ISO 13485 LI flashcards

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

ISO 13485

International standard specifying requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices that consistently meet customer and applicable regulatory requirements.

Applicable regulatory requirements

The national and regional laws and regulations governing the device in each market where it is placed; the QMS must identify and meet them, and they take precedence over the standard where they conflict.

Documented information

The standard's umbrella term covering both documents, which state requirements or arrangements and can be revised, and records, which provide evidence of results and must not be altered.

Validation

Confirmation, through objective evidence, that requirements for a specific intended use or application have been fulfilled; used where output cannot be verified by later monitoring or measurement.

Verification

Confirmation, through objective evidence, that specified requirements have been met; applied to design outputs, purchased product and product at defined stages of realization.

Risk-based approach

The principle that the QMS and its processes are planned and controlled in proportion to risk, linking risk management outputs to design, purchasing, production and corrective action.

Quality manual requirement

Clause 4.2.1 requires documented information stating the QMS scope, justification for any exclusion or non-application, the processes and their interaction, and the document structure.

Permitted exclusions

Only clause 6.4.1 contamination control and clause 7.5.5 sterile barrier systems may be excluded, and only when not applicable to the activities undertaken; the justification must be recorded.

Management representative

A member of management with defined authority to ensure QMS processes are established and maintained, report on QMS performance, and promote awareness of regulatory and customer requirements.

Management review inputs

Clause 5.6 inputs include feedback, complaint handling, regulatory reporting, audits, process monitoring, corrective and preventive actions, follow-up actions, changes, and new or revised regulatory requirements.

Traceability requirement

Clause 7.5.9 requires a documented procedure and records to trace devices to their batch or serial number and to distribution, mandatory for implantable devices and where regulations require it.

Product preservation

Clause 7.5.11 requires identification, handling, packaging, storage and protection of product to maintain conformity with requirements during internal processing and delivery to the intended destination.

Scope definition

The first planning step: identify device families, lifecycle activities performed and target markets, since these determine which clauses apply and which may be excluded.

Gap analysis

A clause-by-clause comparison of current documents, processes and records against ISO 13485, producing a rated list of gaps that becomes the input to the implementation plan.

Document architecture

The tiered structure of quality manual, procedures, work instructions and specifications, and records, each with an owner, review cycle and link to the clause it satisfies.

Implementation sequencing

A workable order is scope and gap analysis, management commitment and planning, document architecture, process rollout, internal audit, management review, then certification audit.

Competence planning

Clause 6.2 requires determining education, training, skills and experience for personnel affecting product quality, evaluating competence, and keeping records of that evaluation.

Audit programme planning

Scheduling internal audits and management reviews early enough that completed cycles and records exist before the certification body's Stage 2 audit.

Design controls

Clause 7.3 requires design inputs, outputs, review, verification, validation, transfer, change control and a design history file containing the records of these activities.

Supplier evaluation

Clause 7.4 requires evaluating and selecting suppliers on their ability to meet requirements, defining purchasing information, verifying purchased product, and monitoring supplier performance.

Process validation

Clause 7.5.6 requires validating processes whose output cannot be verified by later monitoring or measurement, with defined revalidation criteria and records of the validation.

Calibration control

Clause 7.6 requires monitoring and measuring equipment to be calibrated or verified at specified intervals, identified as to status, safeguarded, and recorded.

Controlled production conditions

Clause 7.5.1 conditions include documented procedures, qualified equipment, calibrated devices, defined operations and defined release, delivery and post-delivery activities.

Feedback process

Clause 8.2.1 requires feedback from production and post-production activities as a QMS input, including a method for early warning of quality problems and input to CAPA.

Internal audit independence

Clause 8.2.2 requires audits at planned intervals by personnel who do not audit their own work, considering process status and importance, with records of audit and results.

Product release authorization

Clause 8.2.3 requires evidence of conformity at appropriate stages and identification of the person authorizing release of product to the customer.

Complaint handling

Clause 8.2.4 requires a documented procedure for timely complaint handling, investigation, determination of regulatory reporting needs, and maintenance of records.

Nonconforming product control

Clause 8.3 requires identification, segregation, evaluation and disposition of nonconforming product, including concession and notification to authorities where required, with records.

Data analysis

Clause 8.4 requires analysis of feedback, conformity to product requirements, process and product characteristics, and supplier data, with results feeding improvement and CAPA.

CAPA cycle

The sequence of identifying an issue, containing it, investigating root cause, determining and implementing action, verifying effectiveness, and closing the record with evidence.

Effectiveness verification

The step confirming that a corrective or preventive action actually eliminated the cause and prevented recurrence; it is the step most frequently missing from CAPA records.

Change control impact

Assessment of how a change affects the device, the QMS and regulatory status, since device or intended-use changes may require notification or new regulatory submissions.

Stage 1 audit

The certification body's readiness review of documentation, scope, internal audit and management review evidence, and identification of areas of concern before the Stage 2 audit.

Stage 2 audit

The certification body's on-site verification that the QMS is implemented and effective, sampling records such as design files, risk files, complaints, CAPA and calibration.

Major nonconformity

An audit finding indicating a significant failure of the QMS or a requirement not implemented; it generally must be corrected and verified before certification is granted.

Surveillance audit

A periodic audit by the certification body after initial certification, at least annually, to confirm the QMS continues to conform and is maintained between recertification audits.