TÜV NORD Polska Sp. z o.o. 40-085 Katowice, ul. Mickiewicza 29

SERTIKA Tel. / faks.: +370 37 314434

Inquiry

This request for quotation form serves as a tool to learn about your business activity. Information provided in the request will be used by the Certifying Body TUV NORD Polska to prepare a quotation for carrying out the process of certification.

Please send the completed inquiry to address or fax: +370 37 314434

GENERAL INFORMATION ABOUT THE COMPANY

Company’s registered name (according to the National Court Register KRS): / President/Executive:
Street, postal code, city/town: / Proxy:
Province: / Phone: Mobile phone:
VAT No.: / e-mail:
www:
Contact person: / fax:

SUBJECT OF THE COMPANY’S ACTIVITY

Proposed scope of certification (the supplied scope will be included in the certificate):

Polish Classification of Activities – PKD:

CLASSIFICATION BASIS

Quality Management System Certification by TÜV NORD Polska / Medical Device Certification by Polish Notified Body TÜV NORD Polska no. 2274 / Długość cyklu certfikacji
ISO 9001 / Directive 93/42/EWG Submission of a new product or material change in the certified product / 3 years - standard
ISO 13485 / Directive 93/42/EWG, Annex V / 5 years(certification of a medical device without quality systems)
Directive 93/42/EWG, Annex VI
Directive 93/42/EWG, Annex II.3
Directive 93/42/EWG, Annex II.3+II.4

EMPLOYMENT INFORMATION

The total number of locations / Localisation I
Headquarters / Localisation II / Localisation III / Localisation IV / Total
Name of company/plant/branch
Address (street, postal code, town/city)
Type of activities performed
Total number of employees including contract and seasonal employees - full time equivalent of the above
Number of employees on 1st shift
2nd shift
3nd shift

If the organisation has more localisations, please copy and fill in the table for all localisations

identical activities performed in all shifts in case of shift-work system

significant part of company's staff perform simple, repetitive tasks (for example, in transport, at work tape, on assembly lines, performing administrative tasks, etc.)

FACTORS RELATED WITH THE ORGANISATION’S ACTIVITIES:

There are exceptions to the requirements of the standard (please tick the applicable exceptions)

7.3 (research and development) 7.5.2(process validation) 7.5.4 (customer’s property)other:

Please tick appropriate items characterising your activity and support briefly your answer

Current status of the quality system:
fully documented
partly documented
certified by:
Certificate expiry date: / the companyuses mainly subcontractors’ services.
Please, list all the subcontracted processes identified in the organisation (required):
the companyhas an accreditation of another body in the industry (name:) / processes in the company are related to on main activity
Business locationcan bedescribed as:
small localisation of the company as compares with the number of employees (e.g. office complex, the company does not have any branches, the company is located on one site)
extensive localisation – complicated logistics including more than one building (it is necessary to move among districts, municipality, towns/cities
yes / no / Does the company outsource important stages of design/production to other companies? Ifso,how thesupplierisassociated withyourquality system?
(audit with the supplier, relationship with your quality system, a pre-inspection of materials received from suppliers, certification to ISO 9001, EN 13485 and MDD)
Proces / Name of the Supplier / Connection
Design
Elements of production process
Packing
Sterilisation
Service
Accessories
Other

INTEGRATED SYSTEMS CERTYFICATION

In the case of the integrated systems certification, please tick the items which will help to define the integration level of your management systems. Ticking all the items means full integration of implemented systems.

Management reviews taking into consideration general business strategy and plan

Integratedapproach to internal audits

Integratedapproach to policy and objectives

Integratedapproach to systemic processes

Integratedset of documentscoveringworkinginstructions, on a good level of development, according to a situation

Integratedapproach to improvement mechanisms (corrections and corrective actions; surveying and continuous improvement)

Integratedapproach to planning with a good use of comprehensive approach to risk management in business

Unified support and managerial responsibility

Systems audit performed: jointly separately

QUOTATION

The quotation should include the following:

Certifyingaudit, according to standard:

Re-certifyingaudit, according to standard:

Supervisionaudit, according to standard:

Suggested tentative audit date:

yes date:no

ADDITIONAL INFORMACTION

While implementing the systems, did you use the services of external consultants?

yes specify who:

no

How did you find us:

Your remarks, wishes:

Name of the person preparing the motion: Date:

Thank you for filling in the request for quotation form.

P11F001 1 z 3Rev. 01/05.2013