ISO 9001 Consulting – QMS Documentation Implementation Checklist

By | June 14, 2017

ISO 9001 Consulting

QMS Documentation Implementation Checklist

Quality Manual

Does the Quality Manual:

  • Outline the structure of the quality management system  
  • Include the supplier’s name, address, quality policy and objectives and organization structure?  
  • Define the Scope of the Quality management system for products, services, facilities, applicable quality system standard and elements, and functional activities?  
  • Define the responsibility and authority for each element of the quality system?  
  • Define the documentation hierarchy? 
  • Make reference to relevant procedures?
  • Is the extent of documentation relative to methods used, skills needed and training given?  
  • Is it consistent with the ISO 9001 standard & quality policy?   

Processes, procedures & flowcharts: 

  • Are all processes falling within the scope of the quality management system identified and defined and are their procedures appropriately documented?
  • Are the processes fully deployed and implemented as documented?  
  • Is there a plan & schedule for implementing the quality system? Are flowcharts used as a tool to map out critical or core processes?
  • Do the quality system procedures include the following:  
    • Purpose, scope, responsibilities and full details  of how, what, when and where all relevant activities are performed?
  • Work Instructions : Are they required? 
  • Records & Forms : Are appropriate records & forms used to support the quality management system? 
  • Are all forms described in the quality system included or referenced ?  
  • Have all resources needed for implementation (personnel; technology, production, measuring and design equipment; specifications & acceptance standards; quality records) been determined & evaluated (present & needed)?  
  • Does the quality system satisfy customer requirements & expectations, needs of society? 
  • Does the quality management emphasize prevention and elimination of nonconformances, reduction of variation and waste.? 
  • Is the Quality system understood by employees & effective?   
  • Are quality system & procedures effectively implemented? 
  • Are they providing the expected results of the quality policy and objectives? 
  • Are the evaluation tools such as management review and internal quality audits being used to determine effectiveness of the quality system?  

Other Useful Training Resources:
Understanding ISO 9001:2015 provides a detailed explanation of each ISO 9001 clause
(requirements).
 
 

ISO 9001 Consulting - QMS Documentation Implementation Checklist

ISO 9001 Consulting – eCourse