Step 1: Preparation

If your business involves calibration, testing, inspection, product certification, management system certification, personnel certification, verification, production of reference materials, or proficiency testing, it is possible that you can become accredited according to an international standard. Accreditation is a way to demonstrate quality and competence, providing assurance to your customers. Determine which standards and requirements that are relevant to your business. Requirement and guidance documents are available on the “working areas” page on Swedac’s website.

Step 2: Application

Submit your application for accreditation on swedac.se. In your application, specify the areas, sectors, or methods for which you seek accreditation. The application fee is 4,000 SEK, covering Swedac’s administrative costs. If assessment activities are required, a cost estimate will be sent to you.

Swedac confirms receipt of the application and checks if it contains sufficient information to make a cost estimate.

A cost estimate is sent out within four weeks from the time Swedac has enough information to calculate the cost. If the application involves a new inspection or certification scheme not previously accredited by Swedac, the scheme must first be evaluated and approved for accreditation. Only then can the processing of your application begin. In these cases, the processing time will be longer.

The customer accepts the fee.

Swedac proposes a lead assessor, an assessment team, and a plan for the accreditation assignment.

Step 3: Planning

Swedac plans the accreditation assignment in consultation with the customer and engages any experts.

Swedac’s goal is to conduct the on-site assessment within 12 weeks after the customer has accepted the fee and submitted complete documentation to Swedac.

Step 4: Assessment on site

On-site assessment is performed by a lead assessor, sometimes along with additional internal or external assessors. The assessment includes the client’s organisational management, equipment and competence of the management and staff.
For accreditation of laboratories and certain inspection bodies, the assessment is completed with proficiency testing and calibrations.
In some forms of accreditation, Swedac participates as an observer while the accredited body work with its customers. Some parts of the assessment may, depending on the circumstances, be conducted remotely. The assessment concludes with Swedac’s representatives presenting their view of the organization and describing any non-conformities from the requirements. The assessment is documented in a report. Any non-conformities from the requirements must be addressed by the customer within four months.

Step 5: Corrective action

Any non-conformities from the requirements should be remedied by the customer within 4 months. Swedac takes a position as to whether the measures can be accepted. In the event of serious or extensive shortcomings, a return visit may be necessary. When all the non-conformities have been corrected, the lead assessor recommends accreditation.

Step 6: Decision

Decisions on accreditation shall be notified within two months of the submission of necessary documentation to Swedac. The processing time can be extended by up to one month on no more than one occasion, if necessary due to investigation of the accreditation case. The decision is sent to the organisation together with an accreditation certificate.

Step 7: Surveillance and reassessment

About six months after accreditation was granted an additional surveillance visit takes place to check that the accredited activities have started according to plan.

An accreditation decision is always followed up by regular surveillances, initially once a year. The aim is to determine whether the activity continues to meet the requirements. The cost for surveillance is charged in the form of an annual fee.

A comprehensive evaluation is made every four years, called a reassessment. After the first reassessment, the surveillance range is extended for most areas of accreditation to 16 months, providing that everything is working fine.

At surveillance/reassessment, any non conformities from the requirements shall be resolved by the customer within two months.

Changing an accreditation

An organisation that is accredited for one area can seek accreditation for a further one or more areas by applying for so-called extended accreditation.

To end an accreditation

If serious deficiencies have been found during a surveillance visit and the steps are not taken to correct the situation, Swedac can withdraw the accreditation or limit its scope. Such a decision can be appealed to the Administrative Court in Jönköping.

If an accredited organisation wants to have its accreditation withdrawn, a written request shall be sent to Swedac, which then withdraws the accreditation.