Development of new areas for accreditation

The standard ISO/IEC 17029:2019, Conformity Assessment – General Principles and Requirements for Validation and Verification Bodies, was issued in 2019. Swedac and many others in the industry believe that this standard will have a significant impact and will be widely used in the future as there has been a lack of a standard for this.

Development work continues to offer more accreditations for verification/validation in various areas. Areas where the standard can be further applied include, for example, verification of contracts in procurement, claims, or self-declarations by companies.

Contacts:
Magnus Pedersen: magnus.pedersen@swedac.se
Kaarlo Book: kaarlo.book@swedac.se (for EU-ETS matters)

Drones are flown today for both private and commercial purposes. However, with the expansion of this new technology, new safety issues have arisen. Drones can interfere with radio equipment and, not least, air traffic.

Within the EU, there is now a new regulatory framework (regulation and implementing regulation) that regulates the technical requirements for civil drone equipment before the product is CE marked and marketed within the EU. The proposal regulates civil drones in six different classes, while drones classified as toys still need to meet the Toy Directive.

The regulation involves both product certification of drones and certification of management systems for drone manufacturers. The specific measures that must be fulfilled before the product can be marketed depend on the drone class.

You can now apply to become a notified body accredited by Swedac to perform product testing.

With an EU-wide regulatory framework where conformity assessment is primarily carried out by notified bodies, independent and equivalent assessments can be conducted throughout the EU.

However, not all drone classes require the involvement of an accredited body. For several classes, so-called internal manufacturing control is sufficient, where the manufacturer ensures and assures that the product meets the set requirements before it is placed on the market. Standards are under development and are expected to be available in 2023.

More information about the regulations, including requirements for drone pilots, is available on the Swedish Transport Agency’s website.

For further information, contact Swedac’s investigator Magnus Pedersen:
magnus.pedersen@swedac.se
+46 33177760

The EU Commission has agreed on a common framework for cybersecurity certification.

The regulation, which came into force in 2019, became effective in the summer of 2021. It means that there is now a harmonized framework for cybersecurity and a classification according to the three assurance levels: basic, substantial, and high security.

The EU Commission, through ENISA (EU Agency for Cybersecurity), is developing certification schemes. Products, services, and processes will be able to be certified according to a cybersecurity system.

The EU Commission recently established the implementing act for the scheme concerning Common Criteria (EUCC). For more information, see EA’s website.

Swedac will offer accreditation of laboratories (ITSEF) and certification bodies (CB) under this scheme at both the Substantial and High levels.

Two additional areas will be subject to certification in the future:

• Cloud Services
• 5G

ICC, the Cybersecurity Certification Authority (part of the Swedish Defence Materiel Administration, FMV), is the supervisory authority in this area.

Relevant Links:

• REGULATION (EU) 2019/881
• ENISA

For accepted schemes where Swedac has accredited bodies, search in the accreditation register. For the schemes listed below, Swedac’s ability to accredit and the time from application to receiving an assessment for accreditation may vary depending on the competence area. For more information about schemes and Swedac’s ability to accredit, contact registrator@swedac.se.

Certification Scheme for Management System Certification:

• Anti-Bribery According to SS-ISO 37001 SIS/TS 60
• Universal Design – Accessibility Through Universal Design for Products, Goods, and Services – SS EN 17161:2019 SIS/TS 176
• Asset Management According to SS-ISO 55001 SIS/TS 64
• GMP+ Feed Safety
• FAMI-QS*
• IAQG 9001*

Certification Scheme for Product, Process, and Service Certification:

• Municipal Business Pilotage According to SS 884000:2013 SIS/TS 48
• Customs Brokerage Services According to SS-EN 16992:2016 SIS/TS 53
• Patient Participation in Healthcare Services According to SS-EN 17398 SIS/TS 602
• CERTALARM
• Trusted Services and E-Identification
• FEMB (Sustainability Requirements for Office and Non-Domestic Furniture for Indoor Use)
• GRMS (Global Red Meat Standard)
• IFS*
• PSAP (NavCert)
• Organic Content Standard
• Textile Exchange (Recycled)
• GLOBAL G.A.P*
• BRC*
• ICAO CORSIA*

Certification Scheme for Personnel Certification:

• EOQ CoS 9000
• IPC Management System Auditor Certification Scheme*

Verification/Validation Program:

• Verification of Environmental Technology According to SS-EN ISO 14034:2018 SIS/TS 95

Inspection Scheme:

• Food Store Quality Standard (FSQS)

Combinations of Multiple Conformity Assessment Activities

• Riskplaza

Link to IAF’s website for Scopes.