Search Our Site
13485store.com The Tools You need to Achieve and Maintain ISO 13485 Certification 13485store.com The Tools You need to Achieve and Maintain ISO 13485 Certification 13485store.com The Tools You need to Achieve and Maintain ISO 13485 Certification
Free Presentations
Free Quickstart Kit - Sign up box with

No software to install or learn:

Simply download the MS Word and Excel files and get started today!

Full email support

1-877-942-6572

15-day money back guarantee


Registrars

info

Selecting a Registrar

The contract you set up with your Registrar (or Certifying Body - CB) will be for the three year period. You would renew your contract after three years to start the cycle again. Since you are starting a relationship that will last at least 3 years or longer, you will want to choose carefully.

Registrar Basics

Generally, when you sign a contract with a Registrar, it will include the Registration Audit, and Surveillance Audits. The Registration Audit is the initial audit that will be done to see if you will achieve registration. Once you are approved, your certificate will be valid for three years.
(See typical Registration Process Flowchart)

After you have your registration, the Registrar will come back every 6 months or year for a Surveillance Audit to see if you are maintaining your system and continuing to meet the requirements of the standard. Registrars vary in their approach, so you will want to find out details from each Registrar you are interested in.

Your certificate will be valid for 3 years. After that period your registrar will be required to do another Registration Audit to renew your certification.


Costs

The costs for the audits and registration will be dependant on the size of your company, the number of locations, the accreditations that you need, and the distance between you and your Registrar.

The costs are typically dependant on the number of audit days required for the registration audit and the surveillance audits, the travel costs for the auditors, and the administration fees and accreditation fees for the registration.

  • A good estimate is $1400/day + expenses, but contact a registrar for a quotation.

  • The number of days is based upon the size and complexity of your operation.

  • Expenses include travel expenses for the auditor to your facility.

  • Number of auditing days a CB can assess is regulated by IAF Guide 66 Annex 1

Choosing a Registrar

The most important factor in choosing a Registrar is how well they can work with you. This includes how well they know your industry, how much experience they have with similar companies, and how well they communicate with you and your employees. There are many rules that a registrar must follow, issued by organizations like the ANAB. See ANAB Rules...

Interview 3 or more Registrars to get a good idea of the options available and differences between Registrars. Look locally if you have good choices, it will save on costs, but if you do not find a good fit look farther. The benefits of your relationship with your Registrar will pay off. Remember that these are experienced professionals that spend day after day evaluating how companies do business. The feedback you get from them is one of the best benchmarking tools available.

iso-registrars View Questionnaire to help you select a registrar

<Back To Top>


Recommended Registrars

BSI
BSI is the leading registrar and training organization offering services to the following standards: ISO 9001:2008, AS9100, ISO 14001, OHSAS 18001 and ISO/TS 16949:2002. ISORegistrars

 


Other registrars we have worked with:

DNV DNV Certification

PRI PRI Network


Complete list of Registrars

Here is a more ISO Registrars complete list of registrars for several standards

<Back To Top>