medical device quality management system certification

Certification core content

The certification of medical device quality management system revolves around the systematic management of the whole life cycle of medical devices, with the following dimensions as the core:

Organizational environment and leadership role: understand the organization and its internal and external environment, identify the needs of interested parties, the commitment of top management, formulate quality policies, clarify responsibilities and authority, and implement management review.

Risk management: establish risk management process according to ISO 14971 standard, run through the whole process of design, production and post-marketing supervision, identify risks, evaluate risks, formulate control measures, and maintain dynamic risk files.

Design and development control: design planning, design input and output, design review and verification, design confirmation (including clinical confirmation), design conversion, and design change control to ensure the completeness and traceability of the design history document (DHF).

Procurement and supplier management: supplier access and evaluation, procurement information documents, incoming inspection, outsourcing process control (such as sterilization and testing), and quality agreement signing.

Production and process control: production environment control (such as clean room), process verification (special processes such as sterilization and welding), equipment calibration and maintenance, work instructions, cleaning and pollution control.

Identification and traceability: product identification, batch/serial number traceability, UDI (unique instrument identification) implementation, DHR maintenance and recall preparation.

Monitoring and measurement: process monitoring, product inspection, internal audit, data analysis and feedback system (including complaint handling)

Complaint handling and adverse event reporting: complaint receiving and investigation, adverse event reporting, supervision and communication mechanism, and post-listing supervision.

Nonconforming product control and corrective and preventive measures: nonconforming product identification and disposal, root cause analysis, CAPA implementation and effect verification.

Documented information control: document control procedures, record keeping, data integrity (ALCOA+ principle), electronic records and audit trail.

Certification process

Medical device quality management system certification is usually divided into the following stages:

Application and acceptance: submit the application materials (business license, system documents, product registration/filing certificate, production license/filing certificate, etc.), and the certification body will review the application to confirm that the organization has the basic conditions for certification (the system has been in operation for 3 months and the implantable medical device has been in operation for at least 6 months; Complete internal audit and management review; No serious record of dishonesty)

First-stage audit (document audit): conduct document audit and site preparation evaluation, review the compliance of system documents with standard requirements, understand the basic situation of the organization, main risks and compliance with laws and regulations, and confirm the adequacy of the second-stage audit preparation.

The second stage audit (on-site audit): conduct on-site audit, including personnel interview, document record inspection, production site inspection, system operation effectiveness verification, evaluate the compliance and effectiveness of the system, and identify nonconformities.

Rectification and review: for the nonconformities found in the audit, the organization shall complete the rectification within the specified time limit and submit the evidence, which will be reviewed by the audit team.

Certification decision and certification: certification certificate will be issued after the technical review is passed, confirming that the organization meets the standard requirements, and the certificate is valid for three years.

Supervision and audit: conduct supervision and audit once a year after obtaining the certificate (the interval shall not exceed 12 months) to confirm that the system continues to meet the certification requirements.

Re-certification audit: Re-certification audit is conducted before the certificate expires, and the certification qualification is extended, usually for three years.

Certification value

Market access guarantee: ISO 13485 certification is the "entry threshold" to enter the European, American and China markets, which can shorten the registration period and reduce the recall risk.

Regulatory compliance support: help organizations meet the requirements of regulatory frameworks such as MDR/IVDR of the European Union, QMSR of the FDA of the United States, MDSAP, etc., and reflect the commitment to fulfill relevant laws and regulations.

Improve management performance: help organizations improve their management level and operational performance, and convey confidence to the public and regulatory agencies.

Enhance market competitiveness: Certified enterprises can show their commitment to quality and regulatory compliance to customers and partners, and have obvious advantages in supply chain access.

Risk reduction: through effective risk management and process control, reduce the risk probability of quality accidents or adverse events in the organization.

Promote continuous improvement: promote the continuous optimization and maturity improvement of the quality management system through the supervision, audit and re-certification mechanism.