Common finding during ISO 9001 certification audits

Here are few common finding during ISO 9001 certification audits:

• Lack of understanding or knowledge of the quality management system or requirements of the standard. Management Representative does not understand the intent of the requirements of the standard.
  
• No actual review of customer requirements, quotations, purchase orders etc., or No amendments to contracts conducted when an order is going to ship late (delivered late), incomplete or in deviation of customer specifications.
  
• Working drawings and specs with unauthorized changes such as white-out, or changes in tolerances/dimensions. Uncontrolled posting, markings, and instructions at the work place. Obsolete documents in use, uncontrolled documents of external origin (customer specifications, ISO standards etc.)
  
• Purchases conducted with unapproved suppliers (subcontractors or vendors) for items critical to quality (calibration services, maintenance services, carriers etc.).
  
• Lack of scheduling/planning (for any process you name, including management review, internal audit and production planning).
  
• No investigation of previous results taken when a device is found to be out-of-calibration.
  
• No control limits for measurements defined and products are accepted based on specified tolerances directly. (Very common, even some auditors are not aware of the concept of control limits).
  
• Inadequate control over nonconforming products. Nonconformities and dispositions not documented.
  
• Verification of effectiveness of corrective action not conducted.
  
• Confusion between Corrective and Preventive action. (Very common, even many auditors are not aware of the difference and how to implement them).