Key Areas for Consideration to Implement and Maintain ISO Standards

We're often asked the same kind of questions by existing and prospective clients. Here are some key areas to focus on to help with achieving and maintaining ISO certification.


 Document Systems

  1. Gap Analysis

       Perform a GAP Analysis against:

  • Quality system
  • Customer requirements
  • Standards or Directive
  • Management expectation
  1. Document Route Planning
  • Flow chart the route for project/product documentation
  • Show the interfaces between each department
  1. Receiving and Filing Supplier Documentation
  • Ensure documents are requested
  • Identify the supply route for supplier documents
  • Identify the filing / retention / retrieval process
  • Ensure the accuracy and content of documents
  • Create a documentation tracker
  1. Transmittal process 
  • Ensure there is a clear and traceable transmittal process between departments, customers, suppliers.
  • Ensure the revision status of documents is maintained and there is a control process for obsolete revisions.
  1. Project Document Sets
  • Technical File content
  • CDM Files
  • Quality File
  • Manufacturing Record Books
  • Installation Records
  • Operating and Maintenance Manuals
  • Data Sheets
  • Test Records
  • Factory Acceptance Testing
  • CE Certificates
  • Handover Packs contents and population
  1. Inspection Reports filing and retrieval
  • Internal and External Inspections
  • Dimension Reports
  • Department Handover Reports
  • Motor and Electrical Test Reports
  1. Identifying Bottlenecks
  • ·       Skills gaps and training needs
  • ·       Departmental handover
  • ·       Unclear / complex / confusing processes
  • ·       Gain clarity on who is the process owner.
  1. System Audits
  • Independent audits
  • Audit from concept hrough to completion
  • Document audits and production Audits
  • Design Standards Verification