General Requirements

 Where are the processes needed for the quality management system identified?
 Have the sequence and interaction of the processes been determined?
 What criteria and methods will be used for operation and control of the processes?

Management
 Where are the processes needed for the quality management system identified?
 Have the sequence and interaction of the processes been determined?
 What criteria and methods will be used for operation and control of the processes?
 How does management ensure that customer needs and expectations are
determined, converted into requirements and fulfilled?
 Does this include customer obligations related to the product-including regulatory?
 Does the quality policy include a commitment to continual improvement?
 Does it provide a framework for establishing and reviewing objectives?
 Do the quality objectives include a commitment to continual improvement?
 Do quality objectives include those needed to meet requirements for product?
 How does the management rep promote customer awareness?
 Does the quality manual include a description of the sequence and interaction of
the processes included in the quality management system?
 Does Management Review consider changes that could affect the quality system?
 Are there records of the output of management review? Do they include:
actions to improve the quality system and its processes
improvement of product related to customer requirements

Resources
 Can the organization demonstrate that resources are provided to address customer
satisfaction?
 Are they provided in a timely manner?
Human Resources
 Has the organization evaluated the effectiveness of training provided?
 Has the organization ensured that its employees are aware of the relevance and
importance of their activities and how they contribute to achievement of the quality
objectives?

Planning
 Has the organization planned for realization of product?
 Does it include product quality objectives?
 Does it include the need to establish processes and documentation, provide
resources and facilities specific to the product?
 Does the plan for measurement and monitoring to ensure conformity and achieve
improvement identify the need for and use of statistics?

Customer Requirements
Does the identification of customer requirements include product requirements not
specified by the customer, but necessary for the intended or specified use
obligations related to product, including regulatory and legal requirements

Review of product requirements

Does the organization confirm customer requirements when the customer does not
provide a documented statement of requirement?
Customer Communication
Has the organization identified and implemented arrangements for communication with
customers relating to:
 product information inquiries
 contracts or order handling including amendments
 customer feedback including complaints

Purchasing Control
How has the organization determined the extent of control of purchasing processes?
Is it dependent on the effect on subsequent realization processes and their output?

Customer Property
Has the organization applied the care of customer supplied property to intellectual
property?

Preservation of Product
Has the organization validated any process where resulting output cannot be verified?
Does verification include:
 qualification of process
 qualification of equipment and personnel use of defined methodologies and
procedures requirements
 for records revalidation
Customer Satisfaction
 Is the organization monitoring information on customer satisfaction and
dissatisfaction?
 Where are the methodologies for obtaining and using this information defined?
 Has the organization analyzed appropriate data to determine:
 suitability and effectiveness of the quality management system
 actions to improve the quality system and its processes
 improvement of product related to customer requirements