The gap analysis refers to the detailed analysis of the present quality management system to determine whether it meets the requirements of the respective standard, be it, ISO 9001:2000. What are the gaps from the specified requirements? Following is an abbreviated checklist to give you an idea about what is involved. Call or e-mail us if you need further assistance.

ISO 9001:2000:

• Does the company have framed a quality policy with the accompanying objectives?
• Does the company have a documented procedure for controlling the documents, issuing the documents, controlling the obsolete documents from unintended use?
• Have the company identified the quality records per the requirements of the standard? Have they defined the storage, identification, and retention requirements?
• Does the company have a purchasing policy with the approval procedures for its suppliers?
• Does the company identify, monitor, measure and analyze different processes?
• Does the company have laid down quality objectives at all levels and at all functions?
• Does the company measure the dissatisfaction or satisfaction levels of the customer?
• Are the measuring devices that affect product quality calibrated?
• Are the data from operations, quality analyzed for continual improvement?
• Does the company have a procedure for assessing the training needs and measuring the effectiveness of training?
• Are there any corrective and preventive actions program laid down?
• Does the company have framed an effective procedure to identify and control the non-conforming product to prevent its unintended use or delivery?
• Does the company take care of the customer’s properties provided for use or incorporation into the product?
• Does the company identify the product by suitable means during product realization? In case of traceability requirement, does the organization control and record the unique identification of the product?
• How does the company determine the competency necessary to perform work affecting product quality? How does the company organize training and evaluate the effectiveness of training?
• How does the company determine, provide and maintain the infrastructure needed to achieve conformity to product requirements?
• How does the company determine and manage the work environment needed to achieve conformity to product?
• How does the organization determine, review the customer’s requirements, even though they were not specified?
• How does the organization pass these requirements to other functions for product realization?
• Does the top management conduct the review of the quality management system to check its continuing suitability, adequacy and effectiveness?