15 Months to Certification: Using SharePoint as the Platform for an ISO 9001 QMS

15 Months to Certification: Using SharePoint as the Platform for an ISO 9001 QMS Barry Peters Vice President, Corporate Quality and Compliance Telerx Marketing NextDocs Confidential

Agenda ,[object Object],[object Object],[object Object],[object Object],[object Object],NextDocs Confidential

Who is Telerx? ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Who is Telerx (cont’d.) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Importance of ISO9001 ,[object Object],[object Object],[object Object],[object Object],NextDocs Confidential

Vendor Selection ,[object Object],[object Object],[object Object],[object Object],NextDocs Confidential

Product Purchase/Scope ,[object Object],[object Object],[object Object],[object Object],NextDocs Confidential ,[object Object],[object Object]

Toolkit Purchased NextDocs Confidential Document lifecycles, overlays, numbering Digital Signature Engine (Arx)

ISO Business Processes ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],NextDocs Confidential

Document Control (ISO clause 4.2.3) NextDocs Confidential

Overview ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],NextDocs Confidential A statement of position to achieve a desired outcome Supports policies by specifying the plan intended to produce a stated outcome. Ensures the stated outcome either via step by step detail of the responsibilities for the employees doing the job or providing other means of instruction in order to perform a job.

Document Lifecycle – Policies and SOPS NextDocs Confidential Draft Feedback Approval Training Effective Retired Where documents are authored Authorized approvers digitally sign the document here Author acts on task when “training is complete” in this stage This is the stage where the current approved version sits Where a document is no longer needed, it is moved to retired SME and others provide revision suggestions on the document here Documents move through by “promotion”

Document Lifecycle – Work Instructions NextDocs Confidential X Draft Feedback Approval Training Effective Retired Where documents are authored Authorized approvers digitally sign the document here Author works with mngmt. on training needs if required and acts on task when “complete” This is the stage where the current approved version sits Where a document is no longer needed, it is moved to retired SME and others provide revision suggestions on the document here Documents move through by “promotion”

Document Libraries- Applied to Lifecycle NextDocs Confidential Draft Feedback Approval Training Effective Retired Lifecycle Stages Working Document Libraries Working Working Training Effective Working

X-Docs: Unique Features ,[object Object],[object Object],[object Object],NextDocs Confidential

Record Control (ISO clause 4.2.4) NextDocs Confidential

Record Control ,[object Object],[object Object],[object Object],NextDocs Confidential

Change Control (ISO Clause 6.3) NextDocs Confidential

Change Control ,[object Object],[object Object],[object Object],[object Object],NextDocs Confidential

Design and Development (ISO clause 7.3) NextDocs Confidential

Design and Development ,[object Object],[object Object],[object Object],[object Object],NextDocs Confidential

Internal Audit Program (ISO clause 8.2.2) NextDocs Confidential

Internal Audit Program ,[object Object],[object Object],[object Object],[object Object],[object Object],NextDocs Confidential

Internal Audit Program (Reports) ,[object Object],[object Object],NextDocs Confidential

Non-Conformances/CAPA (ISO Clauses 8.3-8.5) NextDocs Confidential

Non-Conformances/CAPA ,[object Object],[object Object],[object Object],[object Object],[object Object],NextDocs Confidential

Non-Conformance, CAPA and Effectiveness Checks NextDocs Confidential

Lessons Learned ,[object Object],[object Object],[object Object],[object Object],[object Object],NextDocs Confidential

Questions NextDocs Confidential

15 Months to Certification: Using SharePoint as the Platform for an ISO 9001 QMS

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15 Months to Certification: Using SharePoint as the Platform for an ISO 9001 QMS