PECB ISO 13485 Foundation flashcards

32 cards. Read the term and the definition here. The deck at the top of this page is optional.

Scope of ISO 13485

It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Process approach

The systematic identification of processes needed for the QMS, determination of their sequence and interaction, and the application of criteria, methods, resources and monitoring to control and improve them.

Risk-based approach

Decision rules and control levels are chosen according to the risk associated with the device and process; higher risk leads to more stringent supplier, validation and monitoring controls, not to a different standard.

Quality management representative

A member of management appointed by top management who, irrespective of other responsibilities, has authority and responsibility for ensuring processes needed for the QMS are established, implemented and maintained, and for reporting on QMS performance.

Quality manual

A document stating the scope of the QMS including justification for any exclusion or non-applicability, the documented procedures or references to them, and a description of the interaction between QMS processes.

Documented procedure

A procedure that is established, documented, implemented and maintained in written or electronic form, and is required by the standard for specific activities such as document control, records control, internal audit and corrective action.

Record retention period

Records are retained for at least the lifetime of the device as defined by the organization and not less than two years from the date of product release by the organization, or as specified by regulatory requirements.

Document control requirements

Documents are reviewed and approved before issue, reviewed and updated as needed, changes identified, current versions available at points of use, legible and identifiable, and obsolete documents prevented from unintended use.

Quality objective

A measurable requirement for quality that is consistent with the quality policy, established at relevant functions and levels, and monitored; it is a management review input and a target for process measurement.

Major nonconformity

A failure to fulfil a requirement that would result in the QMS not achieving its intended result, or a significant doubt about the effectiveness of a process or the conformity of product.

Minor nonconformity

An isolated or non-systemic lapse in fulfilling a requirement that does not indicate a failure of the QMS to achieve its intended result and does not create significant doubt about product conformity.

Adverse event

An event that caused or could have caused harm to a patient or user; it is captured through complaint handling and post-market surveillance and feeds risk management and regulatory reporting decisions.

PDCA cycle

Plan, Do, Check, Act: a repeating cycle in which requirements and objectives are planned, processes implemented, results monitored and measured, and actions taken to improve performance.

Medical device definition

A product used for diagnosis, prevention, monitoring, treatment or alleviation of disease or injury, whose principal intended action is not achieved by pharmacological, immunological or metabolic means.

Management review inputs

Inputs include feedback, complaint handling, regulatory reporting, audits, process monitoring, corrective and preventive actions, follow-up from previous reviews, QMS changes, and new or revised regulatory requirements.

Management review outputs

Outputs are decisions and actions related to improvement of the QMS and its processes, improvement of product relative to customer requirements, and the provision of resources needed.

Competence evidence

Records of education, training, skills and experience are maintained for personnel performing work affecting product quality, and the effectiveness of actions taken to achieve the necessary competence is evaluated.

Design and development inputs

Requirements for the device including functional, performance, usability and safety requirements, applicable statutory and regulatory requirements, and information derived from previous similar designs, all reviewed for adequacy and completeness.

Design verification

Confirmation by objective evidence that design and development outputs have met the design and development input requirements; it is performed according to planned arrangements and results are recorded.

Design validation

Confirmation by objective evidence that the device, as designed, meets the requirements for its specified intended use, typically involving evaluation with representative product and, where appropriate, clinical evaluation.

Design transfer

The documented activity confirming that design and development outputs are suitable for becoming part of the organization's product realization processes before the design is released for production.

Supplier evaluation criteria

Criteria for selection and evaluation of suppliers are documented and proportionate to the risk of the purchased product and its effect on device quality; suppliers are monitored and re-evaluated.

Purchased product verification

The organization establishes and implements inspection or other activities necessary to ensure purchased product meets specified purchase requirements, with the extent of verification based on risk.

Process validation

Documented confirmation that a process consistently produces output meeting planned results, required where output cannot be verified by subsequent monitoring or measurement, with revalidation triggered by changes.

Product traceability

Documented procedures for identification and traceability; records are maintained for implantable devices and, where required by applicable regulation, for other devices, linking product to batch and distribution.

Sterilization process records

Records of the parameters used for the sterilization process for each batch must be traceable to each production batch of medical devices, supporting release decisions and post-market investigations.

Nonconforming product control

Documented procedure for identification, segregation, evaluation, disposition and notification of nonconforming product, including notification to the customer and, where applicable, to regulatory authorities before delivery.

Corrective action

Action taken to eliminate the cause of a detected nonconformity and prevent recurrence, including investigation, determination of causes, evaluation of the need for action, and review of the effectiveness of action taken.

Preventive action

Action taken to eliminate the cause of a potential nonconformity to prevent its occurrence; the procedure defines requirements for investigating potential causes and reviewing the effectiveness of the action.

Internal audit independence

Auditors do not audit their own work; audits are planned considering process status, importance and previous results, and records of audit and results are maintained with follow-up on actions.

Complaint handling

A documented process for timely handling of complaints, including investigation and determination of whether the complaint relates to a possible adverse event that must be reported to regulatory authorities.

Monitoring and measurement of product

Product is monitored and measured at appropriate stages of realization against acceptance criteria; records identify the person authorizing release, and release is not made until planned arrangements are completed.