Accreditation and third party approval

Manufacturers or importers (into the EU) are responsible for ensuring that their products meet applicable requirements; for example, by CE marking them. In certain cases, extra checks are required to be conducted by a third-party body; for example, type-examination, conformity to type or product quality assurance.

This kind of third-party body is called a Notified Body. RISE is a Notified Body for some ten CE marking directives or regulations. In Sweden, Notified Bodies are assessed by Swedac in a process similar to accreditation and then notified to the European Commission. In addition to the relevant technical expertise, the Notified Body must also fulfil requirements such as independence, impartiality and financial stability.

Our Notified Bodies:

• RISE Research Institutes of Sweden AB
• RISE SMP Svensk Maskinprovning AB 

RISE Certification is an accredited certification body for management systems in accordance with the standard:

• ISO/IEC 17021-1 Conformity assessment – Requirements for bodies providing audit and certification of management systems.

This accreditation is intended to ensure that certification is performed by independent, competent individuals in an impartial manner. In order to fulfil the requirements as a certification body, operations are conducted with the support of a quality management system.

RISE Certification’s accreditations for certifying management systems:

• RISE Research Institutes of Sweden AB - Swedac

RISE Certification is an accredited certification body for persons in accordance with the standard:

• ISO/IEC 17024 Conformity assessment – General requirements for bodies operating certification of persons.

This accreditation is intended to ensure that certification is performed by independent, competent individuals and that the applicant’s competence is evaluated and the certification process conducted in an impartial manner. Certification is intended to verify the competence of a professional group. In order to fulfil the requirements as a certification body, operations are conducted with the support of a quality management system. 

RISE Certification’s accreditations for certifying persons:

• RISE Research Institutes of Sweden AB - Swedac

RISE Certification is an accredited certification body for products in accordance with the standard: 

• ISO/IEC 17065 Conformity assessment – Requirements for bodies certifying products, processes and services.

This accreditation is intended to ensure that certification is performed by independent, competent individuals and that the product is evaluated and the certification process conducted in an impartial manner. Certification is intended to verify that the product fulfils set requirements. In order to fulfil the requirements as a certification body, operations are conducted with the support of a quality management system. 

RISE Certification’s accreditations for certifying products:

• RISE Research Institutes of Sweden AB - Swedac
• RISE Research Institutes of Sweden AB - A2LA

Our annual Sustainability Report is prepared in accordance with the Global Reporting Initiative (GRI) Core Standard. In order to increase transparency and credibility, RISE has chosen to have its Sustainability Report audited externally by KPMG.

Good laboratory practice (GLP) is a quality assurance system that covers the organisational process and the relations that prevail when non-clinical safety studies on humans and the environment are planned, carried out, supervised, archived and reported. A GLP laboratory must be employed for non-clinical studies of certain medical technical products prior to registration and approval.

GLP requirements are only applicable to non-clinical safety studies and are linked to the regulatory requirements imposed on this type of product. GLP is provided in three expert areas and RISE has three GLP laboratories. Learn more about RISE’s GLP approval by selecting Working areas and then Good Laboratory Practice (GLP) on the Swedac website.

Our GLP-approved areas:

• Cytotoxicity testing
• In-vitro toxicity studies with cell systems and tissues
• Analytical and Clinical Chemistry testing
• Toxicity studies
• Analytical and Clinical Chemistry testing 

All pharmaceuticals must be manufactured in accordance with the EU’s Good Manufacturing Practice (GMP) guidelines. GMP is the element of quality assurance that ensures that products are consistently manufactured and inspected based on the quality standards applicable to the intended area of use and that are required in product specifications or to obtain market approval.

GMP deals with both manufacture and quality controls. Manufacturing permits and GMP certificates are issued by the Swedish Medical Products Agency, the supervisory authority in areas such as the development, manufacture, storage and distribution of pharmaceuticals, which is tasked with ensuring that users receive drugs that meet applicable regulatory requirements. The Swedish Medical Products Agency’s provisions and guidelines for marketing authorisation to manufacture and import medicinal products (LVFS 2004:7) describe requirements applicable to the manufacture of pharmaceuticals. RISE develops and manufactures investigational medicines for clinical trials.  RISE holds a manufacturing permit and GMP certificate. 

The standard used by accreditation bodies when accrediting calibration laboratories is ISO /IEC 17025:2017 – General requirements for the competence of testing and calibration laboratories. On an overall level, those laboratories that meet the requirements of ISO 17025:2017 conduct their activities in accordance with the quality-management standard ISO 9001.

Our accreditations for calibration:

• RISE Research Institutes of Sweden AB
• RISE Innventia AB

The standard used by accreditation bodies when accrediting inspection bodies is ISO /IEC 17020:2012 Conformity assessment – Requirements for the operation of various types of bodies performing inspection.  RISE inspects both products and meters, as well as manufacturers’ own quality-assurance systems. RISE is accredited as a Type A inspection body. In a few cases RISE is accredited as a type C inspection body.

Our accreditations for inspection:

• RISE Research Institutes of Sweden AB
• RISE SMP Svensk Maskinprovning AB
• RISE Fire research AS

RISE is designated as Sweden’s National Metrology Centre. As such, we have overall responsibility in Sweden for the International System of Units (SI base units), internet timekeeping and certain measurement technology activities in the field of chemistry.

RISE is responsible for the following national measurement areas:

• Length
• Volume and flow
• Mass
• Energy
• Pressure 
• Acoustics
• Time and frequency 
• Photometry and radiometry 
• Temperature 
• Electricity
• High frequency and microwaves 

As the National Metrology Centre, we are required to conduct operations in accordance with ISO /IEC 17025:2017 – General requirements for the competence of testing and calibration laboratories. This requirement is placed on us by both the Swedish Government and international agreements. The compliance of the RISE National Metrology Centre’s management system with ISO 17025 is regular checked by Swedac in the course of their supervisory activities. Learn more about:

• International acceptance of National Measurement Sites - RMP (In Swedish)
• Metrological traceability

The European Association of National Metrology Institutes (EURAMET) also has a Technical Committee on Quality TC-Q to which the various European institutes report annually on their quality-assurance activities pursuant to ISO 17025 and their management systems.

The standard used by accreditation bodies when accrediting testing laboratories is ISO/IEC 17025:2017 – General requirements for the competence of testing and calibration laboratories. On an overall level, those laboratories that meet the requirements of ISO 17025:2017 conduct their activities in accordance with the quality-management standard ISO 9001.

Our accreditations for testing:

• RISE Research Institutes of Sweden AB
• RISE Swecast AB
• RISE IVF AB
• RISE SMP Svensk Maskinprovning AB 
• RISE Innventia AB 
• RISE Fire Research AS 
• RISE PFI AS 

RISE is also accredited by the American Association for Laboratory Accreditation (A2LA) for the testing and certification of the formaldehyde content of products.

Flexible accreditation

In many cases, RISE holds flexible accreditation, meaning that we are accredited in a given field rather than for a specific method. This may mean that RISE is able to perform testing using a certain method even if you are unable to find this specifically when searching, as it is within a field in which RISE has flexible accreditation.

The standard used by certification bodies to certify for quality is EN ISO 9001:2015 Quality management systems - Requirements.

Our certifications according to SS-EN ISO 9001:2015
 

• Fiberlab: https://certificatechecker.dnv.com/
• Corrosion: https://certificatechecker.dnv.com/
• Maritime: https://www.a3cert.com/om-oss/utfardade-certifikat/

A designated Technical Service is an organisation or body approved as a test laboratory that has also been notified to the EU or UNECE for conducting Type Approval Testing. Type Approval Testing is proof that a vehicle or component fulfils current technical requirements. 
In order to be designated as a Technical Service in Sweden, the organisation must be accredited by Swedac in accordance with ISO 17025 for those test methods that are to be used for Type Approval. A decision will then be made by the Swedish Transport Agency on approving the organisation’s appointment as a designated Technical Service. There are two kinds of Type Approval: EU and UNECE. 

Among other things, RISE is a designated technical service for:

• ECE R16 Safety belts and restraint systems 
• Directive 77/541/EC on Seat belts and restraint systems 
• ECE R23 Reversing and manoeuvring lamps 
• ECE R43 Safety glazing materials 
• ECE R44 Child restraint systems 
• ECE R46 Devices for indirect vision 
• Directive 2003/97/EC Devices for indirect vision 
• ECE R55 Mechanical coupling components 
• ECE R58 Rear underrun protective devices 
• 70/221/EEC Directive Liquid fuel tanks and rear underrun protection 
• ECE R65 Warning lamps 
• ECE R80 Seats in large passenger vehicles 
• ECE R91 Side-marker lamps 
• ECE R98 Headlamps equipped with gas-discharge light sources 
• ECE R108 Retreaded pneumatic tyres 
• ECE R109 Retreaded pneumatic tyres 
• ECE R112 Headlamps emitting an asymmetrical full or dipped beam 
• ECE R118 Burning behaviour of materials and/or the capability to repel fuel or lubricant 
• ECE R122 Heating systems 
• Directive 2001/56/EC Heating systems 
• Regulation (EU) No 109/2011 Spray suppression systems 

Download RISE's certification for the designated technical service (PDF in Swedish).

RISE is one of Sweden’s Conformity Assessment Bodies (CABs). Designated CABs with the European Union test and certify products prior to launching on markets in countries that have entered into a Mutual Recognition Agreement (MRA) with the EU. MRAs regulate the conditions under which test reports, accreditations and certificates are accepted between the EU and the other party. In order to be designated as a CAB, an organisation must fulfil the requirements for competence laid down in applicable legislation in the country with whom the EU has an MRA. 

A list of MRAs and designated CABs within the EU is available in the NANDO database. Among other countries, RISE is a designated CAB for: Australia, Switzerland and the United States. Example areas include machine safety and electromagnetic compatibility (EMC). 

Bodies may also be designated to carry out tasks such as testing under the terms of free trade agreements. RISE is designated in this capacity for products to be exported to South Korea. You can find a list of such bodies here; RISE’s designation is EU0442.

RISE Certification is a validation and verification body that performs validation and verification under accreditation against the requirements of the standard:

ISO/IEC 17029:2019 Requirements for validation and verification bodies.

The purpose of accreditation is to ensure that validation and verification is carried out by independent and competent persons and that validation and verification is carried out in an impartial manner. In order to meet the requirements as a verification body, the business is conducted with the support of a quality management system.

RISE Certification's accreditations for verification and validation

RISE Research Institutes of Sweden AB - Swedac

In addition to the above third-party authorisations, RISE is also authorised in numbers of other areas; for example, with regard to partners such as other certification bodies, various customers or public authorities in a variety of countries. Listed below are examples of such authorisations:

• The United Arab Emirates Civil Defence General Command
• IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components (IECEE)