The route to accreditation

When applying for accreditation, Swedac conducts an assessment for first time accreditation at the organization applying for accreditation. This assessment verifies that the established accreditation requirements are met.

Planning

Those who wish to become accredited submit an application to Swedac. To cover Swedac’s administrative costs, an application fee is charged. Swedac receives the application and assesses whether sufficient documentation has been provided to make a cost estimate for the specific activity/accreditation area/technical area/cluster covered by the application. If needed, additional information is requested. Within four weeks from the time Swedac has sufficient information to calculate the cost, a cost estimate is sent out. Once the cost is accepted, the process continues with the appointment of an assessment team and any technical assessors. The specific focus of the assessment and the requirements to be evaluated are determined in advance. Based on this, Swedac decides which technical assessors—either Swedac employees or contracted experts—will participate in the assessment. Swedac arranges the necessary travel and accommodation arrangements according to its predetermined instructions and guidelines. In the final step of the planning process, Swedac sends a program to the applicant organization, providing detailed information about the assessment setup, including schedules, any need for protective clothing or special equipment, required documentation, focus areas, and participants. These details are discussed and confirmed with the applicant organization and adjusted if necessary.

Conducting assessment

The assessment begins with an opening meeting where Swedac’s lead assessor presents the agenda and key timings for the day. This is followed by interviews with the organization’s staff, reviews of the management system, witnessing of work performance, and random sampling of documentation of completed work. In some cases, parts of the process may be conducted remotely, determined on a case-by-case basis. However, the requirements always remain the same. The assessment covers both the organization’s management system and the equipment and competence of its management and staff. For the accreditation of laboratories and certain inspection bodies, the assessment is supplemented with comparative measurements and calibrations. A fundamental requirement for the assessment is that Swedac’s staff act impartially and objectively, perform competent reviews, gather sufficient evidence to confirm compliance with the regulations, and make an overall assessment of the customer’s operations. Observations from the assessment are discussed with the customer during the closing meeting and reported by Swedac’s lead assessor. The handling of these observations is also communicated during the reporting process. Some observations may result in non-conformities.

Follow-up

After the assessment and after any non-conformities have been addressed and accepted by Swedac, Swedac decides whether the accreditation application can be granted. An accreditation decision is always followed up with regular surveillance visits, initially once a year. The purpose is to assess whether the organization continues to meet the requirements. After the first reassessment, the surveillance interval for most accreditation areas is extended to 16 months if everything is functioning well. Every four years, a comprehensive evaluation, a so-called reassessment, is conducted.