4 The scope of the organization
4.1 organization and understand the scope
The purpose of the organization, strategic direction, and the desired results of kys determine the elements that will affect your ability to obtain relevant internal and external.
You should review this information about your organization and monitor internal and external factors.
Note 1: understand the scope outer; legal, technological, competitive, Sunday, cultural, social and economic elements of the environment arising from considering you may be able to. This international, national, regional and local.
Note 2: understand the scope of the internal; the organization's values, cultural knowledge and performance-related elements by looking at you may be able to.
4.2 understanding the needs and expectations of the Parties concerned
Products and services that meet customer and applicable statutory and regulatory requirements the organization continuously due to the impact or potential impact on the ability to provide;
Related parties which are relevant to the QMS,
QMS that is relevant to the terms of the relevant parties,
you must identify.
The organization, Information about the parties involved and you should review this monitor and their conditions.
4.3 determine the scope of the quality management system
The scope of the QMS the organization to create its limits, and should determine the applicability.
Determining the scope of this:
the outer and inner elements specified in 4.1,
4.2 specified in the terms of the Parties concerned
The organization's products and services
should be taken into account.
A requirement of this standard, within the specified scope if applicable, the organization must fulfill this requirement.
If any requirement of this standard will not be fulfilled; in this case, the responsibility for ensuring the availability of the organization's products and services and should not affect the ability.
Scope the following figures must be available and should be kept as dobi.
- Products and services covered by the QMS,
- A requirement of this standard is not applied in cases where the justification
4.4 quality management system and processes
The organization comply with the requirements of this standard, the required QMS processes and their interactions that include establish, implement, maintain and continually improve.
The organization should establish processes and practices within their organization needed for the QMS;and
The required inputs and expected outputs of processes,
The sequence of these processes and relationships,
Measurements and control and to ensure the effectiveness of the processes needed, including performance indicators, criteria and methods,
Needed resources and be sure of their existence,
The responsibilities and authorities for these processes the appointment of
6.1 in accordance with the conditions and the risks and opportunities of them focused on the planning and implementation of appropriate activities,
Monitoring, assessment, and, if appropriate, the processes for the evaluation of methods. If it is needed to make sure the desired results are reached, changes in processes,
Opportunities for improvement of the QMS and its processes.
you must identify.
The organization is required to support the operation of the processes to the extent that they must keep their dobi.
The processes are executed as planned to the extent that is necessary to make sure that is clear of dobi.
5.1 leadership and commitment
5.1.1 leadership and commitment to the quality management system
Top management commitment and leadership as related to the QMS;
Taking responsibility for the effectiveness of the QMS,
Created for the QMS, quality policy and quality objectives, strategic direction, and that are compatible with the scope of the organization,making sure
The quality policy is transferred within the organization, because as sure that they are understood and applied,
Integrated into business processes of the organization's QMS requirements, making sure that
By promoting awareness of the process approach,
Sure of the existence of resources needed for the QMS as
QMS the importance of effective quality management and to comply with the conditions by passing
Kys sure that that gets the desired results,as
Kys staff in contributing to the effectiveness of attracting, directing, and supporting
Continuous improvement by encouraging
To demonstrate leadership within their own areas of responsibility, supporting other relevant management roles,
it should show up.
Note: This standard is referred to in “business” in general, can be interpreted as the activities of the organization's purpose entity. Here organization; public, private, profit or non-profit may be.
5.1.2 Upper management, leadership, commitment and customer focus;
Customer requirements, and legal and regulatory requirements have been met,
Affecting its ability and suitability of products and services to increase customer satisfaction, risks, and opportunities that were filed because
Customer requirements, consistently maintained a focus on products and services that meet legal and regulatory requirements,
Focus to increase customer satisfaction maintained
5.2 quality policy
5.2.1 top management;
a) appropriate to the scope and purpose of the organization,
b) provides a framework for the creation and revision of quality objectives,
c) a commitment to meet the requirements of applicable contains
d) a commitment to continuous improvement of kys contains
establish a quality policy should continue to review:
5.2.2 quality policy:
a) must exist as dobi.
b) within the organization are communicated, understood and must be implemented.
C) and, where appropriate, in relevant part should be available.
5.3 Institutional roles, responsibilities and powers
Top management within the organization and respective roles, responsibilities and authorities, since they are forwarded and must be sure that has been understood.
Powers and responsibilities of senior management;
Kys, meets the requirements of this standard,to make sure that
To ensure that the desired outcomes of the process,
Kys performance, opportunities for improvement, change and innovation needs, particularly to report to the top management,
Is supported for customer orientation within the organization to make sure
Also when QMS changes are planned and when it is applied to the width of the QMS integrity is maintained
you must identify.
6 planning for the quality management system
6.1 risks and opportunities for activities
6.1.1 kys of at the planning stage, one should consider the conditions in the establishment clause 4.1 and 4.2. Assess risks and identify opportunities addressing the following:
Kys to give assurance that it will reach the intended results
Prevent the unwanted effects decrease
To ensure continuous improvement.
6.1.2 Organizational plan the following elements:
a) activities that focus on risks and opportunities
1) how the activities within the processes of the QMS that has been applied has been integrated and (4.4),
2) How to assess the effectiveness of these activities.
Risks and opportunities for the acquired activities should be in proportion to the potential impact on the suitability of products and services.
Note: the options for risks and opportunities may include the following: risk aversion to take the risk to pursue an opportunity to destroy the source of a risk, the likelihood or outcome of the change, share the risk, or the risk is to maintain with the decision.
6.2 quality objectives and planning to achieve goals
6.2.1 organizational function, level, establish quality objectives and processes. Quality objectives;
Must be consistent with the quality policy,
It must be measurable,
The applicable circumstances should be taken into account.
Must be related to the increase in the availability of products and services and customer satisfaction
Must be transmitted,
Should be updated when appropriate.
Dobler related to the quality goals of the organization must hide.
6.2.2 planned how the quality goals would be achieved, the organization should determine the following;
What to do
What resources would be needed,
Who would be responsible
Will be complete when
Learn how to evaluate results.
6.3 planning for the changes
When the organization determines the need for changes to the QMS (4.4), the change must be conducted in a planned and systematic manner.
The organization should consider:
a) The purpose of the change and its potential consequences
b) the integrity of kys,
c) availability of resources
d) the sharing of responsibility and authority or re-allocation.
Organization, kys creation, implementation, maintenance and continuous improvement identify the resources needed for, and must provide.
a) the adequacy of existing internal resources and constraints,
b) that what comes from outside suppliers,
you should take into consideration.
Organization; customer, statutory and regulatory requirements that can meet continuously to make sure the needs of the process, including the effective execution of kys should provide the necessary personnel for the purpose of.
Organization, the suitability of the products and services that provide the infrastructure for the execution of processes to identify, should continue to provide.
Note: The Infrastructure;
a) Services to buildings and infrastructure
b) hardware and software equipment,including
c) transportation system,
d) information and Communication Technology,
7.1.4 environment for the execution of the process
Organization, products and services, ensure compliance and establish the necessary environment for the execution of the process, should continue to provide.
Note: the process for the execution of the environment physical, social, psychological, environmental, and may include other factors (temperature, humidity, ergonomic and such as cleaning).
7.1.5 monitoring and assessment resources
Monitoring and measurement of products and services are used for evidence of conformity to determined requirements when
the organization, valid and reliable measurement and monitoring should identify the resources that are needed to be sure of the result.
Organization, resources provided; ongoing monitoring and measurement is appropriate for the specific type of activities, since the goal is always to make sure that you must be sure that appropriate care is provided.
Resources appropriate for the purpose of monitoring and measurement the organization as proof of eligibility must hide dobler.
Here measurement traceability; “legal or regulatory requirements”, “the expectation of a customer or the Party concerned”,
“as a necessary part of ensuring confidence in the validity of the measurement results is considered by the organization when” Measurement Devices;
- Should be calibrated or verified at specific intervals or prior to use (against measurement standards traceable to international or national measurement standards). In cases where such a standard exists, the source used for calibration should be kept as validation or dobi.
- To determine the state of calibration must be defined.
- Adjustments must be protected from damage or deterioration (invalidating the calibration status and measurement results).
Occur during calibration or verification or damage to the device during use, the organization should determine whether the previous measurement results are valid that have been negatively affected. The organization should perform appropriate corrective action when necessary.
7.1.6 corporate information
The organization, its processes and products should determine the suitability of the information and services necessary to ensure run.
This information within the scope necessary for sustainable and must be obtained.
Address the changing needs and trends, The organization should consider the available information and should determine how to get the necessary additional information or that he would be placed.
Note 1: corporate information, intellectual property, and may include information such as lessons learned.
Note 2: to obtain the necessary information organization;
a) internal sources (for example, information learned from success and failure projects within the organization that have not been captured and documented from the experience of local experts),
b) external resources (e.g. standards, academic documents, conferences, information that is collected from customers and suppliers).
you should take into consideration.
Affecting performance and quality should determine the necessary competence for personnel who work under their control.
Of this staff appropriate training, education or experience must be sure that sufficient in terms of.
When applicable, should be made to have the necessary competence and effectiveness of the activities for these activities should be evaluated.
Dobler must hide evidence of competence as appropriate.
Note: Applicable activities may include the following: providing training, mentoring, reassign existing staff, hire competent staff or a contract you make.
The organization is running under the control of the staff:
Relevant quality objectives,
The benefits of their contribution to improving the effectiveness of the QMS, including quality performance,
The consequences of failure to comply with the requirements of the QMS,
you should be aware of.
The QMS internal and external communications related to the organization, should establish, including the following;
What is to be communicated,
Whom will be forwarded to
How will be forwarded.
7.5 documented information
The organization's QMS;
Dobi required by this standard, determined by the effectiveness of the Organization for kys required by dobi, should include.
Note: Due to the scope of the QMS of the following dobi, may vary from one agency to another.
The size and activities of the organization, processes, products and services, the type of
The complexity of processes and relationships,
The competence of personnel.
preparation and update ,
7.5.2 Organization, prepared and updated by the dobi when you should guarantee in accordance with the following;
Characterization and identification (title, date, preparing, such as a reference number),
Format (language, software version, graphics) and media (paper, electronic),
Check for adequacy and appropriateness and review.
7.5.3 control of documented information
18.104.22.168 kys and dobi required by this standard, must be controlled to make sure of the following;
Must be current and must be suitable for use when needed.
Enough should be protected (privacy violation, improper usage, such as the degradation of the integrity).
22.214.171.124 for the control of documented information, the organization should focus on the following activities where applicable:
a) distribution, access, and usage access again,
b) involved in the protection of the league legible, storage and preservation,
c) control of changes (version control),
d) storage and retrieval.
Dobi outsourced by the organization determined the necessity for the planning and implementation of the QMS, should be defined (when possible) and should be checked.
Note: access can mean only dobi a decision on permission to see. It means that the vision may be authorized to change or fear.
8.1 Operational planning and control
Organization, in the provision of products and services meet the necessary requirements and 6.1 in the following ways in order to fulfill the activities identified in the process plan, implement and control (such as also outlined in the draft 4.4);
The determination of requirements for products and services,
Processes and determination of criteria for acceptance of products and services,
Identifying the resources needed to ensure compliance with terms of product and service,
The implementation of control processes in accordance with the criteria,
Demonstrate compliance with the conditions and processes of products and services are executed as planned to ensure the preservation of a sufficient amount of for you to have dobi.
The outcomes of this planning must be appropriate for the organization's operations.
The organization should check the results of the planned changes and unexpected changes, you should review all the activities necessary to mitigate any negative impact on it by doing.
The organization should ensure that the outsourced process is controlled in accordance with Article 8.4.
8.2 determination of terms for products and services
8.2.1 customer communication
the necessary information for the products and services,
including changes, questions, agreements, or other transactions,
to obtain customer opinions and perceptions, including Customer Complaints,
when applicable, the customer of the goods to be addressed or handled,
when appropriate, special conditions for unexpected activities
establish a process to communicate with the Customer about.
8.2.2 determination of the terms of the products and services related to
The organization to be offered to your potential customers should continue to establish and implement a process to determine the terms of the products and services.
Terms of products and services, and legal and regulatory requirements are identified,because
Taken with the ability to meet defined requirements. The products and services offered on claims (complaints) evidenced by,
you must be sure.
related to products and services
8.2.3 review of the terms of
The organization, where applicable;
Shipping and delivery, post-conditions, including the conditions specified by the customer,
Specified by the customer (the customer but the conditions required for
Legal and regulatory requirements applicable to the products and services,
The terms of the contract or order (different than before),
you should review.
Note: includes those that arise from the circumstances in which the relevant parties.
This review is from; products and services offered to the customer and the organization's commitment to the terms of the contract or order which is different from previously described are resolved to ensure that primarily focuses on.
In the case where the customer does not specify the terms in writing to the customer, the terms should be confirmed by the organization before being accepted.
Dobi describing the results of the review (for products and services, including new or changing conditions) must be maintained.
For products and services when the situation changes, relevant personnel about the organization are changed and the changed circumstances of dobi were informed about the issue to ensure that.
products and services
8.3 design and development of
The organization's products and services will be the creation of conditions is not detailed enough to provide products and services or customer or other interested parties are not defined by where; organizational design and development process appropriate education, training, and should continue.
Note 1: The Organization for the development of processes to provide products and services must implement the requirements as given in Article 8.5.
Note 2: development planning and design services to fully focus on the service delivery process. The organization, therefore, may choose to take into account the terms of substance 8.3 and 8.5.
8.3.2 design and development planning
In the determination of the design and development phases and controls the organization, you should consider the following;
Design and development activities of the nature, duration and complexity
Applicable design and development review reviews, including the terms that describe the partial stages of the process,
Design and development verification and instructing the desired current,
Located in the design and development process,responsibilities and powers
Located in the design and development process, individuals and relations between parties and the need to control
Participation in the design and development process the need for customers and user groups
Design and development of dobi required to verify that the conditions are met.
8.3.3 design and development inputs
The organization should determine the following;
Where applicable, function, and performance conditions, including the specific type of products and services that are being designed and developed the conditions required for
Applicable legal and regulatory requirements
Where application has made a commitment to the organization's standards or implementation guides,
Internal and external resources needed for the design and development of products and services,
Products and services in the nature of the potential consequences of the errors,
The expected level of control the design and development process by customers and other interested parties,
Entries for design and development purposes, sufficient, complete, and should be clear. Conflicts must be resolved between entries.
8.3.4 design and development controls
Controls applied to the design and development process, should make sure of the following;
The results obtained by the design and development activities must be clearly defined.
Design and development activities should be carried out as planned.
Design and development outputs design and development input validation should be done to make sure that it meets the requirements.
The results of the products and services specified in the application or the desired user (if known) to validate to make sure that you have the ability to meet the requirements for should be performed.
8.3.5 design and development outputs
Organizational design and development outputs;
The input requirements for design and development,
For the provision of products and services, because of the subsequent processes is enough
Where applicable, the monitoring and measurement requirements and acceptance criteria contains or referral is made
Because manufactured products or services is suitable for the purpose, because it is used safely and correctly
you must be sure.
Keep dobi organizational design and development that emerged from the process.
8.3.6 design and development changes
During the design and development of products and services, the organization, changes in input and output design review should identify and check (within the scope that does not have a negative influence on their suitability to conditions).
They kept dobi design and development changes should be.
8.4 control of outsourced products and services
Supplied from outside the organization, processes, products and services must ensure that they comply with specified requirements.
Organization, outsourced products and services when it occurs in the specified requirements for the control of the following elements is applied;
Add products and services from suppliers external to the organization's own products and services that are provided for
On behalf of the organization, from foreign suppliers for products and services that are provided directly to the customer,
As a result of the organization's decision, a process or part of a process that is provided by external suppliers.
Evaluation of suppliers external to the organization, selection, performance monitoring and re-evaluation, you must determine the criteria for and implement (according to the requirements specified process based on the ability to provide a product or service).
The organization, external suppliers evaluation, performance monitoring and re-evaluation of the results should keep their dobi appropriate.
8.4.2 control the type and scope of the external supply
Process, products and services when determining the type and scope of control to be applied to foreign suppliers, The organization should consider the following:
Supplied from the external supply process, the product and the service of the organization's customer, the potential impact on the ability to consistently meet statutory and regulatory requirements,
The perceived effectiveness of that control is implemented by external vendors.
Supplied from outside the organization, processes, products and services of the unwanted effects (affecting the ability to consistently provide products and services appropriate to the organization's customers) make sure it's not necessary to establish the validation and other activities.
To be outsourced to external suppliers (outsourcing) processes or functions, within the scope of the organization's QMS should be kept. Hence, the organization, above the “A” and “ b” items should consider the desired outcomes of their processes and external suppliers and the implementation of controls should identify.
8.4.3 External suppliers information
The following conditions can be applied for external suppliers must communicate to the organization:
Processes that are executed on behalf of the organization or products and services that are provided,
Products and services, methods, processes or equipment or the acceptance,release,
Including required qualification of personnel competency
The relationship with the organization's QMS,
Control and monitoring of the performance of external suppliers (used by the organization),
Validation conducted at the Supplier's facility by the organization or its foreign customers
The organization, external to the Supplier before forwarding adequacy of specified requirements from you must be sure
8.5 production and service provision
8.5.1 control of production and service provision
The organization, production and service provision-shipment and post delivery activities, including controlled conditions should apply.
Where applicable, include the following controlled conditions;
The availability of documented information that defines the characteristics of products and services.
Describing the activities implemented and the results obtained in the presence of dobi.
Processes and process control monitoring and measurement to verify the criteria at the appropriate stage of the outputs and activities, products and services, the acceptance criteria must be met.
Use of appropriate infrastructure and the environment and process control.
Monitoring and measuring the availability and use of appropriate resources.
Competence and, where applicable, the desired quality of staff.
In places where the output could not be verified with the monitoring and measurement; the ability of processes to provide products and services the ability to meet planned results validation (validation) periodic and again validity.
Products and services; the release of the release, thereby, the implementation of referral and post delivery activities.
8.5.2 identification and traceability
Where it is necessary to ensure the availability of products and services, the organization should use the proper ways to describe the outcomes of the process.
The organization, monitoring and measurement requirements throughout production and service delivery related to the process should identify the status of the outputs.
Where traceability is a requirement, the organization should control the unique identification of the outcomes of the process. Must maintain and dobler required to maintain traceability.
Note: ready for shipment to customer or an internal customer of the organization, the outputs of the process, which is the result of a particular activity (such as the entry of the next process) products, services, Dec, products, components, etc.
8.5.3 assets of customers and external suppliers
The organization, its control and use the assets that belong to the customer or an external supplier must maintain. The organization, its customers, from suppliers or external assets (provided for use or participate in products and services) to identify, verify, protect and keep.
The customer or the Supplier's external assets from misuse, loss, damage, or appropriate for use in case of an external supplier or customer should report this status to the organization.
Note: the presence of the customer include: materials, components, equipment, customer premises, personal data and intellectual assets.
The organization of production and service provision during the conditions necessary to maintain compliance with the scope), the process should ensure that output is maintained.
Note: the Enclosure include identification, handling, packaging, storage, transport, shipping, and protection.
8.5.5 post delivery activities
Where applicable, the organization must meet requirements for product and service, which is combined with post delivery activities.
After shipment activities that are required in determining the scope of the organization;
Compound risks with products and services,
The nature of products and services, their use and their quality of life,
Legal and regulatory requirements,
you should take into consideration.
Note: post delivery activities include; the activities under the warranty provision, contractual obligations such as maintenance services, and supplementary services such as recycling and disposal.
8.5.6 control of changes
To ensure that the organization is consistently appropriate to the specified requirements, production and unplanned changes in the scope of delivery or service is required to review and get it under control.
The results of the review of the organization changes, personal changes and any necessary actions must keep records of their authority that identifies dobi.
8.6 release of products and services
Organization meets the requirements of products and services at appropriate stages to verify that the planned arrangements should apply. Evidence of conformity with acceptance criteria must be maintained.
The release of products and services to the customer; for verification of compliance should not be made satisfactorily completed until the planned arrangements (except the relevant authority and where applicable by the customer to be accepted).
Dobi, shipped to the customer, who released products and services authorized personnel(s) must ensure the traceability of.
8.7 non-optimal process outputs, products, and services
The organization that does not comply with the terms of process, outputs, and is controlled to prevent unintended use or shipment of the products and services that are defined should ensure that.
The organization, the nature of the noncompliance and the impact on the suitability of products and services based on appropriate corrective actions you should perform.
The organization, where applicable, non-optimal process outputs, products and services should address one or more of the following paths;
Allocation, keeping them under control, receive a refund, suspend the delivery of products and services,
Authority to provide for the following;
- Use as it is,
- Release products and the provision of services or the continuation
- Conditional acceptance.
Non-optimal process outputs, products and services when it is fixed, in conformity with the conditions should be verified.
The organization, a non-optimal process outputs, products and services for the activities of the dobi must retain (obtained concessions and non-compliance and the authorities, including the person who makes the assessment).
9 performance evaluation
9.1 monitoring, measurement, analysis and evaluation
The organization should determine the following;
Monitoring and measurement needs are,find out what
Monitoring, measurement, analysis and assessment methods (where applicable, to be sure of the validity of the results),
Monitoring and measurements to be made when
The results of monitoring and measurements, will be analyzed and will be evaluated when
The organization should ensure that monitoring and measurement activities are applied according to the specified requirements. And the results as evidence of appropriate dobi you must be sure that would keep.
The organization must evaluate the effectiveness and quality of the performance of the QMS.
9.1.2 customer satisfaction
The organization must follow the conditions can be met the customer's perception towards the degree.
Organization should obtain information about the customer's opinions and ideas about products and services.
The methods for obtaining and using this information must be determined.
Note: information about the nature of the customer's vision; customer satisfaction for the study of public opinion about the quality of the products or services shipped or the customer data, the Sunday share analysis, compliments, warranty claims and dealer reports.
9.1.3 analysis and evaluation
Organization, monitoring, assessment and analyze and evaluate appropriate data and information from other sources.
The outcomes of analysis and evaluation;
Demonstrate compliance with the conditions of products and services,
To determine customer satisfaction and increase
To ensure the appropriateness and effectiveness of the QMS,
The planning process was successfully applied to indicate that
The performance of the process to determine
The performance of external suppliers to determine
Identifying the need for improvements or opportunities within the QMS
should be used.
The results of analysis and evaluation should be used as inputs for the Management Review.
9.2 Internal Audit
9.2.1 the organization of the QMS;
QMS for the organization's own terms,by
By the terms of this standard,
Effectively applied and maintained
must perform internal audit at planned intervals to provide information about.
Frequency, methods, responsibilities, planning and reporting requirements, including an audit of the program(s) planned, created, should be implemented and should be continued. During this planning, quality objectives, the importance of the associated processes, customer feedback, changes and effects on the organization should be taken into account the results of previous audits.
Audit criteria and scope for each audit should be determined.
To ensure objectivity and impartiality of the audit process, the gunmen should be selected and the tests should be performed.
The results of examinations are reported to the relevant Manager to ensure that should be taken.
Without unnecessary delays, corrections and corrective actions should be made.
The results of the application of audit and investigations of the program with evidence of documented information should be stored.
Note: see ISO 19011 for guidance
9.3 Management Review senior management
9.3.1 continuous suitability, adequacy and effectiveness to ensure you should review the organization's QMS at planned intervals to ni
Diagnosis code must be planned and performed by considering the following
Previous Management Review the activities,status,
Strategic direction, including changes in the QMS internal and external factors that are associated with
Information about quality and performance, including trends and indicators for the following;
1.Non-conformances and corrective actions,
2.Tracking and measuring results
3.The results of examinations
5.External suppliers and other interested parties with relevant topics
6.The adequacy of resources that are required to maintain an effective QMS,
7.The performance of the processes and the suitability of products and services.
By focusing on the effectiveness of activities, risks and opportunities (see Section 6.1)
New potential opportunities for continuous improvement.
9.3.2 ygg the outcomes of the decisions about the activities and should include the following:
Continuous improvement opportunities
Resource requirements, including any need for modifications to the QMS.
Organization, dobi keep as proof of the results of ygs.
Management to improve the organization and identify opportunities to meet customer requirements, and must fulfill all the activities necessary to achieve customer satisfaction.
This, where appropriate, should include the following:
a) improve processes to prevent nonconformities,
b) to meet the requirements of known and anticipated products and services,improve
c) improve the results of the QMS.
Note: Improvements; a correlated manner (corrective action), progressive (continuous improvement), punctuated by a change (a new idea), creativity (innovation), restructuring (such as conversion) occurs in such a way.
10.2 non-compliance and corrective action
10.2.1 arising from complaints, including non-compliance occurs when the organization;
a)if applicable, should be the response of non-compliance;
Check it and take action to correct it
The results should be handled.
Repeat again to assess the need for actions to eliminate the causes of noncompliance;
Non-compliance should be revised,
The reasons for the noncompliance must be determined.
Similar non-conformities (current or potential) should be determined.
Implement required activities
Made the effectiveness of corrective actions should be reviewed,
If necessary, changes should be made in the QMS.
Corrective actions, common-should be appropriate to the effects of compliance.
Note 1: In some cases, you may not be able to eliminate the cause of the noncompliance.
Note 2: corrective action, may decrease the likelihood of recurrence to an acceptable level.
a) The nature of the noncompliance and the subsequent activities of
b) The results of corrective actions,
as a proof must keep hobbies.
10.3 Continuous Improvement
The organization of the QMS suitability, adequacy and effectiveness continuous improvements in.
Analysis and evaluation Management Review organizational outcomes and outputs, are areas of low performance, whether to confirm or continuous improvement opportunities for consideration.
Where applicable, the organization; to investigate the causes of low performance and continuous improvement tools and methods that can be applied to the use and choice of support.