The organization shall plan and develop the processes required for product realization. The planning for product realization shall be consistent with the requirements of other processes in the quality management system.
The organization shall document one or more processes for risk management during product realization. Records of risk management activities shall be maintained (see 4.2.5).
In planning for product realization, where appropriate, the organization shall identify the following:
a) the quality objectives and requirements for the product;
b) the need to establish the processes, documentation (see 4.2.4), and provision of resources for the product, including the infrastructure and the work environment;
c) the validation, verification, surveillance, measurement, inspection and testing, disposition, and disposal of the product required for the product.
The output of this planning should be documented in a form appropriate to the way the organization operates.
Note: See ISO 14971 for more information.
The organization shall identify:
a) Customer-specified requirements, including requirements for delivery and post-delivery activities;
b) Requirements that, although not explicitly stated by the customer, are necessary for a specified use or a known intended use;
c) Applicable regulatory requirements related to the product;
d) Any user training necessary to ensure the specific performance and safe use of the medical device;
e) Any additional requirements identified by the organization.
The organization shall review the requirements related to the product. The review shall be conducted prior to the organization's commitment to provide the product to the customer (e.g., submission of a bid, acceptance of a contract or order, and acceptance of changes to a contract or order) and shall ensure that:
a) the product requirements have been specified and documented;
b) contractual or order requirements that are inconsistent with the previous formulation have been resolved;
c) applicable regulatory requirements have been met;
d) any additional requirements have been met in accordance with the organization's policy;
The organization shall review the product-related requirements. p>
d) any user training identified in accordance with 7.2.1 is available or scheduled to be available;
e) the organization is capable of meeting the specified requirements.
A record of the results of the review and the actions resulting from the review shall be maintained (see 4.2.5).
If the customer does not provide documented requirements, the organization shall confirm the customer requirements before accepting them.
If the product requirements change, the organization shall ensure that the relevant documentation is modified and that appropriate personnel are aware of the changed requirements.
The organization should plan and document arrangements for communicating with customers about:
a) product information;
b) handling of inquiries, contracts, or orders, including changes;
c) customer feedback, including complaints;
d) advisory notices.
The organization shall communicate with regulators in accordance with applicable regulatory requirements.
The organization shall document the design and development process.
The organization should plan and control the design and development of the product. Where appropriate, design and development planning documentation should be maintained and updated as design and development progresses.
During design and development planning, the organization should document:
a) the phases of design and development;
b) the review or reviews required for each phase of design and development;
c) verification, validation, and design transition activities appropriate to each phase of design and development;
d) design and development responsibilities and authorities;
e) a method for ensuring traceability of design and development outputs to design and development inputs;
f) required resources, including necessary personnel capabilities.
Inputs related to product requirements shall be identified and records maintained (see 4.2.5), and shall include:
a) Functionality, performance, usability, and safety requirements based on the intended use;
b) Applicable regulatory requirements and standards;
c) One or more outputs of applicable risk management;
d ) where appropriate, information derived from previous similar designs;
e) other requirements necessary for the design and development of products and processes.
These inputs should be reviewed to ensure that they are adequate and appropriate, and approved.
These requirements should be complete, clear, able to be verified or validated, well and not contradictory.
Note: See IEC 62366-1 for more information.
The design and development outputs shall:
a) satisfy the requirements of the design and development inputs;
b) give appropriate information on sourcing, production, and service delivery;
c) include or refer to the product acceptance criteria;
d) specify the product characteristics that are essential for the safety and proper use of the product. is necessary for the safe and proper use of the product,
Design and development outputs shall be in a manner suitable for validation against design and development inputs, and design and development outputs shall be approved prior to release.
Records of design and development outputs should be maintained (see 4.2.5),
Systematic reviews of design and development should be carried out at appropriate stages in accordance with the documented arrangements for the planned well to:
a) Evaluate the ability of the results of the design and development to meet the requirements:
b) Identify and propose the necessary measures.
Participants in the review should include representatives of functions related to the design and development phase under review, as well as other professionals.
A record of the results of the review and any necessary measures shall be maintained, including the design reviewed, the participants involved, and the date of the review (see 4.2.5).
To ensure that the design and development outputs meet the requirements of the design and development inputs, the design and development shall be validated against the planned and documented arrangements.
The organization should document a validation plan that includes the methodology, acceptance criteria, and, if appropriate, statistical techniques that incorporate sample size rationale.
If the intended use requires the medical device to be connected to, or interfaced with, one or more other medical devices, validation should include confirmation that the design output meets the requirements of the design input when so connected or interfaced,
Records of the results and conclusions of the validation and the necessary measures should be maintained (see 4.2.4 and 4.2.5).
To ensure that the product meets the requirements of the specified application or intended use, the design and development shall be validated in accordance with the documented arrangements for planning wells.
The organization should document a validation plan that includes the methodology, acceptance criteria, and, where appropriate, statistical techniques that incorporate sample size principles.
Design validation should be performed on representative products. Representative products include the initial production unit, lot, or its equivalent. A rationale for the product selection used for validation shall be documented (see 4.2.5).
As part of the design and development validation, the organization shall conduct a clinical evaluation or performance evaluation of the medical device in accordance with applicable regulatory requirements. A medical device used for clinical evaluation or performance evaluation is not considered released for customer use.
If the intended use requires the medical device to be connected to, or interfaced with, one or more other medical devices, the validation should include confirmation that the specified application or intended use has been met when so connected or interfaced.
Confirmation should be completed prior to releasing the product to the customer for use.
A record of the results and conclusions of the validation and the necessary measures shall be maintained (see 4.2.4 and 4.2.5).
The organization shall document procedures for transferring design and development outputs to manufacturing. These procedures shall ensure that the design and development outputs are validated as suitable for manufacturing before they become final production specifications and that the manufacturing capabilities meet the product requirements.
The results and conclusions of the conversion shall be documented (4.2.5).
The organization shall document procedures for controlling design and development changes. The organization should determine the importance of changes to the function, performance, and usability of the medical device, its safety, applicable regulatory requirements, and its intended use.
Design and development changes should be identified, and changes should be subject to:
a) Review:
b) Validation;
c) Confirmation, if appropriate;
d) Approval,
The review of design and development changes should include an evaluation of the impact of the changes on the in-process or delivered components and products, and the risk management of inputs or outputs and products. risk management inputs or outputs and the product realization process.
A record of the changes, their review, and any necessary actions shall be maintained (see 4.2.5).
The organization shall maintain design and development documentation for each medical device type or medical device family. This documentation shall contain or reference records developed to demonstrate compliance with design and development requirements, and it shall also contain records of design and development changes.
The organization shall document procedures to ensure that products purchased comply with the required procurement information (see 4.2.4).
The organization shall establish guidelines for evaluating and selecting suppliers, and the criteria shall:
a) be based on the supplier's ability to provide products that meet the organization's requirements;
b) be based on the supplier's performance;
c) be based on the impact of the purchased product on the quality of the medical device;
d) be commensurate with the risks associated with the medical device.
The organization should plan for supplier surveillance and re-evaluation. The performance of the supplier in meeting the requirements of the purchased product should be monitored. The results of this monitoring should provide input to the supplier re-evaluation process.
Disposition of suppliers that do not fulfill the requirements of the procurement should be appropriate to the risks associated with the product being procured and in accordance with applicable regulatory requirements.
Records shall be maintained of the results of evaluation, selection, surveillance, and reevaluation of supplier capability or performance and any necessary measures resulting from these activities (see 4.2.5).
Purchasing information for the product to be purchased shall be expressed or referenced and include, where appropriate:
a) product specifications;
b) product acceptance, procedure, process, and equipment requirements;
c) supplier personnel qualification requirements;
d) quality management system requirements.
The organization shall ensure that the procurement requirements specified prior to communication with the supplier are adequate and appropriate.
Where applicable, the procurement information shall include a written agreement that specifies that the Supplier shall notify the organization of changes in the Procured Products prior to the implementation of any changes affecting the ability of the Procured Products to meet the specified procurement requirements.
In accordance with the scope and extent of the traceability requirements specified in 7.5.9, the organization shall maintain relevant procurement information in the form of documents (see 4.2.4) and records (see 4.2.5).
The organization shall establish and implement validation or other activities necessary to ensure that the purchased product meets the specified procurement requirements. The scope of validation activities should be based on the results of supplier evaluations and appropriate to the risks associated with the procured product.
If the organization becomes aware of any changes to the purchased product, the organization should determine whether these changes affect the product realization process or the final product of the medical device.
If the organization or its customer intends to perform validation at the supplier's site, the organization should specify the activities to be validated and the method of product release in the procurement information.
Records of validation shall be maintained (see 4.2.5).
Production and service delivery shall be planned, implemented, monitored and controlled to ensure that the product conforms to the specification. Where appropriate, production control shall include, but not be limited to:
a) Documentation of production control procedures and control methods (see 4.2.4);
b) Infrastructure qualification;
c) Implementation of monitoring and measurement of process parameters and product characteristics;
d) Acquisition and use of monitoring and measurement equipment;
e) Implementation of required operations for labeling and packaging;
f) Implementation of required operations for the production and service delivery of products;
g) Implementation of the following
f) Implementing product release, delivery and post-delivery activities.
The organization shall establish and maintain a record (see 4.2.5) for each unit or batch of medical devices that provides information on the scope and extent of traceability and identifies the quantity manufactured and the quantity approved for sale, as specified in 7.5.9, which shall be verified and approved.
The organization shall document the cleaning or contamination control requirements for a product when:
a) the product is cleaned by the organization prior to sterilization or use;
b) the product is supplied in a non-sterile form and cleaning is required prior to sterilization or use;
c) the product is not capable of being cleaned prior to sterilization or use, and its cleanliness when used
d) the product is supplied in a non-sterile form for use where cleanliness is essential for use;
e) process additives are removed from the product during the manufacturing process.
If the product is cleaned in accordance with a) or b) above, the requirements contained in 6.4.1 do not apply to the process prior to cleaning treatment.
When appropriate, the organization shall document the medical device installation requirements and installation validation acceptance guidelines.
The organization shall provide documented requirements for medical device installation and installation validation if the agreed customer requirements allow for the installation of medical devices by external parties other than the organization or its suppliers.
Records of medical device installation and installation validation performed by the organization or its suppliers shall be maintained (see 4.2.5).
If there are defined requirements for medical device service, the organization shall document the service procedures, the materials involved, and the measurements involved, if necessary, for use in performing the service activities and verifying that the product requirements are met.
The organization shall analyze records of service activities performed by the organization or its suppliers:
a) to determine if the information is to be disposed of as a complaint;
b) when appropriate, to form inputs for the improvement process.
Records of service activities performed by the organization or its suppliers should be maintained (see 4.2.5).
The organization shall maintain records of sterilization process parameters for each sterilization lot (see 4.2.5). Sterilization records should be traceable to each production lot of the medical device.
The organization shall validate any production and service delivery process when the output of the process cannot or is not verified by subsequent monitoring or measurement, and therefore makes the problem apparent only after the product has been used or the service has been delivered.
The validation should confirm that the processes have the ability to consistently achieve the planned results.
The organization shall document a process validation procedure that includes:
a) Guidelines specified for the review and approval of the process;
b) Equipment qualification and personnel qualification;
c) Use of specific methodologies, procedures, and acceptance criteria;
d) Statistical techniques that incorporate sample size rationale, where appropriate;
e) Documentation of records. >
e) Recordkeeping requirements (see 4.2.5);
f) Revalidation, including guidelines for revalidation;
g) Approval of process changes.
The organization shall document procedures for validating computer software applications used for production and service delivery. Such software applications shall be validated prior to initial use and, where appropriate, after changes to such software or its applications. Specific methods and activities related to software validation and revalidation should be appropriate to the risks associated with the use of the software, including the impact on the ability of the product to conform to the specification.
Records shall be maintained of the results and conclusions of validation and the measures necessary for validation (see 4.2.4 and 4.2.5).
The organization should document procedures for validation of the sterilization process and sterile barrier system (see 4.2.4).
Sterilization processes and sterile barrier systems should be validated prior to implementation and, where appropriate, prior to implementation of subsequent product or process changes.
Records of the results and conclusions of the validation and the necessary measures taken for validation should be maintained (see 4.2.4 and 4.2.5).
Note: See ISO11607-1 and ISO11607-2 for more information.
The organization shall document the product identification procedure, well identify the product using appropriate methods throughout the product realization.
The organization shall identify the state of the product throughout product realization in accordance with monitoring and measurement requirements, and shall maintain the identification of the state of the product throughout the production, storage, installation, and service of the product to ensure that only products that have passed the required inspections and tests, or that have been released with an authorized release, are dispatched, used, or installed.
If required by applicable regulations, the organization shall document a system for assigning unique device identifiers to medical devices.
The organization shall establish and document procedures to ensure that medical devices returned to the organization can be identified and distinguished from qualified products.
The organization should document traceability procedures. These procedures should specify the country and extent of traceability and the records to be maintained in accordance with applicable regulatory requirements (see 4.2.5).
Where factors such as components, materials, and working environmental conditions used may cause a medical device to fail to meet its specified safety and performance requirements, the records required for traceability should include records of these relevant factors.
The organization should require the supplier or distributor providing distribution services to maintain records of the distribution of medical devices for traceability purposes, and to have access to these records if required for inspection.
Records shall be maintained of the name and address of the recipient of the shipment package (see 4.2.5),
Where customer property is under the control of, or used by, the organization, customer property used by the organization or forming part of the product shall be identified, verified, protected and guarded by the organization. If any customer property is lost, damaged, or found to be unsuitable, the organization falsely reports it to the customer and maintains records (see 4.2.5).
During the processing, storage, disposal, and distribution of the product, the organization shall document procedures for providing protection for product compliance, and the protection shall apply to the components of the medical device.
During the processing, storage, disposal, and distribution of the product, when exposed to anticipated conditions and hazards (sources). The organization shall protect the product from change, contamination, or damage by:
a) designing and fabricating appropriate packaging and shipping crates;
b) if the packaging does not provide protection by itself, documenting the requirements for the special conditions needed,
and, if special conditions are required, they shall be controlled and documented (see 4.2.5).
The organization shall identify the monitoring and measurement to be performed and the monitoring and measurement equipment required to provide evidence that the product meets the identified requirements.
The organization shall establish and document procedures to ensure that monitoring and measurement activities are feasible and performed in a manner consistent with the monitoring and measurement requirements.
To ensure that results are valid, measurement equipment shall, where necessary:
a) be calibrated and/or verified against measurement standards traceable to international or national standards at specified intervals or prior to use, and the basis for the calibration or verification shall be documented when the said standards do not exist (see 4.2.5);
b) be adjusted or re-adjusted, where necessary: this adjustment or re-adjustment (see 4.2.5) shall be documented. (b) be adjusted or readjusted if necessary: such adjustment or readjustment shall be documented (see 4.5)
c) be marked to identify its calibration status;
d) be protected against invalidation of measurements as a result of the adjustment;
e) be protected against damage and degradation during placement, maintenance and storage.
The organization shall perform the calibration or verification in accordance with documented procedures.
In addition, when equipment is found to be non-compliant, the organization shall evaluate and document the validity of previous measurements, and the organization shall take appropriate action with respect to the equipment and any affected products.
A record of the calibration test (verification) results should be maintained (see 4.2.5).
The organization shall document procedures for the validation of computer software applications used for monitoring and measurement requirements. Such software applications shall be validated prior to initial use and, where appropriate, after changes are made to the software or its applications. Specific methods and activities for validation and revalidation of the software shall be appropriate to the risks associated with the use of the software, including the impact on the ability of the product to comply with the specification.
A record of the results and conclusions of the validation and the measures necessary for validation shall be maintained as described in (4.2.4 and 4.2.5).
Note: For more information see: ISO 10012.