Auditors

Revise your existing audit procedure

The new organization of the standard has an impact on how you plan and schedule the audits.

• Will you audit by area of your organization??
• Or will you audit by clause of the standard

Auditing By Area

You will need to identify what clauses of the new standard apply to the area.

Auditing By Clause

Identify what areas have responsibility for each clause. With the new organization, there are more areas with responsibilities for each clause. An audit organized by clause will be moving into different areas of the company.

Develop New Checklists

This revision of the standard requires that the organization identify the processes needed for the quality management system. Create an individual checklist for each "sub-clause" of the standard. Tailor it to your organization. Include the new requirements of the 2000 revision. Checklists with detail on the new requirements will help your auditors be consistent in their interpretations.

Example Questions for the New Checklist

Note: these are examples only and not meant to be all inclusive.

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