485 system for compliance to standard. Step 26 Accelerate Assessment for ISO 13485 ACCELERATE + Accelerate perform ISO 13485 audit for identifying issues to related Implementation. Step 27 ISO 13485 Corrective & Preventive Actions ACCELERATE + Do close loop ISO 13485 corrective & preventive action for all issues raised (STEP 25 & 26)(Accelerate works with Client) Step 28 Final ISO 13485 Registration Audit ACCELERATE + Registrar perform the final ISO 13485 Registration Audit. (Accelerate will support) Step 29 Prepare ISO 13485 action plan for registrar finding ACCELERATE + Submit ISO 13485 Action Plan & close Registrar Findings.. (Accelerate works with Client) Step 30 Client Certified for ISO 13485 ACCELERATE + Accelerate Registered Client in Accelerate Database as "ISO 13485 Certified" Step 31 ISO 13485 Maintaining Upgrade & Training ACCELERATE + Accelerate will provide. (If desired)	ISO 13485: Internal Auditing /Auditor and Implementation   ISO 13485 Executive Management Review meeting ISO 13485   ISO 13485: Introduction & Awareness for meeting ISO 13485 requirements   ISO 13485 Internal Auditing/Auditor and Implementation in Chinese   RISK Management Employee Overview for Medical Device meeting ISO 14971/ISO 13485/FDA/CE MARK CE Marking (90/385) for Active Implantable Medical Devices- Essential Requirements Only CE Marking (90/385) for Active Implantable Medical Devices- Implementation and Auditing CE Marking (93/42 ECC) for medical devices- Implementation and Auditing CE Marking (93/42 ECC) for medical devices- Essential Requirements only CE Marking IVD 98-79 EEC Implementation and Auditing CE Marking IVD 98-79 EEC Implementation and Auditing, Essential Requirements Only Quality Improvement Concepts -continuous improvements-problem solving and customer FDA-GMP Good Laboratory Practice for nonclinical (21 CFR part58) Implementation and Auditing. FMEA, Risk Analysis for Medical Devices 8 D Problem Solving Methodology, Corrective Action, and Good Business Practices Business Continuity/Contingency Planning Implementation and Auditing/Auditor