Sustainability and quality are crucial to everything we do at RISE. Through third-party accreditation and certification, we are able to ensure that the services we provide to our customers and partners maintain a high level of quality.
Our services support the development of high-quality products, processes, methods and services. Some of our services deal with evaluating and quality-assuring products and innovations. In order to be able to offer independent support and advice, these services are often accredited or certified, and therefore regularly reviewed by third-party organisations, including Swedac – Sweden's national accreditation body.
Below, you will find links to third-party websites that describe the scope of RISE’s accreditation and certification. As these are issued to legal entities, there are a number of separate companies within RISE that are accredited and certified.
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 is also accredited by the American Association for Laboratory Accreditation (A2LA) for the testing and certification of the formaldehyde content of products.
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:
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 Certification is an accredited certification body for management systems in accordance with the standard:
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 Certification is an accredited certification body for persons in accordance with the standard:
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 Certification is an accredited certification body for products in accordance with the standard:
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:
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:
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:
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.
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.
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:
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:
The European Association of National Metrology Institutes (EURAMET) also has a Technical Committee on Quality (TC-Q) to which the various European institutes report on their quality-assurance activities pursuant to ISO 17025 and their management systems, both verbally and in writing. Read an extract from:
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:
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 validates and verifies reports on greenhouse gas emissions, as well as information contained in applications for the allocation of emission rights. Verification is conducted under accreditation in accordance with:
This accreditation is intended to ensure that verification is performed by independent, competent individuals in an impartial manner. In order to fulfil the requirements as a verification body, operations must be conducted with the support of a quality management system.
RISE Certification’s accreditations for verifying reports on greenhouse gas emissions:
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:
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.
Contact us if you have questions regarding additional insurance letters and certificates.
Would you like to raise an issue regarding RISE’s quality-assurance activities? Learn more about how we deal with complaints.