Ευρωπαϊκή Εταιρεία
Ελέγχων & Πιστοποιήσεων A.E

Πιστοποίηση κατά τις Έκτακτες Καταστάσεις και Συνθήκες


EUROCERT, operating under recognized standards or regulatory documents has established the following actions.

EUROCERT has assessed the risks of continuing certification and established this document outlining the steps it will take in the event a certified organization is affected by an extraordinary event, such as current pandemic spread.

This established process defines methods for evaluating the current and expected future situation of the certified organization, and define alternate potential short-term methods of assessing the organization to verify continuing effectiveness of its management systems.

To enable EUROCERT to assess risk for continuing certification (with the term “certification”, below we mean certification, inspection, verification and validation) and understand the certified organization’s current and expected future situation, EUROCERT shall gather necessary information from the certified organization before deciding on an appropriate course of action.

The information collected through the through the forms O.E. 67 /E01a, O.E. 67/E02, O.E. 67/E03a, O.E. 67/E04 & REC85_BRCGS. which are completed by the customers.

Based on risk assessment EUROCERT may need to consider alternative short-term methods of assessment to verify continuing system effectiveness for the organization. This may include requesting relevant documentation (for example, management review meeting minutes, corrective action records, results of internal audits, test/inspection reports, etc.) to be reviewed off site to determine continuing suitability of the certification (on a short-term basis only).

If communication with the organization cannot be made, EUROCERT shall follow the normal processes and procedures for suspension and withdrawal of certification.

For developing alternate methods of certification, EUROCERT shall take into consideration the following

The exceptions mentioned in this document may apply in the following cases:

• The certified / controlled / verified company is located in an area (city, city or province in a country) with known cases of COVID-19 or

• The certified / controlled / verified company is located in an area affected by government restrictions and / or official travel bans or

• The company's corporate policy temporarily prohibits visitors due to COVID-19 and does not allow inspectors to attend its premises; or

• The certification body's corporate policy prohibits inspectors from traveling because of COVID-19

Where extraordinary events or circumstances are met, the remote evaluation can be used according to the scope described below:

Management of Initial Certifications

Initial Certification can only be carried out when full control and evaluation of the Management System, data, installation data, equipment and customer personnel is possible.

Generally, initial certification requires on-site audit.

Given current emergency conditions, it is possible to carry out an initial audit, using remote audit techniques and by reviewing documents and data submitted by the audited organization and conducting the on-site evaluation when the extraordinary event or circumstances have been lifted, as soon as it is possible to move to restricted areas where the organization operates.

In this case, a certification decision may be substantiated by the requirement of a documented risk analysis related to the standard and risk of the field of application, the business sector of the organization and the certification scope. EUROCERT has a specific documented risk analysis procedure for this type of certification and shall submit a written request to ESYD before conducting any remote audit, along with a documented risk analysis.

ESYD shall consider the request and may approve or reject it within 10 (ten) working days.

In the case that ESYD approves the implementation of remote audit of the initial certification with a documented risk analysis, the obligation to carry out the on-site audit, due to extraordinary event or circumstance, shall not be waived due to exceptional circumstances, but this will be carried out when conditions permit.

NOTE: The risk analysis shall at least include the requirements of IAF ID3: 2011

Therefore, the Initial Certification is then carried out in two phases (the First phase with Remote Audit and the Second phase with completion of the on-site audit as soon as conditions permit).

Management of Surveillance Audits

Surveillance audits should be completed as soon as possible (with an on-site audit) when the extraordinary event or circumstances have been lifted and as soon as it is possible to move to restricted areas where the organization operates.

The process of surveillance audit (both the first and second annual evaluations of the three-year cycle) should be completed no later than six months after the due date for its implementation under the original three-year program and within 2020, if the extraordinary event or circumstances allow it.

Surveillance audit may be carried out with the technique of a remote audit and / or office evaluation of documents and data submitted by the Certified Organization, if this can be justified by a risk analysis (low risk). Based on the data / evidence collected, EUROCERT may be able to take decision on the continuation and validity of the certification (in the case of LOW RISK organizations).

Therefore, in the case of Low Risk certification scopes and based on the risk analysis and documentation process, the surveillance audit may proceed and be completed based on the data / evidence collected from the remote audit / desk review.

Where the certification scope requires audits or even inspections at production sites, warehouses, accounting offices, assembly sites and any premises outside the office on-site audit shall be carried out under normal circumstances and in all cases with the physical presence of the Audit/ Inspection team.

NOTE: The risk analysis shall at least include the requirements of IAF ID3: 2011

In cases where due to interruption of normal operation of the certified client (due to the extraordinary event or circumstances) it is not possible to implement the remote audit / desk review, EUROCERT may grant a 6-month extension of the certificate's validity.

When the six-month extension has elapsed and the on-site audit and other procedures leading to the issue of the certificate are not possible to be implemented, the certificate shall be cancelled.

Management of the Recertification Audits

Recertification audits should be completed as soon as possible (with an on-site audit) when the extraordinary event or circumstances have been lifted and as soon as it is possible to move to restricted areas where the organization operates.

The recertification audit procedure should be completed no later than six months after the deadline for its implementation under the original three-year program and within 2020, if the extraordinary event or circumstances allow it.

Recertification audit in Low Risk organizations, may be carried out with the technique of Remote Audit and / or office evaluation of documents and data submitted by the Certified Organization, if this can be justified by a risk analysis. Based on the data / evidence collected, EUROCERT may be able to take the decision on the validity/continuation of the certification (in the case of Low Risk organizations).

The Audit due to extraordinary event or circumstances is carried out in two phases (the first phase with the remote audit / desk review and the second phase with the completion of the on-site audit, as soon as the extraordinary event or circumstances allow it).

EUROCERT is obliged to carry out the on-site audit but due to exceptional circumstances, this may be postponed until when conditions allow it, no later than 6 months.

In cases where due to interruption of normal operation of the certified client (due to the extraordinary event or circumstances) it is not possible to implement the remote audit / desk review, EUROCERT may grant a 6-month extension of the certificate's validity.

When the six-month extension has elapsed and the on-site audit and other procedures leading to the issue of the certificate, is not possible to be implemented, the certificate shall be revoked.

Example:

ISO 9001 Certificate is valid from 18/03/2017 to 17/03/2020.                                                               

After a positive result on risk assessment and remote audit, the validity of the certificate can be extended by six months, so in this example the expiry date of the current certificate is extended to 18/09/2020.

The on-site audit is carried out in July 2020 with the date of certification decision on 05/09/2020.

The subsequent certificate is issued and is in line with the previous cycle, thus expiring on 17/03/2023.

Conformity audit activities carried out, related to products that fall under the New Approach Directives and require CE marking e.g. compulsory sector products, national legislation requiring controls (initial, periodic, exceptional etc.), agri-food products (organic etc.) and any other type of products requiring conformity marking shalldefinitely be carried out with an on-site audit at the manufacturer's / producer's / user's premises, etc. with the physical presence of the Audit/ Inspection team.

Furthermore, the surveillance audit cannot be completed on the basis of evidence / evidence collected from the phase of Remote audit / desk review for the following standards:

- ISO22000

-ISO45001 / OHSAS18001 (medium & high-risk activities)

-ISO14001 (medium & high-risk activities)

-ISO22716

-ISO50001

-EN 15224

-ISO 13485

-ISO/IEC 27001

-ISO 13485 (medium & high-risk activities)

In any case, ESYD shall be informed in writing

The categorization into low / high / medium risk activities is based on the IAF procedures as well as the Guidelines issued from ESYD (where available by standard).

Where the on-site audit requires audits or even inspections at production sites, warehouses, accounting offices, assembly sites and any premises outside the office where such inspection is carried out, it shall be carried out under normal circumstances and in all cases with the physical presence of the Audit/ Inspection team

During the remote audit of the organization to be certified / inspected / verified and depending on the findings, because of which the certification process cannot be completed, the relevant Division of EUROCERT will decide on the extension of the certificate of the organization up to 6 months.

Especially for Italy all the above mentioned apply as well as the following:

Regarding ISO 9001 audits for EA 28:

-    In case of an initial or recertification audit, a remote audit may take place provided that:

• The Organization has to demonstrate the urgent reason for the certificate

• Remote audit activities shall cover both management system processes as well as include documentation review of relevant projects, finished or in process.

A certification decision may be made, but within 6 months the audit should be completed with an on-site evaluation, otherwise the certificate will be revoked

• In case of a surveillance audit, postponing for 6 months is highly recommended, otherwise above mentioned regarding surveillance audits apply

Συνολικές επισκέψεις :