Application for on-site J-QMS Audit

* One application need be submitted for each QMS

Applicant

Company:
Contact person/Title:
Address:
Tel.: / FAX:
Email: / Company code:
(if already obtained by PMDA)

* We will send our quotation and invoice to the applicant mentioned above.

Reasons for audit
For making application for product marketing certification under the PMD Act.
For surveillance audit
For 5 years re-certification audit / Method of audit
Combine with annual ISO13485:2003 and J-QMS audit
Single audit for J-QMS

Information on the facility to be audited

*The number of employees should be the total of members engaged in design, purchase, incoming inspection, manufacture, inspection, quality assurance, complaints handling, post market safety, andtop management, who involve with the scope of audit described in the next table.

Facility 1> * In case that audit will be undergone at the same time for more than one facility covered by one quality management system, data on the second facility and after should be described with a copy of this table.

Name:
Address:
Contact person/Title: / Mr/Ms(* Please put the name of the person who may sign the auditplan, report, etc)
Company code:
(if already obtained by PMDA)
Number of employees / Applicable chapters of QMS ordinance / Business category/process carried out by the manufacturing site / Specialty audit
Number of employees: ( ) / Chapters 2 and 3
Chapter 4 / Marketing Authorization Holder
Designated Marketing Authorization Holder
Foreign Certificate Holder
Manufacturing site (design)
Manufacturing site (production)
Manufacturing site (sterilization)
Manufacturing site (storage of finished products in Japan)
Manufacturing site (filling of IVD reagent)
Others --- facilities other than registered manufacturing sites / Containing biological origin materials
Containing pharmaceuticals
Containing nanomaterials
Micromachines
ISO13485 attestation status / J-QMS Audit in the past
ISO13485 : 2003 certified by
TUV SUD group
Other Certification Body( )*
N.A
* Please submit a copy of the certificate and latest auditreport. / Most recent audit conducted on(month)(year).
Audit conducted by:
TUV SUD group
Other organization ()*
N.A
* Please submit the latest auditreport.

Scope of Audit(please specify all the areas to be audited)

The On-site J-QMS auditreport may be utilized mutually with the QMS audit by documents at the time of making applicationfor marketing (product) approval or certification and 5 years re-certification for three years. We would recommend that the applicant will include products/product categories for which the report is expected to be utilized widely in the area of audit, considering your schedule of utilization.

If there are any additions after the previous on-site J-QMS audit, please check the “Addition to the previous items” column.

If the scope of audit contains a number of product categories, increase the number of lines, or attach a list containing the same contents.

No. / Product category1)
Sub-category 2) / General term of representative product
(JMDN code) / Addition to the previous items / Class3) / Remarks 4)
1
2

*The announcement and table of codes mentioned below are available in Japanese only. Please fill out the table above consulting with Marketing Authorization Holder (MAH) or Designated Marketing Authorization Holder (D-MAH) in Japan, in case foreign applicant.

1)State correctly the “relevant product category” and “the number in the Remarks column” in Attachment 2 of the Yakushokukanma Issue 0911 No.5 “About the eligibility of product categories concerning medical devices and in-vitro diagnostic reagents.”
If abbreviated names are used, download “Table of all codes” from , and state the abbreviations of product groups from among those on the Sheet “CODE 212” (product group categories, etc.).

2)In accordance with Section 4. (1) or (2) of the announcement mentioned above, state one from among i, ro, ha and ni.

3)State the class of the product (2 or 3) which is included in the relative product categoryand handled by the facilities to be audited .

4)In accordance with Section 4. (3) of the announcement mentioned above, if it is the product for which the interim measure can apply and it is not requiredcontrol of design and development, state “interim measure applicable product” in this column.

Registered manufacturing site to be included in the QMS Conformity Attestation(state in the case of MAH or Foreign Certificate Holder)

If there are a number of combinations of manufacturing sites, increase the number of lines, or attach a list containing the same contents.

No. / Product category
(Copy and paste from the above table) / Name of the registered manufacturing site (design) / Name of the registered manufacturing site (main manufacture / filling IVD reagents) / Name of the registered manufacturing site (sterilization: if applicable) / Name of the registered manufacturing site (storage of finished products in Japan)
1 / To be audited this time. / To be auditedthis time. / To be audited this time. / To be audited this time.
2 / To be audited this time. / To be auditedthis time. / To be audited this time. / To be audited this time.

Preferred Schedule:

(Specify the date on which you prefer the on-site audit. In the case of combined with the ISO13485, select the same dates as those for ISO13485:2003.)

No. / Desired dates (specify the week at least three months ahead of the submission)
First choice / Week of (month)(day)(year)/Same dates as those for ISO13485:2003
Second choice / Week of (month)(day)(year)/Same dates as those for ISO13485:2003

Audit Report (original) deliver to:

The audit team usually deliver the audit report (original) to the audited facility. If another handling is required, please tick checkbox below.

The audit report (original) needs to be delivered to the applicant, not Audited Facility.

We hereby make application for the on-site JQMS audit as mentioned above.

Signature:

Date of application:

Title: On-site J-QMS audit application
Revision:6
Effective: 2016-11-01 / ID-Number: JPM_F_02.08E / Phone: +81(0)3-3372-4821
Fax: +81(0)3-3372-1621
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TÜV SÜD Japan Ltd.
Sumitomo Fudosan 4-Bldg. 8F,
4-33-4, Nishi-Shinjuku, Shinjuku-ku
Tokyo 160-0023
Japan