Euro Quality System
Frequently asked questions about Euro-Quality System certification. Find answers to your questions about our procedures and services.
Euro-Quality System assigns an auditor whose technical skills match your field of activity and the standard concerned. Our network of partner auditors allows us to find the expert best suited to your sector.
Certification is issued for a period of 3 years. Annual surveillance audits are conducted to verify that your management system remains compliant with the standard.
The initial certification audit takes place in two stages: a Stage 1 audit (documentary review) and a Stage 2 audit (on-site audit). Annual surveillance audits are then scheduled.
Euro-Quality System is committed to respecting the strictest confidentiality regarding all information obtained during audits. This confidentiality is contractually guaranteed with our auditors.
TABLE OF CONTENTS
1. Description of the certification procedure
2. Initial certification
3. Duration of certification
4. Surveillance audit
5. Extension of certification scope
6. Renewal of certification
7. Confidentiality
8. Suspension and withdrawal of certifications
9. Appeals by the certified company
10. Handling of complaints
11. Publicly accessible information
The certification process of the company applying for certification is organized in accordance with the general operating criteria of a certification body as defined in the ISO/IEC 17021 standard.
The certification procedure comprises 5 main phases broken down into 9 steps:
This step recommends a preliminary information visit by a member of our Management Board or a sales manager to the applicant company’s facilities. The admissibility of the application is decided following a comprehensive review of the candidate’s quality, safety and/or environmental system, thus verifying that all requirements of the reference standard are covered. This preliminary information visit is at no cost to the company.
This step translates the application request into the agreement signed between Euro-Quality System France and the company applying for certification.
The audit team is selected and receives a mission brief. The company applying for certification is informed of this choice and may challenge this audit team within 8 days.
The audit team reviews the company’s documentation. This review is generally carried out at our organization’s offices unless the company wishes it to be done at its own premises. A report highlights any remarks and/or non-conformities in the documentation and concludes on the possibility of proceeding to the next phase 2 of the certification process.
At the same time as the documentation review report, an audit plan is sent to the company, which has the opportunity to provide remarks within eight days.
The audit is conducted on the dates set out in the audit plan and in accordance with the planned schedule. The audit team finalizes the audit with a written report presented to the company’s management. This report may be supplemented by remarks from the company’s management. This report is transmitted to the Management Board of our certification body.
The maximum time frame for implementing corrections and corrective actions for any major or critical non-conformity, during the conduct of an audit, is 6 (six) months after the audit date.
The documentation review and evaluation audit reports, as well as the client’s responses to any action requests (following non-conformities against the reference standard), are reviewed by one or two reviewers from the organization. These individuals, independent of the audit team, give an opinion on the certification file.
Based on the reviewers’ opinion, the organization’s Management Board makes the decision, either:
– to grant certification, without or with reservations on the scope;
– to put the decision on hold:
– for additional documentary information;
– for the results of a supplementary audit;
– to refuse certification.
This audit is intended to gather information or evidence on the actions requested during the previous audit to address certain non-conformities in the company’s quality, safety and/or environmental system.
The company benefiting from a favorable decision from the organization’s Management Board receives:
– its certificates and logo(s) referring to its certification,
– a document explaining the terms of reference to the certification issued by our organization and in particular the rules for using the logo(s).
– The certification mark (the logo(s)) is used to promote the certification.
Certification is granted for a period of three years and renewable for periods of three years (Special case: the ELV – End-of-Life Vehicle – approval is granted for a period of 6 years).
During the certification period, the organization conducts periodic surveillance audits. These audits may be combined with other audits of the organization within the company.
The surveillance audit must cover at minimum the effectiveness of the actions taken following the previous audit and, by sampling, the maintenance and application of the other points of the certification standard.
These audits also help identify areas for improvement that will increase the effectiveness of the quality, safety and/or environmental system in place, and improve the company’s profitability.
Closer surveillance audits may also be triggered following:
The certified company may request an extension of its certification scope at any time. The decision to grant or not grant the extension is made by our organization based on the report of the additional extension audit.
During renewal (3 years after certification, except ELV 6 years), the audit team:
Strict measures are taken by our organization to ensure the confidentiality of information collected within the company.
Our organization has the right to suspend, withdraw, reduce the scope or cancel the issued certificate in the following cases (by way of example – non-exhaustive):
Our organization does everything possible to avoid the withdrawal of a certification by allowing the company to remedy in time the anomalies that led to the suspension of the certificate.
The Management Board may request that the company return the original certificates in the event of suspension, withdrawal, cancellation or reduction of certification scope.
Restoration of certification is possible subject to compliance and in all cases within a maximum period of 6 months.
Following a substantiated request from the company, EURO-QUALITY SYSTEM acknowledges receipt of the appeal and contacts the company if necessary.
The appeal is reviewed by competent persons who did not participate in the audit activities or the certification decision concerned. The admissibility of the appeal is assessed and the actions to be taken are defined in full impartiality.
As far as possible, the decision takes into account the elements and expectations expressed by the company.
Any complaint or claim is handled by EURO-QUALITY SYSTEM provided it is submitted in writing. No anonymous complaint or claim will be processed, including if the applicant does not wish to be named, as handling would be impossible.
The complaint or claim is handled by the Management of Euro-Quality System. It is subject to a processing request and feedback to the entity concerned. The applicant is informed of the correspondence and the follow-up. Based on the response, substantiated by the certified company, EURO-QUALITY SYSTEM may decide on corrective measures or dismiss the request; in all cases, the applicant is informed in writing.
Lists may be provided on request to certain organizations (e.g. chambers of commerce).
Any written request for certificate validity receives a response.
No anonymous request (e.g. by phone) is processed.
An ORGANIZATION certified by EURO-QUALITY SYSTEM may refer to its certification provided that:
An ORGANIZATION certified by EURO-QUALITY SYSTEM may use the EURO-QUALITY SYSTEM logotype.
The scope of ISO 20387 states that “users of biobanks, regulatory authorities, organizations and systems using peer assessment, accreditation bodies and other entities may also use this document to confirm or recognize the competence of biobanks.”
Therefore, any of these entities, in addition to the biobank internally, whether second party or third party like EQS, may use this standard and certify conformity of its implementation under its own responsibility.
In its response to Club3CR at the end of 2020, the Director General of Cofrac clearly validated that:
“A certification body may use this standard, provided it demonstrates its competence in the matter.”
For reference, extract from the Cofrac website dated 01/03/2022:
“Accreditation concerns only companies that perform control services… It is therefore aimed at testing and calibration laboratories, verification bodies, medical biology laboratories, and inspection, certification or qualification bodies.”
Nothing requires it. Furthermore, the establishment of an accreditation scheme, in addition to the need for creation by a party or a regulatory text, requires the definition of a flexible accreditation scope, the drafting of reference documents, the identification of assessors, the solicitation of Committees… All these steps take time, during which the level of appropriation of ISO 20387 by French biobanks allows them to maintain a recognized leadership through their certification by a third-party body.
Nothing prevents certification under NF S96-900, and since this standard is not cited in a regulatory text, any certification body can continue to respond to a certification request under this standard.
The decision of the national standardization body to withdraw a standard from its catalogue does not prevent its continued use (numerous examples exist in technical standards).
The market for the provision and valorization of biobanks will dictate the longer-term approach on the coexistence of ISO 20387 and NF S96-900, or even, as currently, on a more targeted international recognition focused on ISO 9001.
Even though the French standardization body cancelled the distribution of the NF S96-900 standard in summer 2023, the certificates issued by Euro Quality System remain valid.
Surveillance and renewal audits can continue to be carried out under this standard.
Although it is appropriate to consider a potential transition, EQS does not impose any mandatory switch to ISO 9001 and/or ISO 20387 and continues to offer certification under NF S96-900.
Euro Quality System (EQS) scrupulously applies the ethical and conflict-of-interest rules derived from IAF (International Accreditation Forum) MDs and COFRAC doctrines related to ISO 17021-1, including for standards such as NF S96-900 or ISO 20387 which are not part of our accreditation scopes, unlike for example ISO 9001 or ISO 14001.
As a result, it is ethically impossible for us to provide consulting and support, a fortiori jointly with a certification audit. We can only carry out pre-audits and/or mock audits under conditions defined by the doctrines and only before the initial audit of a standard.
To date, the reference text cites NF S96-900, the annual data collection table cites NF S96-900 and ISO 9001, and both certifications are taken into account.
Active working groups have expressed good hope of eventually seeing ISO 20387 added as an eligibility criterion.
Our teams are available to provide you with information and advice.
Main site :
14, Avenue de l’Europe,
Regus – Floor 3
77144 Montévrain, France
Tel : 00 33 160 428 948
Headquarter :
1710 Chemin de la Decelle, Drome Sud Provence business park
26130 Saint-Paul-Trois-Châteaux, France