ࡱ> (*#$%&' /AbjbjcTcT 4>>7U 55YYYmmm8m-9>}((&& &8888888k: =8Y&&"&&&8558...&j5Y8.&8..[4I6H֑m@'f5880-95Z=(=$66=Y$6&&.&&&&&88D+&&&-9&&&&=&&&&&&&&& :  A sample section from our 32-page ISO 9001:2008 checklist is shown on the next page. You can order the complete electronic Word file by sending a check for $50.00 to Whittington & Associates, 242 Highlands Drive, Woodstock, GA 30188. Please call 770-517-7944 (or email  HYPERLINK "mailto:Larry@WhittingtonAssociates.com" Larry@WhittingtonAssociates.com) if you have any questions. The file will be transmitted upon receipt of your payment (or a purchase order number). Credit card orders are not accepted.  Company: ________________________________________________________________ Contact: ________________________________________________________________ Email: ________________________________________________________________ Telephone: _________________________ Fax: ______________________________ Scope: ________________________________________________________________ Auditor: _________________________ Date: ______________________________ This checklist can be used to evaluate the conformity level of your quality management system against the requirements of the ISO 9001:2008 standard. Additional criteria for the quality management system may be specified in customer contracts, regulatory documents, and in the organizations own quality manual, plans, procedures, and instructions, but are not considered during the gap analysis. All these requirements must be addressed in your internal audits. Process Owners First, identify the process owners and their managers in the Process Owner table. Process Matrix Next, identify for each row of the Process Matrix, the process areas with Primary responsibility (owner) and Secondary responsibility (user). Use an X for a requirement that is not applicable for a process area. Each row should have a P assigned. Avoid, if possible, multiple primary responsibilities in a single row. Gap Checklist The gap checklist is used to assess the process areas with Primary responsibility for the applicable requirements. Indicate under the Status column a C for Conformity with all the clause requirements. Indicate P for Partial conformity and N if a Nonconformity. Conformity Level Interviews during the gap analysis are with the process owners with Primary responsibility for the applicable requirements. Users of the process (Secondary responsibility) are not interviewed. Their conformity level will be assessed in later internal audits after the system is fully implemented. After completing the checklist for each clause, indicate the conformity level for each row in the Process Matrix as Green for conforming, Yellow for partial conformity, and Red for nonconformity. Process owners will be responsible for writing any documents, and adding any practices, necessary to achieve complete conformity with the requirements. It should be expected that organizations just beginning their implementation of an ISO 9001:2008-based quality management system will have few green areas. The Process Diagram (see next page) can be used to help process owners better understand their process in terms of inputs, resources, methods, measures, and outputs, along with documents and records. The diagram can also be used to help develop any procedures needed for the processes.  Process Owners Process Area (department)Process Manager (owns process)(reports to) Management Owner01. 02.03.04.05.06.07.08.09.10.11.12.13.14.15. Process Matrix P = Primary Responsibility (Owner)S = Secondary Responsibility (User)X = Not ApplicableGreen = ConformingYellow = PartialRed = Nonconformity ClauseISO 9001:2008 RequirementsProcess Areas0102030405060708091011121314154. Quality Management System4.1General Requirements4.2Documentation Requirements4.2.1General4.2.2Quality Manual4.2.3Control of Documents4.2.4Control of Records5. Management Responsibility5.1Management Commitment5.2Customer Focus5.3Quality Policy5.4Planning5.4.1Quality Objectives5.4.2Quality Management System Planning5.5Responsibility, Authority, Communication5.5.1Responsibility and Authority5.5.2Management Representative5.5.3Internal Communication5.6Management Review5.6.1General5.6.2Review Input5.6.3Review Output P = Primary Responsibility (Owner)S = Secondary Responsibility (User)X = Not ApplicableGreen = ConformingYellow = PartialRed = Nonconformity ClauseISO 9001:2008 RequirementsProcess Areas0102030405060708091011121314156. Resource Management6.1Provision of Resources6.2Human Resources6.2.1General6.2.2Competence, Training, and Awareness6.3Infrastructure6.4Work Environment7. Product Realization7.1Planning of Product Realization7.2Customer-Related Processes7.2.1Determination of Product Requirements7.2.2Review of Product Requirements7.2.3Customer Communication7.3Design and Development7.3.1Design and Development Planning7.3.2Design and Development Inputs7.3.3Design and Development Outputs7.3.4Design and Development Review7.3.5Design and Development Verification7.3.6Design and Development Validation7.3.7Control of Design Changes7.4Purchasing7.4.1Purchasing Process7.4.2Purchasing Information7.4.3Verification of Purchased Product7.5Production and Service Provision7.5.1Control of Production and Service7.5.2Validation of Processes 7.5.3Identification and Traceability7.5.4Customer Property7.5.5Preservation of Product7.6Control of Measuring Equipment8. Measurement, Analysis, and Improvement8.1Measurement, Analysis, Improvement8.2Monitoring and Measurement8.2.1Customer Satisfaction8.2.2Internal Audit8.2.3Process Monitoring and Measurement8.2.4Product Monitoring and Measurement8.3Control of Nonconforming Product8.4Analysis of Data8.5Improvement8.5.1Continual Improvement8.5.2Corrective Action8.5.3Preventive Action PROCESS NAME: PROCESS DIAGRAM  SHAPE \* MERGEFORMAT Process Owner: Worksheet Number: Auditor Name: Report Number and Date:  PROCESS (Main Activities)ENVIRONMENT (Workplace Needs)  1. INPUTS (What Received, When, and from Whom)2. OUTPUTS (What Delivered, When, and to Whom) 3. WHAT - Resources (Equipment, Materials, and Tools)4. WHO - Resources (People, Skills, and Experience) 5. METHODS (Procedures, Instructions, and Controls)6. MEASURES (Performance Results and Objectives) DOCUMENTS (Any Documents Not Listed Under Methods)RECORDS (Records Generated by the Process) 4. Quality Management System 4.1 General Requirements C = ConformityP = Partial ConformityN = Nonconformity  ISO 9001 ClauseISO 9001:2008 Requirements Status (C-P-N) 4.1 Has the organization established, documented, implemented, and maintained a quality management system and continually improved its effectiveness in accordance with the ISO 9001 requirements? Refer to clause 5.4.2 (a) for planning to meet these requirements. 4.1 4.1.a Has the organization: a) determined the processes needed for the quality management system and their application throughout the organization? See ISO 9001 clause 1.2. 4.1.b  b) determined the sequence and interaction of these processes? Refer to ISO clause 4.2.2.c on the description required in the quality manual..  4.1.c c) determined criteria and methods needed to ensure that both the operation and control of these processes are effective?  4.1.d d) ensured the availability of resources and information necessary to support the operation and monitoring of these processes?  4.1.e e) monitored, measured where applicable, and analyzed these processes?  4.1.f f) implemented the actions necessary to achieve the planned results and continual improvement of these processes?  4.1 Are these processes managed in accordance with the ISO 9001 requirements?  Note 1 Processes needed for the quality management system should include processes for management activities, provision of resources, product realization, measurement, analysis, and improvement.  4.1 Has the organization ensured control over any outsourced processes that affect product conformity with requirements?  4.1 Has the type and extent of control of these outsourced processes been defined within the quality management system?  4.1 General Requirements (continued) ISO 9001 ClauseISO 9001:2008 Requirements Status (C-P-N) Note 2  An outsourced process is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party.  Note 3Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory, and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as: a) the potential impact of the outsourced process on the organization's capability to provide product that conforms to requirements, b) the degree to which the control for the process is shared; c) the capability of achieving the necessary control through the application of clause 7.4. 4.2 Documentation Requirements 4.2.1 General ISO 9001 ClauseISO 9001:2008 Requirements Status (C-P-N) 4.2.1 4.2.1.a Does the quality management system documentation include: a) documented statements of quality policy and quality objectives?  4.2.1.b b) a quality manual?  4.2.1.c c) documented procedures and records required by ISO 9001? (See clauses 4.2.3, 4.2.4, 8.2.2, 8.3, 8.5.2, and 8.5.3 for documented procedures)   4.2.1.d d) documents, including records determined by the organization to be necessary to ensure the effective planning, operation, and control of its processes?  Note 1 Where the term documented procedure appears within ISO 9001, this means that the procedure is established, documented, implemented, and maintained. A single document may include the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document. Note 2 The extent of quality management system documentation can differ between organizations due to: a) size of organization and type of activities, b) complexity of processes and their interactions, and c) competence of personnel.  4.2.1 General (continued) ISO 9001 ClauseISO 9001:2008 Requirements Status (C-P-N) Note 3 The documentation can be in any form or type of medium.  4.2.2 Quality Manual ISO 9001 ClauseISO 9001:2008 Requirements Status (C-P-N) 4.2.2 4.2.2.a Has the organization established and maintained a quality manual that includes: a) scope of the quality management system, including details of, and justification for, any exclusions? (see ISO 9001 clause 1.2)  4.2.2.b b) documented procedures established for the quality management system, or reference to them?  4.2.2.c c) description of the interaction between processes of the quality management system?  4.2.3 Control of Documents ISO 9001 ClauseISO 9001:2008 Requirements Status (C-P-N) 4.2.3 Are the documents required by the quality management system controlled?  4.2.3 Are records (a special type of document) controlled according to the requirements given in 4.2.4?  4.2.3 Has a documented procedure been established to control documents?  4.2.3.a Does the documented procedure define the controls to: a) approve documents for adequacy prior to issue?  4.2.3.b b) review, and update as necessary, and re-approve documents?  4.2.3.c c) ensure that changes and the current revision status of documents are identified?  4.2.3 Control of Documents (continued) ISO 9001 ClauseISO 9001:2008 Requirements Status (C-P-N) 4.2.3.d  d) ensure that relevant versions of applicable documents are available at points of use?  4.2.3.e e) ensure that documents remain legible and readily identifiable?  4.2.3.f f) ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled?  4.2.3.g g) prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose?  4.2.4 Control of Records ISO 9001 ClauseISO 9001:2008 Requirements Status (C-P-N) 4.2.4 Are records established and controlled to provide evidence of conformity to requirements and of the effective operation of the quality management system?  4.2.4 Has a documented procedure been established for controlling records?  4.2.4 Does the documented procedure define the controls needed for the: Identification of records? 4.2.4 Storage of records?  4.2.4 Protection of records?  4.2.4 Retrieval of records?  4.2.4 Retention time of records?  4.2.4 Disposition of records?   4.2.4 Are records kept legible, readily identifiable, and retrievable?      ISO 9001:2008 Gap Analysis ISO 9001:2008 Gap Analysis Page  PAGE 8 of 32 2000-2008 Whittington & Associates, LLC Revision 6: 11/17/08 Revision 6: 11/17/08 2000-2008 Whittington & Associates, LLC Page  PAGE 9 of 32 PROCESS 2. OUTPUTS 1. INPUTS 3. WHAT 5. METHODS 6. MEASURES 4. 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