logging in or signing up DOUG JONES dstim Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 257 Category: Entertainment License: All Rights Reserved Like it (0) Dislike it (0) Added: February 21, 2008 This Presentation is Public Favorites: 2 Presentation Description No description available Comments Posting comment... By: suhasvaidya (39 month(s) ago) please mail me a copy of the presentation thanks Saving..... Post Reply Close Saving..... Edit Comment Close By: yuwong2 (41 month(s) ago) Do you mind mailing me a copy to yuwong2@hotmail.com. Kind regards YW Saving..... Post Reply Close Saving..... Edit Comment Close By: silkyD (45 month(s) ago) These are very useful slides as they remind of how I must keep Q at the forefront of project deliverables. Do you mind mailing me a copy to dee.alimi@gmail.com. Kind regards D Saving..... Post Reply Close Saving..... Edit Comment Close Premium member Presentation Transcript Understanding the ISO 9001:2000 Quality Management System Standard: Understanding the ISO 9001:2000 Quality Management System StandardQuality Management System4.1 General Requirements: Quality Management System 4.1 General Requirements The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. The organization shall: a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2), b) determine the sequence and interaction of these processes, c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes, e) monitor, measure and analyze these processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes. These processes shall be managed by the organization in accordance with the requirements of this International Standard. Quality Management System4.1 General Requirements: Quality Management System 4.1 General Requirements Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system. NOTE: Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.Quality Management System4.2 Documentation Requirements: Quality Management System 4.2 Documentation Requirements 4.2.1 General. The quality management system documentation shall include: a) documented statements of a quality policy and quality objectives, b) a quality manual, c) documented procedures required by this International Standard, d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and e) records required by this International Standard (see 4.2.4). NOTE 1 Where the term "documented procedure" appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to: a) the size of organization and type of activities, b) the complexity of processes and their interactions, and c) the competence of personnel. NOTE 3 The documentation can be in any form or type of medium.Quality Management System4.2 Documentation Requirements: Quality Management System 4.2 Documentation Requirements 4.2.2 Quality manual. The organization shall establish and maintain a quality manual that includes: a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2), b) the documented procedures established for the quality management system, or reference to them, and c) a description of the interaction between the processes of the quality management system. 4.2.3 Control of documents. Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in (4.2.4). A documented procedure shall be established to define the controls needed: a) to approve documents for adequacy prior to issue, b) to review and update as necessary and re-approve documents, c) to ensure that changes and the current revision status of documents are identified, d) to ensure that relevant versions of applicable documents are available at points of use,Quality Management System4.2 Documentation Requirements: Quality Management System 4.2 Documentation Requirements e) to ensure that documents remain legible and readily identifiable, f) to ensure that documents of external origin are identified and their distribution controlled, and g) to 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. Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.Implementation and Gap Analysis: Implementation and Gap Analysis ISO 9001:2000 Section and Paragraph Key Intent Describe the Key Intents of the Section/Paragraph. At a minimum, include all of the “shall” requirements (you only need to list the paragraph number for explicit “shall” statements). Implementation What items need to exist or should be in place in order for the Key Intent to be realized or to provide evidence of compliance to the “shall statements”? e.g. Documentation, records, measurements and monitoring, analysis, equipment, skills, improvement efforts 4.2.2.a-b 4.2.2.c The boundaries (scope) of the QMS as well as type/location of documented procedures should be clearly outlined. Interaction of the parts of the QMS should be described. Quality Manual with clearly written and justified exclusions and references to level two documentation (procedures). Flowchart(s) of 30,000 foot view of how QMS is structured and input/output statements in the level 2 documents. 4.2.3 A control system needs to be in place to ensure only accurate and current documentation is used to ensure quality. A procedure will exists that describes the required control mechanisms to ensure that controlled docs are authorized, are the only docs used, and are available. This will describe control of external docs as well.The Visual Metaphor: The Visual Metaphor The Metaphor is a useful tool for using one concept as a method to understand another concept. Example of a Metaphor: Food Chain (as in biology). As a useful metaphor it may have nothing to do with food or with chains. It is, however, very useful in understanding business (or other) hierarchies. Constructing a Visual Metaphor can be very useful in understanding the ISO 9001:2000 Standard. Simple rules for constructing the Visual Metaphor: It must be a system that is complex enough to model the ISO Standard. Like any system, it must have a clearly defined input, output, and customer. It cannot be a factory model since this is too close to the actual ISO system. Examples of the Metaphor: Examples of the Metaphor My desk is laid out like a week’s worth of laundry Too many chiefs and not enough Indians Nervous as a long-tailed cat in a room full of rockers Too many irons in the fire Too many cooks spoil the soup Cooking a new dish without a recipe Treated like a red-headed stepchildExamples of Visual Metaphors Used to Successfully Model the ISO System: Examples of Visual Metaphors Used to Successfully Model the ISO System Car Farm Cow Camera Bakery Video PlayerStarting a Visual Metaphor: Starting a Visual Metaphor Owners Manual 4.2.2 $38.00 7.4 Inflated Tires 7.5.1.c 8.2.3 Example: A car, and the system components surrounding the car, can be used as a metaphor to understand the ISO system. System output: Trip from Asheville to Chicago System input: multiple System customer: ???Start Your Visual Metaphor: Start Your Visual Metaphor Put the main component of your system in the center third of a flipchart page. Use ONLY an outline of the main component – NO DETAIL YET! Draw additional components to represent: 4.2.2. The Quality Manual 4.2.4 Control of Records Instructor will lead a discussion.A Simple Process Model: A Simple Process Model Output Material People Machines Methods Environment Supplier Process Customer Process Feedback Customer Process Supplier Process Output Input InputAnother General Process Model“Turtle Diagram”: Another General Process Model “Turtle Diagram”General Process Model -- Linkage: General Process Model -- Linkage Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 INPUT OUT/IN OUT/IN OUT/IN OUT/IN OUTPUT Customer has a need Customer has need met.The ISO 9001:2000 QMS: The ISO 9001:2000 QMSISO 9001:2000 as a Process Model: ISO 9001:2000 as a Process Model Resource Management Management Responsibility Product Realization Measurement, analysis and improvement CUSTOMER CUSTOMER Continual improvement of the quality management system REQUIREMENTS SATISFACTION PRODUCT INPUT ORGANIZATION Input Output From the External Customer To the External CustomerSlide18: EXERCISE CUSTOMER ORIENTED PROCESS (COP) PAGES 1-3Nested Processes: Nested ProcessesManagement Processes (Interface): Management Processes (Interface)Support and Management Process Identification: Support and Management Process IdentificationSlide22: EXERCISE COP SUPPORT PROCESSES AND MANAGEMENT PROCESSES PAGES 4-6Implementation and Gap AnalysisSection 5 of the ISO Standard: Implementation and Gap Analysis Section 5 of the ISO Standard In teams, you will do a short IMPLEMENTATION and GAP ANALYSIS exercise as you discuss Section 5 of the ISO standard. Using the provided worksheets, follow the directions of the instructor in doing the exercise. The instructor will lead a discussion on the results after the teams have completed their work.Management Responsibility5.1 and 5.2: Management Responsibility 5.1 and 5.2 5.1 Management commitment. Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by: a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements, b) establishing the quality policy, c) ensuring that quality objectives are established, d) conducting management reviews, and e) ensuring the availability of resources. 5.2 Customer focus. Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1). Management Responsibility5.3 Quality Policy and 5.4 Quality Planning: Management Responsibility 5.3 Quality Policy and 5.4 Quality Planning 5.3 Quality policy. Top management shall ensure that the quality policy: a) is appropriate to the purpose of the organization, b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system, c) provides a framework for establishing and reviewing quality objectives, d) is communicated and understood within the organization, and e) is reviewed for continuing suitability. 5.4.1 Quality objectives. Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy. 5.4.2 Quality management system planning. Top management shall ensure that: a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.Management Responsibility5.5 Responsibility, Authority and Communication: Management Responsibility 5.5 Responsibility, Authority and Communication 5.5.1 Responsibility and authority. Top management shall ensure that responsibilities and authorities are defined and communicated within the organization. 5.5.2 Management representative. Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes: a) ensuring that processes needed for the quality management system are established, implemented and maintained, b) reporting to top management on the performance of the quality management system and any need for improvement, and c) ensuring the promotion of awareness of customer requirements throughout the organization. NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system. 5.5.3 Internal communication. Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.Management Responsibility5.6 Management Review: Management Responsibility 5.6 Management Review 5.6.1 General. Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records from management reviews shall be maintained (see 4.2.4). 5.6.2 Review input. The input to management review shall include information on: a) results of audits, b) customer feedback, c) process performance and product conformity, d) status of preventive and corrective actions, e) follow-up actions from previous management reviews, f) changes that could affect the quality management system, and g) recommendations for improvement. 5.6.3 Review output. The output from the management review shall include any decisions and actions related to: a) improvement of the effectiveness of the quality management system and its processes, b) improvement of product related to customer requirements, and c) resource needs. Continue Your Visual Metaphor: Continue Your Visual Metaphor Add to your visual metaphor for each of the following: Section 5.3 to 5.4: Something relating to objectives, AND Something relating to quality planning. Section 5.6: Something relating to Management Review. Instructor will lead a discussion.Implementation and Gap AnalysisSection 6 of the ISO Standard: Implementation and Gap Analysis Section 6 of the ISO Standard In teams, complete the IMPLEMENTATION and GAP ANALYSIS exercise as you discuss Section 6 of the ISO standard. Using the provided worksheets, follow the directions of the instructor in doing the exercise. The instructor will lead a discussion on the results after the teams have completed their work.Resource Management6.1 and 6.2: Resource Management 6.1 and 6.2 6.1 Provision of resources. The organization shall determine and provide the resources needed: a) to implement and maintain the quality management system and continually improve its effectiveness, and b) to enhance customer satisfaction by meeting customer requirements. 6.2.1 Human resources: General. Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience. 6.2.2 Human resources: Competence, awareness and training. The organization shall: a) determine the necessary competence for personnel performing work affecting product quality, b) provide training or take other actions to satisfy these needs, c) evaluate the effectiveness of the actions taken, d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and e) maintain appropriate records of education, training, skills and experience (see 4.2.4). Resource Management6.3 and 6.4: Resource Management 6.3 and 6.4 6.3 Infrastructure. The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable: a) buildings, workspace and associated utilities, b) process equipment (both hardware and software), and c) supporting services (such as transport or communication). 6.4 Work environment. The organization shall determine and manage the work environment needed to achieve conformity to product requirements.ISO Jeopardy (Part 1): 1 1 3 2 4 5 1 3 2 4 5 1 3 2 4 5 1 3 2 4 5 3 2 4 5 Rainy Day Planning Is There a DOC in the House? It’s a Management Thing Good, Better, Best Hodgepodge ISO Jeopardy (Part 1) Continue Your Visual Metaphor: Continue Your Visual Metaphor Add to your visual metaphor for each of the following: Section 6.2: Something relating to human resources Section 6.3 or 6.4: Something relating to infrastructure or environment. Instructor will lead a discussion.Implementation and Gap AnalysisSection 7.1 through 7.3 of the ISO Standard: Implementation and Gap Analysis Section 7.1 through 7.3 of the ISO Standard In teams, complete the IMPLEMENTATION and GAP ANALYSIS exercise as you discuss the first part of Section 7 of the ISO standard. Using the provided worksheets, follow the directions of the instructor in doing the exercise. The instructor will lead a discussion on the results after the teams have completed their work.Product Realization7.1 Planning of Product Realization: Product Realization 7.1 Planning of Product Realization The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1). In planning product realization, the organization shall determine the following, as appropriate: a) quality objectives and requirements for the product; b) the need to establish processes, documents, and provide resources specific to the product; c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance; d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4). The output of this planning shall be in a form suitable for the organization's method of operations. NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan. NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes.Product Realization7.2 Customer-Related Processes: Product Realization 7.2 Customer-Related Processes 7.2.1 Determination of requirements related to the product. The organization shall determine: a) requirements specified by the customer, including the requirements for delivery and post-delivery activities, b) requirements not stated by the customer but necessary for specified or intended use, where known, c) statutory and regulatory requirements related to the product, and d) any additional requirements determined by the organization. 7.2.2 Review of requirements related to the product. The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that: a) product requirements are defined, b) contract or order requirements differing from those previously expressed are resolved, and c) the organization has the ability to meet the defined requirements.Product Realization7.2 Customer-Related Processes: Product Realization 7.2 Customer-Related Processes Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4). Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance. Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements. NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material. 7.2.3 Customer communication. The organization shall determine and implement effective arrangements for communicating with customers in relation to: a) product information, b) enquiries, contracts or order handling, including amendments, and c) customer feedback, including customer complaints.Product Realization7.3 Design and Development: Product Realization 7.3 Design and Development 7.3.1 Design and development planning. The organization shall plan and control the design and development of product. During the design and development planning, the organization shall determine: a) the design and development stages, b) the review, verification and validation that are appropriate to each design and development stage, and c) the responsibilities and authorities for design and development. The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility. Planning output shall be updated, as appropriate, as the design and development progresses.Product Realization7.3 Design and Development: Product Realization 7.3 Design and Development 7.3.2 Design and development inputs. Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include: a) functional and performance requirements, b) applicable statutory and regulatory requirements, c) where applicable, information derived from previous similar designs, and d) other requirements essential for design and development. These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other. 7.3.3 Design and development outputs. The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release. Design and development outputs shall: a) meet the input requirements for design and development, b) provide appropriate information for purchasing, production and for service provision, c) contain or reference product acceptance criteria, and d) specify the characteristics of the product that are essential for its safe and proper use.Product Realization7.3 Design and Development: Product Realization 7.3 Design and Development 7.3.4 Design and development review. At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1) a) to evaluate the ability of the results of design and development to meet requirements, and b) to identify any problems and propose necessary actions. Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4). Product Realization7.3 Design and Development: Product Realization 7.3 Design and Development 7.3.5 Design and development verification. Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4). 7.3.6 Design and development validation. Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained (see 4.2.4). 7.3.7 Control of design and development changes. Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4). Continue Your Visual Metaphor: Continue Your Visual Metaphor Add to your visual metaphor for each of the following: Section 7.2.1 or 7.2.2: Something relating to product requirements. Section 7.3: Something relating to product design. Instructor will lead a discussion.Implementation and Gap AnalysisSection 7.4 through 7.6 of the ISO Standard: Implementation and Gap Analysis Section 7.4 through 7.6 of the ISO Standard In teams, complete the IMPLEMENTATION and GAP ANALYSIS exercise as you discuss the second half of Section 7 of the ISO standard. Using the provided worksheets, follow the directions of the instructor in doing the exercise. The instructor will lead a discussion on the results after the teams have completed their work.Product Realization7.4 Purchasing: Product Realization 7.4 Purchasing 7.4.1 Purchasing process. The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product. The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4). 7.4.2 Purchasing information. Purchasing information shall describe the product to be purchased, including where appropriate: a) requirements for approval of product, procedures, processes and equipment, b) requirements for qualification of personnel, and c) quality management system requirements. The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.Product Realization7.4 Purchasing: Product Realization 7.4 Purchasing 7.4.3 Verification of purchased product. The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. Where the organization or its customer intends to perform verification at the supplier's premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.Product Realization7.5 Production and Service Provision: Product Realization 7.5 Production and Service Provision 7.5.1 Control of production and service provision. The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable: a) the availability of information that describes the characteristics of the product, b) the availability of work instructions, as necessary, c) the use of suitable equipment, d) the availability and use of monitoring and measuring devices, e) the implementation of monitoring and measurement, and f) the implementation of release, delivery and post-delivery activities. 7.5.2 Validation of processes for production and service provision. The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. Validation shall demonstrate the ability of these processes to achieve planned results.Product Realization7.5 Production and Service Provision: Product Realization 7.5 Production and Service Provision The organization shall establish arrangements for these processes including, as applicable: a) defined criteria for review and approval of the processes, b) approval of equipment and qualification of personnel, c) use of specific methods and procedures, d) requirements for records (see 4.2.4), and e) revalidation. 7.5.3 Identification and traceability. Where appropriate, the organization shall identify the product by suitable means throughout product realization. The organization shall identify the product status with respect to monitoring and measurement requirements. Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4). NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained.Product Realization7.5 Production and Service Provision: Product Realization 7.5 Production and Service Provision 7.5.4 Customer property. The organization shall exercise care with customer property while it is under the organization's control or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4). NOTE Customer property can include intellectual property. 7.5.5 Preservation of product. The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.Product Realization7.6 Control of Monitoring and Measuring Devices: Product Realization 7.6 Control of Monitoring and Measuring Devices The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1). The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. Where necessary to ensure valid results, measuring equipment shall: a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded; b) be adjusted or re-adjusted as necessary; c) be identified to enable the calibration status to be determined; d) be safeguarded from adjustments that would invalidate the measurement result; e) be protected from damage and deterioration during handling, maintenance and storage. Product Realization7.6 Control of Monitoring and Measuring Devices: Product Realization 7.6 Control of Monitoring and Measuring Devices In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained (see 4.2.4). When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary. NOTE See ISO 10012-1 and ISO 10012-2 for guidance. Continue Your Visual Metaphor: Continue Your Visual Metaphor Add to your visual metaphor for each of the following: Section 7.4: Something relating to supplier or product verification. Section 7.5: Something relating to production provisions. Section 7.6: Something relating to control of measuring equipment. Instructor will lead a discussion.Implementation and Gap AnalysisSection 8.1 through 8.2.4 of the ISO Standard: Implementation and Gap Analysis Section 8.1 through 8.2.4 of the ISO Standard In teams, complete the IMPLEMENTATION and GAP ANALYSIS exercise as you discuss the first half of Section 8 of the ISO standard. Using the provided worksheets, follow the directions of the instructor in doing the exercise. The instructor will lead a discussion on the results after the teams have completed their work.Measurement, Analysis and Improvement8.1 General: Measurement, Analysis and Improvement 8.1 General The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed: a) to demonstrate conformity of the product, b) to ensure conformity of the quality management system, and c) to continually improve the effectiveness of the quality management system. This shall include determination of applicable methods, including statistical techniques, and the extent of their use.Measurement, Analysis and Improvement8.2 Monitoring and Measurement: Measurement, Analysis and Improvement 8.2 Monitoring and Measurement 8.2.1 Customer satisfaction. As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined. 8.2.2 Internal audit. The organization shall conduct internal audits at planned intervals to determine whether the quality management system: a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and b) is effectively implemented and maintained.Measurement, Analysis and Improvement8.2 Monitoring and Measurement: Measurement, Analysis and Improvement 8.2 Monitoring and Measurement An audit program shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work. The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure. The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2). NOTE See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance.Measurement, Analysis and Improvement8.2 Monitoring and Measurement: Measurement, Analysis and Improvement 8.2 Monitoring and Measurement 8.2.3 Monitoring and measurement of processes. The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product. 8.2.4 Monitoring and measurement of product. The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1). Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product (see 4.2.4). Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer. Continue Your Visual Metaphor: Continue Your Visual Metaphor Add to your visual metaphor for each of the following: Section 8.2.2: Something relating to internal auditing. Section 8.2.3 or 8.2.4: Something relating to monitoring of process OR product. Instructor will lead a discussion.Implementation and Gap AnalysisSection 8.3 through 8.5 of the ISO Standard: Implementation and Gap Analysis Section 8.3 through 8.5 of the ISO Standard In teams, complete the IMPLEMENTATION and GAP ANALYSIS exercise as you discuss the second half of Section 8 of the ISO standard. Using the provided worksheets, follow the directions of the instructor in doing the exercise. The instructor will lead a discussion on the results after the teams have completed their work.Measurement, Analysis and Improvement8.3 Control of nonconforming product: Measurement, Analysis and Improvement 8.3 Control of nonconforming product The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure. The organization shall deal with nonconforming product by one or more of the following ways: a) by taking action to eliminate the detected nonconformity; b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; c) by taking action to preclude its original intended use or application. Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4). When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements. When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity.Measurement, Analysis and Improvement8.4 Analysis of Data and 8.5.1 Continual Improvement: Measurement, Analysis and Improvement 8.4 Analysis of Data and 8.5.1 Continual Improvement 8.4 The organization shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data shall provide information relating to: a) customer satisfaction (see 8.2.1), b) conformity to product requirements (see 7.2.1), c) characteristics and trends of processes and products including opportunities for preventive action, and d) suppliers. 8.5.1 The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.Measurement, Analysis and Improvement8.5 Improvement: Measurement, Analysis and Improvement 8.5 Improvement 8.5.2 Corrective action. The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered. A documented procedure shall be established to define requirements for: a) reviewing nonconformities (including customer complaints), b) determining the causes of nonconformities, c) evaluating the need for action to ensure that nonconformities do not recur, d) determining and implementing action needed, e) records of the results of action taken (see 4.2.4), and f) reviewing corrective action taken.Measurement, Analysis and Improvement8.5 Improvement: Measurement, Analysis and Improvement 8.5 Improvement 8.5.3 Preventive action. The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems. A documented procedure shall be established to define requirements for: a) determining potential nonconformities and their causes, b) evaluating the need for action to prevent occurrence of nonconformities, c) determining and implementing action needed, d) records of results of action taken (see 4.2.4), and e) reviewing preventive action taken. Slide63: ISO Jeopardy (Part 2) Complete Your Visual Metaphor: Complete Your Visual Metaphor Add to your visual metaphor for each of the following: Section 8.3: Something relating to controlling non-conforming product. Section 8.4: Something relating to analysis of data. Section 8.5: Something relating to continual improvement. Instructor will lead a discussion.Summary and Wrap Up: Summary and Wrap Up The ISO Standard is built around a PROCESS MODEL and PDCA. Emphasis on proactively seeking CUSTOMER INPUT. Very focused on IMPROVEMENT. Must have SMART OBJECTIVES. The proof of effectiveness is in the DOCUMENTED RESULTS.Customer Oriented Processes: Customer Oriented Processes ORGANIZATION CUSTOMER WHO NEEDS TO PARK CUSTOMER FINDS A CONVENIENT PARKING SPACE CUSTOMER WHO NEEDS TO TRANSPORT ITEMS FOR PURCHASE CUSTOMER FINDS CLEAN, WELL-MAINTAINED CART CUSTOMER NEEDS TO LOCATE DESIRED ITEMS CUSTOMER EASILY FINDS DESIRED ITEMS CUSTOMER NEEDS TO PAY FOR ITEMS CUSTOMER MAKES PAYMENT QUICKLY CUSTOMER WANTS TO FIND A HOME IMPROVEMENT STORE CUSTOMER FINDS A STORE CUSTOMER WANTS TO QUICKLY FIND CAR CUSTOMER FINDS CAR QUICKLY 3 You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.
DOUG JONES dstim Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 257 Category: Entertainment License: All Rights Reserved Like it (0) Dislike it (0) Added: February 21, 2008 This Presentation is Public Favorites: 2 Presentation Description No description available Comments Posting comment... By: suhasvaidya (39 month(s) ago) please mail me a copy of the presentation thanks Saving..... Post Reply Close Saving..... Edit Comment Close By: yuwong2 (41 month(s) ago) Do you mind mailing me a copy to yuwong2@hotmail.com. Kind regards YW Saving..... Post Reply Close Saving..... Edit Comment Close By: silkyD (45 month(s) ago) These are very useful slides as they remind of how I must keep Q at the forefront of project deliverables. Do you mind mailing me a copy to dee.alimi@gmail.com. Kind regards D Saving..... Post Reply Close Saving..... Edit Comment Close Premium member Presentation Transcript Understanding the ISO 9001:2000 Quality Management System Standard: Understanding the ISO 9001:2000 Quality Management System StandardQuality Management System4.1 General Requirements: Quality Management System 4.1 General Requirements The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard. The organization shall: a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2), b) determine the sequence and interaction of these processes, c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes, e) monitor, measure and analyze these processes, and f) implement actions necessary to achieve planned results and continual improvement of these processes. These processes shall be managed by the organization in accordance with the requirements of this International Standard. Quality Management System4.1 General Requirements: Quality Management System 4.1 General Requirements Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system. NOTE: Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization and measurement.Quality Management System4.2 Documentation Requirements: Quality Management System 4.2 Documentation Requirements 4.2.1 General. The quality management system documentation shall include: a) documented statements of a quality policy and quality objectives, b) a quality manual, c) documented procedures required by this International Standard, d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and e) records required by this International Standard (see 4.2.4). NOTE 1 Where the term "documented procedure" appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to: a) the size of organization and type of activities, b) the complexity of processes and their interactions, and c) the competence of personnel. NOTE 3 The documentation can be in any form or type of medium.Quality Management System4.2 Documentation Requirements: Quality Management System 4.2 Documentation Requirements 4.2.2 Quality manual. The organization shall establish and maintain a quality manual that includes: a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2), b) the documented procedures established for the quality management system, or reference to them, and c) a description of the interaction between the processes of the quality management system. 4.2.3 Control of documents. Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in (4.2.4). A documented procedure shall be established to define the controls needed: a) to approve documents for adequacy prior to issue, b) to review and update as necessary and re-approve documents, c) to ensure that changes and the current revision status of documents are identified, d) to ensure that relevant versions of applicable documents are available at points of use,Quality Management System4.2 Documentation Requirements: Quality Management System 4.2 Documentation Requirements e) to ensure that documents remain legible and readily identifiable, f) to ensure that documents of external origin are identified and their distribution controlled, and g) to 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. Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.Implementation and Gap Analysis: Implementation and Gap Analysis ISO 9001:2000 Section and Paragraph Key Intent Describe the Key Intents of the Section/Paragraph. At a minimum, include all of the “shall” requirements (you only need to list the paragraph number for explicit “shall” statements). Implementation What items need to exist or should be in place in order for the Key Intent to be realized or to provide evidence of compliance to the “shall statements”? e.g. Documentation, records, measurements and monitoring, analysis, equipment, skills, improvement efforts 4.2.2.a-b 4.2.2.c The boundaries (scope) of the QMS as well as type/location of documented procedures should be clearly outlined. Interaction of the parts of the QMS should be described. Quality Manual with clearly written and justified exclusions and references to level two documentation (procedures). Flowchart(s) of 30,000 foot view of how QMS is structured and input/output statements in the level 2 documents. 4.2.3 A control system needs to be in place to ensure only accurate and current documentation is used to ensure quality. A procedure will exists that describes the required control mechanisms to ensure that controlled docs are authorized, are the only docs used, and are available. This will describe control of external docs as well.The Visual Metaphor: The Visual Metaphor The Metaphor is a useful tool for using one concept as a method to understand another concept. Example of a Metaphor: Food Chain (as in biology). As a useful metaphor it may have nothing to do with food or with chains. It is, however, very useful in understanding business (or other) hierarchies. Constructing a Visual Metaphor can be very useful in understanding the ISO 9001:2000 Standard. Simple rules for constructing the Visual Metaphor: It must be a system that is complex enough to model the ISO Standard. Like any system, it must have a clearly defined input, output, and customer. It cannot be a factory model since this is too close to the actual ISO system. Examples of the Metaphor: Examples of the Metaphor My desk is laid out like a week’s worth of laundry Too many chiefs and not enough Indians Nervous as a long-tailed cat in a room full of rockers Too many irons in the fire Too many cooks spoil the soup Cooking a new dish without a recipe Treated like a red-headed stepchildExamples of Visual Metaphors Used to Successfully Model the ISO System: Examples of Visual Metaphors Used to Successfully Model the ISO System Car Farm Cow Camera Bakery Video PlayerStarting a Visual Metaphor: Starting a Visual Metaphor Owners Manual 4.2.2 $38.00 7.4 Inflated Tires 7.5.1.c 8.2.3 Example: A car, and the system components surrounding the car, can be used as a metaphor to understand the ISO system. System output: Trip from Asheville to Chicago System input: multiple System customer: ???Start Your Visual Metaphor: Start Your Visual Metaphor Put the main component of your system in the center third of a flipchart page. Use ONLY an outline of the main component – NO DETAIL YET! Draw additional components to represent: 4.2.2. The Quality Manual 4.2.4 Control of Records Instructor will lead a discussion.A Simple Process Model: A Simple Process Model Output Material People Machines Methods Environment Supplier Process Customer Process Feedback Customer Process Supplier Process Output Input InputAnother General Process Model“Turtle Diagram”: Another General Process Model “Turtle Diagram”General Process Model -- Linkage: General Process Model -- Linkage Step 1 Step 2 Step 3 Step 4 Step 5 Step 6 INPUT OUT/IN OUT/IN OUT/IN OUT/IN OUTPUT Customer has a need Customer has need met.The ISO 9001:2000 QMS: The ISO 9001:2000 QMSISO 9001:2000 as a Process Model: ISO 9001:2000 as a Process Model Resource Management Management Responsibility Product Realization Measurement, analysis and improvement CUSTOMER CUSTOMER Continual improvement of the quality management system REQUIREMENTS SATISFACTION PRODUCT INPUT ORGANIZATION Input Output From the External Customer To the External CustomerSlide18: EXERCISE CUSTOMER ORIENTED PROCESS (COP) PAGES 1-3Nested Processes: Nested ProcessesManagement Processes (Interface): Management Processes (Interface)Support and Management Process Identification: Support and Management Process IdentificationSlide22: EXERCISE COP SUPPORT PROCESSES AND MANAGEMENT PROCESSES PAGES 4-6Implementation and Gap AnalysisSection 5 of the ISO Standard: Implementation and Gap Analysis Section 5 of the ISO Standard In teams, you will do a short IMPLEMENTATION and GAP ANALYSIS exercise as you discuss Section 5 of the ISO standard. Using the provided worksheets, follow the directions of the instructor in doing the exercise. The instructor will lead a discussion on the results after the teams have completed their work.Management Responsibility5.1 and 5.2: Management Responsibility 5.1 and 5.2 5.1 Management commitment. Top management shall provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by: a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements, b) establishing the quality policy, c) ensuring that quality objectives are established, d) conducting management reviews, and e) ensuring the availability of resources. 5.2 Customer focus. Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 and 8.2.1). Management Responsibility5.3 Quality Policy and 5.4 Quality Planning: Management Responsibility 5.3 Quality Policy and 5.4 Quality Planning 5.3 Quality policy. Top management shall ensure that the quality policy: a) is appropriate to the purpose of the organization, b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system, c) provides a framework for establishing and reviewing quality objectives, d) is communicated and understood within the organization, and e) is reviewed for continuing suitability. 5.4.1 Quality objectives. Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy. 5.4.2 Quality management system planning. Top management shall ensure that: a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.Management Responsibility5.5 Responsibility, Authority and Communication: Management Responsibility 5.5 Responsibility, Authority and Communication 5.5.1 Responsibility and authority. Top management shall ensure that responsibilities and authorities are defined and communicated within the organization. 5.5.2 Management representative. Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes: a) ensuring that processes needed for the quality management system are established, implemented and maintained, b) reporting to top management on the performance of the quality management system and any need for improvement, and c) ensuring the promotion of awareness of customer requirements throughout the organization. NOTE The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system. 5.5.3 Internal communication. Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.Management Responsibility5.6 Management Review: Management Responsibility 5.6 Management Review 5.6.1 General. Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records from management reviews shall be maintained (see 4.2.4). 5.6.2 Review input. The input to management review shall include information on: a) results of audits, b) customer feedback, c) process performance and product conformity, d) status of preventive and corrective actions, e) follow-up actions from previous management reviews, f) changes that could affect the quality management system, and g) recommendations for improvement. 5.6.3 Review output. The output from the management review shall include any decisions and actions related to: a) improvement of the effectiveness of the quality management system and its processes, b) improvement of product related to customer requirements, and c) resource needs. Continue Your Visual Metaphor: Continue Your Visual Metaphor Add to your visual metaphor for each of the following: Section 5.3 to 5.4: Something relating to objectives, AND Something relating to quality planning. Section 5.6: Something relating to Management Review. Instructor will lead a discussion.Implementation and Gap AnalysisSection 6 of the ISO Standard: Implementation and Gap Analysis Section 6 of the ISO Standard In teams, complete the IMPLEMENTATION and GAP ANALYSIS exercise as you discuss Section 6 of the ISO standard. Using the provided worksheets, follow the directions of the instructor in doing the exercise. The instructor will lead a discussion on the results after the teams have completed their work.Resource Management6.1 and 6.2: Resource Management 6.1 and 6.2 6.1 Provision of resources. The organization shall determine and provide the resources needed: a) to implement and maintain the quality management system and continually improve its effectiveness, and b) to enhance customer satisfaction by meeting customer requirements. 6.2.1 Human resources: General. Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience. 6.2.2 Human resources: Competence, awareness and training. The organization shall: a) determine the necessary competence for personnel performing work affecting product quality, b) provide training or take other actions to satisfy these needs, c) evaluate the effectiveness of the actions taken, d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and e) maintain appropriate records of education, training, skills and experience (see 4.2.4). Resource Management6.3 and 6.4: Resource Management 6.3 and 6.4 6.3 Infrastructure. The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable: a) buildings, workspace and associated utilities, b) process equipment (both hardware and software), and c) supporting services (such as transport or communication). 6.4 Work environment. The organization shall determine and manage the work environment needed to achieve conformity to product requirements.ISO Jeopardy (Part 1): 1 1 3 2 4 5 1 3 2 4 5 1 3 2 4 5 1 3 2 4 5 3 2 4 5 Rainy Day Planning Is There a DOC in the House? It’s a Management Thing Good, Better, Best Hodgepodge ISO Jeopardy (Part 1) Continue Your Visual Metaphor: Continue Your Visual Metaphor Add to your visual metaphor for each of the following: Section 6.2: Something relating to human resources Section 6.3 or 6.4: Something relating to infrastructure or environment. Instructor will lead a discussion.Implementation and Gap AnalysisSection 7.1 through 7.3 of the ISO Standard: Implementation and Gap Analysis Section 7.1 through 7.3 of the ISO Standard In teams, complete the IMPLEMENTATION and GAP ANALYSIS exercise as you discuss the first part of Section 7 of the ISO standard. Using the provided worksheets, follow the directions of the instructor in doing the exercise. The instructor will lead a discussion on the results after the teams have completed their work.Product Realization7.1 Planning of Product Realization: Product Realization 7.1 Planning of Product Realization The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1). In planning product realization, the organization shall determine the following, as appropriate: a) quality objectives and requirements for the product; b) the need to establish processes, documents, and provide resources specific to the product; c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance; d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4). The output of this planning shall be in a form suitable for the organization's method of operations. NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan. NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes.Product Realization7.2 Customer-Related Processes: Product Realization 7.2 Customer-Related Processes 7.2.1 Determination of requirements related to the product. The organization shall determine: a) requirements specified by the customer, including the requirements for delivery and post-delivery activities, b) requirements not stated by the customer but necessary for specified or intended use, where known, c) statutory and regulatory requirements related to the product, and d) any additional requirements determined by the organization. 7.2.2 Review of requirements related to the product. The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that: a) product requirements are defined, b) contract or order requirements differing from those previously expressed are resolved, and c) the organization has the ability to meet the defined requirements.Product Realization7.2 Customer-Related Processes: Product Realization 7.2 Customer-Related Processes Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4). Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance. Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements. NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material. 7.2.3 Customer communication. The organization shall determine and implement effective arrangements for communicating with customers in relation to: a) product information, b) enquiries, contracts or order handling, including amendments, and c) customer feedback, including customer complaints.Product Realization7.3 Design and Development: Product Realization 7.3 Design and Development 7.3.1 Design and development planning. The organization shall plan and control the design and development of product. During the design and development planning, the organization shall determine: a) the design and development stages, b) the review, verification and validation that are appropriate to each design and development stage, and c) the responsibilities and authorities for design and development. The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility. Planning output shall be updated, as appropriate, as the design and development progresses.Product Realization7.3 Design and Development: Product Realization 7.3 Design and Development 7.3.2 Design and development inputs. Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include: a) functional and performance requirements, b) applicable statutory and regulatory requirements, c) where applicable, information derived from previous similar designs, and d) other requirements essential for design and development. These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other. 7.3.3 Design and development outputs. The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release. Design and development outputs shall: a) meet the input requirements for design and development, b) provide appropriate information for purchasing, production and for service provision, c) contain or reference product acceptance criteria, and d) specify the characteristics of the product that are essential for its safe and proper use.Product Realization7.3 Design and Development: Product Realization 7.3 Design and Development 7.3.4 Design and development review. At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1) a) to evaluate the ability of the results of design and development to meet requirements, and b) to identify any problems and propose necessary actions. Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4). Product Realization7.3 Design and Development: Product Realization 7.3 Design and Development 7.3.5 Design and development verification. Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4). 7.3.6 Design and development validation. Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product. Records of the results of validation and any necessary actions shall be maintained (see 4.2.4). 7.3.7 Control of design and development changes. Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4). Continue Your Visual Metaphor: Continue Your Visual Metaphor Add to your visual metaphor for each of the following: Section 7.2.1 or 7.2.2: Something relating to product requirements. Section 7.3: Something relating to product design. Instructor will lead a discussion.Implementation and Gap AnalysisSection 7.4 through 7.6 of the ISO Standard: Implementation and Gap Analysis Section 7.4 through 7.6 of the ISO Standard In teams, complete the IMPLEMENTATION and GAP ANALYSIS exercise as you discuss the second half of Section 7 of the ISO standard. Using the provided worksheets, follow the directions of the instructor in doing the exercise. The instructor will lead a discussion on the results after the teams have completed their work.Product Realization7.4 Purchasing: Product Realization 7.4 Purchasing 7.4.1 Purchasing process. The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product. The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4). 7.4.2 Purchasing information. Purchasing information shall describe the product to be purchased, including where appropriate: a) requirements for approval of product, procedures, processes and equipment, b) requirements for qualification of personnel, and c) quality management system requirements. The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.Product Realization7.4 Purchasing: Product Realization 7.4 Purchasing 7.4.3 Verification of purchased product. The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. Where the organization or its customer intends to perform verification at the supplier's premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.Product Realization7.5 Production and Service Provision: Product Realization 7.5 Production and Service Provision 7.5.1 Control of production and service provision. The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable: a) the availability of information that describes the characteristics of the product, b) the availability of work instructions, as necessary, c) the use of suitable equipment, d) the availability and use of monitoring and measuring devices, e) the implementation of monitoring and measurement, and f) the implementation of release, delivery and post-delivery activities. 7.5.2 Validation of processes for production and service provision. The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. Validation shall demonstrate the ability of these processes to achieve planned results.Product Realization7.5 Production and Service Provision: Product Realization 7.5 Production and Service Provision The organization shall establish arrangements for these processes including, as applicable: a) defined criteria for review and approval of the processes, b) approval of equipment and qualification of personnel, c) use of specific methods and procedures, d) requirements for records (see 4.2.4), and e) revalidation. 7.5.3 Identification and traceability. Where appropriate, the organization shall identify the product by suitable means throughout product realization. The organization shall identify the product status with respect to monitoring and measurement requirements. Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4). NOTE In some industry sectors, configuration management is a means by which identification and traceability are maintained.Product Realization7.5 Production and Service Provision: Product Realization 7.5 Production and Service Provision 7.5.4 Customer property. The organization shall exercise care with customer property while it is under the organization's control or being used by the organization. The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4). NOTE Customer property can include intellectual property. 7.5.5 Preservation of product. The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.Product Realization7.6 Control of Monitoring and Measuring Devices: Product Realization 7.6 Control of Monitoring and Measuring Devices The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1). The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. Where necessary to ensure valid results, measuring equipment shall: a) be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded; b) be adjusted or re-adjusted as necessary; c) be identified to enable the calibration status to be determined; d) be safeguarded from adjustments that would invalidate the measurement result; e) be protected from damage and deterioration during handling, maintenance and storage. Product Realization7.6 Control of Monitoring and Measuring Devices: Product Realization 7.6 Control of Monitoring and Measuring Devices In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained (see 4.2.4). When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary. NOTE See ISO 10012-1 and ISO 10012-2 for guidance. Continue Your Visual Metaphor: Continue Your Visual Metaphor Add to your visual metaphor for each of the following: Section 7.4: Something relating to supplier or product verification. Section 7.5: Something relating to production provisions. Section 7.6: Something relating to control of measuring equipment. Instructor will lead a discussion.Implementation and Gap AnalysisSection 8.1 through 8.2.4 of the ISO Standard: Implementation and Gap Analysis Section 8.1 through 8.2.4 of the ISO Standard In teams, complete the IMPLEMENTATION and GAP ANALYSIS exercise as you discuss the first half of Section 8 of the ISO standard. Using the provided worksheets, follow the directions of the instructor in doing the exercise. The instructor will lead a discussion on the results after the teams have completed their work.Measurement, Analysis and Improvement8.1 General: Measurement, Analysis and Improvement 8.1 General The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed: a) to demonstrate conformity of the product, b) to ensure conformity of the quality management system, and c) to continually improve the effectiveness of the quality management system. This shall include determination of applicable methods, including statistical techniques, and the extent of their use.Measurement, Analysis and Improvement8.2 Monitoring and Measurement: Measurement, Analysis and Improvement 8.2 Monitoring and Measurement 8.2.1 Customer satisfaction. As one of the measurements of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined. 8.2.2 Internal audit. The organization shall conduct internal audits at planned intervals to determine whether the quality management system: a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and b) is effectively implemented and maintained.Measurement, Analysis and Improvement8.2 Monitoring and Measurement: Measurement, Analysis and Improvement 8.2 Monitoring and Measurement An audit program shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work. The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure. The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2). NOTE See ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance.Measurement, Analysis and Improvement8.2 Monitoring and Measurement: Measurement, Analysis and Improvement 8.2 Monitoring and Measurement 8.2.3 Monitoring and measurement of processes. The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product. 8.2.4 Monitoring and measurement of product. The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1). Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product (see 4.2.4). Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer. Continue Your Visual Metaphor: Continue Your Visual Metaphor Add to your visual metaphor for each of the following: Section 8.2.2: Something relating to internal auditing. Section 8.2.3 or 8.2.4: Something relating to monitoring of process OR product. Instructor will lead a discussion.Implementation and Gap AnalysisSection 8.3 through 8.5 of the ISO Standard: Implementation and Gap Analysis Section 8.3 through 8.5 of the ISO Standard In teams, complete the IMPLEMENTATION and GAP ANALYSIS exercise as you discuss the second half of Section 8 of the ISO standard. Using the provided worksheets, follow the directions of the instructor in doing the exercise. The instructor will lead a discussion on the results after the teams have completed their work.Measurement, Analysis and Improvement8.3 Control of nonconforming product: Measurement, Analysis and Improvement 8.3 Control of nonconforming product The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure. The organization shall deal with nonconforming product by one or more of the following ways: a) by taking action to eliminate the detected nonconformity; b) by authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; c) by taking action to preclude its original intended use or application. Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4). When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements. When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity.Measurement, Analysis and Improvement8.4 Analysis of Data and 8.5.1 Continual Improvement: Measurement, Analysis and Improvement 8.4 Analysis of Data and 8.5.1 Continual Improvement 8.4 The organization shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data shall provide information relating to: a) customer satisfaction (see 8.2.1), b) conformity to product requirements (see 7.2.1), c) characteristics and trends of processes and products including opportunities for preventive action, and d) suppliers. 8.5.1 The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.Measurement, Analysis and Improvement8.5 Improvement: Measurement, Analysis and Improvement 8.5 Improvement 8.5.2 Corrective action. The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered. A documented procedure shall be established to define requirements for: a) reviewing nonconformities (including customer complaints), b) determining the causes of nonconformities, c) evaluating the need for action to ensure that nonconformities do not recur, d) determining and implementing action needed, e) records of the results of action taken (see 4.2.4), and f) reviewing corrective action taken.Measurement, Analysis and Improvement8.5 Improvement: Measurement, Analysis and Improvement 8.5 Improvement 8.5.3 Preventive action. The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems. A documented procedure shall be established to define requirements for: a) determining potential nonconformities and their causes, b) evaluating the need for action to prevent occurrence of nonconformities, c) determining and implementing action needed, d) records of results of action taken (see 4.2.4), and e) reviewing preventive action taken. Slide63: ISO Jeopardy (Part 2) Complete Your Visual Metaphor: Complete Your Visual Metaphor Add to your visual metaphor for each of the following: Section 8.3: Something relating to controlling non-conforming product. Section 8.4: Something relating to analysis of data. Section 8.5: Something relating to continual improvement. Instructor will lead a discussion.Summary and Wrap Up: Summary and Wrap Up The ISO Standard is built around a PROCESS MODEL and PDCA. Emphasis on proactively seeking CUSTOMER INPUT. Very focused on IMPROVEMENT. Must have SMART OBJECTIVES. The proof of effectiveness is in the DOCUMENTED RESULTS.Customer Oriented Processes: Customer Oriented Processes ORGANIZATION CUSTOMER WHO NEEDS TO PARK CUSTOMER FINDS A CONVENIENT PARKING SPACE CUSTOMER WHO NEEDS TO TRANSPORT ITEMS FOR PURCHASE CUSTOMER FINDS CLEAN, WELL-MAINTAINED CART CUSTOMER NEEDS TO LOCATE DESIRED ITEMS CUSTOMER EASILY FINDS DESIRED ITEMS CUSTOMER NEEDS TO PAY FOR ITEMS CUSTOMER MAKES PAYMENT QUICKLY CUSTOMER WANTS TO FIND A HOME IMPROVEMENT STORE CUSTOMER FINDS A STORE CUSTOMER WANTS TO QUICKLY FIND CAR CUSTOMER FINDS CAR QUICKLY 3