How Do I Get Certified?

If you are interested in certification and would like to recieve a no obligation quotation from NSAI please complete the relevant quotation form.
This quotation can in turn, on your authorisation, initiate the application process.

We review all quotation requests to make sure we have all the information necessary before a quotation is provided.  If you need any assistance in completing these forms we will be happy to help. 

Our quotations cover the period corresponding to the certification cycle, in most cases three years, and are calculated to ensure that every customer receives the quotation best suited to their organisation.

Preliminary Assessment - Stage 1 of the Registration Process

We carry out the full assessment in two stages, staring with a Preliminary Assessment (Stage 1).

The Preliminary Assessment involves an inspection of your documentation and a review ranging over various areas including:

• The proposed scope of your registration
• The status of implementation of your management system
• The appropriate regulatory and legal requirements
• Your management policies and objectives
• Whether the system addresses the key areas of your business
• Your site-specific activities – top level process review
• Your key management elements, e.g. internal audits, reviews and complaints procedures
• Your readiness to move onto Stage 2 of the assessment, the Registration Assessment.

The Preliminary Assessment takes place on-site. We recommend an interval of several weeks between the Preliminary Assessment and the Registration Assessment to allow time to resolve any issues arising from the Preliminary Assessment.

After the Preliminary Assessment is completed, we will produce a brief report evaluating your readiness to proceed to the next stage and identifying any areas that need to be improved before moving to Stage 2.

If the Preliminary Assessment finds that your organisation is not ready for full Registration Assessment, it becomes, in effect, a Gap Assessment. That means that a second Preliminary Assessment will have to be carried out.

Registration Assessment – Stage 2 of the Registration Process

The Registration Assessment (Stage 2) involves a full review of your management system, including relevant records and documents.

Its purpose is to confirm that your management system is properly controlled and has predictable outcomes.

Through the PDCA (Plan-Do-Check-Act) process, you will be expected to identify and implement any necessary changes to your system.

At the end of the Registration Assessment, NSAI issues a detailed report, together with the outcome (whether to recommend registration or not).

We will identify any issues found during the assessment. You in turn will be expected to submit an action plan detailing what changes are planned to be made to the management system to eliminate or reduce the risk of the same issues re-occurring.

If there are any major deficiencies identified, we may have to revisit the site until we are satisfied that closure has been demonstrated.

When we receive a satisfactory response from the applicant, the file is independently reviewed by NSAI technical and management before the certificate is issued.

Applicants can proceed at their own pace, with assessment dates arranged to suit.

Gap Assessment "Not applicable to Medical Device Certification Activities"
If you are unsure whether you are ready to undergo assessment for registration, we can offer you a Gap Assessment, in which we:

• Conduct an on-site analysis of your current system
• Assess this against the relevant standard
• Prepare a report highlighting the gaps between your current system and the standard.

A gap assessment is optional and is not a requirement of the certification process.

At least once a year, NSAI visits each registered organisation to ensure the management system is being maintained and is achieving its expected outcomes. During each visit, part of the management system is reviewed in depth.

Certificates expire every three years, with the expiry date indicated on the certificate. Before the expiry date we undertake a detailed reassessment, reviewing the performance of the whole management system to make sure every element is performing satisfactorily. The results of the previous visits are taken into account.

Any issues raised at the reassessment are handled the same way as at the end of the registration process. When we receive a satisfactory response, we renew the certificate.

Granting, refusing, maintaining, renewing, suspending, restoring or withdrawing certification or expanding or reducing the scope of certification

Certificates of Registration are issued to organisations who have been assessed and who comply with the requirements of the appropriate standard. Certificates remain valid until revoked or revised by NSAI or until the organisation surrenders its registration.  

Continued compliance with the requirements of the standard is monitored through on-going surveillance and reassessment audits for the duration of the registration.

Suspension is a period of probation which may result in removal, voluntary withdrawal or revocation.  If certification is withdrawn or suspended, certification may be restored once the reason for issue has been satisfactorily addressed.

An organisation may expand or reduce the scope of certification if, for example, the scope of their operation changes

NSAI retains the right to refuse certification for any reason but an organisation has the option to appeal any such decision.

One of the core values within the NSAI Customer Charter is impartiality, here we state that; 
“We protect our impartiality which guarantees no predisposition in our work or in our dealings with business and public alike” 

A copy of the NSAI Customer Charter and NSAI Customer Action Plan can be found on the NSAI webpage - Our customer service promise and complaints procedure