Legal Company Name:



|Legal Company Name: |      |Date: |      |

|(As it will appear on Contract) | | | |

|Address: |      |Suite:       |Phone |      |

|City: |      |State:       |Fax: |      |

|Zip Code: |      |Country:       |Email |      |

|Management Representative:       |Website: |      |

|If the person filling out the form is different than Management Representative, Please list your name:       |

1. Standard(s) Pursuing Certification:

| ISO 9001:2008 with Design | AS9100 | ISO 13485 | BS OHSAS 18001 |

| ISO 9001:2008 without Design | ISO 14001 | TL 9000 | Other:       |

|Note: Please use the unique Company Profile for the following standards: e-Stewards, R2, RIOS, BIFMA, PS-Prep, ISO 22301, SFI/PEFC CoC and Social |

|Responsibility (SA8000) |

2. How did you learn about Orion?

| Website | Advertisement | Consulting | Sales Call | Tradeshow | Word of Mouth |

| Magazine/Newspaper Article | Other:       |

General Company Information

3. Activities that the organization realizes (performs), Please check all that apply:

| Service | Design | Commercialization | Manufacture | Distribution |

| Other:       |

|Activities and/or services that the organization provides: |

|      |

4. List your major processes?

|      |

5. Do you have any outsourced processes?

| No | Yes, Please list: |

|      |

6. Is ITAR applicable to your facilities or processes?

| Yes |No | Not Applicable |

7. Do you have security restrictions/ requirements for the areas/processes required by the scope of the audit?

| No | Yes, identify security requirements:       |

8. Indicate any ISO Certification(s) that the organization has:

|      |

|What organization granted the certificate:       |Date of last audit:       |

|Issue Date:       |Expiration. Date:       |(Please Attach a Copy of Your Certificate) |

9. Do you have more than one facility that will be certified?

| No | Yes, Please answer questions A thru C. | |

| |Will all the facilities be included on the same certificate? | Yes | No |

| | Do all the facilities operate under the same management manual? | Yes | No |

| |Does your company already have locations certified to these standards? | Yes | No |

| |If yes, describe any cooperation and/or knowledge transfer regarding conformance to the standard between your site and the certified |

| |site(s):       |

10. **REQUIRED** Please complete the chart below for each facility that will be certified regardless

of your answer to question above.

|Site Profile |

|Location |Primary |No. of Employees|No. of |Hours of Shift |

| |Language | |Shifts | |

|      |      |      |      |      |

|      |      |      |      |      |

|If Site No. Exceeds 2, Please Attach additional Site Information |

| |

|Preferred Dates for Your Certification Activities |

|Pre-Audit:       |Stage 1:       |Stage 2:       |

11. Indicate the stage and percentage that your Management System is currently implemented:

| Documentation | Implementation | Internal Audit |

|%      |%      |%      |

|*The Documentation stage includes the manual and procedure. |

|*The Implementation stage has to have objective evidence |

12. Did you use a consulting service to implement and/or develop your Management System?

| No | Yes, Name/Organization:       |

13. Surveillance Interval Requested: Annual Semi-annual

pany’s SIC/NAICS Codes (if unknown leave blank):

|      |

15.If requesting more than one Standard to be Certified and if using Combined Management or Integrated Management Systems for the Certification, please answer the following questions:

|Do you use an integrated Management System Manual for all the standards being pursued for certification? | Yes | No |

|Do you have integrated procedures for the Management System Functions? | Yes | No |

|Do you have an integrated Management Review for all the standards being pursued for certification? | Yes | No |

|Do you have integrated internal audits for all the standards being pursued for certification? | Yes | No |

|Do you have integrated improvement mechanism (such as corrective action process, preventative action processes, | Yes | No |

|continual improvement process as applicable for all the standards being pursued for certification? | | |

|Do you have an integrated approach to planning and resources for all standards being pursued for certification? | Yes | No |

|Is there unified management support and responsibilities for all standards being pursued for certification? | Yes | No |

Specific Standard Certification Questions

16. For ISO 9001 Certification only:

|Please indicate any clause(s) of that are not included in the certification scope (if applicable)       |

17. For TL 9000 Certification only:

| |Which Option(s) are being pursued? Hardware (H) Software (S) Services (V) |

| |Please list product categories that will be covered:       |

| |List the revision of TL/Measurement Handbook requesting certification:       |

18.For ISO 14001Certification only:

|Describe the three important significant environmental aspects |

| |      |

|Identify the three most significant environmental impacts and objectives: |

| |      |

19. For BS OHSAS 18001 Certification only:

|Identify the three most significant Occupational Health and Safety Hazards (OHSAS 18001, 4.3.1):       |

|Identify the three most significant Occupational Health & Safety Risks (OHSAS 18001, 4.3.1): |

| |      |

20.0 For ISO 13485, please Check Below what Category(ies) applies to your Company

| |Technical Areas |Product Categories Covered by the |

| | |Technical Areas |

| |Code:08103 |•Non-active devices for anesthesia, emergency and intensive care |

| |General non-active, non-implantable medical devices |• Non-active devices for injection, infusion, transfusion and dialysis |

| | |• Non-active orthopedic and rehabilitation devices |

| | |• Non-active medical devices with measuring function |

| | |• Non-active ophthalmologic devices |

| | |• Non-active instruments |

| | |• Contraceptive medical devices |

| | |• Non-active medical devices for disinfecting, cleaning, rinsing |

| | |• Non-active devices for in vitro fertilization (IVF) and assisted |

| | |reproductive technologies (ART) |

| |Code: 08203 |• Non-active cardiovascular implants |

| |Non-active implants |• Non-active orthopedic implants |

| | |• Non-active functional implants |

| | |• Non-active soft tissue implants |

| |Code: 08303 |• Bandages and wound dressings |

| |Devices for wound care |• Suture material and clamps |

| | |• Other medical devices for wound |

| | |care |

| |Code: 08403 |• Non-active dental |

| |Non-active dental devices and accessories |devices/equipment and instruments |

| | |• Dental materials |

| | |• Dental implant |

| |Code: 08503 |No Examples |

| |Non-active medical devices other than specified above | |

| |Code: 08603 |• Devices for extra-corporal circulation, infusion and haemopheresis |

| |General active medical devices |• Respiratory devices, devices including hyperbaric chambers for oxygen |

| | |therapy, inhalation anesthesia |

| | |• Devices for stimulation or inhibition |

| | |• Active surgical devices |

| | |• Active ophthalmologic devices |

| | |• Active dental devices |

| | |• Active devices for disinfection and sterilization |

| | |• Active rehabilitation devices and active prostheses |

| | |• Active devices for patient positioning and transport |

| | |• Active devices for in vitro fertilization (IVF) and assisted reproductive|

| | |technologies (ART) |

| | |• Software |

| |Code: 08703 |• Devices utilizing ionizing rays |

| |Devices for imaging |• Devices utilizing non-ionizing rays |

| |Code: 08803 |• Monitoring devices of non-vital physiological parameters |

| |Monitoring devices |• Monitoring devices of vital physiological parameters |

| |Code: 08903 |• Devices utilizing ionizing radiation |

| |Devices for radiation therapy and thermo therapy |• Devices utilizing non-ionizing radiation |

| | |• Devices for hyperthermia / hypothermia |

| | |• Devices for (extracorporeal) shockwave therapy (lithotripsy) |

| |Code: 09003 | |

| |Active (non-implantable) medical devices other than specified| |

| |above | |

| |Code: 09103 |• Active implantable medical devices for stimulation / inhibition |

| |General active implantable medical devices |• Active implantable medical devices delivering drugs or other substances |

| | |• Active implantable medical devices substituting or replacing organ |

| | |functions |

| |Code: 09203 |No Example |

| |Implantable medical devices other than specified above | |

| |Code: 09303 |Reagents and reagent products, calibrators and control materials for: |

| |Reagents and reagent products, calibrators and control |Clinical Chemistry; Immunochemistry (Immunology); Haematology, Haemostasis,|

| |materials |Immunohematology; Microbiology; Infectious Immunology; Histology, Cytology;|

| | |and Genetic Testing |

| |Code: 09403 |No Examples |

| |In Vitro Diagnostic Instruments and software | |

| |Code: 09503 |No Examples |

| |IVD medical devices other than specified above | |

| |Code: 10203 |No Examples |

| |Ethylene oxide gas sterilization | |

| |Code: 10303 |No Examples |

| |Moist heat sterilization | |

| |Code: 10403 |No Examples |

| |Aseptic processing sterilization | |

| |Code: 10503 |No Examples |

| |Radiation sterilization (e.g. gamma, x-ray, electron beam) | |

| |Code: 10603 |No Examples |

| |Sterilization method other than | |

| |specified above | |

| |Code: 09603 |No Examples |

| |Medical devices incorporating medicinal substances | |

| |Code: 09703 |No Examples |

| |Medical devices utilizing tissues of animal origin | |

| |Code: 09803 |No Examples |

| |Medical devices incorporating derivates of human blood | |

| |Code: 09903 |No Examples |

| |Medical devices utilizing micromechanics | |

| |Code: 10003 |No Examples |

| |Medical devices utilizing nonmaterial | |

| |Code: 10103 |No Examples |

| |Medical devices utilizing biological active coatings and/or | |

| |materials or being wholly or mainly absorbed | |

| |Code: 06003 |Contract Manufacturers |

| |Manufacturers who make parts or assemblies for Medical Device| |

| |Companies | |

| |Code: 06903 |Distributors |

| |Distribution of Medical Devices | |

| |Code: 07003 |Repair Depot |

| |Repair of Medical Devices |Maintenance Services |

| |Code: 07103 |Service Companies |

| |Services related to Medical Devices | |

| |Code: 07403 |Software Companies |

| |Software for Medical Devices | |

| |Code: 07603 |Calibration Companies |

| |Calibration and Testing of Medical Devices | |

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Please complete and save this form for your personal records and email a copy to marketing@, or alternatively fax this form to: 303-645-4875. If you have any questions, please call 303-645-4017

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