iso 9000:2008 auditing ty stokes april 2010. agenda what is iso 9000:2008 auditing? brainstorming...

ISO 9000:2008 Auditing

Ty Stokes

April 2010

Agenda

• What is ISO 9000:2008 auditing?• Brainstorming activity• Background of ISO 9000:2008 auditing• Audit process• Real world examples• Exercise• Summary

ISO 9000:2008 Auditing Defined

Review of an organization’s quality system in order to achieve quality throughout the process

Brainstorming Exercise

• How can this tool be used in your organization?

• How would ISO 9000 auditing improve the quality of products in the company?

ISO 9000:2008

Group of standards for quality management systems including:

• Procedures for key business processes

• Process monitoring to ensure effectiveness

• Keeping records

• Checking output for defects

• Regularly reviewing individual processes

• Facilitating continual improvement

ISO 9000:2008 Standards• ISO 9000:2008 – Fundamentals and Vocabulary

• ISO 9001:2008 – Requirements

• ISO 9004:2008 – Guidelines for Performance Improvement

Why is the update important for auditing?

Reasons for Audits

• Verify processes• Assess successful process implementation• Judge effectiveness of target levels• Reduce and eliminate problem areas• Report non-conformance and corrections• Report good practices• Continual improvement

Types of Audits

• Internal Audits– Performed by trained employee

• External Audits– Independent audit organization– Certification

Internal Audit

Before the audit:

• Plan the audit– Scope?– How will it be conducted?

• ChecklistBurr, John T. “Keys to a Successful Internal Audit.” Quality Progress (1997)

Checklist Example

Standard Question Observation and Comments

4.2.1 The QMS documentation includes:Documented statements of a quality policy and objectives

A quality manual

Documented procedures and records required by ISO 9000:2008

Documents to ensure effective planning, operation, and control of processes  

4.2.3 Documents required by QMS are controlled

Procedures are in place ensure that documents are reviewed and updated as necessary

Additional Questions

Internal Audit (Continued)

During the audit:

• Maintain control

• Ask good questions and focus on interview

• Record observations

• Follow up

Additional Things to Remember During Audit

• Don’t be biased

• Keep an open mind

• Be patient

• Remember that the audit is for continuous improvement

• Always state the facts

• Report accurately and clearly

ISO Registration Process

External Audits

• Documented Quality System Audit– Onsite audit of QMS

• Certification Audit– Sample of business processes

• Process Audit– Optional

External Audits

• Final Certification Audit– Determines system’s effective implementation

• Continual Certification Audits– After certification– Ensure continued implementation

A Real World Example:Astro Aerospace

• Wanted to be a Boeing supplier• AS 9100 audits (aerospace specification

supplement to ISO 9001)

“The successful completion of this audit reflects our commitment to quality and

customer satisfaction. The results of this audit also provide the framework for

Astro to meet our customer's and industry's standard.”

A Real World Example:Bristow Group

• Set an ambitious goal to exceed SMS requirements

• Have frequent audits to monitor and control processes

• Audits lead to continuous improvement

Exercise

• Think of something you do everyday

• Write down the process involved

• What improvements can be made?

Why is this important?

• What is the purpose of an audit?– Why is this important?

• Will this be beneficial to the customer?

• Will this be beneficial to the company?

Summary

Audits are important because they:

• Provide transparency

• Give a means for continual improvement

• Prove that standards are being followed

• Promote effective control

• Increase efficiency

Additional Readings

• Barnes, Frank. “Good Business Sense is the Key to Confronting ISO 9000.” Review of Business (2000): 11-15.

• Burr, John T. “Keys to a Successful Internal Audit.” Quality Progress (1997): 75-77.

• ISO 9001:2008 Self Assessment Checklist, Quality Management System, Feb 2009

Additional Readings

• Evans, Andy and Parker, John. “Beyond Safety Management Systems.” AeroSafety World (2008): 12-17

• Ni, Zhijiang and Stanislav Karapetrovic. "Perennial self-audit: model and applications." Managerial Auditing Journal (2003): 363-373.

Additional Readings

• www.qualityprogress.com

• Foster, S. Thomas. Managing Quality: Integrating the Supply Chain. 4th Edition. Prentice Hall, 2010. 85-91.