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 – eCourse