dicentra’s certification and audit processes are designed to ensure organizations meet ISO 13485 standards through a systematic and transparent approach. Below is an overview of the key processes and policies:
Audit Processes
dicentra’s audit processes ensure compliance with ISO 13485 standards. A flowchart detailing each stage of the audit process is available for reference. Key stages include:
Pre-Certification Activities:
Clients submit an application and collaborate with dicentra to exchange information, define the certification scope, and identify potential areas of concern. An audit program is developed based on this exchange to ensure all requirements are addressed.
Initial Certification:
- Stage 1 Audit: A documentation review is conducted to verify that the organization’s Quality Management System (QMS) aligns with ISO 13485 requirements. Identified gaps are communicated for resolution.
- Stage 2 Audit: An on-site audit assesses the implementation of the QMS, including compliance with processes, operational controls, and regulatory requirements. Non-conformities, if any, are documented and require corrective actions.
Surveillance Audits:
These are conducted annually to verify that certified organizations maintain compliance. Surveillance audits may include reviewing process updates, corrective actions, and any changes in the organization’s operations.
Special Audits:
Special audits may be required due to significant changes, such as modifications to the certification scope, major organizational changes, or client-requested adjustments.
Audit Follow-Up:
Organizations are required to resolve non-conformities through corrective actions, which are reviewed by dicentra. Once approved, certifications are maintained or adjusted as necessary.
Certification Procedures
dicentra’s certification procedures ensure transparency and consistency. The main processes include:
- Granting Certification: Certification is awarded once the organization successfully completes the Stage 1 and Stage 2 audits, and any non-conformities are resolved. Certification documents are issued to confirm compliance with ISO 13485.
- Maintaining Certification: Organizations are required to participate in periodic surveillance audits to ensure ongoing adherence to certification standards. Failure to comply may result in suspension or withdrawal.
- Renewing Certification: At the end of the three-year certification cycle, a recertification audit is conducted. This involves a comprehensive review of the organization’s QMS to verify continued compliance.
- Suspending or Withdrawing Certification: Certification may be suspended or withdrawn if significant non-conformities are identified, certification marks are misused, or requirements are otherwise unmet.
- Adjusting Scope: Certification scopes can be expanded or reduced to reflect changes in the organization’s operations or services. This requires additional audits or documentation review.
Management Systems and Certification Schemes
dicentra specializes in certifying management systems under ISO 13485. Our certification schemes include:
- Quality Management Systems (QMS) for Medical Devices: Certification for organizations across all stages of the medical device lifecycle, including design, development, manufacturing, distribution, installation, and servicing.
- Alignment with Global Standards: Certification schemes align with internationally recognized standards, including the Medical Device Single Audit Program (MDSAP), CE Marking, and UKCA certification.
- Flexible Certification Options: dicentra works with both single-site and multi-site organizations, tailoring the certification process to their unique needs.
Use of dicentra’s Name and Certification Mark
Organizations certified by dicentra are granted the right to use our certification mark, which reflects their adherence to ISO 13485 standards. Guidelines include:
- Proper Use: The certification mark must only be used in association with the certified scope of operations. Organizations must not imply certification for non-certified products, services, or processes.
- Compliance with Branding Guidelines: Detailed usage guidelines are provided to certified organizations to ensure appropriate representation of their certification.
- Misuse Consequences: Unauthorized or improper use of the certification mark may result in suspension or withdrawal of certification.
Information Requests, Complaints, and Appeals
dicentra is committed to transparency and fairness in all its certification activities. Mechanisms for handling inquiries include:
- Information Requests: Clients or stakeholders can request details regarding certification status, audit processes, or the certification scope of dicentra-certified organizations. Requests are handled promptly and transparently.
- Complaints: Complaints related to dicentra’s services or certified organizations are reviewed thoroughly. dicentra ensures impartial investigation and resolution of all complaints.
- Appeals: Organizations can appeal certification decisions by submitting a formal request for review. Appeals are overseen by dicentra’s impartiality committee to ensure fairness.
Policy on Impartiality
dicentra’s impartiality policy ensures that all certification activities are conducted independently and without bias. Key principles include:
- Independence from External Pressures: dicentra operates independently of financial, commercial, or other external interests that could influence certification decisions.
- Conflict of Interest Management: Comprehensive policies are in place to identify and mitigate conflicts of interest, ensuring objectivity in all certification activities.
- Impartiality Committee Oversight: An impartiality committee regularly reviews dicentra’s certification processes to ensure they remain fair, transparent, and aligned with industry best practices.
