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ISO 9001:2015

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Continuous improvement

The organization must continually improve the appropriateness, adequacy, and effectiveness of the reporting system. Quality management. The organization shall consider the results of the analysis and evaluation, and the outputs of the review by management, to determine if there are needs or opportunities that should be considered as part of continuous improvement.

Nonconformity and corrective action

When a non-conformity occurs, including any caused by complaints, the organization must: a) react to the non-conformity and, where applicable: 1) take action to control and correct it; 2) deal with the consequences; b) evaluate the need for actions to eliminate the causes of the nonconformity, so that no occur again or occur elsewhere, by: 1) review and analysis of the nonconformity; 2) determination of the causes of non-conformity; 3) determining whether similar nonconformities exist, or potentially may occur; c) implement any necessary action; d) review the effectiveness of any corrective action taken; e) if necessary, update the risks and opportunities determined during planning; and f) if necessary, make changes to the quality management system. Corrective actions must be appropriate to the effects of the nonconformities found.

Generalities

The organization shall determine and select opportunities for improvement and implement any action required to meet customer requirements and increase customer satisfaction. These should include: a) improve products and services to meet requirements, as well as consider needs and future expectations. b) correct, prevent or reduce unwanted effects; c) improve the performance and effectiveness of the quality management system.

Performance evaluation

Management review

Top management should review the organization's quality management system at intervals planned, to ensure their continued suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization.

internal audit

The organization shall carry out internal audits at planned intervals to provide information about whether the quality management system: a) conforms to: 1) the organization's own requirements for its quality management system. 2) the requirements of this International Standard. b) is effectively implemented and maintained.

Monitoring, measurement, analysis and evaluation

The organization must determine: a) what needs monitoring and measurement; b) the monitoring, measurement, analysis and evaluation methods necessary to ensure valid results; c) when monitoring and measurement should take place; d) when monitoring and measurement results should be analyzed and evaluated. The organization shall evaluate the performance and effectiveness of the quality management system. The organization shall retain appropriate documented information as evidence of the results.

Operation

Control of non-conforming outputs

The organization shall ensure that outputs that do not conform to its requirements are identified and controlled to prevent unintended use or delivery. The organization shall take appropriate actions based on the nature of the nonconformity. and its effect on the conformity of products and services. This should also apply to non-conforming products and services detected after delivery of the products, during or after the provision of services.

Release of products and services

The organization shall implement the planned arrangements, at the appropriate stages, to verify that the requirements of the products and services are met. The release of products and services to the customer should not take place until they have been satisfactorily completed planned arrangements, unless otherwise approved manner by a relevant authority and, where applicable, by the customer. The organization shall retain documented information on the release of products and services. Documented information should include. a) evidence of compliance with the acceptance criteria. b) traceability to the people who authorize the release.

Production and service provision

Controlled conditions should include, where applicable: a) the availability of documented information that defines: 1) the characteristics of the products to be produced, the services to be provided, or the activities to be play. 2) the results to be achieved. b) the availability and use of adequate monitoring and measurement resources. c) the implementation of monitoring and measurement activities at the appropriate stages to verify that the criteria for the control of the processes or their outputs are met, and the criteria for acceptance for products and services. d) the use of adequate infrastructure and environment for the operation of the processes. e) the appointment of competent persons, including any qualifications required. f) the validation and periodic revalidation of the ability to achieve the planned results of the production and service provision processes, when the resulting outputs cannot be verified by subsequent monitoring or measurement activities. g) the implementation of actions to prevent human errors. h) the implementation of release, delivery and post-delivery activities.

Control of externally supplied processes, products and services

The organization shall ensure that externally supplied processes, products and services are in accordance with the requirements. The organization must determine the controls to apply to processes, products and services externally supplied when: a) The products and services of external providers are intended to be incorporated within the the organization's own products and services. b) products and services are provided directly to customers by external providers on behalf of the organization. c) a process, or part of a process, is provided by an external provider as a result of an organization decision.

Design and development of products and services

The organization shall establish, implement and maintain a design and development process that is adequate to ensure the subsequent provision of products and services.

Requirements for products and services

Communication with clients should include: a) provide information regarding products and services. b) deal with inquiries, contracts or orders, including changes. c) Obtain customer feedback regarding products and services, including customer complaints. d) manipulate or control the client's property. e) establish the specific requirements for contingency actions, when pertinent.

Planning and operational control

a) determining the requirements for products and services; b) the establishment of criteria for: 1) processes. 2) acceptance of products and services. c) the determination of the resources necessary to achieve compliance with the requirements of the products and services. d) the implementation of process control in accordance with the criteria. e) the determination, maintenance and preservation of the information documented in the extension needed for: 1) have confidence that processes have been carried out as planned. 2) demonstrate the conformity of products and services with your requirements. The output of this planning must be adequate for the organization's operations.

Support

Documented information

The organization's quality management system must include: a) the documented information required by this International Standard. b) the documented information that the organization determines is necessary for the effectiveness of the quality management system.

Communication

The organization shall determine the internal and external communications relevant to the quality management, including: a) what to communicate. b) when to communicate. c) to whom to communicate. d) how to communicate. e) who communicates.

Toma de conciencia

La organización debe asegurarse de que las personas que realizan el trabajo bajo el control de la organización tomen conciencia de: a) la política de la calidad. b) los objetivos de la calidad pertinentes. c) su contribución a la eficacia del sistema de gestión de la calidad, incluidos los beneficios de una mejora del desempeño. d) las implicaciones del incumplimiento de los requisitos del sistema de gestión de la calidad.

Competencies

The organization must: a) determine the necessary competence of the persons who carry out, under their control, work that affects the performance and effectiveness of the quality management system. b) ensure that these persons are competent, based on education, training or appropriate experience. c) where applicable, take actions to acquire the necessary competence and evaluate the effectiveness of actions taken. d) retain appropriate documented information as evidence of competence.

Means

a) people b) Infrastructure c) Environment for the operation of the processes d) Monitoring and measurement resources -Traceability of measurements e) Knowledge of the organization

Planning

Planning for changes

The organization should consider: a) the purpose of the changes and their potential consequences; b) the integrity of the quality management system. c) the availability of resources. d) the assignment or reassignment of responsibilities and authorities.

Quality objectives and planning to achieve them

Quality objectives must: a) be consistent with the quality policy. b) be measurable. c) take into account the applicable requirements. d) be relevant for the conformity of products and services and for increasing the customer satisfaction. e) be monitored. f) communicate. g) be updated, as appropriate. The organization shall maintain documented information on the quality objectives.

Actions to address risks and opportunities

Determine the risks and opportunities that need to be addressed in order to: a) ensure that the quality management system can achieve its intended results. b) increase the desirable effects. c) prevent or reduce unwanted effects. d) achieve improvement. The organization must plan: a) actions to address these risks and opportunities; b) the manner of: 1) integrate and implement the actions in your quality management system processes 2) evaluate the effectiveness of these actions.