QMS…?
ISO 13485 adds to the requirements of ISO 9001 by demonstrating responsibility for “maintaining the effectiveness of the quality management system.”
It is the "policies, processes, and procedures" required for planning and execution of a core business plan. Often an eQMS (electronic) software is required to meet the standard, including documentation to achieve certification or CE standard(s).
13485 exceeds 9001 documentation and records in:
• regulatory documents with system documentation (4.2)
• a file identifying product specification documents (4.2)
• a device master record that must specifically define QMS requirements (4.2)
• changes to QMS documentation that must be reviewed and approved by the original approver or another designated individual with adequate background information (4.2)
• changes that must be reviewed and approved by the original approving function or another identified individual who has sufficient subject matter expertise (4.2)
• requiring the manufacturer to designate data retention standards based on product lifetime and regulatory requirements (4.2)
Management Responsibility
ISO 13485 requires organizations to identify a member of the management team who is responsible for each aspect of the QMS.
Also, the management team is responsible for quality policy and a framework for QMS review (5.3)
• QMS goals and compliance must be verified and measured by management (5.4)
• Every member of the organization must have defined responsibilities for managing, performing, and verifying the QMS (5.5)
• Management is responsible for maintaining QMS standards by assigning responsibility (5.5)
• Management review must include regulatory updates (5.6)
Both ISO 9001:2015 and ISO 13485:2016 adopted more in-depth focus on:
1.) resource management defined as the various equipment, buildings, and IT resources needed for quality product realization and 2.) specific requirements for device manufacturers focused on environmental standards and contamination control for product safety, such as:
• Maintenance activity requirements must be documented (6.4)
• Retain records of maintenance-related activities (6.4)
• Document requirements for personnel health, cleanliness, and clothing (6.4)
• If applicable, document procedures for monitoring the work environment (6.4)
• Create formal systems for the containment of contaminated product if applicable (6.4)
• Develop documented requirements for active risk management (7.1)
• Maintain risk management records (7.1)
• Create policies for customer communications in the event of advisory notices (7.2.3)
Product Realization
ISO 13485 emphasizes in-depth, specifically to improve safety and customer satisfaction. It defines process, equipment, cleanliness, and risk management in the product life cycle. Specific standards for production and the supply chain include:
• traceability of documented, defined, and retained relevant purchasing information (7.3)
• access to procedures, requirements, SOPs, and reference materials to personnel at the point of execution (7.5)
• creation and implementation of SOPs for labeling and packaging (7.5)
• creating specific record for each batch of devices manufactured and approved (7.5)
• verification of and approval of each device batch record (7.5)
• documenting sterilization, including sterilization before use (7.5)
• specific requirements for the installation and verification of the device, including guidelines for other organizations who may install or verify a device (7.5)
• records of installation and verification (7.5)
• documentation of servicing activities, procedures, and records (7.5)
• creating procedures to identify and address returned products (7.5)
• creating a process for traceability and the identification of product status (7.5)
• documentation of all SOPs related to conformity (7.5)
• documentation of all procedures related to assuring product shelf life (7.5)
Measurement, Analysis, and Improvement
Key differences between 9001 and 13485:
1.) standards for customer feedback,
2.) monitoring product performance
3.) how to address a non-conforming product…
Including:
• procedure for a feedback system which provides early warning of non-conformances (8.2.1)
• review of non-conformances within the feedback system (8.2.1)
• monitor and measure products for quality throughout production (8.2.4)
• verify all quality requirements are met before the product is released or delivered (8.2.4)
• document rework activities and the release of nonconforming product which meets regulatory requirements (8.3)
• create formal procedures for quality data collection, analysis, and retention (8.4)
• document the implementation of advisory notices (8.5)
• justify customer complaints which don't result in CAPA (8.5)
• create documented procedures for notifying regulators of adverse events (8.5)
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