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“Uploading Support Documentation Training” Please Note … A copy of this presentation will be emailed. There is a quiz available on the LMS course # OL-INT-USDT. “Uploading Support Documentation Training” After completing the quiz, contact Alan Gardiner (alan.gardiner@bsigroup.com) to be activated.

Uploading Support Documentation A presentation by Alan Gardiner, Documentation Specialist, BSI Wednesday April 14, 2010

Documents Which Documents are Needed? What Formats are Used? Where do you Upload these Documents? What Actions after Uploading? What if I have a Problem? Where is this Documented?

1. WHICH DOCUMENTS are Needed? Depends on … the standard and the visit type See the Document Upload Matrices Locations for Internal and External auditors on next slide  Example is TS on next screen

Document Upload Matrices BSI internal auditors - Connect URL: https://connect.bsi-global.com/sites/USAOperations/Shared%20Documents/Forms/AllItems.aspx Click Shared Documents Double click the document “Document Upload Matrices” BSI external auditors - Bulletin Board on PG URL: https://pga.bsi-global.com/referenceboard.aspx?bname=er_qms_americas

TS Document Upload Matrix Replace or Include on another next slide a list of documents to be uploaded under the CRN and Cert numbers.

2. What FORMATS are used? Successful Upload: Mainstream applications Adobe Acrobat (.pdf) MS Word (.doc) MS Excel (.xls) MS PowerPoint (.ppt) Text file (.txt) Size “Error – File upload is limited to 2 MB” Successful Upload: Success - Document has been queued

3. WHERE do you Upload these Docs? Under the SMO/Report number doc type Cn Ex: A7s (doc type C7) … CAPs (doc type C9) … CAPA (CF) … A218 (CE) … checklists (CH) … Under the Client Reference Number doc types An and Bn Ex: transfer docs (doc type BE) … concessions (AF) … A731 (AA) … Under the Certificate Ex: A903-Sampling plans (doc type AG – ONLY Under the Cert, not the CRN) … Certificate correspondence (AA) …probation letter (AA) … A513 (BD) …

Doc Types under REPORT/SMO

Doc Types under CLIENT REF NO. (CRN)

Doc Types under CERTIFICATE

DEMO Report number Client Reference Number Certificate A556 (doc type CH) A755 (doc type CC) Client Reference Number A089 – Concession (AF) (note: May also pertain to a specific report, then also upload under the report number using doc type CI – Internal Concession) A731 – Name or Address Change (AA) Certificate A903-Sampling plan (AG) Sample Data Report – 4839676 - A556 (CH) and A755 (CC). Client Ref Number – A731 (address change) - CIBA V-0009600686-003 (AA) and A089 concession - ALCOA -0047178719-000 (AF) Certificate - EMS 76834 A513 - LDI IN-0047157878-000 (BD) and FM 35957 A903 Multi Site Sampling Plan (AG)

4. What Actions After Uploading? Email Reports.msamericas@bsigroup.com First time upload to confirm (if you want to) If incorrectly upload a document. Cert workflow/request is located by the Documentation Specialist. Comments are Inserted/updated. Status is changed In Review Awaiting Docs Overdue Docs

5. What if I have a PROBLEM? Oversized docs Wrong file format (example: Visio) If upload error, email Reports mailbox document removed and/or replaced.

6. Where is this DOCUMENTED? See the latest Document Upload matrices Please refer to the online version since it does change frequently. We prefer that the document not be printed. updated per instructions from Regulatory, Management, and Technical Review. maintained by the Documentation Specialist

Updates What Typically Changes? New doc types By UK – to distinguish docs New documentation required How do we keep everyone informed when there is a change to the upload procedure? Document Upload Matrices on CONNECT. Rely only on the online version – not printed. Version dated at top of each page Page 2 shows what was changed and when. Do A Demo – Upload a few documents.

Contact Alan Gardiner Documentation Specialist BSI Management Systems Name: Alan Gardiner Title: Documentation Specialist Address: BSI Management Systems 12110 Sunset Hills Rd, Suite 200 Reston, VA 20190-5902

Contact Info - Email reports.msamericas@bsiamericas.com DO NOT Send to Alan’s personal email. Documents need to be available to others in the office who assist with uploading.

Contacts - Phone Voice: (703) 674-1985 Faxes: (703) 674-1007 Brief message with enough info so that I can start the research. (SMO/Cert number, client name and location.) Faxes: (703) 674-1007 Cover page – total number of pages. I will contact you if there are missing pages.

QUESTIONS?