OBJECTIVE OF THE CHECKLIST DOCUMENT

The objective of these checklists is to assist you in the planning, implementation, and internal auditing of your ISO 9001:2000 quality management system. In particular, the checklists can be used effectively in the following three ways: 1. Establishing a Baseline and Action Plan: The checklists provide a baseline at the start of implementation to identify what needs to be done to revise or develop your quality management system to meet the ISO 9001:2000 Standard. Implementation Guidelines and Checks: The checklists provide a reference to measure progress and to verify that your quality management system, documentation, and practices are complete and correct as you proceed in establishing and implementing your ISO 9001:2000 quality management system. Internal Auditing: The checklists clearly define what to audit and how to document that your quality management system is conforming to ISO 9001:2000.

2.

3.

Checklists help to ensure that the audit is conducted in a systematic and comprehensive manner, and the proper evidence and documentation are obtained. More specifically, comprehensive checklists guide the auditor (or audit team) in the following ways: 1. Checklists specify what elements of the quality management system need to be observed, and what levels of performance or adherence are required to satisfy the Standard. Checklists specify what personnel need to be interviewed, and the types of questions or issues to address. Checklists specify the relevant quality system procedures and/or work instructions that need to be evaluated for effectiveness and adherence under routine and non-routine conditions. Checklists specify what evidence needs to be obtained to properly sample and document the performance and effectiveness of your quality management system. Checklists assist in developing an audit schedule, and in pacing the audit to complete your objectives in the allotted time.

2.

3.

4.

5.

Checklists help you do a better job with much less effort.

USING STANDARD CHECKLISTS

Standard checklists can be a valuable tool to assist you in the planning, implementation, and internal auditing of your ISO 9001 quality management system. Since individual companies need to interpret and fine-tune the implementation of the Standard to meet their individual needs and unique characteristics, standard checklists also need to be fine-tuned. The diskette allows you to select and modify these checklists to incorporate your specific quality policies, procedures, work instructions, and other unique characteristics, and to sample and select the checklists needed to audit taking into consideration the status and importance of the processes and areas to be audited. Use the diskette to select and modify the checklists to best suit your needs.

STATUS CODE DEFINITIONS

N: Nonconformance. Indicates a nonconformance of some aspect of the Quality Management System to the ISO 9001:2000 Standard. Examples include, but are not limited to, system absences and nonconformance of company employees to follow documented policies, procedures, and work instructions. Weakness. Indicates a weakness of the Quality Management System. This means that the element under consideration may conform to the letter of the ISO 9001:2000 Standard, but has the potential to fail under certain circumstances; for example, system elements which are in place but under-developed and/or misunderstood. Opportunity. Indicates an opportunity to improve the Quality Management System, including findings which may not be specifically required by the ISO 9001:2000 Standard or findings that could pass a registrars audit, but undermine the effectiveness of the Quality Management System. An example would be a finding where documentation could be streamlined or simplified to facilitate understanding or better reflect organizational practice. Another example would be an opportunity to increase the effectiveness of the Quality Management System, utilizing the approaches and guidelines provided in the ISO 9004:2000 document. Compliance. Indicates that the Quality Management System element has been examined under the guidelines of the checklist and that no nonconformances were found. Note, however, that this does not necessarily mean that there are no nonconformances in the Quality Management System element, only that none were found under the scope of the examination. Not Applicable. Indicates that the particular element or checklist question is not applicable to the organization or department being audited.

W:

O:

C:

X:

TABLE OF CONTENTS
NUMBER OF CHECKLIST ITEMS BY ISO 9001:2000 CLAUSE/REQUIREMENT Clause/Requirement Number of Checklist Items Page

QUALITY MANAGEMENT SYSTEM 4.1 4.2 General Requirements Documentation Requirements

37 4 33

1 2 5

MANAGEMENT RESPONSIBILITY 5.1 5.2 5.3 5.4 5.5 5.6 Management Commitment Customer Focus Quality Policy Planning Responsibility, Authority and Communication Management Review

27 1 1 7 5 6 7

21 22 23 24 27 30 34

RESOURCE MANAGEMENT 6.1 6.2 6.3 6.4 Provision of Resources Human Resources Infrastructure Work Environment

11 1 8 1 1

39 40 41 45 46

Clause/Requirement

Number of Checklist Items

Page

PRODUCT REALIZATION 7.1 7.2 7.3 7.4 7.5 7.6 Planning of Product Realization Customer-related Processes Design and Development Purchasing Production and Service Provision Control of Monitoring and Measuring Devices

156 10 18 35 15 56 22

47 48 53 63 82 89 114

MEASUREMENT, ANALYSIS & IMPROVEMENT 8.1 8.2 8.3 8.4 8.5 General Monitoring and Measurement Control of Nonconforming Product Analysis of Data Improvement

77 5 30 16 3 23

125 126 129 145 153 155

Total Checklist Items

308

CLAUSE 8 MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.2

MONITORING AND MEASUREMENT

QMS CHECKLIST QUESTION (ISO 9001 REQUIREMENT) AUDITING GUIDELINES

1. Does the organization monitor information relating to customer perception as to whether the organization has met customer requirements? (Clause 8.2.1) Check that customer satisfaction is measured and monitored. Possible sources include customer surveys, customer complaints, direct communication with customers, consumer reports, benchmarking, etc. State the methods utilized. Assess the suitability of these methods and the degree to which methods extend beyond reactive or passive approaches (e.g., analysis of customer complaints).

REMARKS & EVIDENCE

STATUS

**

2. Has the organization defined the methodologies for obtaining and using information on customer satisfaction? (Clause 8.2.1) Ensure the methods used, including details of information source(s) and frequency of measurement, are defined and state the evidence.

8.2

MONITORING AND MEASUREMENT

QMS CHECKLIST QUESTION (ISO 9001 REQUIREMENT) AUDITING GUIDELINES

3. Does the organization have a defined process / procedure to document, communicate, resolve, and subsequently prevent customer satisfaction problems and customer complaints? (Clause 8.2.1) Review the process / procedure utilized, and verify that customer complaints are identified and resolved according to this process. Review records of past customer complaints and verify that these issues were considered for possible corrective action (see also Clause 8.5.2).

REMARKS & EVIDENCE

STATUS

**

4. Does the organization have a documented procedure for internal audits which includes responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records? (Clause 8.2.2) Ensure this documented procedure exists and verify it addresses each of the issues above.

8.2

MONITORING AND MEASUREMENT

QMS CHECKLIST QUESTION (ISO 9001 REQUIREMENT) AUDITING GUIDELINES

5. Are internal audits performed at planned intervals which assess if the quality management system conforms to the planned arrangements (see 7.1), to the requirements of ISO 9001 and to the quality management system requirements established by the organization; and is effectively implemented and maintained? (Clause 8.2.2) Ensure that internal audits do not audit solely to the requirements of ISO 9001, but also to additional requirements that may be defined in the organization's quality manual, procedures, and work instructions. Review recent internal audit records to verify. Review records of past internal audits to ensure that both compliance to requirements and effectiveness of processes utilized are addressed.

REMARKS & EVIDENCE

STATUS

**

To order this manual or any of our other documentation for ISO 9001:2000 Contact: Laura Schultz Steudel & Schultz, LLC 6417 Normandy Lane, Suite 200, Madison, WI 53719 Tel: 608-271-3121 / Toll Free Tel: 866-271-3121 /. Fax: 608-271-4755 www.isopocketguides.com info@isopocketguides.com