ISO 13485: Medical Devices

Orion is a knowledgeable partner who can help you to achieve the standards certification you need to operate and expand your business in your primary markets. When it comes to the devices that can save lives and improve health standards, certifications are unquestionably critical. Orion can facilitate accreditation for required standards for manufacturers of medical devices, as suited to a variety of markets.

Meeting room people smiling - ISO 13485 Certifications

Why Work with Orion on ISO 13485?

Orion is a trusted partner the medical industry can rely on for its certification needs.

We are currently the only firm endorsed by three industry associations to audit their members, and we reward this trust by only using auditors that have an overall customer satisfaction rating of 99% or better. Our auditors have over 15 years of auditing experience, making them seasoned and proven professionals.

Our vast and lengthy experience means that we truly know and understand the medical device industry, including its typical processes, commonly used software, and industry terminology. As a result, our auditing services are efficient and effective, and we will work with you to establish mutual goals up front to make sure your needs are fully met. If you are looking to certify to multiple standards, we also provide integrated audits so that you can achieve certification in one audit, ultimately saving you both time and money.

What is ISO 13485?

The international standard that outlines the requirements for a comprehensive management system within the design and manufacture or servicing of medical devices.

ISO 13485 is applicable not only to manufacturing, but also to the service industry. From concept to ongoing inspection capabilities (i.e. for devices that are implanted in patients), medical devices have a set of specifications that are unique, such as sterilization.

For manufacturers planning to market their product in Europe, another standard may need to be considered.

Breakdown of the Standard

This standard represents the requirements for a comprehensive management system within the design and manufacture of medical devices. This standard is somewhat unique in that some of its requirements separate it from the main ISO 9001 quality management standard, so many organizations that are ISO 13485 compliant are not able to also be ISO 9001 compliant. Some of these unique considerations include the need to ensure that all medical devices are sterile, the ability to track and inspect devices that are implanted in patients, and the management of risk during product development.

Overview of the Audit Process

Orion Assessment Service can assist your organization in achieving certification from the initial application request, and through to the required stages which include:

Sign the Agreement

1

Sign the Agreement

Orion must provide a quote for all ISO standards. The terms and conditions must be signed and returned to Orion along with any required deposit.
1

Perform GAP Audit (optional)

2

Perform GAP Audit (optional)

Prior to your Stage 1 or Stage 2 audit, Orion can perform a gap audit to identify major gaps in meeting the requirements of the standard. This independent review will identify strengths, weaknesses, and opportunities for improvement. Many companies prefer undergoing a preliminary gap audit to ensure they fully understand the standard’s requirements prior to their actual certification audits.
2

Perform Stage 1 Audit:
Readiness Review

3

Readiness Review

This review is conducted to determine whether your organization is ready to move to Stage 2 Audit (Certification Audit) by confirming that:

  • The management system addresses all the requirements of the standard.
  • The management system has been implemented and the client is ready for the Stage 2 Audit (Certification Audit).

Note that a full management review and internal audit must occur prior to conducting the Stage 2 Audit (Certification Audit)

3

Perform Stage 2 Audit:
Certification Audit

4

Certification Audit

This onsite audit is conducted to ensure that the processes and documents examined during the Stage 1 Audit (Readiness Review) are in use and that the system is implemented according to the requirements of the standard.

The key deliverables from this stage include:

  • An audit report detailing positive aspects, issues for resolution (non-conformances), and areas for improvement.
  • A recommendation regarding your registration.
4

Finalize Audit Report
and Receive Certificate

5

Finalize Audit Report and Receive Certificate

The results from the Stage 1 and Stage 2 audits are reviewed to ensure that all Orion accreditation requirements have been met and a proper recommendation made. At this point, approval is given to either certify, seek clarification, or not certify.

5

Perform Surveillance
or Recertification Audit

6

Perform Surveillance or Recertification Audit

Registration is based on a 3-year cycle. To maintain your certification, your organization must participate in an onsite review each year. The first two are surveillance audits and only look at a portion of your system, whereas the third-year review (re-certification) is a more comprehensive audit and looks at your overall system for continued effectiveness.

6

Sign the Agreement

1

Sign the Agreement

Orion must provide a quote for all ISO standards. The terms and conditions must be signed and returned to Orion along with any required deposit.
1

Perform GAP Audit (optional)

2

Perform GAP Audit (optional)

Prior to your Stage 1 or Stage 2 audit, Orion can perform a gap audit to identify major gaps in meeting the requirements of the standard. This independent review will identify strengths, weaknesses, and opportunities for improvement. Many companies prefer undergoing a preliminary gap audit to ensure they fully understand the standard’s requirements prior to their actual certification audits.
2

Perform Stage 1 Audit:
Readiness Review

3

Readiness Review

This review is conducted to determine whether your organization is ready to move to Stage 2 Audit (Certification Audit) by confirming that:

  • The management system addresses all the requirements of the standard.
  • The management system has been implemented and the client is ready for the Stage 2 Audit (Certification Audit).

Note that a full management review and internal audit must occur prior to conducting the Stage 2 Audit (Certification Audit)

3

Perform Stage 2 Audit:
Certification Audit

4

Certification Audit

This onsite audit is conducted to ensure that the processes and documents examined during the Stage 1 Audit (Readiness Review) are in use and that the system is implemented according to the requirements of the standard.

The key deliverables from this stage include:

  • An audit report detailing positive aspects, issues for resolution (non-conformances), and areas for improvement.
  • A recommendation regarding your registration.
4

Finalize Audit Report
and Receive Certificate

5

Finalize Audit Report and Receive Certificate

The results from the Stage 1 and Stage 2 audits are reviewed to ensure that all Orion accreditation requirements have been met and a proper recommendation made. At this point, approval is given to either certify, seek clarification, or not certify.

5

Perform Surveillance
or Recertification Audit

6

Perform Surveillance or Recertification Audit

Registration is based on a 3-year cycle. To maintain your certification, your organization must participate in an onsite review each year. The first two are surveillance audits and only look at a portion of your system, whereas the third-year review (re-certification) is a more comprehensive audit and looks at your overall system for continued effectiveness.

6

Sign the Agreement

Orion must provide a quote for all ISO standards. The terms and conditions must be signed and returned to Orion along with any required deposit.
1

Perform GAP Audit (optional)

Prior to your Stage 1 or Stage 2 audit, Orion can perform a gap audit to identify major gaps in meeting the requirements of the standard. This independent review will identify strengths, weaknesses, and opportunities for improvement. Many companies prefer undergoing a preliminary gap audit to ensure they fully understand the standard’s requirements prior to their actual certification audits.
2

Perform Stage 1 Audit:
Readiness Review

This review is conducted to determine whether your organization is ready to move to Stage 2 Audit (Certification Audit) by confirming that:

  • The management system addresses all the requirements of the standard.
  • The management system has been implemented and the client is ready for the Stage 2 Audit (Certification Audit).

Note that a full management review and internal audit must occur prior to conducting the Stage 2 Audit (Certification Audit)

3

Perform Stage 2 Audit:
Certification Audit

This onsite audit is conducted to ensure that the processes and documents examined during the Stage 1 Audit (Readiness Review) are in use and that the system is implemented according to the requirements of the standard.

The key deliverables from this stage include:

  • An audit report detailing positive aspects, issues for resolution (non-conformances), and areas for improvement.
  • A recommendation regarding your registration.
4

Finalize Audit Report
and Receive Certificate

The results from the Stage 1 and Stage 2 audits are reviewed to ensure that all Orion accreditation requirements have been met and a proper recommendation made. At this point, approval is given to either certify, seek clarification, or not certify.

5

Perform Surveillance
or Recertification Audit

Registration is based on a 3-year cycle. To maintain your certification, your organization must participate in an onsite review each year. The first two are surveillance audits and only look at a portion of your system, whereas the third-year review (re-certification) is a more comprehensive audit and looks at your overall system for continued effectiveness.

6

Schedule a Consultation

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