Questionnaire to Prepare for a TÜV Management Service Certification Audit

TÜV SUD America Inc. 10 Centennial Drive Peabody, MA 01960 USA Fax: 978-977-0182 www.TUVamerica.com Application

This application helps us to quote and prepare for an audit. Address for Audit Billing Address Company Address

Management Rep. Contact Person Telephone Extensio n Fax E-Mail Internet URL: http://www. When do you plan to select a certification body? Requested date for a Pre-audit? Requested date for a Stage 1 audit? - Requested date for a Certification audit?

SIC Code or NAICS or NACE Code Code

ISOF-04, Rev 19, Effective 2014-02-14 Page 1 of 7 TÜV SUD America Inc. 10 Centennial Drive Peabody, MA 01960 USA Fax: 978-977-0182 www.TUVamerica.com Application

The audit will be based on the following requirements: (check all that apply) ISO 9001: with design ISO 9001: without design ISO 14001: OHSAS 18001 SA8000 ISO 13485: with design ISO 13485: without design Canadian Medical Device Regulations (CMDCAS program) Medical Device Single Audit Program (MDSAP) ISO/TS 16949 with design ISO/TS 16949 without design AS9120 AS9100 TL 9000 EN 15038 ANSI/ESD-S20.20 Responsible Recycling (R2) Other ______

Location 1 Location 2 Location 3 Address:

Number of Buildings: Approximate total area of all buildings: ft2 m2

Major processes Relationship in organization, i.e. headquarters, support site

Continued…. Location 1 Location 2 Location 3 Number of shifts: Number of Employees: Total number of employees  Number on 1st shift:  Number on 2nd shift:  Number on 3rd shift:  Number working in Design:  Number in Field Service:  Number in direct Manufacturing:  Number in Administration:  Number in Quality / Test / Inspection:  Number in Environmental Protection  Number in Occupational Health & Safety  Use separate sheet if more than 3 locations.

Are there any employees that you did not include yes no because you consider them to be outside the If yes, please explain: scope of the audit?

Are there any additional temporary employees yes no that could be present at the time of the audit? If yes, please explain:

Propose wording for scope statement to be used on Certificate? (i.e., scope regarding products and activities such as: ‘Design and Manufacturing of XXXX for the YYYY industry’)

Most important purchased raw materials / services:

List Manufacturing processes:

Does your organization have any processes, activities, programs, specifications, systems, yes no If yes, please provide details areas, or facilities that will not be accessible to the auditors because of security, confidentiality, or other restrictions? List any Outsourced processes: An outsourced process is performed by an organization outside the scope of the management system although the outsourced function or process is within the scope. (e.g., process performed by a supplier or by a sister organization that is not included in your internal audit program.) Are you currently certified by another certification yes no If yes, please attach copy of body? certificate If yes above, reason for transfer Are you using a consultant? yes no If yes, what company?

If applicable, what other regulatory / industry standards are relevant to your company? For ISO 14001 only: Solvents Acids What types of Hazardous Materials are used: Bases Metals Other: ______For ISO 14001 only: Federal: State / Province:

List applicable environmental regulatory Local: agencies: For R2 only: yes no If yes, please provide details (number Do you have any potentially hazardous and description) processing technologies For R2 only: Please describe the nature and complexity of the downstream recycling chain For R2 only: Do you currently export any recycled or yes no If yes, please provide details processed materials. For AS9100 / AS9120 audits only; Are International Traffic in Arms Regulations yes no If yes, please provide details (ITAR) applicable to your organization? For CMDCAS only: Does the site to be certified currently hold a Medical Yes Will apply within next 12 months Device License issued by Health Canada? For CMDCAS only: Class I Class II Class III Class IV If you have or plan to apply for a medical device Describe below including product type and license in Canada, what products are included? intended use: For MDSAP only: USA Canada Which countries are you currently or planning to ship medical devices into? Brazil Australia FOR INTEGRATED AUDITS ONLY - DO YOU HAVE: (INTEGRATED AUDITS ARE AUDITS OF MULTIPLE STANDARDS PERFORMED AT THE SAME TIME, E.G. 9001 & 14001, 14001 & 18001, 9001 / 14001 AND 18001) An integrated documentation set, including work yes no instructions to a good level of development

Management Reviews that consider the overall yes no business strategy and plan An integrated approach to internal audits; yes no

An integrated approach to policy and objectives yes no

An integrated approach to systems processes; yes no

An integrated approach to improvement mechanisms, (corrective and preventive action; yes no measurement and continual Improvement);

Integrated management support and yes no responsibilities. Who designs the products / Check all that apply: services that you provide to your Customers provide product designs that we produce. customer? We design our own products at the site to be certified. Our company designs products at another location that we produce at the site to be certified. We outsource design activities to suppliers / subcontractors. We are a distributor of products that are designed and manufactured by other companies. Use of electronic media / Check all that apply: communication Management system documentation / processes are located on a company network / intranet. Design records (including verification & validation results) are stored electronically on a company network / intranet Training records are stored electronically on a company network / intranet Records of activities done at remote sites are stored electronically on a company network / intranet (e.g., sales, service, etc.) These are accessible from the main site. Video teleconferencing capabilities are available.

Dress Code is: business (tie) business casual (no tie) casual

Safety Equipment auditors ear plugs steel-toed shoes should bring: safety glasses safety glasses with side-shields other ______

Enclosed with this application: advertising material plant layout organization chart other information ______

Other than English, what languages should the auditors speak or need translators for?

Date Completed by:

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