Verify how the organization demonstrates the purpose and potential consequences of changes. Verify how the organization considers the integrity of the QMS. Verify how resources are made available.
Verify how responsibility and authority is allocated and reallocated. Show me how the capabilities and constraints on internal resources are considered. Show me how needs from external providers are considered. Verify how the organization provides persons necessary to consistently meet customer, applicable statutory and regulatory requirements for the QMS including the necessary processes.
Verify how the organization determines, provides and maintains the infrastructure for the operation of processes to achieve products and services conformity. Verify how the organization determines, provides and maintains the environment for the operation of processes to achieve products and service conformity. Verify how resources are determined to ensure valid and reliable monitoring and measuring results.
Verify how the organization ensures that the resources provided are suitable for the specific type of monitoring and measurement activities being undertaken and that they are maintained to ensure continued fitness of purpose.
Verify documented information that shows evidence of fitness for purpose of monitoring and measurement resources. Show me how measurement instruments are verified or calibrated at specific intervals against national or international standards.
If no standards, show me documented information which is used as the basis for calibration or verification. Show me how measurement instruments are identified. Show me how measurement instruments are safeguarded from adjustments, damage and deterioration. Verify how the organization determines the validity of previous measurements if you find an instrument to be defective during verification or calibration.
Verify any actions taken. Verify how the organization determines the necessary knowledge for the operation of processes and achieves conformity of products and services.
Verify how knowledge is maintained and made available to the extent necessary. Verify how the organization determines current knowledge and how its acquires additional knowledge when addressing changing needs and trends.
Show me how you determine competence on the basis of appropriate education, training or experience. Show me how you take actions to acquire necessary competence where applicable and how do you evaluate the effectiveness of those actions. Verify documented information as evidence of competence where appropriate. Verify documented information that shows the effectiveness of the QMS. Show me that your documented information contains appropriate identification, format language, software version, graphics, Show me how the documented information is reviewed and approved for suitability and adequacy.
Show me how you control documented information and make it available and suitable for use. Tell me how you protect your documented information. Verify how the organization controls the distribution, access, retrieval, use, storage, preservation, legibility, control of changes, retention and disposition of documented information.
Verify documented information of external origin is identified, as appropriate, and controlled. Verify how requirements for products and services are determined. Verify how criteria for processes and acceptance for products and services are determined.
Verify how resources are determined. Verify how process control is implemented. Show me documented information that demonstrates processes have been carried out as planned and can demonstrate conformity of products and services. Determine how output from the planning process is suitable for operations. Verify how planned changes are controlled. Verify how unintended changes are reviewed and what actions are taken to mitigate any adverse effects, as necessary.
Verify how outsourced processes are controlled. Verify process to determine the requirements for products and services to be offered to potential customers and how the process is established, implemented and maintained. Verify how product and service requirements including statutory and regulatory requirements are defined.
Verify that the organization has the ability to meet the defined requirements and substantiate any claims for its products and services. Verify how the organization reviews.. Show me that the review is conducted prior to the organization's commitment to supply products and services to the customer. Verify how the organization resolves differences in the contract or order requirements from those previously defined. Verify how the organization confirms customer requirements where the customer doesn't provide a documented statement.
Verify documented information of reviews describing new or changed requirements to products and services. Verify documented information of amended reviews and how relevant personnel are made aware of those changes. Verify documented information that confirms design and development requirements have been met. Verify that the inputs are complete and unambiguous. Verify documented information on design and development inputs are retained. Verify documented information of these activities are retained.
Verify documented information on design and development outputs are retained. Verify documented information on design and development changes, the result of reviews, the authorization of changes and the actions taken to prevent adverse impacts are retained.
Verify controls applied to externally provided processes, products and services when products and services are intended for incorporation into the organization's own products and services, products and services are provided directly to the customer or a process, or part of a process, is provided by an external provider as a result of a decision by the organization.
Verify how the organization determines and applies criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers.
Verify documented information of activities and actions arising from the evaluations. Verify how the organization determines controls applied to the external provision of processes, products and services and the resulting output. Verify how the organization considers the potential impact of the external provided processes, products and services on its ability to meet customer and applicable statutory and regulatory requirements. Verify the effectiveness of the controls applied by the external provider.
Verify how the organization determines the verification, or other activities, necessary to ensure the externally provided processes, products and services meet requirements.
Verify the organization communicates to external providers its requirements for.. Verify the availability and use of suitable monitoring and measuring resources.
Verify the implementation of monitoring and measuring activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met.
Verify the use of suitable infrastructure and environment for the operation of processes. Verify the appointment of competent persons, including any required qualification. Verify the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement. Verify the implementation of actions to prevent human error i.
Verify the implementation of release, delivery and post-delivery activities. How does the organization identify the status of process outputs. Verify how the organization controls the unique identification of process outputs when traceability is required. The demands of relevant interested parties. Check how the organization has learned how the ISO standard is used within the organization. If the organization has determined any of the demands of the ISO standard not to be applicable, show how conformity of products and services are not influenced by this.
Verify the QMS scope is documented. Verify scope states what products and services are comprised by the QMS and how it supports instances where demands cannot be applied.
Verify how the processes for the QMS were determined. Validate the inputs and outputs to the processes. Show how the processes have been determined and how they cooperate. Verify the criteria, methods, measurement and related performance indicators required to operate and control the processes. Verify how resources are managed and allocated. Verify how responsibilities and authorities are defined. Verify how hazards and opportunities are analysed and what efforts are taken to discuss them.
Validate the sequence and cooperation of the processes. Verify what techniques are used to control, measure and evaluate processes. Verify changes, if required, are implemented to achieve meant results. Reviewed documented information designed to maintain the operation of its processes. Leadership 2. Verify top management presents leadership and commitment by. Taking accountability for QMS effectiveness.
Communicating the importance of effective QMS and of conforming to its demands. Assuring the QMS is integrated into company's business processes. Promoting the value of the process approach and risk-based thinking. Assuring resources are accessible. Assuring intended outcomes. Engaging, directing and encouraging persons to contribute to the effectiveness of the QMS.
Promoting continuous development. Supporting other important management roles to show their leadership as it applies to their areas of responsibility. Assuring the QMS policy and objectives are built and are agreeable with the strategic direction and context of the organization. Check how top management presents leadership and commitment with respect to customer focus by assuring that.
The hazards and opportunities that affect product and service compliance and the ability to improve customer satisfaction are determined and addressed. Customer and applicable statutory and regulatory demands are determined, recognised and consistently met. The focus of enhancing customer happiness is sustained. Verify that the QMS Policy is sustained as documented information. Verify QMS Policy is communicated, understood and used within the organization.
Verify QMS Policy is accessible to relevant interested parties. Verify top management assigns responsibility and authority for.. Planning 3. Examine how hazards and opportunities are determined and addressed so the QMS can accomplish its intended results, prevent and decrease undesired consequences and achieve continual development.
Examine how operations are planned to address hazards and opportunities. Verify how actions are involved and implemented into the QMS processes. Check how the company assesses the effectiveness of the actions.
Check how actions are taken to address hazards and opportunities defined as being appropriate to the potential influence on the conformity of goods and services. Verify that the quality objectives are.. Verify objectives are written down. Verify how the company determines what will be done, with what supplies, when completed and how the results will be assessed for quality purposes. Verify how responsibility and authority are allocated and reallocated.
Verify how the company considers the integrity of the QMS. Verify how resources are made accessible. Verify how the company presents the purpose and potential results of changes. Support 4. Show how the capacities and constraints on internal resources are granted. Show how demands from external providers are considered. Verify how the company provides people required to consistently meet customers, applicable statutory and regulatory demands for the QMS including the important processes.
Verify how the company determines, provides and sustains the infrastructure for the operation of methods to achieve products and services conformity. Verify how the company determines, provides and sustains the environment for the operation of processes to achieve products and service conformity. Verify how resources are determined to ensure valid and reliable controlling and measuring results.
Verify how the company assures that the provided resources are suitable for the specific type of observing and measurement projects being offered and that they are kept to ensure remained fitness of purpose. Verify documented information that confers proof of fitness for the purpose of controlling and measurement resources.
Show how measurement instruments are validated or calibrated at specific intervals against national or international standards. If there are no standards, show documented information which is handled as the basis for calibration or verification. Show how measurement devices are identified. Show how measurement instruments are safeguarded from improvements, damage and deterioration. Verify how the company determines the validity of previous measurements if you find an instrument to be broken during verification or calibration.
Document any actions taken. Verify how the company determines the required knowledge for the operation of methods and achieves compliance of products and services. Verify how knowledge is sustained and made accessible to the extent required.
Check how the organization determines current knowledge and how it receives additional knowledge when addressing changing needs and trends. Show how you determine proficiency on the basis of relevant education, training or experience. Show how you take actions to obtain necessary competence, where suitable, and how you estimate the effectiveness of those actions. Verify documented information as confirmation of competence where relevant.
Show that your documented information includes appropriate identification, format language, software version, graphics, Show how the documented information is reviewed and accepted for appropriateness. Check if documented information of external origin is classified, as appropriate, and regulated. Show how you monitor documented information and make it accessible and suitable for use. Explain how you defend your documented information. Establish documented information demanded by the ISO standard.
Show how the company controls the distribution, admittance, retrieval, control, warehouse, preservation, intelligibility, control of changes, retention and disposal of documented information.
Operation 5. Verify how the demands for products and services are defined. Verify how criteria for methods and acceptance for products and services are defined. Explain how resources are defined.
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