ISO 9001: 2000 Internal Audit Checklist: Section 5
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The following checklist can be used as a basis for ISO9001:2000 audits. Cut and paste this text into an spreadsheet and add your company specific header. The audit check sheet covers section 5 of the standard so it is focused on management responsibility. This check list will cover management commitment, customer focus, quality policy and management review. This section will require participation from the top management and from the quality representative. The quality representative should be the best source for information about the management reviews.
| Question | Reference Documents | Notes |
| 5.0 Management Responsibility | ||
| 5.1 Management Commitment | ||
| Has top management provided evidence of its commitment to the development and maintenance of the QMS including | ||
| a) Communication of the importance of meeting the customer regulatory and legal requirements. | ||
| b) maintaining and communicating the quality policy. | ||
| c) Ensuring that quality objectives are established and routinely evaluated. | ||
| d) Routinely (once per year minimum) conducting management reviews of the QMS. | ||
| e) Ensuring the QMS is given adequate resources. | ||
| 5.2 Customer Focus | ||
| How does top management ensure that customer requirements are determined and their needs are meet? | ||
| What program exists to increase customer satisfaction? | ||
| 5.3 Quality Policy | ||
| How does top management ensure that the quality policy: | ||
| a) meets the need of the organization | ||
| b) Continuously improves | ||
| c) Is communicated and understood throughout the organization ( Has the entire organization been trained on the QMS) | ||
| d) is periodically reviewed | ||
| 5.4 Planning | ||
| 5.4.1 Quality Objectives | ||
| Are the Quality objectives consistent with the quality policy? | ||
| Are the quality objectives measurable ? | ||
| Are quality objective set for appropriate levels of the organization? | ||
| 5.4.2 Quality Management System Planning | ||
| How has top management assured that the resources needed to achieve the quality objectives are identified and planned? | ||
| If the output from planning objectives documented (ex. work instructions, procedures, quality manual, quality plans, etc)? | ||
| 5.5 Responsibility Authority and Communication | ||
| 5.5.1 How has top management ensured that the responsibilities and Authority are defined and communicated within the organization (Org Charts and/or Quality responsibly defined in training records)? | ||
| 5.5.2 Management Representatives | ||
| Has top management assigned member of management who have the responsibility and authority ( and which document defines these tasks): | ||
| Ensuring that processes are established, implemented and maintained (usually engineering and quality personnel)? | ||
| Reporting to top management on the status of the QMS including areas that need improvement ( usually presenter of the QMS status in the management review meeting)? | ||
| Promote the critical nature of meeting the customers requirements in every level of the organization (usually the quality or customer service manager)? | ||
| 5.5.3 Internal Communication | ||
| How does top management ensure that communication of quality issues is communicated throughout the organization (what process or document defines this flow)? | ||
| 5.6 Management Review | ||
| Does Management review the QMS at planned intervals to ensure the effectiveness of the plan ? | ||
| Are records of the management review kept maintained as quality records? | ||
| Are the minimum requirements for a management review described in a procedure? | ||
| Does the management team meet at least once per year? | ||
| 5.6.2 Management Review Input | ||
| Does the management review include the all of the following sources for quality information: | ||
| Customer feedback? What procedure describes how customer feedback is gathered and presented? | ||
| Result of both internal and external audits (including findings and follow-up items)? | ||
| Action items from previous management review meeting? | ||
| Corrective and preventive actions? | ||
| Any significant items that could effect the QMS (changes in personnel, training requirements, new products, etc...)? | ||
| Product conformity and process performance metrics? | ||
| 5.6.3 Management Review Output | ||
| Is the feedback from the management review tracked to ensure that quality is continuously improving (maybe using corrective and preventive actions system)? | ||
| Are the outputs from the management review given the proper resources for corrective and preventive action? |
Go To ISO 9001:2000 Checklist (section 6)