7.1 PLANNING OF PRODUCT REALIZATION The organization needs to plan and develop the processes needed for product realization consistent with the requirements of the other processes of the QMS.
You have indicated that you do not perform product realization planning. You should have an exclusion for this in your Quality Manual.
The organization must determine, as appropriate, product quality objectives and requirements, processes and documents, resources for the product, required acceptance activities for the product (with acceptance criteria), and records needed.
The output of this planning needs to be in a form suitable for the organization’s method of operations.
7.2 CUSTOMER-RELATED PROCESSES 7.2.1 DETERMINATION OF REQUIREMENTS RELATED TO THE PRODUCT The organization needs to determine all requirements, including those specified by the customer (with delivery and post-delivery activities), not stated by the customer but necessary, statutory and regulatory, and any additional requirements considered necessary.
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Sales Procedure and
Product Requirement Review Record .
You have indicated that you do not determine requirements related to the product. You should have an exclusion for this in your Quality Manual.
7.2.2 REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT The organization needs to review the requirements prior to the commitment to supply a product to the customer (e.g., submission of tenders, acceptance of contracts or orders, acceptance of changes).
You have indicated that you do not review requirements related to the product. You should have an exclusion for this in your Quality Manual.
The review needs to ensure that product requirements are defined, differing requirements are resolved, and that the organization has the ability to meet the requirements.
Records of the results of the review and actions arising from the review must be maintained.
Where the customer provides no documented requirements, the customer requirements must be confirmed by the organization before acceptance.
Where the requirements are changed, the organization must ensure that relevant documents are amended and that relevant personnel are made aware of the changes.
7.2.3 CUSTOMER COMMUNICATION The organization needs to determine and implement effective arrangements for communicating with customers about product information, inquiries, contracts or order handling, and customer feedback.
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Registry of Customer Complaints template.
You have indicated that you do not have customer communication. You should have an exclusion for this in your Quality Manual.
7.3 DESIGN AND DEVELOPMENT 7.3.1 GENERAL An organization is required to have a procedure for design and development that should meet all the requirements of ISO 13485:2016.
You have indicated that you do not perform design work. You should have an exclusion for design and development in your Quality Manual.
7.3.2 DESIGN AND DEVELOPMENT PLANNING You have indicated that you do not perform design work. You should have an exclusion for design and development in your Quality Manual.
During the design and development planning, the organization must determine the stages, reviews, verification and validation for each stage, and responsibilities and authorities.
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Project Plan and Review .
The organization needs to manage interfaces between different groups involved in design and development, and ensure effective communication and clear assignment of responsibility.
The planning output needs to be updated, as appropriate, as the design and/or development progresses.
7.3.3 DESIGN AND DEVELOPMENT INPUTS Inputs relating to product requirements must be determined and records maintained.
These inputs need to include functional and performance requirements, statutory and regulatory requirements, information derived from previous similar designs, and other essential requirements.
The inputs need to be reviewed for adequacy and complete, unambiguous, and non-conflicting requirements.
7.3.4 DESIGN AND DEVELOPMENT OUTPUTS The outputs of design and development must be able to be verified against the inputs.
Design outputs must be approved prior to release.
Outputs need to meet the input requirements, provide purchasing, production and service information, include acceptance criteria and specify essential characteristics of the product.
7.3.5 DESIGN AND DEVELOPMENT REVIEW At appropriate stages, planned reviews of design and development need to be performed in order to evaluate that the design will meet requirements, identify any problems, and propose necessary actions.
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Design Review Minutes template.
Participants in such reviews need to include representatives of functions concerned with the design and development stage(s) being reviewed.
Records of the results of the reviews and any necessary actions must be maintained.
7.3.6 DESIGN AND DEVELOPMENT VERIFICATION Verification needs to be planned and performed to ensure the design and development outputs meet the input requirements.
Records of the results of the verification and any necessary actions must be maintained.
7.3.7 DESIGN AND DEVELOPMENT VALIDATION Design and development validation needs to be planned and performed to ensure that the resulting product is capable of meeting the requirements.
Where practicable, validation should be completed prior to the delivery or implementation of the product.
Records of the results of validation and any necessary actions must be maintained.
7.3.8 DESIGN AND DEVELOPMENT TRANSFER The organization is required to develop procedures to control design and development transfers and ensure that it can effectively control these transfers. The organization is also required to maintain records for these transfers.
The organization is required to develop procedures to control design and development transfers and ensure that it can effectively control these transfers. The organization is also required to maintain records for these transfers.
The organization is required to develop procedures to control design and development transfers and ensure that it can effectively control these transfers. The organization is also required to maintain records for these transfers.
7.3.9 CONTROL OF DESIGN AND DEVELOPMENT CHANGES Design and development changes must be identified, and records maintained.
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Change Review Record .
Changes need to be reviewed, verified and validated, and approved before implementation, including evaluation of the changes to constituent parts and product already delivered.
Records of the review of changes and any necessary actions must be maintained.
7.3.10 DESIGN AND DEVELOPMENT FILES The organization is required to maintain design and development files for each part of the design and development process. The organization is also required to keep records for the results of design and development, which should be compliant with the design requirements.
7.5 PRODUCTION AND SERVICE PROVISION 7.5.1 CONTROL OF PRODUCTION AND SERVICE PROVISION You have indicated that you do not need to control production or service provision. You should have an exclusion for this in your Quality Manual.
The controlled conditions must include availability of information that describes the product, availability of work instructions, use of equipment (including monitoring and measurement), and product release, delivery and post-delivery activities.
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Procedure for Production and Service Provision .
7.5.2 CLEANLINESS OF PRODUCT The organization is required to determine and document requirements of cleaning and contamination control for devices that are cleaned prior to sterilization, those that cannot be cleaned prior to sterilization, devices supplied as nonsterile to be cleaned before sterilization, devices supplied as nonsterile but must be cleaned when used, and process agents to be removed from product during manufacturing.
7.5.3 INSTALLATION ACTIVITIES The organization is required to establish and document medical device installation requirements and a verification requirements system. The organization is also required to maintain records for such installation activities and verification of installation services.
You have indicated that you do not need to control installation activities. You should have an exclusion for this in your Quality Manual.
7.5.4 SERVICING ACTIVITIES The organization is required to maintain a record of medical device servicing activities, and maintain records and identify improvement opportunities from servicing complaints.
You have indicated that you do not need to control servicing activities. You should have an exclusion for this in your Quality Manual.
7.5.5 PARTICULAR REQUIREMENTS FOR STERILE MEDICAL DEVICES The organization is required to maintain a record of its medical device sterilization process parameters, and maintain records for each batch.
You have indicated that you do not need to control medical devices sterilization. You should have an exclusion for this in your Quality Manual.
7.5.6 VALIDATION OF PROCESSES FOR PRODUCTION AND SERVICE PROVISION The organization needs to validate production and service provision processes where the resulting output cannot be verified later.
You have indicated that you do not need to validate processes for production or service provision. You should have an exclusion for this in your Quality Manual.
Validation must demonstrate the ability of these processes to achieve planned results.
The organization needs to establish these processes including, as applicable, criteria for review and approval, approval of equipment, qualification of personnel, methods and procedures, records and revalidation.
7.5.7 PARTICULAR REQUIREMENTS FOR VALIDATION OF PROCESSES FOR STERILIZATION AND STERILE BARRIER SYSTEMS The organization is required to develop a procedure for validation of processes for sterilization and for sterile barrier systems. Validation records should be maintained along with actions arising from those validation results.
You have indicated that you do not need to control medical devices sterilization, as it is done by some third party. You should have an exclusion for this in your Quality Manual.
7.5.8 IDENTIFICATION The organization needs to identify the product, where appropriate, by suitable means throughout product realization.
You have indicated that you do not require identification of products. You should have an exclusion for this in your Quality Manual.
The organization needs to identify the product status with respect to monitoring and measurement requirements throughout product realization.
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Record of Traceability .
Where identification is a requirement, the organization needs to control and record the unique identification of the product, and maintain records.
7.5.9 TRACEABILITY The organization needs to maintain treaceablity of the product, where appropriate, by suitable means throughout product realization.
You have indicated that you do not require traceability of products. You should have an exclusion for this in your Quality Manual.
The organization needs to maintain traceablity of the product status with respect to monitoring and measurement requirements throughout product realization.
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Record of Traceability .
Where traceability is a requirement, the organization needs to control and record the traceablity of the product, and maintain records.
7.5.10 CUSTOMER PROPERTY The organization needs to exercise care with customer property while it is under the organization’s control or being used by the organization.
You have indicated that you do not deal with customer property. You should have an exclusion for this in your Quality Manual.
The organization needs to identify, verify, protect, and safeguard customer property provided for use or incorporation into the product.
7.5.11 PRESERVATION OF PRODUCT The organization needs to preserve the product during internal processing and delivery to maintain conformity to requirements.
As applicable, this preservation needs to include identification, handling, packaging, storage, and protection for the product and its constituent parts.
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Warehousing Procedure .
7.6 CONTROL OF MONITORING AND MEASURING EQUIPMENT The organization needs to determine the monitoring and measurement to be undertaken, and the equipment needed to provide evidence of product conformity.
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List of Equipment .
You have indicated that you do not deal with monitoring and measurement equipment. You should have an exclusion for this in your Quality Manual.
The organization needs to establish processes to ensure that monitoring and measurement can be carried out consistent with the requirements.
The organization needs to assess and record the validity of the previous measurements when equipment is found out of conformance.
When equipment is not compliant, you need to take action on the equipment and affected product, and maintain records.
When used in the monitoring and measurement of requirements, the ability of computer software needs to be confirmed prior to initial use and reconfirmed as necessary.
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