ISO 13485 LA flashcards

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

Medical Device File

A documented set of records for each device or device family that demonstrates conformity to ISO 13485 and applicable regulatory requirements, including design, production, and post-market information.

Objective Evidence

Records, statements of fact, or other verifiable information that can be checked and confirmed, used by auditors to evaluate conformity against audit criteria.

Major Nonconformity

A finding indicating a systemic failure, absence of a required control, or a condition that would likely result in the device not meeting requirements or regulatory obligations.

Audit Criteria

The set of requirements used as a reference against which objective evidence is compared, such as ISO 13485 clauses, regulations, and the organization's own procedures.

Process Approach

A management principle where activities are understood and managed as interrelated processes, with their inputs, outputs, sequence, and interaction defined and measured for effectiveness.

Design Transfer

The activity ensuring that design outputs are translated into production specifications and that manufacturing processes can consistently produce the device as designed.

Management Review

A planned top-management activity reviewing QMS suitability, adequacy, and effectiveness, with defined inputs such as audit results and outputs including improvement actions.

Corrective Action

Action taken to eliminate the cause of a detected nonconformity and prevent recurrence, requiring root cause analysis and verification of effectiveness.

Audit Plan

A document describing the activities and arrangements for an audit, including scope, criteria, schedule, auditor assignments, and processes to be audited.

Opening Meeting

A meeting at the start of an audit to confirm the audit plan, scope, criteria, schedule, and communication arrangements with the auditee's management.

Audit Sampling

Selecting a subset of records or activities for examination, based on risk, criticality, and volume, with the rationale documented in the audit records.

Auditor Competence

The demonstrated ability to apply knowledge, skills, and personal attributes to conduct audits, maintained through education, training, experience, and evaluation.

Nonconformity Report

A document recording a nonconformity that states the requirement, the objective evidence observed, and the specific location or record where the finding was identified.

Triangulation

Confirming a finding by gathering evidence from multiple independent sources, such as interviews, observation, and records, before concluding nonconformity.

Closing Meeting

A meeting at the end of an audit where findings and conclusions are presented to the auditee, and corrective action expectations and timelines are discussed.

Audit Report

A document recording the audit scope, criteria, findings, conclusions on conformity, and any limitations, distributed to authorized parties after the audit.

Corrective Action Verification

The process of confirming that actions taken in response to a nonconformity have been implemented and are effective in preventing recurrence.

Audit Program

A set of one or more audits planned for a specific timeframe and purpose, managed to ensure coverage of QMS processes and effective use of audit resources.

Audit Program Manager

The person responsible for establishing, implementing, monitoring, and reviewing an audit program, including resource allocation and auditor competence.

Auditor Independence

The principle that auditors must not audit their own work or have a conflict of interest, ensuring impartiality and objectivity in audit conclusions.

Documented Information

Information required to be controlled and maintained by the organization, including procedures and records, covering both creation and retention requirements.

Validation

Confirmation through objective evidence that requirements for a specific intended use or application have been fulfilled, often through testing or clinical evaluation.

Verification

Confirmation through objective evidence that specified requirements have been fulfilled, typically applied at each stage of design and production.

Risk-Based Thinking

An approach that considers risks and opportunities in planning and controlling QMS processes and product realization, linking to ISO 14971 risk management.

Supplier Evaluation

The process of assessing and selecting suppliers based on defined criteria, and monitoring their performance to ensure purchased product meets requirements.

Contamination Control

Requirements to control the work environment and personnel to prevent contamination of product, particularly important for sterile and cleanroom-manufactured devices.

Audit Scope

The extent and boundaries of an audit, including the organizational units, processes, locations, and time period covered by the audit.

Checklist Tailoring

Adapting audit checklists to the specific audit criteria, processes, and risks of the organization rather than using a generic template unchanged.

Follow-Up Audit

An audit conducted after corrective actions are implemented to verify their effectiveness, often required after major nonconformities.

Audit Conclusion

The auditor's judgment on the conformity of the audited QMS against the audit criteria, based on the objective evidence gathered during the audit.

Audit Frequency

The planned interval between audits of a process or area, determined by risk, criticality, prior results, and regulatory requirements within the audit program.

Auditor Rotation

The practice of assigning different auditors to successive audits of the same area to reduce familiarity bias and maintain objectivity.