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 organizations 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?
Burr, John T. Keys to a Successful Internal Audit. Quality Progress (1997)

Checklist

Checklist Example
Standard Question
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 Documents required by QMS are controlled Procedures are in place ensure that documents are reviewed and updated as necessary Additional Questions

Observation and Comments

4.2.3

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

Dont 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

Registrar Selection Documented Quality System Audit Certification Audit Process Audit Final Certification Audit

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 systems 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.