INTRODUCTION TO THE ISO 9001:2000 CHECKLIST AND AUDIT GUIDE
Purpose. This checklist and audit guide can be used to conduct gap analyses against the requirements of the ISO 9001:2000 standard and is also extremely useful in conducting internal auditor training for both new auditors and those already trained to the ISO 9001/2:1994 standards. As you probably know, the ISO 9000:1994 standards focused on product/service conformance and quality system compliance and the ISO 9000:2000 standards focus on achieving these objectives (as well as customer satisfaction) through process management and continuous improvement of the quality system itself. Detailed cross-references in our ISO 9001:2000 checklist will facilitate “restructuring” of quality management systems structured in accordance with the 1994 standards. Our checklist and audit guide (especially when used in conjunction with our ISO 9000:2000 Internal Auditor Training package and Process Management Guide is especially useful in determining how to assess for effectiveness and the need for improvement.
General information. This 42 page document identifies all Quality Management System (QMS) requirements of ISO 9001:2000 (stated in the form of audit questions), and provides guidelines for use by internal auditors trying to determine the organization's compliance with each requirement. The document serves as a gap analysis tool, internal auditor training tool, and an internal audit reporting tool.Target group. This document is intended specially for use by all personnel responsible for conducting internal quality audits to the ISO 9001:2000 standard. This document is used to conduct and document results of a gap analysis performed to identify differences between an organization's documented QMS and ISO requirements. During the gap analysis, the auditor identifies and adds to the checklist specific documents/records that identify where in the organization documented QMS specific requirements are addressed and how records (or objective evidence of compliance) will be documented. The document also includes appropriate cross references to requirements contained in the ISO 9001/2:1994 standards, making it very useful in conducting a document review to identify gaps between an ISO 9001/2:1994 based QMS and the requirements of the new standard. The audit questions and guidelines contained in the checklist are useful training tools and can help the internal auditor ensure all requirements are addressed during the conduct of the audit itself. Program. This easy to use and edit 42 page MS Word document has the following features: All requirements are stated in the form of questions (new/revised requirements are in bold italics), each with audit guidelines and appropriate cross references back to the 1994 standards. It is also intended for use in conjunction with our other ISO 9001:2000 internal audit and assessment tools, including our 154 slide power point ISO 9001:2000 Internal Auditor Training package, our 57 page ISO 90001:2000 Implementation Guide, and our complete set of (23) Process Assessment Worksheets - which contain examples of specific process inputs, outputs, linkage, controls and measures for assessing the effectiveness of each of the key QMS processes required by ISO 9001:2000.
INSTRUCTIONS FOR USE
Gap Analysis Tool. All ISO 9001:2000 requirements are stated in the checklist in the form of questions. For each “2000” requirement cross-referenced to an ISO 9001/2:1994 requirement, change the “generic” entry in the “Organization's Documents” column to reflect exactly where in your current system a “2000” requirement is addressed. For “new or revised” requirements (i.e. checklist questions are in bold italics) identify new or revised policy/procedures needed in the “Fully Documented?” column of the checklist and identify actions related to their development on the “Summary of Observations and Findings” page.
Internal Auditor Training and Internal Audit Tool. The information contained in the “Audit Guidelines” column is very useful in facilitating discussions of each requirement and methodologies for assessing compliance and effectiveness, and is a very useful “field tool” to help trained auditors keep focused on the specific assessment at hand. Auditors can record field observations and findings in either the “Fully Documented?” and/or the “Fully Implemented?” column of the checklist, as appropriate. Auditors or Audit Team Leaders can also use the “Quality System Assessment Summary” and “Summary of Observations and Findings” pages to summarize audit results for management. Also included for your possible use are: an “Applicable Requirements Checklist” and an “Audit Planning Worksheet”, - particularly useful in planning, scheduling and conducting internal audits of your own unique departments, functions, and/or processes. Finally, a “Nonconformance Report” worksheet is included to record individual incidents identified during the course of your internal audits. All of these tools are designed for use in multiple applications, including situations where multiple ISO 9001:2000 requirements need to be assessed as they apply to a selected audit area (i.e. unique department, function, and QMS process) to be audited.
System Restructuring and/or Cross-Reference Tool. At a minimum, use the information collected during the gap analysis to develop a simple “cross reference” table to help internal auditors and registrars find where in your documented system a “2000” requirement is addressed. In the absence of another model that makes sense to your business, it is recommended that you completely restructure your quality system manual to address each “2000” requirement in the sequence of the standard. While some level II procedures and level III work instructions may need to be developed or require minor revisions, restructuring of these documents is not needed. Remember, process maps, deployment flowcharts or other documentation methods of choice can/should be used to define part(s) of your system where a procedure is not needed or required by the standard.
The ISO 9001:2000 Checklist and Audit Guide and many other powerful yet inexpensive QMS training and implementation tools are available from our web site at www.isoqual.net and will be transmitted via email the day your order is received. Order today and begin using these tools tomorrow!
Best of luck as you make the "Move from Conformance to Performance.”
ISOONLINE is “Helping Quality People Excel”.
Quality management system - General requirements |
Clause 4.1 |
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4.1 Has the organization established, documented, and implemented a quality management system (QMS) in accordance with the requirements of ISO 9001:2000? Specifically:
a) Are QMS processes identified?
b) Have the sequence and interaction of QMS processes been determined?
c) Have the criteria and methods required to ensure the effective operation and control of QMS processes (including outsourced processes) been defined?
d) Are resources and information available to support QMS process operation and monitoring?
e) Are QMS processes monitored, measured, and analyzed?
f) Are actions implemented to achieve planned results and continual improvement of QMS processes?
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(Note: clause 4.2 defines documentation requirements)
Review quality manual and interview key members of top management to determine if the organization has adopted a systematic approach for:
1) identifying and managing QMS processes. Interviews should assess the degree to which “process ownership”, involvement, & responsibility is known - as well as the approach adopted for managing interfaces associated with the following QMS processes (or elements) and their related sub-processes: Clause:
4. Quality Mgt. System 5. Management Responsibility 6. Resource Management 7. Product Realization 8. Measurement, Analysis and Improvement
2) ensuring the criteria, methods, information and responsibilities for managing QMS processes (including outsourced processes) are in place.
3) ensuring that data is collected, analyzed and used to assess QMS process effectiveness and to identify needed actions or improvements.
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Quality manual and/or process flow charts / diagrams. (see DFC 4.1, Sequence and Interaction of Key QMS Processes)
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4.2.1
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Quality management system - Documentation requirements - General |
Clause 4.2.1 |
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4.2.1 Is the quality system documented as required by ISO 9001:2000? Specifically,
a) and b) Are the quality policy, quality objectives and quality manual documented? |
Review quality manual to ensure it complies with requirements of clause 4.2.2 and that it contains documented statements of a quality policy and quality objectives. |
Quality manual |
4.2.1 |
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4.2.1c) Are there documented procedures as required by the standard? at a minimum:
Control of Documents (clause 4.2.3) Control of Records (clause 4.2.4) Internal Audit (clause 8.2.2) Control of Nonconforming Product (clause 8.3) Corrective Action (clause 8.5.2) Preventive Action (clause 8.5.3) Others, as appropriate, which may include: |
Review quality manual to ensure it contains or references documented procedures as required by the standard and other documented procedures as appropriate for the size and type of the organization, the complexity and interaction of processes, and competence of personnel.
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Quality manual, and DFC 4.1, Sequence and Interaction of Key QMS Processes
Documented procedures |
4.2.1
4.2.2 |
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Planning (5.4, 7.1, 8.1, 8.5.1) Internal Commun. (5.5.3) Management Review (5.6) Resource Management (6) Competency&Training (6.2.2) Customer Processes (7.2) Design and Development (7.3) Purchasing (7.4) Operations Control (7.5.1) |
Validation of Special Proc. (7.5.2) Product ID/Traceability (7.5.3) Customer Property (7.5.4) Preservation of Product (7.5.5) Ctl of Monitor/Meas Devices (7.6) Cust Sat. Monitoring/Meas (8.2.1) Process Monitoring/Meas (8.2.3) Product Monitoring/Meas (8.2.4) Analysis/ Improvement (8.4, 8.5) |
Review QMS processes to ensure they are adequately defined in procedures, process or job descriptions, work instructions, or other appropriate system documentation. |
Other QMS documentation |
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4.2.1 d) and e) Does the QMS identify all other appropriate documentation and records needed to ensure effective planning, operation and process control, including those required by:
Applicable international, national, regional and Industry sector standards? Relevant statutory and regulatory requirements?
Other requirements for documentation and Records imposed by customers, other Interested parties, or the organization itself? |
(Note: QMS documents and records are controlled per clauses 4.2.3 and 4.2.4)
Ensure applicable standards and statutory/regulatory documents and related record requirements are identified in the QMS.
Review other external or internal documents to ensure QMS identifies documentation and records needed to effectively manage the organization's products, processes and activities. |
Other QMS documentation and records
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4.5.1 4.16 |
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Quality management system - Documentation requirements - Control of documents |
Clause 4.2.3 |
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4.2.3 Is a documented procedure established to control all documents required for the QMS?
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Verify that the documented procedure details rules (per 4.2.3 a-g) for controlling: Quality manual Documented Procedures External Documents Work Instructions Product documentation (including drawings, specifications, bills of material, parts lists, production plans, control plans, etc.).
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Document Control procedure: see SOP 4.2.3, Control of Documents, DFC 4.2.3.01, Internal Document Change Control Process, and DFC 4.2.3.02, External Document Change Control Process)
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4.5.1 |
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4.2.3.a) and b): Are new/revised documents reviewed for adequacy and approved by authorized personnel prior to issue or update? |
Review documents for evidence of review/approval.
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All new and revised documents. |
4.5.2, 4.5.3 |
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See PAW 4.2.3.01, Internal Document Change Control Process Assessment Worksheet. |
4.2.3 Are documents:
c) identified by their current revision status,
d) available at locations where they are needed
e) legible, readily identifiable and retrievable?
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Review documents for proper identification, revision status, and legibility
Test the distribution system to verify documents are available and retrievable.
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All controlled documents,
Master lists, Distribution lists, etc. |
4.5.2 |
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4.2.3.f) Are external documents identified and their distribution controlled?
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Review external documents (identified per clause 4.2.1.d) for proper identification and control.
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All applicable external documents: standards, customer documents, and statutory/regulatory documents
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4.5.2 |
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See PAW 4.2.3.02, External Document Change Control Process Assessment Worksheet |
4.2.3.g) Are obsolete documents removed from points of use and/or suitably identified if retained for any purpose to preclude unintended use? |
Review retained obsolete documents for proper identification; identify any obsolete documents not removed from points of use.
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All obsolete documents |
4.5.2 |
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Quality management system - Documentation requirements - Control of records |
Clause 4.2.4 |
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4.2.4 Is a documented procedure established to control the identification, storage, protection, retrieval, retention and disposition of records needed to provide evidence of product conformity and effective operation of the QMS? Specifically, |
Verify that the documented procedure stipulates how records are identified, collected, indexed, accessed, file, stored, maintained and disposed of. |
Quality Records procedure: see SOP 4.2.4, Control of Records. |
4.16 |
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Ask for a record and note how long it takes to retrieve; identify causes for breakdowns in record management system.
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Quality Records procedure. |
4.16 |
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Verify that records are suitably protected and note any signs of record deterioration, damage or loss due to inadequate storage.
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Verify that record holders, locations and retention periods are stipulated for each record or record category.
Verify that records are retained as required by procedures and/or customer requirements.
Verify that records are disposed of in a timely manner.
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Including, as a minimum, records for: |
Note: The adequacy of records is determined throughout the audit or assessment.
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See DFC 4.2.4, Record Control Process. |
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See PAW 4.2.4, Record Control Process Assessment Worksheet. |
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Management Review (5.6.1) Competency / Training (6.2.2) Record Requirements (7.1.d) Prod Reqmnts Review (7.2.2) Design Inputs (7.3.2) Design Reviews (7.3.4) Design Verification (7.3.5) Design Validation (7.3.6) Design Chg. Review (7.3.7) |
Supplier Evaluation (7.4.1) Product ID/Traceability (7.5.3) Cust Property Reports (7.5.4) Calibration / Verif Results (7.6) Internal Audit Results (8.2.2) Prod. Conformity/Release (8.2.4) Prod. Nonconformity/Action (8.3) Corrective Action Results (8.5.2) Preventive Action Results (8.5.3) |
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Management responsibility - Quality policy |
Clause 5.3 |
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5.3 Has top management established a quality policy that:
a) is appropriate to the organization's purpose?
b) includes a commitment to comply with requirements and continually improve the QMS?
c) provides a framework for establishing and reviewing quality objectives?
d) is communicated and understood within the organization?
e) is reviewed for continuing suitability?
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Review the quality manual to ensure top management has established/approved the quality policy.
Review other organizational policy documents to determine their consistency with the quality policy.
Review the quality policy to determine if it promotes customer satisfaction and continual improvement.
Ask a random sampling of managers and/or employees if they understand the process for establishing and reviewing quality objectives (per clause 5.4.1).
Ask a random sampling of employees what the quality policy is and how they contribute to attaining its objectives. Determine if communications are consistent with other internal/external communications (see clauses 5.1.a), 5.5.1, 5.5.3, 6.2.2.d, 6.3.c), 7.2.3, 7.3.1, and 7.4.2).
Ask top management how the quality policy is reviewed, revised, and controlled (per clause 4.2.3)
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Quality manual. |
4.1.1
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Resource management - Provision of resources |
Clause 6.1 |
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6.1 Are resources determined and provided as needed:
a) to implement and maintain the QMS and continuously improve its effectiveness? and
b) to enhance customer satisfaction by meeting customer requirements? |
Note: required resources should be identified during QMS planning per clause 5.4.2.
Through observation or interviews, identify any evidence that required resources are not provided as needed. |
Resource allocation plans and related provisions or procedures regarding their development and update. |
4.1.2.2 |
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Resource management - Human resources |
Clause 6.2 |
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6.2.1 Are responsibilities defined in the QMS assigned to competent personnel? |
Review organization charts, job descriptions, to verify that personnel are qualified to perform work assignments. |
Organization charts, job descriptions, etc. |
4.1.2.2 |
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6.2.2
a) Does the organization determine the necessary competence for personnel performing activities affecting product quality?
b) Is training provided or other actions taken to satisfy competency needs?
c) Is the training provided (or other actions taken) evaluated for effectiveness?
d) Are employees aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives?
e) Are appropriate training and qualification records maintained? (see clause 4.2.4) |
Verify that personnel competency is determined on the basis of appropriate education, training, skills and work experience, and that
Training needs are identified.
Review training plans and records to verify that:
required training is provided.
Completed training is Evaluated for effectiveness.
QMS awareness training is provided and/or interview employees to assess awareness. Determine if communications are consistent with other internal/external communications (see clauses 5.1.a), 5.3.d , 5.5.1, 5.5.3, 6.3.c), 7.2.3, 7.3.1, and 7.4.2)
Verify adequacy of employee qualification/training records. |
Competency review results
Training plans Training records |
4.18
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8.1 Measurement, analysis and improvement - General |
4.10 + 4.20.1 |
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8.2.1 Measurement, analysis and improvement - Monitoring and measurement - Customer satisfaction |
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8.2.2 Measurement, analysis and improvement - Monitoring and measurement - Internal audit |
4.17 |
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8.2.3 Measurement, analysis and improvement - Monitoring and measurement - of processes |
4.9 + 4.20 |
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8.2.4 Measurement, analysis and improvement - Monitoring and measurement - of product |
4.10 + 4.20 |
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8.3 Measurement, analysis and improvement - Control of nonconforming product |
4.13 |
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8.4 Measurement, analysis and improvement - Analysis of data |
4.14 + 4.20 |
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8.5.1 Measurement, analysis and improvement - Improvement - Continual improvement |
4.1.1 + 4.1.3 + 4.9 + 4.14 + 4.17 |
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8.5.2 Measurement, analysis and improvement - Improvement - Corrective action |
4.14.1 + 4.14.2 |
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8.5.3 Measurement, analysis and improvement - Improvement - Preventive action |
4.14.1 + 4.14.3 |
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Overall Strengths and Weaknesses Observed |
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Strengths |
Weaknesses and Opportunities for Improvement |
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Specific Audit Incidents (i.e. Findings requiring corrective action and opportunities for improvement) are summarized on the following page. |
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Year / Month: |
2002 |
2003 |
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Department, Function, and/or Process to be Audited: |
April |
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August |
September |
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November |
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January |
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March |
April |
May |
June |
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August |
September |
Sales |
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Admin |
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Technical |
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Planning |
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Logistics |
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Purchasing |
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Storage Area 1 |
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Storage Area 2 |
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Production Process 7.5.1.1 |
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Production Process 7.5.1.2 |
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Special Process 7.5.2 |
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Design Process 7.3.1 |
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Design Process 7.3.2 |
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IsoQual Form 8.2.2-1 Rev 1-1-03
Key:
P = Audits planned to be conducted once a year
A = Additional audits taking into account STATUS, IMPORTANCE, PRIOR AUDITS
Organization: |
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QUALITY SYSTEM CHECKLIST AND AUDIT GUIDE |
Standard: |
ISO 9001:2000 |
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Question (those relating to new/ revised requirements are in italics) |
Audit Guidelines |
Organization's Documents |
ISO 9001:1994 Cross Reference |
Fully Documented? Y or N (and comments) |
Fully Implemented? Y or N (and comments) |
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Auditor Name: |
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Date: |
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Audit Ref. |
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Page |
IsoQual Form 8.2.2-3 - Rev 1-1-03
Organization: |
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QUALITY SYSTEM CHECKLIST AND AUDIT GUIDE |
Standard: |
ISO 9001:2000 |
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QUALITY SYSTEM ASSESSMENT SUMMARY |
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Requirement |
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Not Met |
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ISO 9001:2000 |
ISO 9001:1994 |
Met |
Minor |
Major |
Comments |
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Organization: |
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QUALITY SYSTEM CHECKLIST AND AUDIT GUIDE |
Standard: |
ISO 9001:2000 |
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QUALITY SYSTEM AUDIT PLAN (for use in planning & conducting internal audits) |
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