1502.02 basic data - organisation - dqs-med.de · web viewno / yes: … (e.g. iso 13485 ......

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1502.02 Basic Data - Organisation

DQS Reference No.: Date created: YYYY-MM-DD Date revised: YYYY-MM-DD

NOTE: On revising the information in this document: mark the changed information in a different font colour and include a revi-sion mark on the right side of the changed information. The revision mark includes the date of changing the information and initials or the revising person e.g.: 2010-01-31 AB. The revision marks may only be deleted by a representative or DQS Medizinprodukte GmbH.

Enter revision marks here ↓

1.0 Company Profile

1.1. Company Legal Name Provide the company name according to company registration as well as any further names used (corporate identity).

1.2. Company Address Provide the complete street address according to the company registration. A P.O. Box address, or specific other mailing or invoicing addresses can be entered as additional address, if so desired.

1.3. Contact Persons Provide a top management contact (e.g. CEO or other person authorised to sign in the name of your company), and a contact responsible for your quality management system (e.g. management representative). Additional contact(s) can be provided, if necessary.

1.4. Company Scope What does your company do? Provide a brief description of your company’s operations, key processes and products and/or services provided to the market.

e.g. manufacturing of printed circuit boards for use in medical devices, provision of contract manufacturing services, design and manufacture of intravenous infusion sets… (specify)

1.5. Company’s Existing CertificationsOther than DQS

Does your company have currently valid quality management system (QMS) or regulatory (CE marking, CMD-CAS, other) certifications issued by certification bodies other than DQS?If yes, please provide copies of certificates.

No / Yes: … (e.g. ISO 13485:2003 issued by … expiry date …)

1.6. Company Size Provide the number of locations operated by your company, and the total number of employees (full-time equi-valent).

1.7. Company’s Legal Ob-ligations

What legal obligations are relevant for your company’s scope?What national or regional regulatory quality management system requirements does your company have to com-ply with?

e.g. particular laws, regulations, etc… (specify)

1.8. Belonging to a Cor-poration

Does your company belong to a larger corporation? If yes, please identify the corporation and your company’s functions in it.

No / Yes: … (specify the corporation)

1.9. Use of Consultancy Does your company receive guidance from an external provider relating to the management system? If yes, identify the consultancy service provider.

No / Yes: … (name the consultant(s))

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Type of address: Registered street address

Street address 1st line

Street address 2nd line

City

County / State

ZIP / Postal Code

Country

Type of contact: Top Management Management System (QMS)

Mr. / Ms., Degree:

Last Name:

Given Names:

Job Title:

Telephone:

Fax:

E-Mail:

Total number of sites / locations:

Total number of employees:



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1.0 Company Profile

2.0 Certification Profile

2.1. Certification Stand-ards / Regulations

For what activities and to which standards and/or regulations does your company require assessments and/or certification by DQS-MED? Choose from the options in the following table by entering “X” in the final column.

Activity (examples) Standard / Regulation “X”

Company with a quality management system (general, international) ISO 9001:2008Manufacturer of medical devices, QMS requirements (German) DIN EN ISO 13485:2010Manufacturer of medical devices, QMS requirements (European) EN ISO 13485:2003 + AC:2009Manufacturer of medical devices, QMS requirements (international) ISO 13485:2003Manufacturer of medical devices for the EU/EEA (CE marking): Medical Devices Directive 93/42/EEC:

Class I (measuring) Annex II without II(4) Annex V

Class I (sterile) Annex II without II(4) Annex V

Class IIa (non-active medical devices) Annex II without II(4) Annex V

Class IIa (active medical devices) Annex II without II(4) Annex V Annex VI

Class IIb Annex II without II(4) Class III Annex II including II(4)

Manufacturer of medical devices for Canada: Class II / III / IV ISO 13485:2003 under CMDCAS (Ca-nadian Medical Devices Regulations)

Manufacturer of medical devices for the USA, subject to GMP FDA QS Regulations / 21CFR820Manufacturer of primary packaging materials for pharmaceuticals ISO 15378:2006(Other: … please specify) …

To add lines to the table, place the cursor in the above line and press [TAB] multiple times.

2.2. List of Locations Use the following table to provide information on all locations of your company that are relevant for any of the chosen Certification Standards / Regulations (see 2.1).Include any head offices (HO) and any operating locations!NOTE: Any relevant locations that are owned by your company but operate under an independent management system (i.e. a different management system from the one in your company), are considered suppliers (internal suppliers). Provide information on these in 2.3.

No.(automatic)

Location Name Location Address Personnel countTotal No.

No. of shifts

No. of shift workers

L1 (see 1.2)L2


2.3. List of Suppliers and SubcontractorsIncluding OEMs

Use the following table to provide information on all suppliers and subcontractors your company uses for any activities and/or products that are:

relevant for any of the Certification Standards/Regulations (see 2.1), AND critical for the quality of services and/or products provided to the market by your company.

This typically includes providers of contract services such as design and development, production, assembly, packaging, clean room, sterilisation, labelling, final inspection etc., providers of any critical parts or materials, any providers of finished devices (original equipment manufacturers, OEMs), and any critical internal suppliers operating under an independent management system.

No.(automatic)

Supplier Name Supplier Address

S1S2

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3.0 QMS Profile This section applies for all certifications (including MDD 93/42/EEC and CMDCAS).

3.1. QMS Certification Scopes

Enter the scopes of certification as they have to appear on your QMS certificates issued by DQS Medizin-produkte GmbH to chosen QMS standards (see 2.1). Different scope statements can be provided for differ-ent standards.NOTE: The scope on your certificate to ISO 13485 under CMDCAS is strictly regulated in Health Canada guidance GD207. At least one Medical Device (see 5.1) must be included, for which your company holds or intends to apply for a Medical Device License.To access GD207, please follow this link . To access a list of examples for generic device groups please follow this link .

e.g.: ISO 13485: …ISO 9001: …CMDCAS: Design, production, distribution, installation and servicing of [generic categories]…

3.2. QMS Locations Use the following table to provide information on those Company Locations (see 2.2), that are involved in the QMS Certification Scopes (see 3.1). Different location scope statements can be provided for different standards.NOTE: Overlaying of Location Scopes in the following table must result in the respective QMS Certification Scope (see 3.1).Templates for Location Scopes can be easily generated by copying and pasting the corresponding QMS Certification Scope.

Location No.

e.g. L1, L2…

- see 2.2

Location Scope:

What parts of the QMS Certification Scope activit-ies (see 3.1) are applicable at this location?

Identify the head office (HO)!

This location is involved in (only applicable to medical

devices – ISO 13485)(mark with “X”)

This location is subordinate to location No.

e.g. L1, L2…- see 2.2

Des

ign

Prod

uctio

n

Ster

iliza

tion

Fina

l

L1


3.3. QMS Suppliers and Subcontractors

Use the following table to provide information on those Company Suppliers and Subcontractors (see 2.3), who are relevant for / involved in the QMS Certification Scopes (see 3.1). NOTE: If a supplier has a valid certification for the provided product or service, attach a copy of the sup-plier’s current certificate! You can insert the copy directly into the table by going to the menu: Insert / Object / Create from file / Show as icon.

Supplier No.

e.g. S1, S2…

- see 2.3

Supplier Scope:

What products, OEM products or services that are relevant for the QMS Certification Scope (see 3.1)

are obtained from this supplier?Identify any OEMs!

This supplier is involved in (only applicable to medical

devices – ISO 13485)(mark with “X”)

Does this sup-plier have a

QMS certified for the provided product/service?If yes, enter expiry date

below and at-tach certific-

ate copy!

Des

ign

Prod

uctio

n

Ster

iliza

tion

Fina

l

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http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/keyword_motscles2-eng.php

http://www.hc-sc.gc.ca/dhp-mps/md-im/qualsys/cmdcas_scecim_accep_cert13485_2-eng.php



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3.4. Links to other QMSs Is the QMS, for which your company applies the above-named standards, linked with other QMSs of your company or related companies (e.g. suppliers, internal supplier arrangements)?

No / Yes: … (describe)

3.5. Location of all QMS records At which location(s) can all records be accessed that are specified by the QMS and QMS stand-ards’ requirements?

e.g. L1, L2, available online etc… (specify)

4.0 Regulatory ProfileMDD 93/42/EEC(CE marking)

This section applies if the certification to MDD 93/42/EEC is requested (see 2.1).If the certification to MDD 93/42/EEC has not been chosen, skip to 5.0.

NOTE: Complete Company/Certification/QMS Profiles must be provided in 1.0/2.0/3.0.

4.1. Is your company a Legal Manufacturer of Medical Devices in Europe?

Are Medical Devices of the risk classes III, IIb, IIa, and/or I (measuring or sterile) being placed on the European market in the name and under the responsibility of your company as Manufac-turer, or is your company intending to do so in the near future?NOTES:1. ‘Medical Devices’ are defined in the MDD 93/42/EEC Article 1 (2) a)2. ‘Risk class’ must be determined according to MDD 93/42/EEC Annex IX3. ‘Manufacturer’ is defined in the MDD 93/42/EEC Article 1 (2) f)To access the MDD 93/42/EEC, please follow this link.

Yes / No

4.2. List of Medical Devices Ensure that a complete and up-to-date list of medical devices is provided to DQS Medizin-produkte GmbH using the form List of Medical Devices (or equivalent).Enter the revision date of the currently used List of Medical Devices.

The revision date of the currently valid list of medical devices is …. (YYYY-MM-DD)

4.3. Registration with DIMDI and Safety OfficerOnly applicable for Manufactur-ers located in Germany

Provide your Manufacturer’s “DIMDI-Code” (“Hersteller-Code”) and your company Safety Of-ficer’s (“Sicherheitsbeauftragter”) name and current contact information below.The “Hersteller-Code” is assigned to your company by DIMDI after processing of your MPG §25 announcement.

DIMDI-Code: DE/00000…Safety Officer: (Name, Phone / Fax / E-Mail)

4.4. EU Representative Only applicable for Manufactur-ers located outside the EU/EEA

Use the following table to provide information on your EU representative. Include a complete street address (P.O. Box addresses are not accepted by the European authorities).

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EU Representative’s Company Legal Name

EU Representative’s Contact Person

EU Representative’s DIMDI-Code(Only applicable if located in Germany)

DE/00000…

Street address

City

County / State

ZIP / Postal Code

Country

Telephone

Fax

E-Mail

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1993L0042:20071011:EN:PDF



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4.5. Location of all QMS records and Technical Documenta-tion on Medical Devices

At which location(s) can the complete QMS records and Technical Documentation (technical files) of Medical Devices be accessed, that are specified by the MDD 93/42/EEC Annex II.3 and/or An-nex V.3 as well as any applicable harmonized standards (e.g. EN ISO 13485, EN ISO 14971, EN ISO/IEC 60601 series, EN ISO 10993 series etc.)?To access the list of harmonized standards under the MDD 93/42/EEC, please follow this link.

e.g. L1, L2, available online etc… (specify)

5.0 Regulatory Profile

ISO 13485:2003 un-der CMDCAS

This section applies if the certification to ISO 13485 under the CMDCAS program is requested (see 2.1).

If the certification under CMDCAS has not been requested, skip to 6.0

NOTE1: Complete Company/Certification/QMS Profiles must be provided in 1.0/2.0/3.0. NOTE2: Canadian Medical Devices Regulations (CMDR), Part 1, and ISO 13485:2003 are mandatory cri -teria for your QMS in case of certification under the CMDCAS system.

5.1. Is your company a Legal Manufacturer of Medical Devices in Canada?

Does your company have Medical Device Licenses for Medical Devices of the risk classes IV, III and/or II being placed on the Canadian market in the name and under the trade name, trade mark and responsibility of your company as Manufacturer, or is your company intending to apply for in the near future?NOTES:1. ‘Medical Devices’ are defined in the Food and Drugs Act section 2 “device” and CMDR section 1

“medical device”.2. ‘Risk class’ must be determined according to CMDR schedule 13. ‘Manufacturer’ is defined in the CMDR section 1 “manufacturer”To access the Food and Drugs Act, please follow this link.To access the CMDR, please follow this link.

Yes / No

5.2. Locations and Suppliers (CMDCAS)

List all locations and suppliers indicated in 3.2 and 3.3 who are involved with the activities and products contained in the Certification Scope (CMDCAS) entered in 3.1.

The involved sites are L1, L2…, and suppliers S1, S2… (specify)

5.3. List of Medical Devices Ensure that a complete and up-to-date list of medical devices is provided to DQS Medizinprodukte GmbH using the form List of Medical Devices (or equivalent).Enter the revision date of the currently used List of Medical Devices.

The revision date of the currently valid list of medical devices is …. (YYYY-MM-DD)

5.4. Company IDOnly applicable if your com-pany already has active Med-ical Device Licenses

Provide your Company ID number assigned to your company by Health Canada. You can find the Company ID number on your Medical Device Licenses or in your company’s online active Medical Devices Licenses listing at www.mdall.ca.

(a 6-digit number)

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http://www.mdall.ca/

http://laws-lois.justice.gc.ca/eng/SOR-98-282/index.html

http://laws-lois.justice.gc.ca/eng/F-27/index.html

http://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/index_en.htm



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5.5. Regulatory Corres-pondent

Use the following table to provide information on the Regulatory Correspondent.NOTE: ‘Regulatory Correspondent” is a person officially authorized by Manufacturer to correspond with Health Canada on its behalf with respect to licensed device(s).

5.6. Location of all QMS re-cords

At which location(s) can documents be accessed that are specified by the QMS and the Canadian Med-ical Devices Regulations, Part 1?

e.g. L1, L2, available online etc…

6.0 Essential Changes

This section applies in any of the following situations:- You apply to transfer your existing certification from another certification body to DQS Medizinprodukte GmbH - DQS Medizinprodukte GmbH plans your upcoming assessment or review- Before or on occurrence of circumstances resulting into essential changes to Basic Data - Before or on conducting of recalls, advisory notices, field corrections, incident reports etc.

DQS Medizinprodukte GmbH requests you to update the Basic Data whenever one of the above situations occurs.

This section is not applicable at the initial certification application.

6.1. Changes to the Company Profile

Have there been any changes to your Company Profile (see section 1.0) since the last conducted audit activ-ity? If yes, please describe.

No / Yes: … e.g. new company name, new company address, changed contact persons, changed company scope, new or cancelled certifications by other certification bodies, changed number of employees, changed legal obligations, mergers and acquisitions, new consultants etc. (specify)

6.2. Changes to the Certification Profile

Have there been any essential changes to your Certification Profile (see section 2.0) since the last conducted audit activity? If yes, please describe.

No / Yes: … e.g. new or cancelled DQS certifications, new company locations, new suppliers etc. (specify)

6.3. Changes to theQMS Profile

Have there been any essential changes to your QMS Profile (see section 3.0) since the last conducted audit activity? If yes, please describe.

No / Yes: … e.g. changed certification scopes, changed QMS locations, changed QMS suppliers, changed inter-action with other QMSs – new supplier agreements, changed location of records

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Does your company use a Regulatory Correspondent? No / Yes: (fill in below)What are the tasks executed by the Regulatory Corres-pondent (e.g. reporting of incidents and recalls, informa-tion regarding the new regulations, etc)?

Regulatory Correspondent’s Company Legal Name

Regulatory Correspondent’s Contact Person

Street address

City

County / State

ZIP / Postal Code

Country

Telephone

Fax

E-Mail



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6.4. Changes to Regulatory Profiles Only applicable for Med-ical Devices Manufactur-ers

Have there been any essential changes to your Regulatory Profiles as Medical Devices Manufacturer (Europe and/or Canada – see sections 4.0 and 5.0) since the last conducted audit activity? If yes, please describe.

No / Yes: … e.g. new, changed and discontinued medical devices in Europe or Canada (current revision state of the list of medical devices), new or discontinued Medical Device Licenses from Health Canada, changed list of locations and suppliers involved in the ISO 13485 certification scope under CMDCAS, new or changed EU Rep-resentative or Regulatory Correspondent, changed location of technical files and QMS documentation etc. (spe-cify)

6.5. Regulatory ActionsOnly applicable for Med-ical Devices Manufactur-ers

Have you conducted any of the following regulatory actions with regards to devices contained in your DQS Certification Scopes to MDD 93/42/EEC and/or ISO 13485 under CMDCAS since the last conducted audit activity?

Recalls, advisory notices or field safety corrective actions (FSCA) Incidents or near-incidents Mandatory problem reporting

If yes, include a brief description. Attach any clarifying documents, e.g. correspondence with regulatory agen-cies, corrective action reports etc., if necessary.

No / Yes: …

7.0 Version Information

Use the following table to record the information on the current version of this document.

When is it required to submit a version containing signature(s) and who should sign?

- It is required that a printed copy (or protected PDF) of the current Basic Data is signed by the Company Representative (Top Management or Management Representative) and by the DQS Medizinprodukte GmbH’s Lead Auditor at the opening meeting of an on-site audit activity

- In all other cases, it is sufficient to submit the Microsoft® Office Word (DOC or DOCX) document by e-mail (e.g. submis-sion by the certified Company on request from DQS Medizinprodukte GmbH)

How to send a version containing new signatures to DQS Medizinprodukte GmbH and who submits?

- The signed copy must be submitted to DQS Medizinprodukte GmbH as record in Adobe® PDF format - The Microsoft® Office Word DOC/DOCX document identical with the signed PDF must be attached as separate file to-

gether with the signed copy, i.e. there are 2 files to send: DOC/DOCX and PDF- The signed Basic Data is normally sent to DQS Medizinprodukte GmbH by the DQS Medizinprodukte GmbH’s Lead Aud-

itor using the intranet upload engine

Date Name Company and Position

Signature (only at the audit)Place only on printed cop-ies or protected PDFs!

Additional Notes / Remarks

YYYY-MM-DD Max MustermannDQS Medizinprodukte GmbH Lead Auditor

YYYY-MM-DD Anna MustermannXYZ GmbH Management Representat-ive

YYYY-MM-DD N NDQS Medizinprodukte GmbH Sector Representative

Contact person changed – phone information from XYZ GmbH


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