General background
In accordance with ISO/IEC 17011, Swedac must assess whether a conformity assessment scheme referred to in the application for accreditation is appropriate for accreditation purposes. The term “conformity assessment scheme” refers to a documented and publicly available body of rules that determines;
– the object of conformity assessment, e.g. a product, process, service, system or person;
– the requirements to be met by the object of conformity assessment;
– the assessment activity to be used for conformity assessment, e.g. testing, inspection or certification and any other additional activity considered necessary to ensure that the requirements are met;
– the requirements imposed by the owner of the conformity assessment scheme on the party performing the conformity assessment, and any specific application of these requirements; and
– the requirements imposed by the owner of the conformity assessment scheme on the accreditation body, and any specific application of these requirements.
In order for a conformity assessment scheme to be appropriate, there must be an owner who takes responsibility for it. This policy sets out the criteria applied by Swedac when assessing appropriateness. For the purpose of clarity, the policy makes a distinction between criteria that relate to the owner of the conformity assessment scheme and criteria that relate to the design and objective of the conformity assessment scheme.
The policy will be used mainly on the following occasions:
– Swedac receives an application for accreditation under a private conformity assessment scheme. If Swedac has not previously conducted any accreditation under this conformity assessment scheme, Swedac will carry out an appropriateness assessment of the conformity assessment scheme in accordance with this policy.
– Swedac receives a request from the owner of a private conformity assessment scheme for Swedac to accept applications for accreditation under a specific conformity assessment scheme. Also in this case, Swedac will carry out an appropriateness assessment of the conformity assessment procedure in accordance with this policy.
– Swedac receives a referral, which contains rules on conformity assessment, from a regulatory authority. In this case, Swedac uses the policy as a starting point when formulating the statement of opinion. In the event that ambiguities or open questions are identified, there is often an in-depth consultation between Swedac and the regulatory authority.
There are several reasons why Swedac has grounds to impose requirements on the appropriateness of a conformity assessment procedure, including;
– Swedac’s responsibilities include to ensure that its activities, and activities for which Swedac gives any kind of approval, comply with legislation in force;
– as Swedac is a signatory to MLA/MRA agreements with EA (European co-operation for accreditation), ILAC (International Laboratory Accreditation Cooperation) and IAF (International Accreditation Forum), it is required to comply with the requirements of ISO/IEC 17011;
– as Swedac is a signatory to MLA/MRA agreements with EA (European co-operation for accreditation) and IAF (International Accreditation Forum), it has to comply with their requirements for how to assess the appropriateness of conformity assessment schemes;
– one of the conformity assessment activity standards (ISO/IEC 17024), under which Swedac conducts accreditation, imposes requirements on the conformity assessment scheme itself, which means that the applicant certification body is made responsible for the design of the conformity assessment procedure to which the application relates.
Swedac’s policy does not specify absolute requirements, but the criteria that Swedac uses when assessing appropriateness. In each individual case, the assessment can be subject to influence by particular aspects, such as:
– whether or not the conformity assessment scheme is regulated;
– whether the conformity assessment scheme is intended to also be applied in countries other than Sweden;
– the purpose and scope of the conformity assessment scheme;
– the assessment activity that is intended to be applied.
Using the set criteria, Swedac conducts an overall assessment in each individual case of whether or not the conformity assessment procedure can be considered appropriate from an accreditation point of view.
Even in cases where Swedac assesses that the conformity assessment procedure is appropriate from an accreditation point of view, Swedac reserves the right to refrain from undertaking the assignment to conduct accreditation under the conformity assessment procedure, when the required competences or other resources cannot be made available. In such cases, Swedac will make efforts to find an alternative solution.
Guidelines for designing a conformity assessment scheme
Swedac’s policy, which is presented below, therefore deals with the characteristics that a conformity assessment scheme should have in order to be appropriate for accreditation from Swedac’s point of view. Fulfilling these criteria does not guarantee that the conformity assessment scheme is designed in a way that makes it likely that the purpose of the conformity assessment scheme is fulfilled.
Useful guidance on how to design conformity assessment schemes based on product certification in order to ensure that the intended purpose will be met, are provided in the following technical reports published by ISO/IEC:
– ISO/IEC TR 17026 Conformity assessment — Example of a certification scheme for tangible products;
– ISO/IEC TR 17028 Conformity assessment — Guidelines and examples of a certification scheme for services;
– ISO/IEC TR 17032 Conformity assessment — Guidelines and examples of a scheme for the certification of processes.
A description of different types of conformity assessment schemes based on product certification and of the basic concepts used in product certification is provided in ISO/IEC 17067.
The documentation of a conformity assessment scheme always includes a normative document (requirements specification) that describes the requirements that shall be fulfilled by the object of conformity assessment. ISO/IEC 17007 provides guidelines on how such a normative document should be designed in order to be appropriate for use in a conformity assessment scheme.
For conformity assessment schemes based on conformity assessment activities other than product certification, there are currently no specific guidelines from ISO or IEC.
Criteria for assessing the appropriateness of a conformity assessment scheme
Swedac’s criteria related to the owner of the conformity assessment scheme:
A1. Is the owner of the conformity assessment scheme a legal entity or an entity registered to conduct business activity?
A2. Does the owner of the conformity assessment scheme have a mandate to establish and change the requirements of the conformity assessment scheme1 ?
A3. Does the owner of the conformity assessment scheme take responsibility for providing the accreditation bodies and accredited bodies affected with relevant information about the scheme and changes to it?
A4. Does the owner of the conformity assessment scheme undertake to manage and administer the scheme in a non-discriminatory and transparent manner?
A5. Has the owner of the conformity assessment scheme committed itself to accept results from bodies accredited by signatories to MLA and MRA agreements with EA, ILAC and IAF?
A6. Has the owner of the conformity assessment scheme committed itself to restrict the procedure to accredited bodies?
1) In this context, an underlying standard/requirement document under which conformity assessment is conducted is not itself considered part of the scheme.
Swedac’s criteria related to the design and purpose of the conformity assessment scheme:
B1. Are the specified requirements compatible with in Sweden applicable legislation, e.g. requirements for non-discrimination and gender equality?
B2. Is the availability of the conformity assessment scheme restricted to a certain applicant or to a limited set of applicants?
B3. Is the purpose of the conformity assessment scheme to promote health and safety in general, health and safety in the workplace, consumer protection or environmental protection?
B4. Is a description of the conformity assessment scheme publicly available?
B5. Do possible requirements imposed by the owner of the conformity assessment scheme on Swedac comply with requirements set in ISO/IEC 17011, EC Regulation (EC) 765/2008 or relevant mandated documents issued by EA, IAF or ILAC?
B6. Does the conformity assessment scheme include limitations or is it designed in a way that makes the execution of decisions on withdrawal of accreditation difficult to enforce?
B7. Is accreditation to be based on one of the standards listed below?
– ISO 14065 Greenhouse gases – Environmental information – Requirements for bodies validating and verifying environmental information;
– ISO 15189 Medical laboratories – Requirements for quality and competence;
– ISO/IEC 17020 Conformity assessment – Requirements for the operation of various types of bodies performing inspection;
– ISO/IEC 17021-1 Conformity assessment – General requirements for bodies operating certification of management systems;
– ISO/IEC 17024 Conformity assessment – General requirements for bodies operating certification of personnel;
– ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories;
– ISO 17034 General requirements for the competence of reference material producers;
– ISO/IEC 17043 Conformity assessment – General requirements for proficiency testing;
– ISO/IEC 17065 Conformity assessment – Requirements for bodies certifying products, processes and services.
B8. Do possible additional requirements imposed by the owner of the conformity assessment scheme on accredited bodies comply with requirements set in the standard under which the body is to be accredited?
B9. Does the conformity assessment scheme have such contents that it justifies the recognition of the accredited body’s competence, impartiality and/or ability to continuously deliver reliable results?
B10. Does the conformity assessment scheme contain requirements for accredited bodies that are not related to the task of conducting conformity assessment?
B11. Is the conformity assessment scheme based on a requirements specification that is publicly available?
B12. Has the requirements specification been selected in the order of preference below?
– International standard;
– European standard;
– National standard;
– Industry standard;
– Self-developed standard.
B13. When the scheme is not regulated in legislation, does the requirements specification contain contents over and above legal requirements in force?
B14. Has the scheme owner validated the appropriateness of the specified requirements with regard to the purpose of the scheme?
B15. Where applicable, does the requirements specification refer to SI units?
B16. Is the requirements specification reviewed and updated as necessary and at appropriate intervals, through a consensus process involving interested parties?
B17. Does the conformity assessment scheme regulate the validity of issued certificates in the event of unforeseen events?