ISO 9001 Implementation Checklist

- Management Responsibility 

Management Commitment   

• How does mgmt demonstrate its commitment visibly, actively & continually?
• Are the following ways used to demonstrate commitment? 
• Do we ensure that all personnel understand & implement the quality policy ? 
• Do we initiate, manage & follow up on the implementation of the quality policy & the quality system? 
• Are adequate resources provided to implement and maintain the quality management system?
• Do we refuse to accept deviations from the quality policy or wasted resources in any part or aspect of the company? 
• Are management reviews, monitoring and feedback, follow-up on actions taken? 
• Is progress on measurement criteria monitored? 

Management Responsibility & Authority 

• Has executive management defined & documented the organization structure, responsibility & authority for all personnel that manage, perform and verify work affecting quality, in the following areas? 
• Prevent non-conformances's - product, process, system, equipment & personnel? 
• Identify & record problems? 
• Provide solutions ? 
• Verify implementation of solutions? 
• Control nonconforming product/services? 

Management Representative 

• Is the MR appointed by & a member of top mgmt & has the appointment been documented in the quality manual ? Is the mr’s telephone and address recorded in the quality manual? 
• Does the MR have defined authority to : 
• Establish, implement & maintain quality system requirements to iso 9000 std ? 
• Report on performance of qs to mgmt for review and improvement? 
• Liaise with external bodies on quality system matters ? 
• Do these duties conflict with his/her other duties ? 
• Has the appointment been communicated internally & externally ? 
• Is the Mgmt rep accessible to all - internally & externally, re quality system matters? 
• Is the MR identified on the organization chart ?  

Management Review 

• Are management review's conducted by top management? Do they understand the purpose and importance of the review activity? 
• Is the quality system reviewed at defined (monthly, quarterly, six-monthly, yearly) intervals to ensure it is suitable & effective in satisfying : 
• • Requirements of ISO 9000 standard? 
  • Quality policy & objectives ? 
  • Is the frequency of review (defined intervals) periodically reviewed to determine if adequate?  
  • Consider review results, maturity of the quality system, its effectiveness in achieving quality policies and objectives?  
  • Trends which may indicate system problems? 
  • Do chronic problem areas receive special attention? 
  • How are management reviews scheduled and communicated? 
  • Does the management review include: 
  • A review of all quality system processes? 
  • Organizational structure? 
  • Structure & degree of implementation of quality management system ? 
  • Adequacy of staffing & resources? 
  • Product & process & service performance? 
  • Customer feedback & internal quality audits, product, service and process performance? 
  • Correctice action reports? 
  • Impact of facility, technology, product and process changes? 
  • Is the quality system effective? Were quality objectives objectives achieved?  
  • What measurements were used to establish progress or accomplishment of goals/objectives? Are these realistic or do they need to be changed? 
  • Are required changes implemented in a timely manner ? 
  • Are all changes actioned and followed up to ensure effectivity? 
  • Are records kept of management reviews? 
  • Is there a procedure documenting the above points? 

Automotive - Organizational Interfaces 

• Is the APQP process used to develop a system to manage concept development, prototype and production activities as applicable? How was this done? 
• Is a multi-disciplinary approach used for decision-making? 
• Is there a system to communicate necessary information and data in the customer-prescribed format? Does the system include internal communications? How is this done? 
• Does the multi-disciplinary include interfaces to design and process engineering, production, purchasing, QA, costing, service, shipping, maintenance, sales and marketing, subcontractors, MIS, etc? 

Automotive - Management Review 

Does the review include all requirements of the quality system standard including supplementary (section II and III) requirements? 

Automotive  -  Business Plan 

• Is there a Business Plan? Who is responsible for its development, review and approval? 
• Are there documented methods used to track, update, revise and review the plan? Are Business Plans controlled documents?Are plans reviewed at least once a year? 
• How is the plan communicated within the company? Has the plan been implemented? Are requirements being met? Are employees empowered to meet business goals? 
• Does the Business Plan include - market related issues, financial planning and cost, growth projections, plant/facilities plans, cost objectives, human resource development, R&D plans, projects and funding, projected sales figures, quality objectives, customer satisfaction plans, key internal quality and operational performance measureables, health,safety and environmental issues? 
• Does the plan cover short-term and longer-term goals? Are these based on analysis of competitive products and bench-marking inside and outsied the automotive industry? 
• What methods are used to determine current and future customer expectations? 
• Have objective methods been established to define what information should be collected, with what frequency and what collection methods are used?  

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

If you need assistance beyond what you find on this website, contact us at:artjlewis@rogers.com or call Art Lewis today at 905-593-8867 with your specific management system needs.