A Proposal to Provide ISO 9000, ISO 13485 Consulting Services FOR SMALL/MEDIUM SIZE SERVICE OR MANUFACTURING COMPANIES SUBMITTED BY QNET LLC Telephone 763-441-0899   INTRODUCTION The following proposal outlines an affordable and practical approach to provide ISO 9000, ISO 13485 consulting services to meet the needs of small/medium size service or manufacturing companies, to ensure their registration to ISO 9000, ISO 13485. These services consist of materials/techniques that QNET has used successfully since 1989 with companies that ranged from 4 to 10,000+ employees. Companies typically complete registration to ISO 9000,EN 46000, ISO 13485 within 6 to 12 months. QNET consulting services have assisted more than 200 companies achieve ISO 9000, ISO 13485 registration. All of our clients have been successful in their initial registration audit. QNET consulting services have established a track record for helping clients achieve registration on schedule AND installing quality systems that generate hard-dollar savings/improvements and operate with minimal overhead. CONTENTS The contents of the proposal include the following: Overview--- A description of the approach proposed by QNET Work Plan ---Project tasks and deliverables Costs--- Estimated project costs QNET ---Business background, project director, biography and client references OVERVIEW QNET proposes to work together with the client to develop and install a quality system and prepare for ISO 9000, ISO 13485 registration. We propose that QNET provide advice in the form of consulting, and that client’s ISO project team and other staff apply that advice to design, implement and maintain their quality system. The consulting services provided by QNET will: Include a review of the existing quality documentation and practices to identify changes and additions required for ISO 9000, ISO 13485 registration. Train the ISO project team members and other staff as needed in documentation, internal auditing and how the requirements apply to their operation. Instruct and demonstrate to the ISO project team members and other staff how to prepare and maintain ISO 9000, ISO 13485 documentation to ensure registration AND a streamlined system that will minimize maintenance costs. Equip the ISO project team members and other staff with the skills and knowledge required to design, install, maintain, audit and improve an ISO 9000, ISO 13485 compliant quality system. Ensure compliance with the requirements of ISO 9000, ISO 13485.   WORK PLAN The following work plan describes tasks that would be supported by QNET consulting and training; the time frames indicated are estimates and can be adjusted as needed. Train ISO project team members ........Visit #1 Prior to the training, QNET will work via phone/fax/email to set a schedule and develop the agenda for the ISO project team training. Prior to the training, QNET will forward pre-read materials and training workbooks to be distributed to the ISO project team members. Prior to the training, QNET will review the current quality system documentation, and list the required changes and additions for ISO 9000, ISO 13485. Consultant conducts ISO project team training to prepare them for planning and carrying out the implementation of the quality system. The training will include the following: Provide sufficient background information to clearly communicate the project’s advantages to the company and their individual areas. Provide a clear vision of the finished product they will develop and install as a team, using documentation examples from other registered companies. Clearly define the intent and specific application of the requirements of the standard to the current operation. Review the sequence and nature of the tasks listed in the work plan including: finalize the 5 issues regarding scope of registration; review QNET list of questions/key issues to address with potential registrars. develop approach for informing and updating all employees; establish quality system documentation structure and document control techniques after reviewing samples from registered companies; review the changes/additions recommended by the consultant for the quality manual and procedures; review internal documentation and practices for all requirements; review QNET questionnaire for gap analysis. 5. Review QNET self-paced instructional material for learning how to interpret and apply ISO 9000, ISO 13485 requirements to client’s operations.. 6. Evaluate and select specific methods/formats/techniques to be implemented. 7. Complete QNET implementation checklist to mark progress at the close of the training; 8. Assign and schedule work plan tasks to ISO project team members. Deliverables – List of consultant’s recommended changes and additions to current client’s documentation; ISO project team pre-read materials and workbooks; QNET implementation checklist; QNET gap analysis questionnaire; QNET self-paced instruction – How to Interpret and Apply ISO 9000, ISO 13485 Requirements.   Conduct Gap Analysis............Visit #2 Consultant works with ISO project team members to complete an ISO 9000, ISO 13485 audit of the current operation to identify additions and changes required for ISO registration. The consultant (1) documents and reviews the list of changes to be added to the work plan and assigned to various project team members or areas of the organization; and (2), provides sample formats and techniques from registered companies suitable for addressing the required changes. Deliverables – Audit findings and samples of documentation.   Review Quality Documents...............Visit #3 Consultant provides technical assistance as needed to project members as they prepare assigned documentation (quality manual, procedures, flow charts, etc.). Consultant conducts a review of the completed documentation and indicates the required corrections. Consultant provides a status on the progress of work completed to date and to update the work plan as needed. Deliverables – Consultant’s recommended corrections to the quality manual, procedures and other documentation.   Train Personnel ................Visit #4 Consultant conducts Internal Auditing Training to prepare project team members and other key staff to plan, conduct and record findings for internal quality audits. The training prepares participants to perform internal quality audits in compliance with the requirements of ISO 9000, ISO 13485 and includes the following: Structured exercises to analyze in detail the requirements of the standard relating to the internal quality audit program. Auditor selection and training, audit scheduling and resource allocation, audit documentation and records, etc. Audit tools and techniques for preparing, conducting and documenting internal quality audits. Auditor trainees work in teams to complete a live full audit including: Prepare an audit plan and outline. Conduct an audit interview and examine related documents, work instructions and records. Record audit findings and prepare an audit report. Consultant works with the project team to schedule, prepare and carry out the initial set of preliminary audits of the quality system Deliverables – QNET Internal Quality Auditing Training Materials and Workbook, preliminary audit schedule, audit checklist and completed report of audit findings. COSTS The cost of providing the services outlined in the work plan is estimated to be: (total amount to be supplied upon request.). The breakdown of the costs is as follows: Professional Services Travel and Lodging (At Cost) Other Expenses (Training Materials) Total Estimated Cost …………………...$ Please contact Yvonne Halpaus for a complete customized proposal for your Company. Via phone: (763) 441-0899 or E-Mail: QNET@CE-Mark.com

BACK