ISO 9001 checklist checklijst

Simple checklist for ISO 9001:2015, after all the white papers ...

ISO 9001. Checklist ISO9001. Why an ISO 9001 checklist? Anyone who has (had to) make their quality management system suitable for the new ISO 9001 standard, ISO 9001:2015 , does not have to complain about information.
There is a lot to be found about this on the internet: whitepapers, advisors who present themselves, certifying bodies who want to do test audits, ..   So 'trees - forest' story.
 

Immediately a digital quality system

Use the structure of a digital quality system. That is why we have only given the most important points of attention as a checklist in a table below. And of course we immediately apply this in our digital quality system Proware, according to the Metaware concept

Try online now in 60 seconds . Click here. If you have ISO9001 substantive questions, you can do that too

 

Click here for the spreadsheet version.
 

Points of attention - checklist ISO 9001:2015  
     
Lawsuit Sub-processes New aspects
Management process  
 
  • Context of the organization
  • Leadership (does the board play a leading role in the management system?)
 
  • Management review
  • Context of the organization (What are the most important aspects and developments?)
 
  • Objectives and actions (improvement process at company level)
  • Risks and opportunities (at the company level and based on context)
   
  • Objectives and actions (SMART and with global elaboration, resources and timing actions)
   
  • Monitoring and measurement (Key KPIs at the company level, including analysis and action)
   
  • Knowledge (strategic and future-oriented)
     
Product development process  
 
  • Sales (determine requirements for the product and context)
  • Context of the organization (Included in specification)
 
  • Product development and product change
  • Risks and opportunities (with regard to product, process and project)
 
  • Process development  (sections 6.6 and 8.1)
  • Monitoring and measuring (Process KPIs, Product measurements)
   
  • Knowledge (Critical technological knowledge, now and in the future; lessons learned)
   
  • Documentation (of the development process and of products and processes)
   
  • Objectives and actions with regard to the process (SMART and with elaboration resources and timing actions)
     
Production, export service  
 
  • No
  • Context of the organization (Included in specification)
   
  • Risks and opportunities (only in case of changes)
   
  • Monitoring and measuring (Process KPIs, Product measurements)
   
  • Knowledge (Critical process and product knowledge, now and in the future)
   
  • Documentation (process description, instructions, etc.)
   
  • Objectives and actions with regard to the process (SMART and with elaboration resources and timing actions)
     
HRM    
 
  • Recruitment & selection
  • Context of the organization (Labor market)
 
  • Orient
  • Risks and opportunities (Availability of personnel)
 
  • Competency management (usually in the assessment cycle)
  • Monitoring and measuring (Process KPIs)
 
  • Managing critical functions
  • Knowledge (Personnel planning, including succession; contacts with colleges and universities)
   
  • Documentation (process description, instructions, etc.)
   
  • Objectives and actions with regard to the process (SMART and with elaboration resources and timing actions)
     
Change process  
 
  • Process and organizational changes
  • Context of the organisation (Possible reason for changes)
 
  • Changes to assets and facilities
  • Risks and opportunities (In the event of changes with substantial risks to service/product)
   
  • Monitoring and measuring (Possible changes to process KPIs)
   
  • Knowledge (Continuity in critical knowledge)
   
  • Documentation (of change process and new situation)
   
  • Objectives and actions with regard to changes (SMART and with elaboration of resources and timing actions)
   
  • Continuity of delivery/service during the change
     
Facilities and means of production  
 
  • Maintenance
  • Risks and opportunities (with regard to availability and continuity)
 
  • Availability analysis
  • Objectives and actions
   
  • Monitoring and measuring (KPIs if process is critical for product/service quality)
     
Described management system  
 
  • All business processes
  • Risks and opportunities (Degree of documentation depends on risk. Is this also the practice?)
 
  • Document management
  • Standard sets minimum requirements for documentation and registrations (Are they met?)
   
  • Changes have been made, such as redefinition of scope and lapsed management representative
     

For those who are still struggling with this new ISO 9001 standard. Get  our cloud solution ready in 60 seconds on trial Proware , a simple and innovative software tool for quality management. Even more? It takes a little longer... but in a few hours we also have our own and suitable example, in accordance with ISO 9001:2015 of course. Supported by our certified colleagues from Meta-audit or recognized business partners.

First see, then watch our video and demos on the product page.