Section 8 - ISO 19011

What The Auditor Is Looking For: Section 8 - ISO 19011

The most critical factor for an auditor to record in the audit findings and report is all conclusions must be supported by objective evidence. Objective evidence is provable and retrievable. The auditor must not present or record subjective evidence or conclusions. If it can't be verified, it can't be presented. The auditor is looking for:

· Objective evidence of compliance to procedures and work instructions

· Objective evidence of compliance to the ISO 9001 or other standards’ requirements

The objective evidence can be:

- Records

- Documentation (work instructions, procedures, standards)

- Knowledge/training of employees from interviews

- Compliant product handling

The types of nonconformances:

A nonconformity, sometimes called a discrepancy or finding, is when you find objective evidence of noncompliance to:

1. Procedures, work instructions or workmanship standards:

The auditor finds objective evidence that the procedure, work instruction, workmanship standard, checklist, or specification is not being followed, (i.e. the procedure calls for keeping a record of an inspection on the traveler/router, or for signing-off on a sales order as evidence of contract review, and while auditing the records the auditor finds that this not being done.)

2. The requirements of the standard that is being audited to:

The auditor finds objective evidence that a requirement of the standard is not met in the procedure or in the implementation of the procedure, (i.e. the procedure calls for an inspection to be made but does not require a record of the inspection to be made nor for the inspection/verification status on the inspected product be maintained. This is nonconformity to clauses 8.2.4 and 7.5.2 of ISO 9001. Or, orders are being shipped late without agreement from the customer, clause 7.2.2 of ISO 9001.

3. Customer requirements not fulfilled:

This is one of the most often found nonconformances. Sometimes it is caused by product requirements not being met. However, ignoring the customers’ shipping date or packaging and labeling requirements are more apt to be the reason for nonconformity.

Levels of nonconformities:

Minor nonconformity: objective evidence of deviations from the procedure’s or the standard’s requirements.

1. The deviation is NOT systemic (throughout the management system).

2. The deviation does NOT imply that nonconforming products are systematically shipped to the customer.

3. The deviation does NOT imply that nonconforming products are KNOWINGLY shipped to the customer.

Major nonconformity: objective evidence of deviations from the procedure’s or the standard’s requirements.

1. The deviation IS systemic (throughout the management system). For example, a requirement is not addressed anywhere in the management system.

2. The deviation implies that nonconforming products ARE systematically shipped to customers.

3. The deviation implies that nonconforming product IS knowingly shipped to customers.

Section 1. ISO 19011 Scope reference and definitions

Section 2. ISO 19011 Principles of auditing

Section 3. ISO 19011 Managing an audit program

Section 4. ISO 19011 Audit program implementation

Section 5. ISO 19011 Audit activities

Section 6. ISO 19011 Preparing for onsite activities

Section 7. ISO 19011 Conducting onsite activities

Section 8. ISO 19011 What the auditor is looking for

Section 9  ISO 19011 Audit reporting

Section 10. ISO 19011 Audit techniques

Section 11. ISO 19011 Audit path

Section 12. ISO 19011 Effective communications

Section 13. ISO 19011 Sampling

Section 14. ISO 19011 Audit completion and follow-up

Section 15. ISO 19011 Competence and evaluation of auditors

This represents a summary of the section in ISO 19011:2002. It's suggested that you obtain an copy of "ISO 19011 Explanations and Definitions".