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QMS Operational Procedure	QOP-82-02
Section 8.2	Section Revision: C	Revision Date: 5/20/2014
Internal Quality Audits
Approved By: Todd Gifford		Date: 7/12/2010

I  PURPOSE

The purpose of this procedure is to provide for a system and instructions, and to assign responsibilities for conducting internal quality audits.

II  APPLICATION

This procedure applies to all activities comprising the quality system.  This procedure directly concerns Quality Assurance and the executive management, and is indirectly relevant to all departments.

III  PROCEDURE

1. Internal quality audit plan

1.1 The President is responsible for planning and scheduling internal quality audits. Each section is audited at least once a year. In addition to the annually scheduled audits, certain sections may be selected for more frequent auditing, depending on their status, importance, and past compliance history.

1.2 The President schedules dates and assigns audit teams for all auditable sections.

1.3 The internal audit plan is synchronized with management reviews of the quality system (refer to Procedure QOP-56-01, Management Review), so that results of an auditing cycle are available for the management review meeting.

2. Audit team

2.1 Personnel assigned to carry out internal audits are independent of those having direct responsibility for the audited activity. If there is no conflict of interest, it is usually Quality Assurance that conducts the audits. Activities that are the responsibility of Quality Assurance are usually audited by trained IQA individuals from other departments.

2.2 Internal auditors are trained by in-house IQA-certified Trainers or professional IQA Trainers. Quality Assurance maintains a copy of the ISO9001:2008 standard on the company Intranet.  IQA Training, whether done in-house or by professionals, is recorded in the Training Records.

3. Preparing for audit

3.1 Auditors prepare for an audit by familiarizing themselves with the ISO 9001 standard, refreshing their knowledge of the quality manual and relevant operational procedures, reviewing corrective actions files, and reviewing the IQA checklist.

4. Conducting and reporting the audit

While conducting the audit, auditors seek objective evidence demonstrating whether the audited activities conform with the requirements of the documented quality system, and whether the system is effectively implemented and maintained. When a nonconformity is noted, it is brought to the attention of, and discussed with, the President. Before the end of an audit each noted nonconformity is documented using the Internal Audit/Management Corrective Action and Preventive Action Form QF-82-02-01. Auditors fill out only part of the form, describing the noted nonconformity. The form is then handed over to the President who uses the rest of the from to propose a corrective action and follow through to close out the corrective action.

5. Corrective action and follow up

5.1 Once a nonconformity is identified and documented, further processing of the nonconformity report is similar to the corrective action requests (Procedure QOP-85-02, Corrective and Preventive Action). Upon receiving the report, the President and appropriate managers investigate the cause of the problem noted as a nonconformity, proposes a corrective action to be taken, and indicates the date by which the corrective action will be fully implemented.

5.2  When there is objective evidence that the corrective action is implemented and effective, the nonconformity report is closed out. If more work is needed to fully implement the action, a new follow-up date is set.

6. Documentation and record

6.1 Internal audits and implementation of resulting corrective actions are documented using Internal Audit Checklist Form QF-82-02-02 for documenting the Audits, and the Internal Audit/Management Corrective and Preventive Action Form QF-82-02-01 for documenting findings that require Corrective Action.

6.2 The Internal Audit Checklist Form QF-82-02-02 contains the results and documentation of the Audit.  The Internal Audit/Management Corrective and Preventive Action Form QF-82-02-01 contains a description of any nonconforming condition found during the Audit, the proposal for a corrective action, and corrective action implementation information.

6.3 At the end of an auditing cycle, all nonconformity reports established during the cycle are compiled and analyzed, and are presented at the management review meeting.

ASSOCIATED DOCUMENTS

QF-82-02-02 Quality Form:  Internal Quality Audit Checklist Form and Archived IQA Records

QF-82-02-01 Quality Form [Cedar Rapids Location]: Internal Audit/Management Corrective and Preventive Action Form

QF-82-02-03 Quality Form: Internal Audit Plan

Operational Procedure QOP-85-02: Corrective and Preventive Actions