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HEX AND QUALITY
ACCREDITATION FROM 2012 TO 2020!

HeX GROUP, a testing laboratory historically accredited since 2012, has made the ISO 17025 standard the backbone of its organisation. The extension audit in January 2020 was a real challenge for HeX: to comply with the new version of the ISO 17025 standard: 2017!

Following the 17 days of cumulative audits, the auditors and various technical experts deployed by the Belgian accreditation body declared HeX GROUP and HeX LAB to be in compliance with the requirements of the international standard ISO 17025 version 2017, and renewed the accreditation certificates 464-TEST, 464-CAL and 661-TEST for a period of 5 years…

CHANGES IN THE ACCREDITATION SCOPE

Number of accredited activities

2017: HeX Lab activities are accredited for the first time.

2018: First accreditation of HeX Mapping & Calibration activities

2020: A NEWFOUND AUTONOMY:

Since 2018, HeX has experienced a deterioration in relations with the Belgian accreditation body’s own staff.

As a result of this sentiment, and thus to a loss of confidence in the Belgian accreditation system, HeX has adapted to this situation and has decided to voluntarily renounce its 464-TEST, 464-CAL, 464-INSP and 661-TEST accreditations as of 01 January 2021

HeX is aware that this decision is risky, but HeX is also convinced that it has many advantages

With this relinquishment, HeX has decided, on the strength of its experience and expertise, to launch itself and to provide its clients and partners with its own proof of organisational, technical, relational and quality competence, in complete transparency, and to build a collaboration with them in full knowledge and trust. This renunciation does not mean a change in the Quality of HeX services. This is not the case.

HeX GROUP is continuously pursuing a quality policy in its operations and at all stages of the identified processes with the aim of fully satisfying the requirements of its customers and the requirements of the international standard ISO 17025:2017.

HeX: ISO 17025 Compliant

WHAT IS HEX PUTTING IN PLACE TO MEET THE REQUIREMENTS OF ISO 17025:2017?

Complete, defined and functional management structure

– Process approach and risk analysis

– Consistent system with strong values regarding confidentiality, impartiality and thoroughness.

– Competent staff following a defined and comprehensive training, qualification and monitoring process

– Efficient, robust and monitored equipment

– Continuous improvement, customer satisfaction and internal audits

– Fluidity and completeness of the documentation system

– Validation and monitoring of test and calibration methods

– Change management

– Assurance of the validity of the results by multiple technical means such as:

intermediate checks of measuring instruments,

intra-laboratory testing campaigns,

participation in proficiency testing according to ISO 17043,

blind sample or object testing.

assessment of the laboratory’s repeatability and reproducibility,

the use of reference materials.

Accreditation is a tool for RECOGNITION by a single body: BELAC, attached to the Belgian Ministry of Economics. Accreditation is therefore a means of quickly identifying a service provider that complies with the requirements of a standard (ISO 17025, ISO 17020, ISO 15189, ISO 17021, ISO 17034, and certification bodies).

An organisation such as HeX is committed to comply with with ISO 17025 standard requirements, without applying for recognition as such.

HEX RECALLS THAT IT ISN NOT AN ACCREDITED LABORATORY, AND CANNOT BE CONSIDERED AS SUCH.

SO HERE IS THE COMPARISON BETWEEN THESE TWO PROVIDERS:
SO HERE IS THE COMPARISON BETWEEN THESE TWO PROVIDERS:
Logo-compare-belac-qualite@2x
icon-prestataire-belac

Bellac accredited service provider

HeX company

Compliance with the requirements of ISO 17025

Continuous improvement, customer satisfaction and internal audits

Process approach and risk analysis

Logo applied to reports

Fluidity and completeness of the documentation system

Auditors selected by BELAC

Auditors selected by HeX customers

Audit by external and independent technical experts every 18 months

Requirements audited by independent experts

ISO 17025

ISO 17025 - and/or PIC/S PE010 and/or any other as required by the customer

Standardised and documented testing, calibration and inspection methods

Expertise and technical innovation

Automatic recognition guaranteed internationally

*

Not automatic

* Linked to the signature of the multilateral agreements of BELAC with EA and ILAC

COMMITMENT AND GUARANTEE

WHAT ARE HEX'S QUALITY OBJECTIVES AND COMMITMENTS?

HeX GROUP complies with the normative, legislative, regulatory or other texts deemed relevant with regard to the performance of tests and calibrations as well as the criteria used to determine compliance, if applicable.

HeX’s aim is to build a relationship of trust with its customers. This construction is based on transparency and accessibility to the information the customer needs, including:

• Quality manual reworded clearly. It describes the objectives, the means implemented, the “Process” organisation and the main rules to be followed so that the efficiency and continuous improvement of the management system are permanent

• Quality Agreement in which HeX commits to the ISO 17025:2017 requirements

• Cross-reference table between ISO 17025:2017 and all HeX documentation? (Available on request)

• Precise list of technical activities performed under “ISO 17025 COMPLIANCE”

Scope ISO 17025 Compliant HeX-GROUP

Scope ISO 17025 Compliant HeX-LAB

Scope ISO 17020 Compliant HeX-GROUP

• Availability of HeX teams and premises for supplier audits for its customers or prospects.

HeX GROUP is committed to continuous innovation in all its activities in order to meet the current and future needs of its customers under the best possible conditions.

This innovation is reflected in the implementation of new avant-garde technical solutions and anticipation of regulatory and normative developments. Standardisation is a strategic tool for innovation, but outdated and out-of-date standardised methods can put the brakes on innovation.

What can be done when a standard does not include efficient technical solutions available on the market? What is there to choose between:

– Strict or even limited compliance with a standard and use of outdated or obsolete technical solutions

– Improving the quality of the result, to exceed the requirements of a standard, by using recent and innovative technical solutions

In this case, HeX has chosen to progress and adapt its methods to safe and available technological developments, while securing the requirements of the ISO 17025 standard and analysing the related risks and impacts.

Beyond the formal, technical and organisational aspects, the policy followed by HeX also aims to promote a spirit of quality within the company, which is an essential complement to real progress.

HOW DOES HEX ENSURE THAT ITS SKILLS ARE MAINTAINED?

HeX uses a third party to put together a team of external consultant auditors. The quality and competence of these independent consultants is assessed on the basis of their curriculum vitae and experience in the field. For example, they may have contributed to the drafting of international standards and, at the same time, have solid and long-term experience as a COFRAC and/or BELAC assessor.

HeX also offers the possibility for customers to nominate auditors to ensure bilateral trust between HeX and its customers; as well as the impartiality of the auditor(s).

Regarding the frequency, HeX applies the same interval schedule as for BELAC audits, i.e. at least every 18 months (“If the accreditation cycle is extended to 5 years, it includes 3 surveillance audits” 3.3.2 BELAC 3-11 Rev 13-2020)

THIRD-PARTY RECOGNITION

IS ACCREDITATION BY ANOTHER EQUIVALENT BODY BEING CONSIDERED?

In general, a laboratory applies for accreditation to the accreditation body of the country in which it resides (BELAC for Belgium, COFRAC for France, UKAS for United Kingdom, TÜRKAK for Turkey, etc. )

The only possible exception is if there is no accreditation body in the country concerned, which is not the case for HeX. So to the question, “Is accreditation by another equivalent body being considered?,” the answer is no, because it is not feasible.

Nevertheless, these national accreditation bodies play an important role in harmonising practices. HeX is convinced of the value of such a body and remains open to possible collaboration if trust is regained and proof of impartiality and neutrality provided.

WHAT ABOUT OTHER POSSIBLE THIRD-PARTY RECOGNITIONS?

HeX is convinced that its system is efficient and secure, so it is exploiting all available avenues to obtain official recognition by an independent third party. To date (2020), GMP accreditation is currently under active preparation and recognition as a Notified Body for medical devices (ON - Medical Device Regulation) is also being considered by the Management and the QA Team.

Can the auditor force me to use an accredited provider?

For the tests and calibrations carried out in controlled environments such as “Clean Rooms” by HeX, there is to date, no legal obligation to choose an accredited service provider. The choice and selection of a provider lies in the ability of this provider to meet your own requirements (quality, organizational, etc.) that you, as a client, deem important. Thus, there is no legal reason for your auditor to require HeX to be accredited for its services in your Clean Rooms.

CHOOSING HEX

HOW AND WHY SHOULD HEX BE SELECTED, DESPITE THE LACK OF ACCREDITATION?

The selection of a provider is based on your own selection criteria such as:

– Staff skills and management of staff qualifications

– Qualification and monitoring of critical equipment

– Management of non-conformities

– Analysis of causes and implementation of action plans (CAPA)

– Change Control

The list is not exhaustive as there are many criteria.

When selecting a service provider, a qualification file of the provider must be produced on the basis of defined criteria. When the complete and comprehensive qualification file provides evidence that HeX meets your needs it becomes an approved provider. No additional elements may be requested by the auditor.

In addition, HeX offers to draw up a Quality & Technical Agreement to define and structure the various commitments, responsibilities and guarantees provided by HeX

HOW CAN WE GIVE AUDITORS CONFIDENCE?

Following regular audits by the independent third party, an attestation document is issued. Like an accreditation certificate, it will show the date of application of the certificate and its validity.

The technical appendices will also be present to specify the scope of application of this certificate and it will be signed by the independent manager of this audit team. CVs to attest to the competence of the auditors can be provided on request to easily demonstrate the competence and relevance of this audit to your auditor.

OUR PLUS

AFTER ACCREDITATION, WHAT CHANGES?

The specific BELAC logo no longer appears on HeX reports and associated documents.

Nevertheless, nothing changes in terms of the quality of our services, which will always be carried out with the same thoroughness and professionalism that characterises HeX today.

THE SERVICES WILL ALWAYS BE PERFORMED IN STRICT COMPLIANCE WITH THE REQUIREMENTS OF THE ISO17025 STANDARD.