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Esta versión no presenta grandes cambios de fondo, sino solamente corrige desviaciones de la versión hasta ahora vigente. El enfoque de la enmienda es clarificar los requisitos, no añadirlos o retirarlos. Esto para usted significará menos confusión en la interpretación de los requisitos. Ejemplos de alguno de los cambios: Apartado 1.1. Generalidades: Los términos "legal" y "reglamentario" asociado al producto. Apartado 4.1. Requisitos Generales: "Determinar" en lugar de "identificar" los procesos necesarios para el sistema de gestión. Apartado 4.2.1. Requisitos de la documentación (Generalidades): Incluye "los registros determinados por la organización necesarios para asegurar la planificación eficaz", que ya aparece en el 7.1. De la versión del 2000. Apartado 6.2.2. Competencia, toma de conciencia y formación: Incluye asegurar que se han alcanzado las competencias necesarias en lugar de asegurar la efectividad de las acciones tomadas. No hay cambio conceptual. Apartado 8.2.1. Satisfacción del cliente: Introduce el término "indicador" para la medición de la satisfacción del cliente como "uno de los indicadores para el desempeño del sistema de gestión de calidad". La nueva ISO 9001: 2008, principales cambios en sus requisitos 1.1 Objeto y Campo de aplicación. Generalidades Al hablar del producto pedido por el cliente, también incluye productos comprados o productos intermedios resultantes de los procesos. Los requisitos legales y reglamentarios y los del cliente aplicables, son equivalentes a los requisitos del producto. 4.1 Requisitos generales 4.2 a) La organización debe determinar (no identificar) los procesos necesarios para la calidad. Nota 2 y 3) Los procesos de compras (7.4) se aplican también a los procesos externos, con sus controles. 4.2.1 Documentación general d) Se incluirán documentos y registros para el control de procesos. Nota: “un solo documento puede incluir los requisitos de varios procedimientos”.
4.2.3 Control de los documentos f) los documentos de origen externo necesarios para la planificación / operación de la gestión del sistema de calidad, deben identificarse y su distribución, controlada. 4.2.4 Control de los registros Los registros se deben permanecer legibles, fácilmente identificables y recuperables. 6.2.2 Competencia, formación y toma de conciencia (dentro de 6.2 Recursos humanos) a) determinar la competencia necesaria para el personal relacionado con la conformidad con los requisitos del producto (no la calidad del producto). b) proporcionar formación para lograr la competencia necesaria, cuando aplique. c) asegurarse que la competencia necesaria se ha logrado (no la efectividad de las acciones tomadas). 6.3 Infraestructura c) los sistemas de información se incluyen como servicios de apoyo. 6.4 Ambiente de trabajo Nota : Se clarifica que este requisito se refiere a las condiciones bajo las cuales se realiza el trabajo como, ruido, temperatura, humedad, iluminación o condiciones climáticas, a fin de lograr la conformidad con los requisitos del producto. 7.1 Planificación de la realización del producto c) Se añade medición como actividad a determinar dentro de planificación. 7.2.1 Determinación de los requisitos relacionados con elproducto d) Otros requisitos necesarios (no determinados) por la organización. Nota: También se incorpora la postventa, que puede incluir garantías y obligaciones como mantenimiento o reciclado. 7.3.1 Planificación del diseño y desarrollo Nota l: Diseño, desarrollo, verificación y validación: tienen propósitos diferentes, pudiéndose registrar separadamente o conjuntamente.
7. formación.3 Control de producto no conforme Las diferentes maneras de tratar los productos no conformes se harán cuando sea aplicable.2.5.4 Propiedad del cliente Se incluye como propiedad también los datos personales . se controlará la identificación del producto y se mantendrán registros. 2) Los procesos como soldaduras. .3 Identificación y trazabilidad La organización identificará el estado del producto a través de todo el proceso de realización del mismo. 7.3. esterilización. se deben considerar en relación sobre la conformidad con los requisitos y la eficacia del sistema.2 Auditoría interna Deben mantenerse registros de las auditorías y de sus resultados. Si la trazabilidad es requisito.3 Seguimiento y medición de los procesos Nota : Cuando se determinen los métodos adecuados para los procesos. tratamiento térmico. servicio de atención de llamadas o de emergencias.5. 7.6 Control de dispositivos de medición Nota :La confirmación de la capacidad del software incluye su verificación y la gestión de la configuración.3 Resultados del diseño y desarrollo Nota: También se incluye la preservación de producto. si aplica en la producción o prestación del servicio.5.7.2. 8.2 Validación de los procesos de la producción y de la prestación del servicio Notas del autor : 1) Si no se incluye la verificación antes de la entrega. necesitan validación. se debe incluir en 7. 7. 8. 8.1 (Planificación de la realización del producto).
1 – Documentation requirements. 6. general Clarification that QMS documentation also includes records.General requirements Clause a . These conditions include noise.3 (f) . verification and .2.Infrastructure Clause c – Clarification that "information systems" are included as part of the infrastructure. 4. temperature.Determination of requirements related to the product Note includes clarification of the meaning of "post delivery activities. 4.a single document may address the requirements for one or more procedures. lighting.2.2 . training and awareness Clause b – "provide training or take other actions to satisfy these needs" changed to "where applicable.4 has been added. and a requirement for a documented procedure may be covered by more than one document.2.4. and weather as part of the working environment." 7. 7.1 .3 .Planning of product realization The term "measurement" had been added to the activities. 5. Note 1 was changed .4 .2. 4.Competence.5.Management representative Additional clarification that the management representative be a member of the organization’s management. 6.2. humidity.1 . Notes cover definition of outsourced process and types of control that may be applied to these processes.Work environment Clarification of "work environment" to include conditions under which work is performed.4 . Reference to clause 7.2 .The word "determine" replaces the word "identify" for processes.1 (c) .Design and development planning A note has been added clarifying that design and development review. provide training or take other action to achieve the necessary competence" 6.3.Control of records Editorial changes to better align with ISO 14001.Control of documents Clarification that only external documents determined by the organization to be necessary for the planning and operation of the QMS need to be identified and have their distribution controlled. 7.1 .
user opinion surveys.Control of monitoring and measuring equipment 7. The note has been amended to specify that personal data is "customer property.2.5.Customer property Slight wording change in the requirement to inform the customer of any problem regarding his property.Customer satisfaction Note added to explain that monitoring of customer perception can include input from sources such as customer satisfaction surveys.Identification and traceability Added/clarified that the organization shall identify product status with respect to monitoring and measuring requirements throughout product realization.3 . However. 8. The references to ISO 10011-1.Design and development outputs Note added to clarify that information needed for production and service provision may include details for preservation of the product.Internal audit The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes.6 ." so it now reads "be calibrated or verified.3 .6 has changed from monitoring and measuring “devices” to “equipment” The reference to paragraph 7.3." preservation shall include … 7.1 has been removed Clause a – Changed "and/or" to "or.5. customer data on delivered product quality. and ISO 10011-3 are now changed to ISO 19011. they can be conducted and recorded separately or in any combination. 7.Preservation of product Slight wording changes: – Added "in order to maintain conformity to requirements.1 .4 . 7.validation have distinct purposes. as suitable for the product and the organization. warranty claims." 7. Records of audits include audit results. ISO 10011-2. and dealer reports. lost business analysis.5 ." – Addition of the term "As applicable. or both. 7.2.2 .5. compliments. ." Clause c – from "be identified to enable the" to "have identification in order to" Note 1 – the references to ISO 10012-1 and ISO 10012-2 have been removed Note added – Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use. 8.2.
2 . 8.3 .5." 8." 8.Corrective action Item f) updated to read "reviewing the effectiveness of the corrective action taken.Control of nonconforming product Editorial changes only – rearrangement of the paragraphs. it is advisable that the organization should consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system.4 .Monitoring and measurement of processes A change of words: "to ensure conformity of the product" was removed at the end of the last sentence. Note added: "When determining suitable methods.8.3 .2. 8.3 .Analysis of data References to other clauses updated in items b)." . and d).Preventive action Item e) updated to read "reviewing the effectiveness of the preventative action taken.5. c).
.the products it provides provided.text from the standard is shown in italic font to distinguish them from our comments.deleted text is indicated by strikethroughs .1 General In this section of the Introduction. .its varying needs. An activity or set of activities using resources.its the size and organizational structure of the organization. and managed in order to enable the transformation of inputs into outputs. including certification bodies. . or risks associated with that environment. and regulatory requirements applicable to the product.its business environment. to assess the organization's ability to meet customer. ISO 9001:2008 adds "business environment" to the list of factors that influence the design and implementation of a quality management system. statutory and regulatory requirements are those applicable to the product. can be considered as a process. it has to identify determine and manage numerous linked activities. For an organization to function effectively. and .new text is underlined and shown in standard font . 0. Most of the text in ISO 9001:2000 has not been affected by ISO 9001:2008. . The definition of Process Approach has been clarified by adding text: .its particular objectives. changes in that environment. The design and implementation of an organization's quality management system is influenced by . ISO 9001:2008 changes "regulatory" to "statutory and regulatory" and clarifies that the Customer. 0. and the organization's own requirements.2 Process Approach ISO 9001:2008 focuses on "determine" linked activities rather than "identify" linked activities to clarify that a Process can be an activity or set of activities.the processes it employs employed. This International Standard can be used by internal and external parties.The revisions to ISO 9001:2000 are described below . statutory.
Annex A shows the correspondence between ISO 9001:2008 and ISO 14001:2004. a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements. This International Standard has been aligned with ISO 14001:1996 in order During the development of this International Standard. as a result. 0.The application of a system of processes within an organization. and their management to produce the desired outcome. together with the identification and interactions of these processes. Scope 1. NOTE: At the time of the publication of this International Standard. ISO 9004 is under revision.1 General This section refers to the product as meeting Customer and applicable “regulatory” requirements as well as enhancing Customer satisfaction by assuring conformity to Customer and applicable “regulatory” requirements. but can also be used independently.3 Relationship with ISO 9004 The revision to ISO 9004:2000 is expected by summer of 2009 with extensive changes. ISO 9001:2008 adds a Note about the upcoming revision to ISO 9004. ISO 9001:2008 has expanded the uses of "regulatory" to "statutory and regulatory".A Quality Management Approach”. and .4 Compatibility with Other Management Systems This section refers to ISO 14001:2004 instead of ISO 14001:1996 and refers to the appendix that compares the clauses of ISO 9001:2008 to the clauses of ISO 14001:2004. can be referred to as the "process approach". ISO 9001:2008 no longer indicates "similar structures in order to assist their application as a consistent pair". 1. The title of the revised ISO 9004 is expected to be. “Managing for the Sustained Success of an Organization . they have similar structures in order to assist their application as a consistent pair. The present editions of ISO 9001 and ISO 9004 have been developed as a consistent pair of are quality management system standards which have been designed to complement each other. Although the two International Standards have different scopes. due consideration was given to the provisions of ISO 14001:2004 to enhance the compatibility of the two standards for the benefit of the user community. including a new clause structure that no longer matches ISO 9001. 0.
b) aims to enhance customer satisfaction through the effective application of the system. ISO 9001:2008 has expanded Product to include any intended output resulting from the product realization processes.a the product intended for. the term “product” only applies only to . including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. it can also mean “service”. 2. or required by. claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within Clause 7. Where exclusions are made. only the edition cited applies. ISO 9000:20002005. Quality management systems . the latest edition of the referenced document (including any amendments) applies. . a customer . For undated references. 1. to provide product that meets customer and applicable statutory and regulatory requirements. Terms and Definitions Old definitions from this section were removed and the only text remaining is shown below: For the purposes of this document International Standard. the terms and definitions given in ISO 9000 apply. Normative Reference The key change here is to refer to ISO 9000:2005 instead of ISO 9000:2000. NOTE 2: Statutory and regulatory requirements can be expressed as legal requirements. wherever the term “product” occurs. For dated references.any intended output resulting from the product realization processes. or responsibility. A second Note has been added to explain that “statutory and regulatory” requirements can be expressed as “legal” requirements. and such exclusions do not affect the organization's ability.2 Application ISO 9001:2008 replaces "regulatory" with "statutory and regulatory". NOTE 1: In this International Standard. The following referenced documents are indispensable for the application of this document.Fundamentals and vocabulary 3. Throughout the text of this International Standard.
Control of such The type and extent of control to be applied to these outsourced processes shall be identified defined within the quality management system.1 has been expanded and two new Notes have been added: NOTE 1: Processes needed for the quality management system referred to above should include processes for management activities. and measurement. the requirement change above indicates processes are only measured where applicable. The current Note under clause 4. analysis. not just identified. Quality Management System 4. Processes are monitored but may not need to be measured. product realization. e) monitor. and improvement. . We recognize or establish something as being a particular thing when we identify but we apply reason and reach a decision when we determine . Regarding outsourcing: Where an organization chooses to outsource any process that affects product conformity with to requirements. and analyze these processes. This addition clarifies that specific controls are to be defined and applied.. The new Note below provides an explanation of what is considered an outsourced process. measure (where applicable). NOTE 2: An outsourced process is identified as one being needed for the organization's quality management system.4. provision of resources. the words "Identify" and "Determine" used above have slightly different meanings. analysis. The text above expands from "measurement" to "measurement. and improvement" to match the title for clause 8 to clearly state that these processes are included rather than should be included.to determine the process implies more analysis and judgment. the word "Identify" has been replaced with "Determine". but chosen to be performed by a party external to the organization.2). a) Identify Determine the processes needed for the quality management system and their application throughout the organization (see 1.1 General Requirements Sub-clause (a). therefore. and . Although similar. the organization shall ensure control over such processes..
b) the degree to which the control for the process is shared. 4. including records.4.1. Preventive Action. c) documented procedures and records required by this International Standard. Outsourcing a process to another organization typically involves the purchase of those services.2. NOTE 3: Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all Customer.4.1 has added two more sentences: A single document may include the requirements for one or more procedures. d) and e) have been restructured. including the controls mentioned in 7.2. 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. which we’ve always done in our kits. statutory. and d) documents. and e) records required by this International Standard (see 4. You can see that adding "records" to sub-clause (c) allowed sub-clause (e) to be dropped.4). Sub-clause (d) has been expanded to include the necessary records.3. in one Corrective and Preventive Action procedure. apply equally to the supplier selected to perform the outsourced process. which we’ve always done in our kits. The first Note for clause 4.The new Note below identifies the factors influencing the control of an outsourced process. .2. Using the second sentence you could split the required procedure for the Control of Documents into two separate documented procedures. and regulatory requirements. Corrective Action and 8. A requirement for a documented procedure may be covered by more than one document.4.2. as a result.1 General Sub-clauses c). c) the capability of achieving the necessary control through the application of clause 7. Using the first sentence you could combine documented procedures in 8.5. operation and control of its processes. the requirements of clause 7. needed determined by the organization to be necessary to ensure the effective planning.2 Documentation Requirements 4.5.
2. 4. The organization shall establish a documented procedure shall be established to define the controls needed for the identification.2. Records shall remain legible.1 Management Commitment 5. and retrievable.4 Control of Records Clause 4. 4.2.controlling records regulates their use. Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled.2 Customer Focus 5. readily identifiable and retrievable. The requirement for a documented Record Control procedure has been rewritten and is now a separate paragraph for emphasis and moved up in the section.2 Quality Manual No changes in ISO 9001:2008. storage. Management Responsibility 5. and The change in sub-clause (f) clarifies that not all external documents should be identified and controlled .3 Quality Policy . Records shall remain legible. retrieval. and disposition of records. 5.2.4 has expanded from records being "maintained" to having them "controlled".only those needed for the planning and operation of the quality management system.2. retention time.4.2.3 Control of Documents The only revision to clause 4. readily identifiable.3 is shown below: f) to 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. protection.4. Retention time has been reduced to "retention" and this requirement is now a separate paragraph and moved to the end of clause 4. Maintaining a record keeps it in good condition .
5.5.5. Personnel performing work affecting conformity to product quality requirements shall be competent on the basis of appropriate education.6 Management Review No changes in ISO 9001:2008.4.2 Human Resources 6.1 Responsibility and Authority No changes in ISO 9001:2008. 5. Authority. 6.2.1 Provision of Resources No changes in ISO 9001:2008.3 Internal Communication No changes in ISO 9001:2008. Resource Management 6. skills and experience. irrespective of other responsibilities. 5. and Communication 5.1 through 5. which was inappropriate: Top management shall appoint a member of the organization's management who. . shall have responsibility and authority that includes: 5. Product quality is conformity to product requirements so this clarification should not be considered a change. 5.2 Management Representative Some companies outsource the role of Management Representative to someone in a different organization or to a contract consultant.5 Responsibility. 6.5.1 General Work affecting "product quality" is changed to work affecting "conformity to product requirements".4 Planning No changes in ISO 9001:2008 for clauses 5. training.
6.4 Work Environment Add a Note to explain the term “work environment” by giving examples of work environment conditions for achieving conformity to product requirements. or information systems). c) supporting services (such as transport. 6. and other factors (such as noise.2 Competence. Adding the phrase "where applicable" to the following sub-clause recognizes that training or other actions may not be necessary since individuals may already have the necessary competence . 7. NOTE: Conformity to product requirements may be affected directly or indirectly by personnel performing any task within the quality management system. provide training or take other actions to satisfy these needs achieve the necessary competence. can affect conformity to product requirements. NOTE: The term "work environment" relates to conditions under which work is performed including physical. the requirement has been revised to specifically mention competence. and Training This clause title is the first to change from "Competence. temperature.2. or communication. and Awareness.A new Note has been added to 6. verifying or managing work within the scope of the quality management system.2. 6.1 to explain that anyone performing.2.1 Planning of Product Realization . Training. Product Realization 7. Training. environmental. and Training" to "Competence. The change in 6. Awareness.2: a) determine the necessary competence for personnel performing work affecting conformity to product quality requirements.3 Infrastructure Added "information systems" as an example of a supporting service. lighting. and Awareness". humidity.since "these needs" could be taken out of context. including supporting services.2. b) where applicable. or weather).1 from “product quality” to “product requirements” caused a change in the sub-clause of 6.
7. validation. as appropriate: b) the need to establish processes.Addition of "measurement" as one of the required activities to be determined during the planning of product realization.3 Design and Development 7.3. actions under warranty provisions. c) required verification.2 Customer-Related Processes 7. 7. d) any additional requirements determined considered necessary by the organization. and The following text clarifies that additional requirements “considered necessary” must be determined. and supplementary services such as recycling or final disposal. NOTE: Post delivery activities include.2. for example.2. the organization shall determine the following. contractual obligations such as maintenance services. In planning product realization. and documents.2. inspection and test activities specific to the product and the criteria for product acceptance. and to provide resources specific to the product.2 Review of Requirements Related to the Product 7. Some organizations didn’t consider important post-delivery activities as described by the new Note below.1 Design and Development Planning . measurement. The organization shall determine: c) statutory and regulatory requirements related applicable to the product. monitoring.1 Determination of Requirements Related to the Product The change from "related" to "applicable" emphasizes that requirements are those that are relevant and can be applied to the product rather than those that are simply associated with the product. 7.3 Customer Communication No changes in ISO 9001:2008.
7.7 Control of Design and Development Changes No changes in ISO 9001:2008 for clauses 7. 7. Requirements shall be complete. 7.3 Design and Development Outputs To enable is to make it possible.3.6 Design and Development Validation 7. NOTE: Information for production and service provision can include details for the preservation of product. which can be verified.3.5 Design and Development verification 7.7. verification and validation have distinct purposes. They can be conducted and recorded separately or in any combination. These The inputs shall be reviewed for adequacy. 7.5.4 Design and Development Review 7.1 Control of Production and Service Provision .The new Note below explains that functions can be carried out separately or in any combination for review.2 Design and Development Inputs The revision only changes "These inputs" to "The inputs".5 Production and Service Provision 7. as suitable for the product and the organization.4 through 7.3. which can’t be verified. but to be suitable means it is meant for use.3.3. unambiguous and not in conflict with each other. NOTE: Design and development review.3.3.4 Purchasing No changes in ISO 9001:2008. The outputs of design and development shall be provided in a form that enables suitable for verification against the design and development input and shall be approved prior to release. The new Note below is a reminder that the design output should consider product packaging. verification and validation of design and development.3. 7.
The requirement has expanded from recording product identification to keeping any type of record associated with product traceability. therefore.4 Customer Property The Note now includes "personal data" as an example of Customer property.6 has been changed to refer to the control of monitoring and measuring “equipment” instead of “devices”. as a consequence.2.The title of clause 7. The change below clarifies that the implementation activities are those related to the “product”. 7. or otherwise found to be unsuitable for use. the terminology has been changed below: d) the availability and use of monitoring and measuring devices equipment. and post-delivery activities.3 Identification and Traceability Some organizations thought that identification only applied to the final product but identification applies from received product to in-process and final product. damaged. If any customer property is lost. 7. The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. deficiencies become apparent only after the product is in use or the service has been delivered. NOTE: Customer property can include intellectual property and personal data. delivery.2. broadening its applicability to service organizations.5. The organization shall identify the product status with respect to monitoring and measurement requirements throughout product realization.5. 7. f) the implementation of product release.5.4). . This includes any processes where and.4). this shall be reported the organization shall report this to the customer and records maintained maintain records (see 4.2 Validation of Processes for Production and Service Provision Any process output that can't be verified could result in deficiencies becoming known only after the product is in use or the service has been delivered. the organization shall control and record the unique identification of the product and maintain records (see 4. Where traceability is a requirement.
7. measuring equipment shall: a) be calibrated or verified. The text below was moved to a standalone sentence for emphasis.4).2. or both. . where no such standards exist.5.2. c) be identified have identification to enable in order to determine the its calibration status to be determined.1). which we have always stated in our calibration procedure. storage. Measuring equipment may come with the identification already in place but you’ll still need to add a label if verification is used to assure accuracy before and after use. at specified intervals. The organization shall preserve the conformity of product during internal processing and delivery to the intended destination in order to maintain conformity to requirements. This requirement clarifies equipment might be calibrated and/or verified.2. or prior to use. This As applicable. against measurement standards traceable to international or national measurement standards. the basis used for calibration or verification shall be recorded (see 4. Preservation shall also apply to the constituent parts of a product. and protection. handling. The change below allows product preservation to be applied as applicable rather than mandate inclusion of all provisions.4). preservation shall include identification.7. The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices equipment needed to provide evidence of conformity of product to determined requirements (see 7. packaging. Records of the results of calibration and verification shall be maintained (see 4.6 Control of Monitoring and Measuring Devices Equipment The clause title is the second to change.5 Preservation of product "Conformity to requirements" is better than "conformity of product". Where necessary to ensure valid results. A new Note was added to explain that confirmation of software includes verification and configuration management.
8. and for reporting results and maintaining records (see 4. A documented procedure shall be established to define the responsibilities and requirements for planning and conducting audits. dealer reports. NOTE: Monitoring customer perception can include obtaining input from sources such as customer satisfaction surveys.1 Customer Satisfaction Examples of monitoring Customer perceptions has been added to this clause. The responsibilities and requirements for planning and conducting audits.2 Monitoring 8.4). lost business analysis. measurement.2. NOTE: See ISO 10012-1 and ISO 10012-2 for guidance.1 General Conformity of the product has been revised to "conformity to product requirements" The organization shall plan and implement the monitoring. and improvement processes needed a) to demonstrate conformity of the to product requirements. customer data on delivered product quality.2. NOTE: Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use. establishing records and reporting results. 8. and Improvement 8. 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.When used in the monitoring and measurement of specified requirements. Records of the audits and their results shall be maintained (see 4.2. analysis. Analysis.2 Internal Audit Emphasis was given to a "documented procedure" and "establishing records" was moved ahead of "reporting results" because records are being produced during audits and should be reviewed before reporting results. Measurement. user opinion surveys. . compliments. warranty claims.4) shall be defined in a documented procedure. 8.2.
This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7. 8.2.An immediate correction might be needed before determining the cause of the nonconformity and taking corrective action to prevent its recurrence. ISO 10011-2 and ISO 10011-3 ISO 19011 for guidance. When determining what is a "suitable" method for monitoring and measuring processes. NOTE: When determining suitable methods.4). The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. the reference to product conformity was removed. as appropriate. therefore. the organization should consider the impact of the process on conformity to product requirements and system effectiveness. has been replaced with a reference to ISO 19011. NOTE: See ISO 10011-1. it is advisable that the organization consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system. to ensure conformity of the product.2. ISO 10011. . When planned results are not achieved. Guidelines for Quality and/or Environmental Management Systems Auditing.2.3 Monitoring and Measurement of Processes For some supporting processes. monitoring and measuring processes are only indirectly related to product conformity. Guidelines for Auditing Quality Systems. The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes. correction and corrective action shall be taken. 8. Evidence of conformity with the acceptance criteria shall be maintained. Evidence of conformity with the acceptance criteria shall be maintained.1). Records shall indicate the person(s) authorizing release of product for delivery to the customer (see 4.4 Monitoring and Measurement of Product The requirement to maintain evidence of conformity with acceptance criteria has been moved and release of product means delivery to the Customer.
of the nonconformity. 8. Records of the nature of nonconformities and any subsequent actions taken. shall be maintained (see 4. or potential effects. The text below was moved from paragraph 4 to become paragraph 3. by the customer. The deleted text below was moved from paragraph 3 to paragraph 4.4 Analysis of Data . When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements. unless otherwise approved by a relevant authority and. Records of the nature of nonconformities and any subsequent actions taken. shall be maintained (see 4. Tthe organization shall deal with nonconforming product by one or more of the following ways: d) by taking action appropriate to the effects.The release of product release and delivery of service delivery to the customer shall not proceed until the planned arrangements (see 7. the organization shall take action appropriate to the effects. of the nonconformity when nonconforming product is detected after delivery or use has started.2. The requirement in paragraph 4 below is from paragraph 3 . The added phrase "where applicable" means where relevant and suitable to disposition nonconforming product and a new method was added to the list. which includes rework to eliminate the detected nonconformity. shall be defined in a documented procedure.no changes were made since it includes “subsequent actions” such as re-verification. including concessions obtained. A documented procedure shall be established to define Tthe controls and related responsibilities and authorities for dealing with nonconforming product. where applicable. When nonconforming product is detected after delivery or use has started. 8. including concessions obtained. or potential effects.3 Control of Nonconforming Product The sentence below now begins with the requirement for a documented procedure. Where applicable.4) The deleted text below was moved to entry (d).4).2.1) have been satisfactorily completed.
2.5. 8. c) characteristics and trends of processes and products.4).2 shows the reverse correspondence from ISO 14001:2004 clauses to ISO 9001:2008 clauses.1 in the Annex was revised to show the correspondence of ISO 9001:2008 clauses with ISO 14001:2004 (instead of ISO 14001:1996). The organization shall take action to eliminate the cause causes of nonconformities in order to prevent recurrence.2.5.4). Preventive Action.2. 8. including opportunities for preventive action (see 8.2. and d) suppliers (see 7.2 Corrective Action The requirement below was made to be consistent with a similar sentence in 8.1 to 8.4).5.2. Annex A Table A.3 Preventive Action This clause was changed to match 8.4) and to add new references (8. f) reviewing the effectiveness of the corrective action taken.5.1) b) conformity to product requirements (see 7.3.3. The analysis of data shall provide information relating to a) customer satisfaction (see 8. e) reviewing the effectiveness of the preventive action taken.2. and 7.2.3 and 126.96.36.199 Improvement 8.1 Continual Improvement No changes in ISO 9001:2008. Some organizations interpreted reviewing as checking that an action was taken instead of determining the effectiveness of the action.4. Table A.5. 8. 8.2.The changes below were to revise a reference (from 7. Annex B .4).1) (see 8.
The old Annex B that showed the correspondence of ISO 9001:2000 and ISO 9001:1994 clauses has been replaced since the clause structure of ISO 9001:2000 and ISO 9001:2008 are the same.1) identifies the text changes from ISO 9001:2000 to ISO 9001:2008. . The new Annex B (Table B.
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