1. Introduction
During the ongoing Covid-19 pandemic, it is important that Swedac and accredited bodies continue to act in accordance with the principles on which the accreditation system is based, so that the general public and businesses can continue to rely on accredited services. Both Swedac and accredited bodies need to be able to provide and perform our services even though we have to limit our travel, we have limited access to the necessary materials, and our activities need to be conducted with fewer resources. Swedac has therefore compiled these guidelines to describe how Swedac will act, and what requirements Swedac will set for accredited bodies during the ongoing pandemic.
2. All accredited bodies
2.1 Temporary interruption of activities or certain services
If the accredited body chooses or is forced to temporarily stop an accredited activity due to the ongoing pandemic, this must be notified to Swedac if the temporary interruption is of such an extent and nature that it affects
- the body’s competence to carry out the activity, or
- the body’s ability to fulfil the agreements entered into, or other undertakings.
On receipt of such a notification, Swedac will assess whether the accreditation shall be temporarily suspended, based on the aforementioned aspects.
In the cases where accreditation is governed by legislation, all interruptions longer than four weeks must be notified to Swedac. Such information will be communicated to the regulatory authority.
2.2 Notification of change that may affect the accredited body’s ability to meet the requirements for accreditation
In accordance with Section 11 of Swedac’s Regulations and General Guidelines (STAFS 2015:8) on Accreditation, accredited bodies must inform Swedac without delay of any changes that may affect the body’s ability to meet the requirements for accreditation or the conditions for conducting its activities. If the accredited body’s activities need to be conducted with reduced staff numbers, without access to certain equipment, or without access to the activities of its customers, this may constitute a change that must be notified to Swedac by the accredited body.
In order for Swedac to be able to give consideration to a change notice, Swedac needs to review a risk analysis and a statement from the accredited body. The risk analysis and statement need to highlight the following:
- The risk that accreditation requirements may not be met
- The time period during which the accreditation requirements may remain unmet
- The measures that the accredited body plans to take in order to reduce the risk of it not being able to meet the accreditation requirements
- The extent to which the reliability of the reports or certificates issued will be affected by the accredited body not being able to meet the accreditation requirements
- The measures that the accredited body plans to take in order to reduce the risk that the reliability of the reports or certificates issued will be affected.
Once Swedac has reviewed the risk analysis and statement in accordance with the above, Swedac will make an assessment that may result in any of the following:
- No action
- Further assessment activities
- Temporary suspension of the accreditation, partially or in its entirety
- Revocation of the accreditation, partially or in its entirety
2.3 If Swedac is not given the opportunity to carry out surveillance
In cases where the accredited body considers that it is not appropriate for Swedac to carry out surveillance on the scheduled date, e.g. due to a high level of sick leave at the accredited body, or if it needs to give priority to maintaining critical societal functions, Swedac will aim to schedule the assessment to a later date. Primarily within the normal surveillance interval (12 or 16 months +/- 2 months after the previous site visit), or, when this is not appropriate, within an extended surveillance interval (12 +/- 6 months or 16 months +/- 8 months after the previous site visit). If this is also not possible, Swedac will temporarily suspend the accreditation.
2.4 If work is performed/performed without it being possible to meet the accreditation requirements
If the accredited body performs a service without meeting the requirements for accreditation, the customer using the service must be contacted and informed about this. The report or certificate that the accredited body then issues cannot then include the accreditation symbol or refer to accreditation in any other way.
Please note that it is not possible to issue an unaccredited report if the accredited service is governed by legislation. In such cases, no report shall be issued. There is also no possibility to issue an unaccredited certificate within the accreditation scope of a certification body.
2.5 If the management of nonconformities found is delayed
If the accredited body has difficulties to close nonconformities within the specified time, e.g. as a result of limited resources or difficulties in performing certain work tasks, this must be notified to Swedac. In order for Swedac to be able to give consideration to a request for deferral with corrective actions, Swedac needs to review a risk analysis carried out by the accredited body, see under “Notification of change notice…” above.
3. Accredited certification, verification and validation bodies
3.1 All types of certification, verification and validation
Some schemes do not accept that an on-site audit can be fully replaced by a remote audit. If an accredited body nevertheless considers that it can apply a methodology that ensures adequate reliability without being on site, the body must contact Swedac before performing the audit. If necessary, Swedac will then consult with the owner of the scheme to confirm the appropriateness of this.
3.2 Management system certification
3.2.1 Certification audits
A certification audit normally contains certain elements that are difficult to perform without being on site. If the certification body chooses to perform such elements through remote assessment, the certification body must document both the methodology used and a risk analysis indicating that the methodology used can be implemented without adversely affecting the reliability of the result.
3.2.2 Recertification audits
A recertification audit is normally expected to have been completed and a recertification decision made before a certificate expires. If the certification body has collected sufficient evidence to demonstrate the integrity of the effective operation of the management system, IAF ID 3 permits the validity of a certificate to be extended for a period not normally exceeding six months.
Due to the uncertainty over how long travel and social distancing restrictions will remain in force, it is not certain that six months will be long enough for accredited certification bodies to carry out the necessary audits in time. Swedac has therefore decided to apply a rule stating that recertification audits must have been completed no later than three months after the lifting of the restrictions on travel or social distancing that prevented the completion of the recertification audit. However, if this means that the period of validity of the certificate needs to be extended by more than twelve months, the certificate must be revoked, and a new certification audit must be conducted before a certificate can be reissued.
4. Accredited inspection bodies
A surveillance assignment performed during accreditation normally contains elements difficult to perform without being on site. If the inspection body nevertheless chooses to perform such elements through a remote assessment, the inspection body must document both the methodology used and a risk analysis indicating that the methodology used can be implemented without adversely affecting the reliability of the result.
Some conformity assessment schemes do not allow an on-site assessment to be replaced by a remote assessment. If the inspection body nevertheless considers that it can apply a methodology that ensures sufficient reliability without being on site, the inspection body must contact Swedac before using such methodology in practice. If necessary, Swedac will then consult with the owner of the conformity assessment scheme to confirm the appropriateness of this.
5. Swedac’s assessments
5.1 General
Swedac’s ambition is to protect the health and safety of the assessment teams and the staff of the accredited bodies. Swedac therefore follows the decisions and recommendations, for example, on travel and social distancing, from the government and relevant authorities, mainly the Public Health Agency of Sweden and the National Board of Health and Welfare.
This means that in cases where it is not possible to conduct an assessment on site, Swedac will conduct assessments remotely to the greatest extent possible. This primarily means phone and web-based meetings, that management systems are made available electronically, and that documents and records are displayed remotely on the assessment team’s display screens. Swedac primarily uses Skype for this purpose. When appropriate and possible, Swedac can also perform witness audits via video. In all remote assessments, Swedac will give consideration to whether the technology used is/was satisfactory for achieving the reliability required in the assessment result.
Before Swedac conducts a remote assessment, Swedac’s assessment team will contact the accredited body to agree on and test the technical solution in practice. Current experience suggests that remote assessments take slightly longer than on-site assessments, and that the assessment may need to be divided into several shorter sessions. Swedac’s lead assessor, together with the accredited body, will go through how this affects the assessment schedule.
5.2 Transition of accreditation to new edition of SS-EN ISO/IEC 17025
The SS-EN ISO/IEC 17025:2005 standard will expire as a harmonised standard on 30 November 2020. At the same time, accreditations issued based on this standard will also cease to apply. Swedac’s ambition is to complete all assessments prior to the transition to the new edition SS-EN ISO/IEC 17025:2018 in conjunction with the normal surveillance of the accredited laboratories. Swedac is of the opinion that fulfilment of the additional requirements in the new edition of the standard can be assessed remotely. Swedac will therefore aim to complete such assessments in order to be able to make accreditation decisions based on the new edition before the expiry of the previous standard.
5.3 Time-limited accreditations
Swedac normally issues accreditation decisions to be valid until further notice, i.e. without a specified period of validity. However, some conformity assessment schemes require accreditation decisions to be issued with a time-limited period of validity. It is Swedac’s ambition to conduct all the necessary assessments in good time in order to be able to make decisions on continued accreditation before the validity of time-limited accreditations expire.
If Swedac considers that certain elements cannot be performed by remote assessment, and if it is also not possible to conduct an on-site assessment before the validity of the time-limited accreditation expires, Swedac will consult with the scheme owner on how to resolve the situation.