ISO 13485:2016 Vocabulary Flashcards

ISO 13485:2016 Overview

• The standard specifies requirements for a quality management system (QMS) for organizations involved in the medical device life-cycle.

• Applies to design, development, production, storage, distribution, installation, servicing, and disposal of medical devices.

• Applicable to organizations regardless of size or type, including suppliers and providers of related services (e.g., calibration, sterilization).

Scope and Applicability

• Organizations must demonstrate ability to provide medical devices that meet customer and regulatory requirements.

• Requires identification of applicable regulatory requirements and their integration into the QMS.

Definitions (Clause 3)

• Advisory Notice: Communication providing guidance or actions required post-delivery.

• Authorized Representative: Person/entity acting on behalf of the manufacturer within regulations of a jurisdiction.

• Clinical Evaluation: Assessment of clinical data to verify device safety and performance.

• Nonconforming Product: Product that fails to meet specified requirements, must be documented and controlled.

• Risk: Combination of probability of occurrence of harm and severity of that harm.

Management Responsibility (Clause 5)

• Top management must demonstrate commitment to quality by:

• Establishing quality policy and objectives.

• Ensuring resources are available and effective.

• Conducting regular management reviews to ensure QMS effectiveness.

Resource Management (Clause 6)

• Organizations must provide necessary resources, including:

• Competent personnel with the right education and training.

• Infrastructure (buildings, equipment, etc.).

• Controlled work environment to achieve conformity of product.

Product Realization (Clause 7)

• Planning and development of processes related to product realization must include:

• Determination of customer requirements and other needs related to the product.

• Planning for design and development, including inputs and outputs.

• Control over purchasing and validation processes to ensure quality.

Measurement, Analysis and Improvement (Clause 8)

• Organizations must implement processes to assess product conformity and QMS effectiveness:

• Internal audits and monitoring for corrective actions.

• Analysis of data to identify trends and areas for improvement.

Document Control (Clause 4.2)

• Organizations must control documentation and records to ensure:

• Adequate review and approval prior to issuance.

• Identification and availability of current documents.

• Retention of obsolete documents as defined by the organization or regulatory requirements.

Changes from ISO 13485:2003 to ISO 13485:2016

• Increased detail on organizational context and regulatory obligations.

• Clarifications in terms and definitions to ensure compliance with evolving regulatory landscapes.

• Introduction of new requirements, including those for risk management and documentation processes.

Annex A: Highlights the comparison between ISO 13485:2003 and ISO 13485:2016, indicating significant changes and improvements in the standard.

Annex B: Correspondence between ISO 13485:2016 and ISO 9001:2015 for better alignment in quality management requirements across sectors.