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BS EN ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes > 7 Product Realization > Flashcards

7 Product Realization Flashcards

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USMLE® Step 1 flashcards
1
Q

7 Product realization
7.1 Planning of product realization

The organization shall plan and develop:

A

7.1 Planning of product realization

The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system.

The organization shall document one or more processes for risk management in product realization.
Records of risk management activities shall be maintained (see 4.2.5).

In planning product realization, the organization shall determine the following, as appropriate:

a) quality objectives and requirements for the product;
b) the need to establish processes and documents (see 4.2.4) and to provide resources specific to the product, including infrastructure and work environment;

c) required verification, validation, monitoring, measurement, inspection and test, handling, storage,
distribution and traceability activities specific to the product together with the criteria for product
acceptance;

d) records needed to provide evidence that the realization processes and resulting product meet
requirements (see 4.2.5).

The output of this planning shall be documented in a form suitable for the organization’s method of
operations.

NOTE Further information can be found in ISO 14971.

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2
Q
  1. 2 Customer-related processes
  2. 2.1 Determination of requirements related to product

The organization shall determine:

A

7.2.1 Determination of requirements related to product

The organization shall determine:

a) requirements specified by the customer, including the requirements for delivery and post-delivery
activities;

b) requirements not stated by the customer but necessary for specified or intended use, as known;
c) applicable regulatory requirements related to the product;
d) any user training needed to ensure specified performance and safe use of the medical device;
e) any additional requirements determined by the organization.

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3
Q

7.2.2 Review of requirements related to product

The organization shall review:

A

7.2.2 Review of requirements related to product

The organization shall review the requirements related to product. This review shall be conducted prior to the organization’s commitment to supply product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that:

a) product requirements are defined and documented;
b) contract or order requirements differing from those previously expressed are resolved;
c) applicable regulatory requirements are met;
d) any user training identified in accordance with 7.2.1 is available or planned to be available;
e) the organization has the ability to meet the defined requirements.

Records of the results of the review and actions arising from the review shall be maintained (see 4.2.5).

When the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.

When product requirements are changed, the organization shall ensure that relevant documents are
amended and that relevant personnel are made aware of the changed requirements.

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4
Q

7.2.3 Communication

The organization shall:

A

7.2.3 Communication

The organization shall plan and document arrangements for communicating with customers in relation to:

a) product information;
b) enquiries, contracts or order handling, including amendments;
c) customer feedback, including complaints;
d) advisory notices.

The organization shall communicate with regulatory authorities in accordance with applicable regulatory requirements.

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5
Q
  1. 3 Design and development
  2. 3.1 General

The organization shall:

A

7.3.1 General

The organization shall document procedures for design and development.

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6
Q

7.3.2 Design and development planning

The organization shall plan and control:

A

7.3.2 Design and development planning

The organization shall plan and control the design and development of product. As appropriate, design and development planning documents shall be maintained and updated as the design and development progresses.

During design and development planning, the organization shall document:

a) the design and development stages;
b) the review(s) needed at each design and development stage;

c) the verification, validation, and design transfer activities that are appropriate at each design and
development stage;

d) the responsibilities and authorities for design and development;
e) the methods to ensure traceability of design and development outputs to design and development inputs;
f) the resources needed, including necessary competence of personnel.

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7
Q

7.3.3 Design and development inputs

Inputs relating to product requirements shall be:

A

7.3.3 Design and development inputs

Inputs relating to product requirements shall be determined and records maintained (see 4.2.5). These
inputs shall include:

a) functional, performance, usability and safety requirements, according to the intended use;
b) applicable regulatory requirements and standards;
c) applicable output(s) of risk management;
d) as appropriate, information derived from previous similar designs;
e) other requirements essential for design and development of the product and processes.

These inputs shall be reviewed for adequacy and approved.

Requirements shall be complete, unambiguous, able to be verified or validated, and not in conflict with
each other.

NOTE Further information can be found in IEC 62366–1.

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8
Q

7.3.4 Design and development outputs

Design and development outputs shall:

A

7.3.4 Design and development outputs
Design and development outputs shall:

a) meet the input requirements for design and development;
b) provide appropriate information for purchasing, production and service provision;
c) contain or reference product acceptance criteria;
d) specify the characteristics of the product that are essential for its safe and proper use.

The outputs of design and development shall be in a form suitable for verification against the design and development inputs and shall be approved prior to release.

Records of the design and development outputs shall be maintained (see 4.2.5).

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9
Q

7.3.5 Design and development review

At suitable stages, systematic reviews of design and development shall:

A

7.3.5 Design and development review

At suitable stages, systematic reviews of design and development shall be performed in accordance
with planned and documented arrangements to:

a) evaluate the ability of the results of design and development to meet requirements;

b) identify and propose necessary actions.
Participants in such reviews shall include representatives of functions concerned with the design and development stage being reviewed, as well as other specialist personnel.

Records of the results of the reviews and any necessary actions shall be maintained and include the
identification of the design under review, the participants involved and the date of the review (see 4.2.5).

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10
Q

7.3.6 Design and development verification

Design and development verification shall be:

A

7.3.6 Design and development verification

Design and development verification shall be performed in accordance with planned and documented arrangements to ensure that the design and development outputs have met the design and development input requirements.

The organization shall document verification plans that include methods, acceptance criteria and, as
appropriate, statistical techniques with rationale for sample size.

If the intended use requires that the medical device be connected to, or have an interface with, other medical device(s), verification shall include confirmation that the design outputs meet design inputs when so connected or interfaced.

Records of the results and conclusions of the verification and necessary actions shall be maintained
(see 4.2.4 and 4.2.5).

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11
Q

7.3.7 Design and development validation

Design and development validation shall be:

A

7.3.7 Design and development validation

Design and development validation shall be performed in accordance with planned and documented arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use.

The organization shall document validation plans that include methods, acceptance criteria and, as appropriate, statistical techniques with rationale for sample size.

Design validation shall be conducted on representative product. Representative product includes initial production units, batches or their equivalents. The rationale for the choice of product used for validation shall be recorded (see 4.2.5).

As part of design and development validation, the organization shall perform clinical evaluations or performance evaluations of the medical device in accordance with applicable regulatory requirements.

A medical device used for clinical evaluation or performance evaluation is not considered to be released for use to the customer.

If the intended use requires that the medical device be connected to, or have an interface with, other medical device(s), validation shall include confirmation that the requirements for the specified application or intended use have been met when so connected or interfaced.
Validation shall be completed prior to release for use of the product to the customer.

Records of the results and conclusion of validation and necessary actions shall be maintained (see 4.2.4
and 4.2.5).

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12
Q

7.3.8 Design and development transfer

The organization shall:

A

7.3.8 Design and development transfer

The organization shall document procedures for transfer of design and development outputs to
manufacturing.

These procedures shall ensure that design and development outputs are verified as suitable for manufacturing before becoming final production specifications and that production capability can meet product requirements.

Results and conclusions of the transfer shall be recorded (see 4.2.5).

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13
Q

7.3.9 Control of design and development changes

The organization shall:

A

7.3.9 Control of design and development changes

The organization shall document procedures to control design and development changes. The organization shall determine the significance of the change to function, performance, usability, safety and applicable regulatory requirements for the medical device and its intended use.

Design and development changes shall be identified. Before implementation, the changes shall be:

a) reviewed;
b) verified;
c) validated, as appropriate;
d) approved.

The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product in process or already delivered, inputs or outputs of risk management and product realization processes.

Records of changes, their review and any necessary actions shall be maintained (see 4.2.5).

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14
Q

7.3.10 Design and development files

The organization shall:

A

7.3.10 Design and development files

The organization shall maintain a design and development file for each medical device type or medical device family.

This file shall include or reference records generated to demonstrate conformity to the requirements for design and development and records for design and development changes.

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15
Q
  1. 4 Purchasing
  2. 4.1 Purchasing process

The organization shall:

A

7.4.1 Purchasing process

The organization shall document procedures (see 4.2.4) to ensure that purchased product conforms to specified purchasing information.

The organization shall establish criteria for the evaluation and selection of suppliers. The criteria shall be:

a) based on the supplier’s ability to provide product that meets the organization’s requirements;
b) based on the performance of the supplier;
c) based on the effect of the purchased product on the quality of the medical device;
d) proportionate to the risk associated with the medical device.

The organization shall plan the monitoring and re-evaluation of suppliers. Supplier performance in meeting requirements for the purchased product shall be monitored. The results of the monitoring shall provide an input into the supplier re-evaluation process.

Non-fulfilment of purchasing requirements shall be addressed with the supplier proportionate to the risk associated with the purchased product and compliance with applicable regulatory requirements.

Records of the results of evaluation, selection, monitoring and re-evaluation of supplier capability or performance and any necessary actions arising from these activities shall be maintained (see 4.2.5).

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16
Q

7.4.2 Purchasing information

Purchasing information shall:

A

7.4.2 Purchasing information

Purchasing information shall describe or reference the product to be purchased, including as appropriate:

a) product specifications;
b) requirements for product acceptance, procedures, processes and equipment;
c) requirements for qualification of supplier personnel;

d) quality management system requirements.
The organization shall ensure the adequacy of specified purchasing requirements prior to their
communication to the supplier.

Purchasing information shall include, as applicable, a written agreement that the supplier notify the organization of changes in the purchased product prior to implementation of any changes that affect the ability of the purchased product to meet specified purchase requirements.

To the extent required for traceability given in 7.5.9, the organization shall maintain relevant purchasing information in the form of documents (see 4.2.4) and records (see 4.2.5).

17
Q

7.4.3 Verification of purchased product

The organization shall:

A

7.4.3 Verification of purchased product

The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchasing requirements. The extent of verification activities shall be based on the supplier evaluation results and proportionate to the risks associated with the purchased product.

When the organization becomes aware of any changes to the purchased product, the organization shall determine whether these changes affect the product realization process or the medical device.

When the organization or its customer intends to perform verification at the supplier’s premises, the organization shall state the intended verification activities and method of product release in the purchasing information.

Records of the verification shall be maintained (see 4.2.5).

18
Q
  1. 5 Production and service provision
  2. 5.1 Control of production and service provision

Production and service provision shall:

A

7.5.1 Control of production and service provision

Production and service provision shall be planned, carried out, monitored and controlled to ensure that product conforms to specification.

As appropriate, production controls shall include but are not limited to:

a) documentation of procedures and methods for the control of production (see 4.2.4);
b) qualification of infrastructure;
c) implementation of monitoring and measurement of process parameters and product characteristics;
d) availability and use of monitoring and measuring equipment;
e) implementation of defined operations for labelling and packaging;
f) implementation of product release, delivery and post-delivery activities.

The organization shall establish and maintain a record (see 4.2.5) for each medical device or batch of medical devices that provides traceability to the extent specified in 7.5.9 and identifies the amount manufactured and amount approved for distribution.

The record shall be verified and approved.

19
Q

7.5.2 Cleanliness of product

The organization shall document requirements for:

A

7.5.2 Cleanliness of product

The organization shall document requirements for cleanliness of product or contamination control of
product if:

a) product is cleaned by the organization prior to sterilization or its use;

b) product is supplied non-sterile and is to be subjected to a cleaning process prior to sterilization or
its use;

c) product cannot be cleaned prior to sterilization or its use, and its cleanliness is of significance in use;
d) product is supplied to be used non-sterile, and its cleanliness is of significance in use;
e) process agents are to be removed from product during manufacture.

If product is cleaned in accordance with a) or b) above, the requirements contained in 6.4.1 do not apply
prior to the cleaning process.

20
Q

7.5.3 Installation activities

The organization shall document:

A

7.5.3 Installation activities

The organization shall document requirements for medical device installation and acceptance criteria for verification of installation, as appropriate.

If the agreed customer requirements allow installation of the medical device to be performed by an external party other than the organization or its supplier, the organization shall provide documented requirements for medical device installation and verification of installation.

Records of medical device installation and verification of installation performed by the organization or its supplier shall be maintained (see 4.2.5).

21
Q

7.5.4 Servicing activities

If servicing of the medical device is a specified requirement, the organization shall:

A

7.5.4 Servicing activities

If servicing of the medical device is a specified requirement, the organization shall document servicing procedures, reference materials, and reference measurements, as necessary, for performing servicing activities and verifying that product requirements are met.

The organization shall analyse records of servicing activities carried out by the organization or its supplier:

a) to determine if the information is to be handled as a complaint;
b) as appropriate, for input to the improvement process.

Records of servicing activities carried out by the organization or its supplier shall be maintained (see 4.2.5).

22
Q

7.5.5 Particular requirements for sterile medical devices

The organization shall

A

7.5.5 Particular requirements for sterile medical devices

The organization shall maintain records of the sterilization process parameters used for each sterilization batch (see 4.2.5).

Sterilization records shall be traceable to each production batch of medical devices.

23
Q

7.5.6 Validation of processes for production and service provision

The organization shall:

A

7.5.6 Validation of processes for production and service provision

The organization shall validate any processes for production and service provision where the resulting output cannot be or is not verified by subsequent monitoring or measurement and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.

Validation shall demonstrate the ability of these processes to achieve planned results consistently.

The organization shall document procedures for validation of processes, including:

a) defined criteria for review and approval of the processes;
b) equipment qualification and qualification of personnel;
c) use of specific methods, procedures and acceptance criteria;
d) as appropriate, statistical techniques with rationale for sample sizes;
e) requirements for records (see 4.2.5);
f) revalidation, including criteria for revalidation;
g) approval of changes to the processes.

The organization shall document procedures for the validation of the application of computer software used in production and service provision. Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application.

The specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software, including the effect on the ability of the product to conform to specifications.

Records of the results and conclusion of validation and necessary actions from the validation shall be maintained (see 4.2.4 and 4.2.5).

24
Q

7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems

The organization shall:

A

7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems

The organization shall document procedures (see 4.2.4) for the validation of processes for sterilization
and sterile barrier systems.

Processes for sterilization and sterile barrier systems shall be validated prior to implementation and following product or process changes, as appropriate.

Records of the results and, conclusion of validation and necessary actions from the validation shall be
maintained (see 4.2.4 and 4.2.5).

NOTE Further information can be found in ISO 11607-1 and ISO 11607-2.

25
Q

7.5.8 Identification

The organization shall document:

A

7.5.8 Identification

The organization shall document procedures for product identification and identify product by suitable means throughout product realization.

The organization shall identify product status with respect to monitoring and measurement requirements throughout product realization.

Identification of product status shall be maintained throughout production, storage, installation and servicing of product to ensure that only product that has passed the required inspections and tests or released under an authorized concession is dispatched, used or installed.

If required by applicable regulatory requirements, the organization shall document a system to assign unique device identification to the medical device.

The organization shall document procedures to ensure that medical devices returned to the organization are identified and distinguished from conforming product.

26
Q
  1. 5.9 Traceability
  2. 5.9.1 General

The organization shall:

A

7.5.9.1 General

The organization shall document procedures for traceability. These procedures shall define the extent of traceability in accordance with applicable regulatory requirements and the records to be maintained (see 4.2.5).

27
Q

7.5.9.2 Particular requirements for implantable medical devices

The records required for traceability shall:

A

7.5.9.2 Particular requirements for implantable medical devices

The records required for traceability shall include records of components, materials, and conditions for the work environment used, if these could cause the medical device not to satisfy its specified safety and performance requirements.

The organization shall require that suppliers of distribution services or distributors maintain records of the distribution of medical devices to allow traceability and that these records are available for inspection.

Records of the name and address of the shipping package consignee shall be maintained (see 4.2.5).

28
Q

7.5.10 Customer property

The organization shall:

A

7.5.10 Customer property

The organization shall identify, verify, protect, and safeguard customer property provided for use or incorporation into the product while it is under the organization’s control or being used by the organization.

If any customer property is lost, damaged or otherwise found to be unsuitable for use, the organization shall report this to the customer and maintain records (see 4.2.5).

29
Q

7.5.11 Preservation of product

The organization shall:

A

7.5.11 Preservation of product

The organization shall document procedures for preserving the conformity of product to requirements during processing, storage, handling, and distribution.

Preservation shall apply to the constituent parts of a medical device.

The organization shall protect product from alteration, contamination or damage when exposed to expected conditions and hazards during processing, storage, handling, and distribution by:

a) designing and constructing suitable packaging and shipping containers;
b) documenting requirements for special conditions needed if packaging alone cannot provide preservation.

If special conditions are required, they shall be controlled and recorded (see 4.2.5).

30
Q

7.6 Control of monitoring and measuring equipment

The organization shall:

A

7.6 Control of monitoring and measuring equipment

The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements.

The organization shall document procedures to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.

As necessary to ensure valid results, measuring equipment shall:

a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards: when no such standards exist, the basis used for calibration or verification shall be recorded (see 4.2.5);
b) Be adjusted or re-adjusted as necessary: such adjustments or re-adjustments shall be recorded (see 4.2.5);
c) have identification in order to determine its calibration status;
d) be safeguarded from adjustments that would invalidate the measurement result;
e) be protected from damage and deterioration during handling, maintenance and storage.

The organization shall perform calibration or verification in accordance with documented procedures.

In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements.

The organization shall take appropriate action in regard to the equipment and any product affected.

Records of the results of calibration and verification shall be maintained (see 4.2.5).

The organization shall document procedures for the validation of the application of computer software used for the monitoring and measurement of requirements.

Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application.

The specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software, including the effect on the ability of the product to conform to specifications.

Records of the results and conclusion of validation and necessary actions from the validation shall be maintained (see 4.2.4 and 4.2.5).
NOTE Further information can be found in ISO 10012.

BS EN ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes (6 decks)

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