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Quality Management System Requirements
Quality management system requirements include planning, support, operation, leadership role, organizational environment, performance evaluation, improvement, scope, etc.
Edited at 2024-01-19 09:38:38- cáncer de pulmón
El cáncer de pulmón es un tumor maligno que se origina en la mucosa bronquial o las glándulas de los pulmones. Es uno de los tumores malignos con mayor morbilidad y mortalidad y mayor amenaza para la salud y la vida humana.
- diabetes
La diabetes es una enfermedad crónica con hiperglucemia como signo principal. Es causada principalmente por una disminución en la secreción de insulina causada por una disfunción de las células de los islotes pancreáticos, o porque el cuerpo es insensible a la acción de la insulina (es decir, resistencia a la insulina), o ambas cosas. la glucosa en la sangre es ineficaz para ser utilizada y almacenada.
- sistema digestivo
El sistema digestivo es uno de los nueve sistemas principales del cuerpo humano y es el principal responsable de la ingesta, digestión, absorción y excreción de los alimentos. Consta de dos partes principales: el tracto digestivo y las glándulas digestivas.
Quality Management System Requirements
- cáncer de pulmón
El cáncer de pulmón es un tumor maligno que se origina en la mucosa bronquial o las glándulas de los pulmones. Es uno de los tumores malignos con mayor morbilidad y mortalidad y mayor amenaza para la salud y la vida humana.
- diabetes
La diabetes es una enfermedad crónica con hiperglucemia como signo principal. Es causada principalmente por una disminución en la secreción de insulina causada por una disfunción de las células de los islotes pancreáticos, o porque el cuerpo es insensible a la acción de la insulina (es decir, resistencia a la insulina), o ambas cosas. la glucosa en la sangre es ineficaz para ser utilizada y almacenada.
- sistema digestivo
El sistema digestivo es uno de los nueve sistemas principales del cuerpo humano y es el principal responsable de la ingesta, digestión, absorción y excreción de los alimentos. Consta de dos partes principales: el tracto digestivo y las glándulas digestivas.
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- Outline
Quality Management System Requirements
scope
It is necessary to prove its ability to stably provide products and services that meet customer requirements and legal and regulatory requirements.
Through the effective application of the system, including the process of system improvement, and ensuring compliance with customer requirements and applicable legal and regulatory requirements
Normative reference documents
For dated reference documents, only the dated version applies to this document.
For undated referenced documents, the latest version (including all amendments) applies to this document.
Terms and definitions: The terms and definitions defined in GB/T 19000-2016 apply to this document
organizational environment
Understand the organization and its environment
The organization should identify the various external and internal factors that are relevant to its purpose and strategic direction and that affect its ability to achieve the intended results of the quality management system
The organization shall monitor and review information related to these external and internal factors
Understand the needs and expectations of relevant parties
Stakeholders related to the quality management system
Requirements from interested parties related to the quality management system
Determine the scope of the quality management system
Understand the various external and internal factors referred to in the organization and its environment
Understand the needs and expectations of the stakeholders mentioned in the
Organization's products and services
Quality management system and its processes
The organization shall determine the processes required for the quality management system and their application throughout the organization
Determine the required inputs and desired outputs of these processes
Determine the sequence and interaction of these processes
Identify and apply the guidelines and methods required to ensure the effective operation and control of these processes
Determine the resources required for these processes and ensure they are available
Assign responsibilities and authorities for these processes
Address risks and opportunities as required
Evaluate these processes and implement changes required to ensure the expected results of these processes are achieved
Improve process and quality management systems
To the extent and extent necessary, the organization shall
Maintain documented information to support process operations
Keep documented information to ensure that the process is being carried out as planned
leadership role
Leadership and Commitment
General principles
Responsible for the effectiveness of the quality management system
Ensure that the quality policy and quality objectives of the quality management system are formulated, adapted to the organizational environment, and consistent with the strategic direction
Ensure quality management system requirements are integrated into the organization's business processes
Promote the use of process approaches and risk-based thinking
Ensure resources required for the quality management system are available
Communicate the importance of effective quality management and compliance with quality management system requirements
Ensure the quality management system achieves its intended results
Engage personnel actively, mentor and support them to contribute to the effectiveness of the quality management system
drive improvements
Support other relevant managers to provide leadership within their areas of responsibility
customer-focused
Identify, understand and consistently meet customer requirements and applicable legal and regulatory requirements
Identify and respond to risks and opportunities that may impact the ability to qualify products and services and enhance customer satisfaction
Always committed to enhancing customer satisfaction
policy
Develop quality policy
Adapt to the organization’s purpose and environment and support its strategic direction
Provides a framework for establishing quality objectives
Includes commitment to meet applicable requirements
Includes a commitment to continuous improvement of the quality management system
Communicate quality policy
Ability to obtain and maintain documented information
Communicated, understood and applied within the organization
When appropriate, they can be beaten by relevant parties
Positions, responsibilities and authorities of the organization: Top managers should ensure that the responsibilities and authorities of relevant positions in the organization are assigned, communicated and understood
Ensure that the quality management system meets the requirements of this standard
Ensure that each process obtains its expected output
Report on the performance of the quality management system and opportunities for improvement, especially to top management
Ensure customer focus is driven throughout the organization
Ensure the integrity of the quality management system is maintained when planning and implementing changes to it
plan
Measures to address risks and opportunities
When planning a quality management system
Ensure that the quality management system achieves its intended results
enhance beneficial impact
Prevent or reduce adverse effects
achieve improvements
The organization should plan
Measures to address these risks and opportunities
how
Integrate and implement these measures within the quality management system process
Evaluate the effectiveness of these measures
Quality objectives and planning for their achievement
The organization shall establish quality objectives for relevant functions, levels and processes required by the quality management system
Consistent with quality policy
measurable
Consider applicable requirements
Relevant to product and service qualifications and enhanced customer satisfaction
monitor
communicate
Timely updates
When planning how to achieve quality objectives, the organization should determine
what to do
What resources are needed
Who is responsible
when to complete
How to evaluate the results
Planning of changes: When the organization determines that it needs to make changes to the quality management system, the changes should be implemented according to the planned plan.
The purpose of the change and its potential consequences
Integrity of quality management system
resource availability
Assignment or reallocation of responsibilities and authorities
support
resource
General: The organization shall determine and provide the resources required to establish, implement, maintain and continuously improve the quality management system
Capabilities and limitations of existing internal resources
Need to obtain resources from external providers
Personnel: The organization shall identify and staff the personnel required to effectively implement the quality management system and operate and control its processes
Infrastructure: The organization shall identify, provide and maintain the infrastructure required to operate processes and obtain qualified products and services
buildings and related facilities
Equipment, including hardware and software
transportation resources
information and communication technology
Process operating environment: The organization shall determine, provide and maintain the environment required to operate processes and obtain qualified products and services
social factors
psychological factors
physical factors
Monitor and measure resources
General: When monitoring or measurement is used to verify that products and services conform to requirements, the organization shall identify and provide the resources required to ensure that the results are valid and reliable
Suitable for the specific type of monitoring and measurement activities carried out
be maintained to ensure it remains fit for purpose
Measurement traceability
Calibration and verification should be carried out at specified intervals or before use against measurement standards that can be traced to international or national standards. When the above standards do not exist, documented information as the basis for calibration or verification should be retained.
be identified to determine its status
Protected against invalidation of the calibration status and subsequent measurement results due to adjustments, damage or degradation
Organizational knowledge: The organization shall determine the knowledge necessary to operate its processes and obtain qualified products and services
ability
Determine the competencies required of personnel working under their control who perform tasks that impact the performance and effectiveness of the quality management system
Ensure these personnel are competent based on appropriate education, training or experience
When applicable, take steps to obtain required capabilities and evaluate the effectiveness of the steps
Maintain appropriate documented information as evidence of personnel competency
consciousness
Quality policy
Relevant quality objectives
their contribution to the effectiveness of the quality management system, including the benefits of improved performance
Consequences of non-compliance with quality management system requirements
communicate
What to communicate
When to communicate
Who to communicate with
how to communicate
Who will communicate
documented information
General principles
Documented information required by this standard
Documented information determined by the organization that is necessary to ensure the effectiveness of the quality management system
Create and update
Identification and instructions
form
Review and approve to maintain suitability and adequacy
Control of documented information
The quality management system and documented information required by this standard shall be controlled to ensure
Available and applicable wherever and whenever needed
be properly protected
To control documented information, the organization shall conduct the following activities, where applicable
Distribution, access, retrieval and use
Storage and protection, including maintaining readability
change control
Retention and disposal
run
Production and service provision
Control of production and service provision
Documented information is available to provide for the following
Characteristics of the product to be produced, the service to be provided or the activity to be performed
results to be obtained
Appropriate monitoring and measurement resources are available and used
Monitoring and measurement activities are implemented at appropriate stages to verify compliance with the control criteria for the process or output and the acceptance criteria for products and services
Use appropriate infrastructure for the operation of the process and maintain an appropriate environment
Have competent personnel, including the required qualifications
If the output results cannot be verified by subsequent monitoring or measurement, the ability of the production and service delivery processes to achieve the planned results should be confirmed and revalidated regularly.
Take steps to prevent human error
Perform release, delivery and post-delivery activities
Identification and traceability
When necessary, the organization shall use appropriate methods to identify outputs to ensure that products and services are qualified
The organization shall identify output status in accordance with monitoring and measurement requirements throughout the production and service provision process
When traceability is required, the organization shall control the unique identification of outputs and shall retain documented information required to enable traceability
Property of Customer or External Provider
The organization shall care for property of customers or external providers that is under the control of the organization or used by the organization
The organization shall identify, verify, protect and secure customer and external provider property used by the organization or forming part of its products and services.
If customer or external provider property is lost, damaged, or otherwise unfit for use, the organization shall report it to the customer or external provider and retain documented information of the occurrence.
Guarding: The organization shall guard output as necessary during production and service provision to ensure compliance with requirements
Post-delivery activities
Legal and regulatory requirements
Potential adverse consequences associated with products and services
Nature, use and life expectancy of products and services
Customer requirements
customer feedback
Change Control: The organization shall review and control changes to production and service provision as necessary to ensure continued compliance with requirements
Release of products and services
The organization shall implement planned arrangements at appropriate stages to verify that product and service requirements have been met
Products and services should not be released to the customer until planned arrangements have been satisfactorily completed, unless approved by the relevant authorized personnel and, where applicable, the customer.
The organization shall retain documented information regarding the release of products and services
Evidence of compliance with acceptance criteria
Information traceable to the person authorizing the release
Control of unqualified output
The organization shall ensure that output that does not conform to requirements is identified and controlled to prevent unintended use and delivery, and that nonconforming output shall be corrected and verified to conform to requirements.
correct
Quarantine, restrict, return or suspend the provision of products and services
inform customers
Obtain authorization to receive concessions
The organization should retain documented information
Unsatisfactory description
Describe the actions taken
Describe concessions obtained
Identify and dispose of unqualified authorizations
Performance Evaluation
Monitor, measure, analyze and evaluate
General principles
The organization should determine
What needs to be monitored and measured
What methods are needed to monitor, measure, analyze and evaluate to ensure the results are valid
When to implement monitoring and measurement
When to analyze and evaluate monitoring and measurement results
The organization shall evaluate the performance and effectiveness of the quality management system
The organization shall retain appropriate documented information as evidence of results
Customer Satisfaction
The organization shall determine methods for obtaining, monitoring and reviewing this information
The organization should monitor the extent to which and perceptions of customers that their needs and expectations have been met
Analysis and evaluation: The organization shall analyze and evaluate appropriate data and information obtained through monitoring and measurement
Product and service compliance
customer satisfaction
Quality management system performance and effectiveness
Whether the plan is effectively implemented
Effectiveness of actions taken to address risks and opportunities
External provider performance
Need for quality management system improvement
internal review
The organization shall conduct internal audits at planned intervals to provide the following information about the quality management system
Does it comply with
The organization’s own quality management system requirements
Requirements of this standard
Whether it is effectively implemented and maintained
The organization should
Plan, develop, implement and maintain an audit plan based on the importance of the relevant processes, changes affecting the organization and previous audit results. The audit plan includes frequency, methods, responsibilities, planning requirements and reports.
Define the audit criteria and scope of each audit
Select auditors and conduct audits to ensure an objective and fair audit process
Ensure audit results are reported to relevant managers
Take appropriate corrective and corrective actions in a timely manner
Retain documented information as evidence of implementation of the audit plan and audit results
management review
General: Top management should review the organization's quality management system at planned intervals to ensure its continued suitability, adequacy, and effectiveness, and that it is consistent with the organization's strategic direction.
Management review input
Status of actions taken in past management reviews
Changes in internal and external factors related to the quality management system
The following information on the performance and effectiveness of the quality management system, including its trends
Customer satisfaction and feedback from relevant stakeholders
The degree to which quality objectives are achieved
Process performance and product and service conformity
Nonconformities and corrective actions
Monitor and measure results
Audit results
External provider performance
adequacy of resources
Effectiveness of actions taken to address risks and opportunities
Opportunities for improvement
Management review output
Opportunities for improvement
Required changes to the quality management system
Resource requirements
Improve
General principles
Improve products and services to meet requirements and respond to future needs and expectations
Correct, prevent or reduce adverse effects
Improve the performance and effectiveness of quality management systems
Nonconformities and corrective actions: Corrective actions should be proportionate to the impact of the nonconformity
When nonconformities occur, including those arising from complaints, the organization shall
Respond to nonconformities and, where applicable,
Take action to control and correct nonconformities
Disposal of consequences
Through the following activities, evaluate whether measures need to be taken to eliminate the causes of nonconformities and prevent their recurrence or occurrence on other occasions.
Unsatisfactory review and analysis
Determine the cause of nonconformity
Determine whether similar nonconformities exist or are likely to occur
Implement the required measures
Review the effectiveness of corrective actions taken
Update risks and opportunities identified during planning when necessary
Change the quality management system when necessary
The organization shall retain documented information as evidence of:
The nature of the nonconformity and subsequent actions taken
Corrective action results
keep improve
The organization shall continuously improve the suitability, adequacy and effectiveness of the quality management system
The organization shall consider the results of analysis and evaluation and the outputs of management reviews to determine whether needs or opportunities exist that should be addressed as part of continual improvement