ISO 9001:2000 General Requirements Management Responsibility Reviewer Checks Planning the Process Audit

Define key inputs and resources for each of the processes to be reviewed. Use process documentation, flowcharts or SIPOC diagrams to identify these. Process Key Inputs and Resources Determine the processes/activities to be included in the scope of the audit. The scope may be provided as part of an audit schedule or plan, or it may need to be developed by the audit program manager. List the process(es) below: Processes Document No. Management Review Quality Policy Manual Management Review Customer Satisfaction Monitoring Consider the following information relating to the processes to be examined. Previous audit results related to the selected processes Current process metrics relating to the selected processes Significant corrective actions or complaints relating to the selected processes Auditee management Other (list) _____________________________________

Reviewer Checks

Based on your review, add, delete, or modify the questions on this checklist to focus your evaluation and to incorporate local requirements and inputs. Recognize that most of the requirements that must be verified will be called out in local procedures and instructions. Corrective Actions and Current/Recent problems List any problems, CARs, or items from previous audits that should be evaluated or verified during this audit. Problems noted for later examination:

Review the core process metrics relating to quality objectives and the performance of the QMS, including customer feedback. Metric Recent Performance Trend 1. 2. 3. 4. 5. Objectives and/or targets to review: 1. 2.

2003 Joe Kausek & Associates

Quality Objectives, Policy and Improvement

Processes, Metrics and Objectives 1. Who are our primary customers? Answers may be generic or specific. This is a lead in question. Start the audit by interviewing the most senior member of management included in the scope of this audit. The general structure of the interview will be: 1) Who are our primary customers? 2) What are our core processes to meet their needs? 3) How do we measure these processes? 4) What objectives have been established and are they aligned with the commitments of the Quality Policy and our Strategic Plan? 5) How are we performing in achieving these objectives? 6) What are we doing to improve performance? 7) How do we communicate performance? Procedure No. ___________________ Rev. ___________ Executive _______________________________________________

2.

What are the core processes that we to satisfy these customers? Verify familiarity with the core QMS processes and their interrelationships. Can they refer back to the Quality Policy Manual? Have they ever looked at it? 4.1

3.

How do you stay aware of changes to these processes? What is your involvement in planning these changes? 5.4.2

4.

How do we monitor these processes (i.e. what metrics are routinely reported to senior management)? Do metrics relating to processes that form part of the product realization process include process effectiveness and efficiency?

Overall evaluation: Conforms. No deficiencies identified. Opportunity for improvement (OFI). Detail below. Best Practice (BP). Detail below. Be specific. Nonconformity (NC). Provide details below. Reference the specific requirement violated. Executive Metrics 1. 2. Performance? Good Good Good Good Good Good Good Good Poor Poor Poor Poor Poor Poor Poor Poor Actions? Yes Yes Yes Yes Yes Yes Yes Yes No No No No No No No No

5.

How is performance in these areas? Are we doing anything if performance is poor? 4.1, 5.1.1

3. 4. 5. 6. 7.

6.

How do we measure our customers satisfaction? How is performance in this area? Are we doing anything if performance is poor?

8. Customer Satisfaction Metrics 1. 2. 3.

Performance? Good Good Good Poor Poor Poor

Actions? Yes Yes Yes No No No

2003 Joe Kausek & Associates

Quality Objectives

Performance? Good Good Good Good Good Good Poor Poor Poor Poor Poor Poor

Actions? Yes Yes Yes Yes Yes Yes No No No No No No

7.

Have quality objectives been established for the company? Are they related to the policy statement (verify knowledge of policy commitments), business & customer goals? 5.3, 5.4

1. 2. 3. 4. 5. 6.

8.

How is our performance based on these metrics/objectives (4, 5, & 6)? If there are weak areas of performance, are there plans/actions in place to recover? 4.1, 5.1

Greatest challenge:

Actions to address:

Comments and Findings

9.

How do we communicate information about our performance in these areas? How do we communicate other information relating to the QMS? 5.5.3

10. What do you consider to be the greatest challenge, relating to quality or the QMS, facing the firm today? How are we addressing it?

Reference ISO 9001 clause 5. 2003 Joe Kausek & Associates

Responsibilities, Authorities and Awareness of Customer Requirements/Issues

Ask about the responsibilities and authorities related to processes under the control of the manager being interviewed. We continue our review of Management Responsibility by verifying that responsibilities and authorities of those responsible for quality have been identified and communicated throughout the department/organization. The general structure of the interview is as follows: 1) In general, how are responsibilities and authorities defined 2) What does the manager see as his/her responsibilities 3) How engaged is the manager in communications relating to customer requirements and/or issues Manager _______________________________________________ Overall evaluation: Conforms. No deficiencies identified. Opportunity for improvement (OFI). Detail below. Best Practice (BP). Detail below. Be specific. Nonconformity (NC). Provide details below. Reference the specific requirement violated.

1) In general, how are responsibilities and

related authorities communicated to employees? 5.5.1

2) What are your responsibilities in relation

to the QMS? 5.1

3) If the Management Representative

reports to the manager being interviewed, verify that the MRs responsibilities and authorities are clearly defined. 5.5.2 Comments and Findings

4) How do we ensure that customer

requirements are known and met? 5.2

Reference ISO 9001 clause 5.

2003 Joe Kausek & Associates

Management Review
1) If a procedure is available ask to see the procedure. Ask the auditee to walk you through the process (follow along if you have a procedure). During the discussion verify evidence of: This interview focuses on the management review process. The auditor should select the questions to be asked based on the auditees level of involvement with the reviewi.e. is the manager a participant only or the owner of the process. The owner (Plant Manager, CEO, etc.) should be able to discuss all items in this section. A participant should be able to discuss his/her input into the management review along with any related actions that come from the review. Procedure No. _______________________ Rev. __________ Overall evaluation: Conforms. No deficiencies identified. Opportunity for improvement (OFI). Detail below. Best Practice (BP). Detail below. Be specific. Nonconformity (NC). Provide details below. Reference the specific requirement violated. Review Date 1. Attendance? Yes No Comprehensive? Actions? Yes No Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No No No No No No No No No No No No No No No

Frequency of the review Attendance Records and/or minutes Action follow system

Mandatory inputs 5.6.2 Audit results Customer feedback Process performance Product conformance Corr/Prev action status Quality objectives Key process metric trends Follow-up actions from previous reviews Improvement recommendations

Action 1: ____________________________ Action 2: ____________________________ Action 3: ____________________________ Action 4: ____________________________ 2. Yes No

Completed? Completed? Completed? Completed? Yes No

Required outputs: 5.6.3 Need for changes to policy/QMS Need/opportunities to improve products/processes Adequacy of/need for resources

Action 1: ____________________________ Action 2: ____________________________ Action 3: ____________________________ Action 4: ____________________________ 3. Yes No

Completed? Completed? Completed? Completed? Yes No

2) Using information gained from previous

questions, discuss the reporting of relevant process/product and/or problem information relating to the managers area during the Management Review. 5.6

Action 1: ____________________________ Action 2: ____________________________ Action 3: ____________________________ Action 4: ____________________________ Comments and Findings

Completed? Completed? Completed? Completed?

2003 Joe Kausek & Associates

Reference ISO 9001 Clause 5.6

2003 Joe Kausek & Associates