Scope: Ensure That Devices Used Provide the Necessary Accuracy and That Calibration/Verification

Audit Report Summary /( + ) compiled from all sheets (this © 2003 – 2004 Practical Perspectives audit report summary, applicable audit To address aspects of the quality management system (QMS) needing to be considered during each audit and to facilitate action report, etc.) will give you the percentage! Purpose: on any issues raised during the audit. Audit Report Summary for Audit Report - Score:   % Line GENERAL ISSUES: (Things the auditor will have to conclude based upon the evidence   COMMENTS, OBSERVATIONS, OR EVIDENCE TO SUPPORT ANY presented.) FINDINGS Desktop review found the documents clearly describe the process (where required), are I. congruent, and address any ISO 9001:2000 requirements that have to be documented. Area personnel understand the policy, objectives and how they help us live the system.5.3d & II. 6.2.2d Suggested questions are, “What is the quality policy and what are the objectives?” “What role do you play and how do you help us live up to the policy and objectives?”

Assessed while auditing, the documents and records in use were found to be current, III. available (retrievable), legible, and readily identifiable.4.1d, 4.2.3c, 4.2.3d, 4.2.3e, & 4.2.4

Resource needs (people, materials, equipment, and facilities) appear to have been met.4.1d, 5.1e IV. & 6.1

The actions of area personnel (in relation to the processes employed and supporting V. documentation) are a reflection of effective training.6.2.2c ACTION ITEMS: Auditor works with area management to acknowledge issues raised during the audit and to identify the action to be taken and when it will be done, so effectiveness can be re-evaluated. The types of actions are: CA = corrective action, PA = preventive action, and OI = opportunity for improvement. Correction/corrective and/or preventive action as called for by 8.2.2 (actions to eliminate), 8.2.3 (actions to ensure conformity), 8.5.2 (actions to prevent recurrence), and/or 8.5.3 (actions to prevent occurrence) is achieved through this process. 8.2.2 (w/o undue delay), 8.5.2d & Verified as Section 8.5.3c C P O Issue needing attention, cause/potential cause, and action to be taken Results of actions taken 8.2.2 complete or line Who will When will 8.2.2 (cause/action), 8.2.3 (correction/corrective action), 8.5.1 (improvement opportunity), 8.5.2a-d, &/or 8.5.3a-d (verification results), 8.5.2e, & 8.5.3d by? 8.2.2, 8.5.2f, A A I number make it it be happen? done? & 8.5.3e

AREA MANAGEMENT Date: SIGN-OFF: Signifies area management or the department leader has reviewed the results of the audit and has assigned any action items as necessary. Audit Closure: Closed by: Date: The Audit Coordinator signs off after all issues have been resolved or are acknowledged as left open pending the next audit, audit results are included in/summarized for management review, and the schedule is updated. The Audit Coordinator maintains the record (this form and any attached audit report) per the records control procedure (see ISO 9001:2000 section 4.2.4). The back of this form or attachments to it can be used for additional questions or to identify issues, as long as the attributes of the section being added to are considered and applied accordingly.

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