Surveillance submission documents

Updated: July 2024, 9

What is a surveillance audit?

This refers to an inspection of manufacturing facilities for items that have already been certified, and involves an on-site inspection of the quality control supervision system conducted once a year.
The base month is the certification month of the first certified item, and it is possible to handle multiple items at once. 


Submit to the certification body (approximately 3 months before the reference month)
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Apply to receive a quote
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Surveillance review
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Final review by certification board
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Issuance of examination confirmation

Documents to be submitted

1) If the manufacturer has received ISO certification from a certification body
・Information on responsible persons of business entities subject to QMS conformity inspection 

② Certification body requests surveillance audit
・Quality manuals and organizational charts of manufacturers, etc. subject to surveillance audits
・Information on responsible persons of business entities subject to QMS conformity inspection
・Copy of ISO13485 certificate and most recent audit report (if applicable) 

③ When a surveillance audit by another accredited certification body is deemed to be a surveillance audit, or when a QMS conformity survey is deemed to be a surveillance audit.
・On-site surveillance inspection reports conducted by other accredited certification bodies within the past year from the reference month
・Other documents proving that the surveillance examination has been confirmed

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- A copy of the standard conformity certificate issued within the past year from the reference month
・Summary report of QMS investigation for the above-mentioned conformity certificate (when using a conformity certificate issued by a body other than a certification body)
- Copy of valid ISO 13485 certificate (only if the manufacturer, distributor, etc. does not have a written certification for ISO 13485 from a certification body)

Flow of the examination day

Here is an example of the initial time schedule.
The examination will take approximately half a day.

13:00-13:15 Explanation
13:15-14:00 Quality policy, quality goals, supervisor/management manager relations, etc.
14:00-15:00 Quality control supervision system standards, product standards, internal audits, document records, education and training, etc.
15:00-16:00 Manufacturers and distributors (shippability, GVP, etc.), complaint handling, corrective measures, storage, etc.
16:00-16:45 Judge work
16:45-17:00 Final meeting

Other notes

 ① Points to note when applying "ISO/IEC 17021" and "ISO/IEC17065"
・If there is a difference between these and related laws and regulations, the provisions of the relevant laws and regulations shall be applied.
- If there are differences in the names between these standards and related regulations, use "ISO/IEC 17021" and "ISO/IEC17065".
・Use the latest version of each standard. However, the previous version may be used within six months of the publication date of the new standard. If any change procedures are required due to the revision of the standards, they will be carried out during the transitional period. If you have special circumstances, please notify us and we will consult with you.

②When the QMS conformity inspection, etc., covers matters equivalent to or greater than those covered by the surveillance audit, it will be considered as part of the surveillance audit. In other words, multiple overlapping audits will be unnecessary.
Example)
・QMS conformity survey by a registered certification body conducting surveillance audits
・QMS conformity survey by another registered certification body
・QMS conformity survey by the Pharmaceuticals and Medical Devices Agency
- A valid certificate issued by an institution accredited in the drug regulatory system of Japan, the United States, Europe, Australia or Canada, and a copy of the latest audit report, etc. (If the process to be audited cannot be specified, an audit plan, etc. must be attached.) are submitted, and it can be confirmed that audits are conducted approximately once a year.
- If the quality manual includes elements of Chapter 3 of the QMS Ministerial Ordinance and those elements are also audited.
*Subject to change compatibility investigation will be determined on an individual basis.

③ If it is determined that an audit of a registered manufacturing facility related to change management, corrective measures, etc. is necessary, the registered manufacturing facility will be subject to a surveillance audit.
Example)
・There are serious points to be pointed out, and due to the nature of the matter, an examination of the registered manufacturing facility is required.
・If the corrected status cannot be confirmed using the materials and explanations provided by the manufacturer
・If the review is agreed to
・If the registered manufacturing facility that stores the changed or added final product has not been inspected by any investigator for more than three years.

④ Although it is possible to change the registered certification body that conducts surveillance audits, frequent changes should be avoided.

For consultation regarding permits and licenses regarding medical devices, please contact Support Administrative Scrivener Corporation.

At Support Administrative Scrivener Corporation, we provide application support and consulting regarding the Pharmaceutical and Medical Device Act, from those newly entering the medical device industry to existing marketing distributors, manufacturers, and distributors. 

Applications for medical devices are highly specialized and can be said to be one of the fields in which there are few administrative scriveners who can handle them.

Our staff has a track record of applying in all prefectures across the country. Please contact us by all means.