ISO 13485 is the international standard for management systems within the medical devices industry. It is focused on standardizing processes for organizations that provide design, development, manufacturing, installation, service, and /or distribution for medical devices and services.
An ISO 13485 certification audit determines if the quality management system of an organization meets the requirements of ISO 13485 and the activities within the agreed scope.
Before an ISO 13485 certificate can be issued, an organization must understand the audit process, the elements of a quality management system that will be reviewed, and the importance of a quality management system that is maintained.
What is an ISO 13485 certification audit?
During an ISO 13485 certification audit, an independent certification body determines the extent to which an organization’s quality management system meets the requirements of ISO 13485.
The scope of the audit involves the quality management system and the processes falling within the agreed scope. Auditors do not conduct a documentary review. Auditors determine how the management system has adopted its quality management system processes and how effective the processes are.
The audit scope may depend on the following factors:
- scope and location of the organization
- the type of medical devices or services related to medical devices
- regulatory requirements
- complexity of the quality management systems
- activities of suppliers and outsourced services
What do ISO 13485 auditors review?
When reviewing for ISO 13485 certification, auditors examine pertinent information pertaining to the quality management system.
This may include:
- Quality policy, objectives, and management responsibility
- Documentation and record control
- Risk and other management activities
- Controls for design and development (where applicable)
- Evaluation and purchasing controls for suppliers
- Controls for the provision of services and production
- Monitoring and measurement
- Complaints and feedback
- Controls for nonconforming products and services; corrective/preventive actions
- Internal audits and management evaluations
The audit will be a combination of documentation, information, observation, process, operational activity, staff, and sample area observations.
What is the ISO 13485 certification audit process?
There is a structured process that is the same throughout most organizations when regard to the certification audit process.
1. Scope review of certification
The certification body first confirms the organization’s activities, locations, scope, and applicable standard requirements.
2. Stage 1 audit
A Stage 1 audit typically reviews the organization’s readiness for certification. It may include reviewing management-system documentation, understanding the organization’s processes, and identifying areas that require attention before the next stage.
3. Stage 2 audit
The Stage 2 audit is a more detailed assessment of how the quality management system is implemented and maintained in practice. Auditors gather evidence across relevant processes and locations within scope.
4. Audit findings and corrective action
If nonconformities are identified, the organization needs to analyse them and complete appropriate corrective actions. Certification decisions are made after the required process is completed.
5. Surveillance Audits
After certification, periodic surveillance audits are generally conducted to assess continued conformity and maintenance of the management system.
What should an organization do to prepare for an ISO 13485 audit?
Preparing for an ISO 13485 audit is not simply about arranging documents before the auditor arrives. An organization should ensure that its Medical Device Quality Management System (QMS) is properly implemented, maintained, and operating effectively in day-to-day activities.
Before an ISO 13485 audit, an organization should focus on the following key areas:
Define the certification scope: Clearly establish the scope of certification and the medical device-related activities covered by the QMS.
Review documents and records: Ensure that required procedures, work instructions, forms, and quality records are properly controlled, current, and readily available.
Conduct internal audits: Perform internal audits to identify gaps or nonconformities before the certification audit.
Complete management review: Ensure management reviews have been conducted and that required decisions and actions have been addressed.
Close corrective actions: Review previous audit findings, nonconformities, and corrective actions to ensure they have been effectively implemented and closed.
Evaluate suppliers and outsourced processes: Verify that suppliers and externally provided processes are appropriately evaluated, selected, monitored, and controlled.
Ensure employee awareness: Personnel should understand their responsibilities, authorities, and the procedures applicable to their work.
Verify implementation: Ensure that employees actually follow the established procedures and that objective evidence is available to demonstrate implementation.
The Key Is Effective Implementation
The main objective of an ISO 13485 audit should not be to prepare documents only for the audit. The Quality Management System should be effectively implemented and maintained as part of the organization's everyday operations.
When documentation, processes, records, employee responsibilities, and quality controls are consistently implemented, an organization is in a much stronger position to successfully undergo an ISO 13485 audit.
Why does a business need ISO 13485 certification?
ISO 13485 helps companies that manufacture medical devices obtain certification to show that an independent organization evaluated the quality management system in accordance with an internationally accepted standard.
It may provide:
- More consistent quality-management processes
- More control over documentation and records
- A more structured approach to risk and corrective actions
- More confidence for customers, suppliers, and stakeholders
- Support for tendering, supplier, and market access requirements (where applicable)
Certification does not remove an organization’s obligation to fulfill the applicable regulatory requirements. Consideration for the ISO 13485 standard must be made on the organization’s products, markets, and legal obligations.
Final thoughts
ISO 13485 certification audits evaluate the quality management systems of organizations that manufacture medical devices. Beyond looking at the procedures, audits also analyze whether the processes have been deployed and have been sustained.
organizations that employ essential elements such as internal auditing, records management, risk assessment, and innovation will better understand and articulate their conformities to the third party.
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