ISO 13485 Certification | Quality management system for medical devices
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.
Our accreditation means that we have been independently assessed as possessing the expertise and competency to audit and certify to each of the listed standards on our website.
THE EIGHT BENEFITS OF A CERTIFIED ISO 13485ENERGY MANAGEMENT SYSTEM
- You have objective proof that your
organisationattaches great importance to Quality management system for medical devices and that you have it checked regularly by an independent party. This commitment increases confidence in your organisation.
- You achieve higher operating efficiency.
Organisationsthat consider quality management to be an integral part of their business operations usually achieve a higheroperating efficiency than those that do not.
- A certified ISO 13485Quality management system for medical devices increases the quality of your services and raises your staff’s awareness.
- A certified ISO 13485Quality management system for medical devices ensures clear processes and (communication) structures, tasks and responsibilities throughout the entire
organisation. This increases the involvement of your staff, which improves the working atmosphere and reduces the pressure of work.
- You can detect and identify problems in good time, which means that you can quickly take steps to avoid the same mistakes in the future.
- You make it clear to your staff, your partners, your clients
andthe outside world that customer satisfaction is at the core of your business.
- A certified ISO 13485Quality management system for medical devices gives you a positive company image, raising you up to the level of your competitors or perhaps even a level higher.
- It is possibly also in your commercial interest, seeing that more and more clients demand that their suppliers work in accordance with a certified ISO 13485Quality management system for medical devices.
On the one hand, we see that
On the other hand, we see that increasing numbers of
In any case, the introduction of an ISO 13485Quality management system for medical
ISO 13485:2016 Certification Process
We certify numerous companies
* Apply for ISO 13485:2016certification on application form & send
* We will review your application & generate an official proposal. This proposal will include all cost of ISO 13485certification.
* Proposal acceptance
* Euro assessments will send you
* After successful stage 1 audit & closure of stage 1
* After successful stage 2 audit & closure of stage 2
* Subsequently ISO 13485 certification decision is taken by Euro assessments as per its defined procedures & an ISO 13485:2016certificate is issued for your organization.
* Every year a surveillance audit is conducted to ensure continued adherence of your Quality management system for medical
CONTACT US FOR MORE INFORMATION
Would you like more information about an ISO 13485costing and the possibilities for your
Our team will be pleased to help you with preparing and implementing your quality management so that you can derive the ultimate benefit from the certification.
✓Eligibility for submitting tenders or proposals for projects.
✓Generates new business opportunities
✓Can boost your
✓Attract investment and improve brand reputation
✓Improve corporate image. Project international quality in your services.
✓Increased customer confidence and satisfaction
✓Strengthen effectiveness and efficiency
✓Enhance internal effectiveness and improve
✓Minimize corporate risk
✓Reduce information gaps
✓Supports address organizational risks and opportunities in a structured manner
✓Puts larger emphasis on leadership engagement
✓Is more user-friendly for service and knowledge-based organizations
✓Uses simplified language and a common structure and terms, which are mainly supportive
✓Addresses supply chain management more efficiently
- Now that I have selected Euro Assessments, who will be my contact?
In the short term, you may continue to work with the Client Relations Manager who has been assisting you through the selection process. However, for audit-related information, your primary contact, and the person best equipped to help you will be your assigned lead auditor.
- What issues will my auditor be able to help me with?
Your assigned lead auditor is the point of contact for:
✓All of my audit scheduling.
✓ reviewing my documents prior to the Certification Audit.
✓ Coordinating and conducting my Certification Audit.
✓ Interpretations on my quality management system standard.
✓ Future site additions, location, upgrades, etc.
✓ most questions dealing with Euro Assessments and the audit process.
- What will my assigned lead auditor want to know when he/she makes initial contact with me?
Your assigned lead auditor will want to discuss your expected timing for the required certification activities such as document review and the initial assessment. He/she will need to know if you have elected to have a pre-assessment.
- If I am not sure when I want to schedule an auditing activity such as the document review or initial assessment how much notice does my assigned auditor need?
Your assigned lead auditor could be “booked” as far ahead as 3 to6 months or more. It is a good idea to “reserve” time on their schedule that is realistic and achievable. Should you cancel a scheduled time without ample notice, your assigned lead auditor may or may not be able to accommodate your needs. In that case, another lead auditor may be assigned to your account.
- What steps are there in the certification process?
There are 3 basic steps to a certification process and they are:
✓ Document review.
✓ Initial Assessment.
✓ Certification Panel Review of recommendation.
- What if I have a conflict during the audit process regarding an interpretation?
The process of resolving a conflict would be to:
✓ Work with your assigned lead auditor.
✓ conduct a joint phone call with your lead auditor and the Euro Assessments certification manager.
✓ lodge a formal complaint.
- What happens after my assigned lead auditor recommends my company for certification?
Your assigned lead auditor must finalize the audit report, gather all the evidence and submit the package to our office. The Certification Panel team reviews this information and the recommendation is then accepted or, rarely, rejected. If rejected, the auditor may require more information from you. After this process you will be informed by Euro Assessments of your certificate number. This process usually takes 5 working days after a recommendation is made.
- When will I receive a certificate?
Once the recommendation is accepted by the Certification Panel team you could expect your formal certificates in about 7 working days, which is approximately 2 weeks from the initial audit.
- Will there be a charge for my certificates?
Euro Assessments will provide two copies of the certificates at cost included in your certification cost. Additional copies may be obtained for an additional charge of $50 each.
- What happens if I want to change my certificate later?
Notify your assigned lead auditor of your intentions so that he/she can assess whether additional auditing is necessary. There may be a need to conduct an assessment, depending upon the significance of the changes. Any assessment activity will be charged at the rates in place at the time of the assessment. There is no charge to re-issue the certificate following changes.
Fair and use a practical approach to auditing which has aided in the development of a good working relationship between our organisations.” Leading IT CompanyMr. George
Auditors have a pragmatic approach. We find that the audit process benefits our organisation greatly and helps us to continually improve our quality. Leading Manufacturing CompanyMr. David Johnson
They executed the audit schedule in a timely and professional manner. We found the audits very rewarding. I would have no problem recommending Euro Assessments to any organisation considering certification.” Leading Logistic CompanyMs. Sarah James