Guaranteed Certification, Consulting, Training 60-90 days for, ISO 9000, ISO 9001, ISO 14000, ISO 14001, AS 9100, OSHAS 18001, CE Mark, QS 9000, HACCP, ISO 13485, ISO 13488, ISO 16949, ISO 17025, TL 9000, TickIT, Quality, Environment, Aerospace, calibration, Calibration Lab, ISO9000, ISO9001, ISO14000, ISO14001, AS9100, OSHAS18001, QS9000, ISO13485, ISO13488, ISO16949, ISO/TS16949, ISO17025, QS9000, TL9000, fda/cgmp, ISO documentation, ISO templates, standard, standards, consultant, consultants, software, medical, medical device, quality, quality system, telecommunication, aerospace, automotive, environment, environmental, internal audit, lead auditor training, internal auditor training, internal auditor course, supplier audit, acquisition audit, fda audit, cgmp audit, gmp audit

Guaranteed Certification, Consulting, Training 60-90 days for, ISO 9000, ISO 9001, ISO 14000, ISO 14001, AS 9100, OSHAS 18001, CE Mark, QS 9000, HACCP, ISO 13485, ISO 13488, ISO 16949, ISO 17025, TL 9000, TickIT, Quality, Environment, Aerospace, calibration, Calibration Lab, ISO9000, ISO9001, ISO14000, ISO14001, AS9100, OSHAS18001, QS9000, ISO13485, ISO13488, ISO16949, ISO/TS16949, ISO17025, QS9000, TL9000, fda/cgmp, ISO documentation, ISO templates, standard, standards, consultant, consultants, software, medical, medical device, quality, quality system, telecommunication, aerospace, automotive, environment, environmental, internal audit, lead auditor training, internal auditor training, internal auditor course, supplier audit, acquisition audit, fda audit, cgmp audit, gmp audit Guaranteed Certification, Consulting, Training 60-90 days for, ISO 9000, ISO 9001, ISO 14000, ISO 14001, AS 9100, OSHAS 18001, CE Mark, QS 9000, HACCP, ISO 13485, ISO 13488, ISO 16949, ISO 17025, TL 9000, TickIT, Quality, Environment, Aerospace, calibration, Calibration Lab, ISO9000, ISO9001, ISO14000, ISO14001, AS9100, OSHAS18001, QS9000, ISO13485, ISO13488, ISO16949, ISO/TS16949, ISO17025, QS9000, TL9000, fda/cgmp, ISO documentation, ISO templates, standard, standards, consultant, consultants, software, medical, medical device, quality, quality system, telecommunication, aerospace, automotive, environment, environmental, internal audit, lead auditor training, internal auditor training, internal auditor course, supplier audit, acquisition audit, fda audit, cgmp audit, gmp audit


















































                

Latest Success Story: Port of Oakland/Oakland Airport achieves ISO 9001:2000 Certification with ISO Accelerate Group's consulting support.
 

CE Mark (Medical Devices)

ACCELERATE'S steps for CE Marking 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)

ONLINE TRAINING

Select online training from below

ISO 9001:2000 Internal AuditorISO 9001:2000 Executive OverviewISO 9001:2000 Employee AwarenessISO 14001:2004 Internal AuditorISO 14001:2004 Executive OverviewISO 14001:2004 Employee AwarenessISO 13485 Internal AuditorISO 13485 Executive OverviewISO 13485 Employee AwarenessISO 16949 Internal AuditorISO 16949 Executive OverviewISO 16949 Employee AwarenessISO 17025 Internal AuditorISO 17025 Executive OverviewISO 17025 Employee AwarenessISO 14971 Internal AuditorISO 14971 Executive OverviewISO 14971 Employee AwarenessFDA/CGMP Medical OverviewFDA/CGMP Medical Employee OverviewFDA/CGMP Medical Executive OverviewFDA/CGMP Blood OverviewFDA/CGMP Blood Employee OverviewFDA/CGMP Blood Executive OverviewFDA/CGMP Food OverviewFDA/CGMP Food Employee OverviewFDA/CGMP Food Executive OverviewFDA/CGMP Drug OverviewFDA/CGMP Drug Employee OverviewFDA/CGMP Drug Executive OverviewOSHAS 18001 Internal AuditorOSHAS 18001 Employee OverviewOSHAS 18001 Executive OverviewHACCP Internal AuditHACCP Employee OverviewHACCP Executive OverviewTL 9000 Internal AuditTL 9000 Employee OverviewTL 9000 Internal AuditISO 27001 Internal AuditISO 27001 Employee OverviewISO 27001 Executive OverviewEmployee Safety GuidelinesSupplier AuditAS 9100 OverviewESD Employee AwarenessESD Overview/Implement/AuditingEnvironmental/Health/Safety Training

 

    
 

CE Marking/ 46000/93/42/EEC (MEDICAL DEVICES)
Accelerate Client
Precision Therapy (Hong Kong & China). San Aen Tian (Taiwan),
Hewlett-Packard, Cemax, Cobe cardiovascular, Guidant and many others.

What are the Standards?

1. The directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as devices in their own right. Both medical
devices and accessories shall hereinafter be termed devices.

2. The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition of the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with high level of protection of health and safety.

3. The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art.
In selecting the most appropriate solutions, the manufacturer must apply the following principles
in the following order
= eliminate or reduce risk as far as possible (inherently safe design and construction),
= where appropriate take adequate protection measures including alarms if necessary, in relation = to risk that cannot be eliminated,
= inform users of the residual risk due to any shortcomings of the protection measures adopted.

4. The devices must achieve the performances intended by manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in Article 1(2) (a), as specified by the manufacturer.

5. The characteristics and performances referred to in Sections 1, 2 and 3 must not be adversely affected to such a degree that the clinical conditions and safety of the patients and, where applicable, of other persons are compromised during the lifetime of the device as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use.

6. The devices must be designed, manufactured and packed in such a way that their characteristics and performance during their intended use will not be adversely affected during transport and storage taking account of the instructions and information provided
by the manufacturer.

7. Any undesirable side effect must constitute an acceptable risk when weighed against the performance intended,

Source:
Council Directive 93/42/EEC

 

      

Regulatory Models

(Global Harmonization Task Force GHTF members)

US

Australia

Japan

EU

Canada

Regulatory Body

 Food & Drug Administration (FDA) Therapeutic Goods Administration (TGA) Ministry of Heath and Welfare (MHW) Competent Authority (CA)  ( 15 states ) Health Canada (HC)

QS standard

 QSR: 21    CFR 820 ISO 13485/8 or EN 46001/2 QS standard 1128 EN 46001/2/3 ISO 13485/8

Quality Systems auditor

 FDA TGA MHW Notified Body (NB) (3rd party)

Registrar      (3rd party) (CMDCAS)
Pre-market reviewer FDA TGA MHW (NB) (3rd party) HC
Post-market compliance & enforcement FDA TGA MHW (NB) (3rd party) + CA HC (6 Regions)
     

We have 100% success rate and our clients have passed in first attempt at Certification. Our current US operations are in California (San Jose, Oakland, Sacramento, San Francisco, San Diego, Los Angeles, Irvine), CA, Alabama, AL, Alaska, AK, Arizona, AZ, Arkansas, AR, Colorado, CO, Connecticut, CT, Delaware, DE, Florida, FL, Georgia, GA, Hawaii, HI, Idaho, ID, Illinois, IL, Indiana, IN, Iowa, IA, Kansas, KS, Kentucky, KY, Louisiana, LA, Maine, ME, Maryland, MD, Massachusetts, MA, Michigan, MI, Minnesota, MN, Mississippi, MS, Missouri, MO, Montana, MT, Nebraska, NE, Nevada, NV, New Hampshire, NW, New Jersey, NJ, New Mexico, NM, New York, NY, North Carolina, NC, North Dakota, ND, Ohio, OH, Oklahoma, OK, Oregon, OR, Pennsylvania, PA, Rhode Island, RI, South Carolina, SC, South Dakota, SD, Tennessee, TN, Texas, TX, Utah, UT, Vermont, VT, Virginia, VA, Washington, WA, West Virginia, WV, Wisconsin, WI, and Wyoming, WY. With additional operations in Puerto Rico.

 

 
 

Guaranteed Certification, Consulting, Training 60-90 days for, ISO 9000, ISO 9001, ISO 14000, ISO 14001, AS 9100, OSHAS 18001, CE Mark, QS 9000, HACCP, ISO 13485, ISO 13488, ISO 16949, ISO 17025, TL 9000, TickIT, Quality, Environment, Aerospace, calibration, Calibration Lab, ISO9000, ISO9001, ISO14000, ISO14001, AS9100, OSHAS18001, QS9000, ISO13485, ISO13488, ISO16949, ISO/TS16949, ISO17025, QS9000, TL9000, fda/cgmp, ISO documentation, ISO templates, standard, standards, consultant, consultants, software, medical, medical device, quality, quality system, telecommunication, aerospace, automotive, environment, environmental, internal audit, lead auditor training, internal auditor training, internal auditor course, supplier audit, acquisition audit, fda audit, cgmp augmp audit