ISO Implementation 

ISO Implementation involves following steps / activities: 

• Business Need Identification and Commitment from Management 

• Formation of QMS Definition Team 

• Awareness / Training Session Planning 

• Project Team's Handholding & Facilitation 

• Pre-audit Check and Gap Assessment Report 

• Gap Correction and Action Implementation 

• Planning for Final ISO Audit 

QMS Definition 

1. MR / Team shall prepare a plan for new QMS / Process Definition 

2. Assign the procedure writing tasks to SMEs who are part of MR Support Team 

3. Select a tool or portal to host the QMS which is assessible to all in the Organization

   • Tool / Portal can be purchased or developed in-house based upon the cost, schedule etc. 

   • Tool / Portal should have all the modules required for QMS Administration including Document Management, User Management, Access Control etc. 

   • Tool / Portal should be accessible to intranet and internet as well 

   • To protect IP / Content, procedures can be provided in read-only mode 

4. Tool / Portal should have High level View / Structure of QMS and linkage to related procedures.

QMS Release / Roll out: 

1. Once QMS is Defined, Reviewed / Approved, team can release QMS (Procedures, Guidelines, Forms & Templates) 

2. An Org-wide communication should be sent (including details of Procedures, Guidelines, Forms & Templates along with Version number and brief about the usability / applicability) 

3. MR / team should also plan for QMS training for project teams  

QMS Implementation and Effectiveness Check 

1. After QMS release, team should be trained for implementation 

2. Implementation can be planned in phased manner for selected projects / teams / groups 

3. Effectiveness of QMS Implementation can be checked through Audits / Reviews:

   • Project Audit 

   • Process Audit 

   • Product Audit 

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4. Audit reports (Consolidated) should be shared with Management on regular interval as a part of  Executive Review / Status Review