Questions and answers about accreditation

Accreditation is a form of quality assurance that involves a comprehensive approach to ensure requirements are met. These requirements cover many aspects of an organization. Accreditation is a formal recognition that an organization has the competence to perform certain specified tasks and entails regular checks to ensure all requirements are continually met.

Any business, entity, or organization (such as a corporation, sole proprietorship, authority, municipality, or region) with legal capacity can be accredited. Accreditation exists in many areas, for example, healthcare, facilities, environment and food, industry, vehicles, and certification. While an entire hospital cannot be accredited, a laboratory that analyzes blood samples can be. Similarly, an entire car cannot be accredited, but all companies involved in car inspections must be accredited.

Only the authority Swedac accredits in Sweden.

On Swedac’s website, there is a list of the areas for which one can become accredited.

Accreditation is a system that continuously evolves, and new accreditation areas are added. Please contact us if you have questions or requests for accreditation in new areas.

Applications for accreditation are made on Swedac’s website. In the application, you as the customer specify the accreditation areas, activities, techniques, or clusters you want to be accredited for.

When Swedac receives the accreditation application, a case is created, and a confirmation email is sent to the customer with an assigned case number. A cost estimate is sent within four weeks from the time Swedac has sufficient information to calculate the cost. You as the customer need to accept the cost estimate before the accreditation process can continue.

The cost of accreditation is based on several factors such as the accreditation area, number of methods to be assessed, and the size of the organization. Accreditation is a long-term commitment that involves recurring supervision. The cost for this is charged in the form of an annual fee. More information about Swedac’s pricing model is available here. Swedac also charges an application fee of 4,000 SEK to cover administrative costs. If assessment activities are required, a cost estimate will be sent to you.

The accreditation application is made on Swedac’s website, where the required information and documents are listed.

Accreditation can cover an entire organization that includes multiple supervision objects. Supervision objects refer to branches or subsidiaries included in the organization. When applying for accreditation, you as the customer must clarify which branches are to be covered by the accreditation and what activities/scope each branch should be accredited for. For a branch to be considered, the entire organization must apply a common management system. When an organization with a head office and branches has a common management system, the assessment of the management system only needs to be conducted in one place. The level of review of the branches depends on the responsibilities and activities assigned there. The assessment of an organization with branches takes into account:

• The head offices’ ability to manage and follow up the activities at the branches.
• The organization’s ability to apply the management system.
• The organization’s ability to handle deviations and corrective actions from internal and external audits.

Swedac aims to conduct an on-site assessment within 12 weeks after receiving complete documentation and the customer’s acceptance of Swedac’s cost estimate.

The on-site assessment is carried out by one of Swedac’s lead assessors, sometimes together with additional internal or external assessors.

For a new accreditation, meaning the first time an organization is accredited for a specific area, the assessment is conducted in two steps:

Step one: Comparison between Swedac’s and any other relevant authorities’ requirements and the customer’s documentation. This documentation may include quality manuals, procedures, etc. This comparison is largely done before the on-site visit.

Step two: Comparison between the documented work routines and their practical application in the organization. Verification that other quality documentation is known and applied in practice. The assessment covers both the customer’s organizational management system and the equipment and competence of management and staff. For the accreditation of laboratories and certain inspection bodies, the assessment is supplemented with comparative measurements and calibrations. In some forms of accreditation, Swedac observes when the accredited body performs its work, either at the accredited body’s premises or when the accredited body works with its customers. This is called witnessing.

The on-site assessment concludes with a final meeting. Here, Swedac representatives explain their view of the organization and describe any deviations from the requirements. The assessment is documented in a report. The accreditation decision is communicated within two months after Swedac receives the necessary documentation.

If Swedac finds deviations from the requirements during the assessment, these must be addressed by the customer within four months. Swedac will then reassess whether the measures can be accepted. In the case of serious or extensive deficiencies, a follow-up visit may be necessary. Once all deviations have been addressed, the lead assessor can recommend accreditation.

Approximately six months after accreditation is granted, a follow-up visit is conducted to verify that the accredited activities have started as planned. An accreditation decision is always followed up with regular supervision visits, initially once a year. The purpose is to assess whether the organization continues to meet the requirements. Every fourth year, a comprehensive evaluation and reassessment are conducted. After the first reassessment, the supervision interval for most accreditation areas is extended to 16 months if everything is functioning well. During supervision/reassessment, any deviations from the requirements must be addressed by the customer within two months.

The time for assessment varies depending on the scope and area of accreditation. Usually, an assessment takes between one and three days.

The accreditation is valid indefinitely, provided that all requirements are continuously met.