Information of Special Importance to Calibration Laboratories

13th September 2017

Information for testing laboratories, calibration laboratories and other interested parties  

The Accreditation Body of Serbia (АТS) granted its first accreditations in 2000 to testing laboratories according to the then valid reference document for accreditation of laboratories, SRPS ISO/IEC Guide 25. Later in 2001 ATS started accrediting laboratories against SRPS ISO/IEC 17025 and has so far accredited over 400 laboratories.  

For 11 years reference document for accreditation of laboratories has been SRPS ISO/IEC 17025, whose last revision in the Institute for Standardization of Serbia was published in 2006.  Vast experience has been attained in application and assessment of observance of requirements of the said standard both in accredited laboratories and in ATS.   

Due to the changes in the environment where laboratories do business, International Organization for Standardization started activities on revision of ISO/IEC 17025:2005 in 2015 and currently voting on definitive text of the draft of the said international standard is in progress at it is carried out simultaneously in ISO and CEN. The voting will be carried out from 14th August 2017 to 9th October 2017. Publishing the standard globally is planned for November/December 2017. There are significant changes of the structure and content of the standard in comparison to the currently valid version of the standard.

Committee for standards and related documents КS CАSCO, Conformity assessment and quality management of ISS, participants of which are ATS representatives, has already started translating the standard FDIS ISO/IEC 17025, in order to provide the beneficiaries with the translation of the standard the immediately upon publishing on the international level. 

More detailed information on the condition of revision of the standard ISO/IEC 17025 can be found on the webpage of ISS .

ATS invites all accredited laboratories to monitor the state of revision of ISO / IEC 17025 standard and, in accordance with their needs, begin preparations for the harmonization of their work with the requirements of the new edition of the standard.

ATS will, immediately after adoption of appropriate resolution for transition to accreditation of laboratories according to new edition of ISO/IEC 17025 by the International Laboratory Accreditation Cooperation (ILAC), publish new information to all accredited laboratories on transition period and mode of transition to accreditation by ATS according to the future version of ISO/IEC 17025.

19th April 2017

Information for CABs about change of rules in ATS

In February 2017, the Accreditation body of Serbia (ATS) made amendments in two documents: Rules for the Use of the Accreditation Symbol, Reference to Accreditation and ATS Status as a Signatory to the ЕА MLA, ILAC MRA and IAF MLA ATS-PA04 (technical correction published on ATS website on 19th April 2017) and Cross-frontier Accreditation Rules ATS-PA05 in order to conform them with the following changes in international documents:

- ATS-PA04, Rules for the Use of the Accreditation Symbol, Reference to Accreditation and ATS Status as a Signatory to the ЕА MLA, ILAC MRA are completely in compliance with the requirements of ILAC-R7:05/2015, Rules for the Use of the ILAC MRA Mark, IAF ML 2:2016, General principles on the use of the IAF MLA mark and EA-1/19 A:2015, Rules for Use of the EA Logo, as well as IAF resolutions (IAF Resolution 2015-14, Agenda Item 10 и IAF Resolution 2016-17, Agenda Item 9).

One of the significant changes refers to application of the decision by IAF GA (IAF Resolution 2015-14, Agenda Item 10 и IAF Resolution 2016-17, Agenda Item 9) which obligated CABs certifying management systems to use accreditation symbol on conformity assessment certificates for fields they are accredited for, in accordance with the granted Scope of accreditation.

It shall be deemed that the document for management systems certificates were issued by the process of accreditation if they have an accreditation symbol and/or refer to accreditation in the text and/or combined mark (if applicable).

Certification bodies that certify the management systems:

(1) must coordinate (conform) that the certification documents contain a symbol of accreditation or refer to accreditation at the time of making the decision about the recertification at the latest until the 6th November 2019

(2) during the process of making the decision on initial accreditation, i.e. the extension of the scope of accreditation for the new standard, starting 6th November 2019, certification bodies, which certificate the management systems must re-issue, previously issued non-accredited documents of certification in a period of one year until the date of making the final decision about accreditation.

Note: If there is an exception from the previous paragraph, the certification body’s Client, which certifies the management systems must justify this exception to both the certification body as well as to the accreditation body, and if they reach agreement between both parties, the certification in question will be considered to be accredited.

Point 2.2 of the document EA Rules for Use of the EA Logo EA-1/19 A:2015 stipulates that conformity assessment bodies accredited by EA members are not allowed to use EA logo. If you use EA logo on your website, it is vital that the logo be removed if you published it and the proof/information about it be sent to ATS to following email: [email protected]

Likewise, should you be interested in promoting international status of ATS as a signatory to the ЕА MLA/MRA and full member of international accreditation organisations (EA, ILAC, IAF), you can do so by putting the link to e.g. ATS logo which will direct to the ATS internet page containing the text about ATS status and international recognition (http://ml18.ru/en/pages/international-organisations-and-agreements) – About us/International organizations and agreements and pursuant to point 3.2.1 of the Rules for the Use of ATS Logo ATS-PA07 which defines that “ATS logo may, upon request, be approved for use for other purposes, in adverts, articles, publications, on fairs, exhibitions, conferences/seminars and websites of other organizations.”

АТS-PА05, Cross-frontier Accreditation Rules  which defines ATS policy applied when accrediting conformity assessment bodies with the head office outside the Republic of Serbia or CABs established in the Republic of Serbia having sites and/or key activities in another country, and the policy related to cooperation with other accreditation bodies in case of cross-frontier accreditation; these Rules are fully in compliance with the requirements of EA- 2/13 М:2012, ILAC-G21:09/2012 and Regulation (EC) No. 765/2008 and they are additionally updated with the explanations of definitions concerning cross-frontier accreditation laid out in the document EA- 2/13 S1.

3rd March 2014

The International Bureau of Weights and Measures (BIPM) published calibration and measurement capabilities (CMCs) of the Directorate of Measures and Precious Metals (DMDM) for the field of acoustics, ultrasound and vibrations (AUV), subfield: sound in air.

On 27th February 2014 BIPM recognised the CMCs for 12 DMDM calibration services pertaining to calibration of laboratory standard microphones (LS1P and LS2P) by using primary reciprocity calibration method.

CMC List of DMDM is available on the BIPM website: (...).

1st June 2013

In the first half of 2013 the Accreditation Body of Serbia (ATS) changed a series of documents and adopted the new management system documents in line with the requirements of the signed international agreements (EA MLA, ILAC MRA and IAF MLA) and obligations arising therefrom, change of the EA, ILAC and IAF documents, and the ATS wish to upgrade its management system and increase the efficiency of its operation.

With that end in view the following rules were changed:

- ATS-PA04, Rules for the Use of the Accreditation Symbol, Reference to Accreditation and ATS Status as a Signatory to the ЕА MLA, ILAC MRA and IAF MLA  in order to define the policy, conditions and rules for the use of the accreditation symbol and reference to accreditation, and the conditions and mode of use of the marks of international organisation for accreditation and reference to ATS status as a signatory to the said multilateral agreements; these Rules are fully in compliance with the requirements of ЕА-3/01 M: 2012, ILAC-R7:09/2009 and IAF ML 2:2011;

- ATS-PA05, Rules of Cross-frontier Accreditation defining the ATS policy applied when accrediting conformity assessment bodies with the head office outside the Republic of Serbia or CABs established in the Republic of Serbia having sites and/or key activities in another country, and the policy related to cooperation with other accreditation bodies in case of cross-frontier accreditation; these Rules are fully in compliance with the requirements of EA- 2/13 М:2012, ILAC-G21:09/2012 and Regulation (EC) No. 765/2008;

- ATS-PA03, Rules for Obtaining Acceptable Traceability of Measurement in order to be in compliance with ILAC- P10, ILAC Policy on Traceability of Measurement Results, and

- ATS-PA01, Rules of Accreditation that define the entire accreditation procedure, requirements to be met by CABs, rights and obligations of those participating in accreditation granting and maintenance. In addition to harmonisation with the changes in the management system documents and in order to increase the efficiency of the ATS operation and continue observance of the requirements of SRPS ISO/IEC 17011, the following periods of realisation of regular surveillance assessments were changed: “First regular surveillance assessment shall be carried out 6 to 9 months after the accreditation has been granted, second regular surveillance assessment shall be carried out 18 to 21 months after the accreditation has been granted, while the third one shall be carried out 30 to 33 months after the accreditation has been granted”. In accordance with the aforementioned, the time frame in case of realisation of reassessments was changed since this time frame require that reassessments shall be, as a rule, performed 6 months before the expiry of the accreditation validity period as specified in the changed Rules. Hence the plans of realisation of surveillance assessments and reassessments will be changed and accredited CABs will be informed thereof on time. The requirements related to the obligations of CABs and ATS were changed in line with the obligations arising from the signed agreements.

The Rules for the Use of ATS Logo ATS-PA07 were drafted in order to define the policy, conditions and use of the ATS logo and marks of international organisations for accreditation and reference to ATS status as a signatory to the multilateral agreements promoting equivalence of the accreditation systems.

In order to improve the operation of the ATS assessment teams and harmonise the assessor interpretations when performing assessments, ATS started collecting data related to the performed assessments by means of the special form entitled Evaluation of Performed Assessments (ATS-PR09-O02) that is available on the ATS website.

In the previous period ATS issued a larger number of the following guides governing specific fields of testing: ATS-UP27, Guides for the Accreditation of Microbiology Laboratories, and ATS-UP29, Guides for the Application of ISO/IEC 17025 when performing assessments of and granting accreditation to laboratories performing sensory testing, and ATS-UP32, Internal Control of Basic Metrological Parameters in Non-automatic Weighing Instruments between Two Calibrations providing description of the inspection procedure in case of basic metrological parameters affecting the measuring accuracy of non-automatic weighing instruments. The said documents are intended for both CABs and ATS assessors.

The document entitled ATS-UP28 Laboratory Accreditation Guide for Flexible Scopes specify the requirements for laboratories wishing to get accredited for flexible scopes of accreditation and procedures applied by ATS when granting accreditation to such laboratories. The said document is in compliance with EA 2/15 M. Flexibility means that laboratories can change the scope of accreditation they were granted accreditation for with no previous ATS assessments performed.

ATS grants accreditation to laboratories performing sampling and therefore the new Guide ATS-UP25 Accreditation of Sampling Activities stipulates the principles of assessment and accreditation of sampling activities performed by ATS.

All the said documents shall enter into force on the date of their adoption.

8th April 2013

Information about the content of the assessment report/calibration certificate when a laboratory has to state compliance with specifications

(based on ILAC-G8:03/2009, Guidelines on the Reporting of Compliance with Specification)

The information is intended for assessors of the Accreditation Body of Serbia and laboratories that need to provide statements of compliance with specifications in their test reports/calibration certificates.

The following references from ILAC-G8:03/2009, Guidelines on the Reporting of Compliance with Specification enable/explain coherent application of specific requirements of SRPS ISO/IEC 17025:

- For testing laboratories, ISO/IEC 17025:2005 (clause 5.10.3.1 b) requires that “the test report shall, where necessary for the interpretation of the test results include…, where relevant, a statement of compliance/non-compliance with requirements and/or specification”.;

- For calibration laboratories, ISO/IEC 17025:2005 (clause 5.10.4.2) requires that “if a statement of compliance with a specification is made, this shall identify which clauses of the specification are met or not met”. It is permissible to omit the measurement result and its uncertainty from the report as long as they are retained for possible future reference.

Statements of compliance with requirements and/or specifications shall not be considered opinions or interpretations in terms of SRPS ISO/IEC 17025. Therefore, when a laboratory reports such compliance in its test reports/calibration certificates, it has to be properly defined (e.g. statement of compliance with specification, conclusion, etc, but not “opinion”, “interpretation” or “opinion and interpretation”).

When laboratories provide statements of compliance with requirements and/or specifications in their test reports/calibration certificates, these test reports/calibration certificates shall, among other things, contain the following:

  • Test/calibration results with expanded uncertainty;
  • Coverage probability for expanded uncertainty;
  • A statement of compliance should not be reported in a way where it could be confused with inspection or product certification and it can only pertain to a test/calibration item, and
  • Source of specification.

When a specification describes an interval with an upper and lower limit, a statement of compliance or non-compliance should only be made where the ratio of the expanded uncertainty interval to the specified interval is reasonably small and fit for purpose (meaning that the laboratory should be able to meet the needs of the customer).

Measurement results can be stated without measurement uncertainty only when a specification or legal requirements require so (e.g. when it is stated that measurement uncertainty has been accounted for when setting the limits).

Stating compliance with specification for a single quantity

When a measurement result, including extended uncertainty, is compared with the specification interval (upper and lower specification limit) 4 cases can be defined (Figure 1):

  • Case 1: measurement result with expanded uncertainty is below the upper specification limit or above the lower specification limit;
  • Case 2: measurement result is below the upper specification limit or above the lower specification limit, but the interval of expanded uncertainty is outside the specification limit;
  • Case 3: measurement result is above the upper specification limit or below the lower specification limit, but the interval of expanded uncertainty includes part of the specification interval;
  • Case 4: measurement result with expanded uncertainty is above the upper specification limit or below the lower specification limit.

Figure 1. Compliance with specification for upper and lower limits

In case 1 compliance with the specification can be stated as “Compliance” or “Compliance – The measurement result is within (or below) the specification limit when the measurement uncertainty is taken into account with a 95% coverage probability for extended uncertainty”.
In case 4 noncompliance with the specification can be stated as  “Non-compliance – The measurement result is outside (above upper or below lower) the specification limit when the measurement uncertainty is taken into account with a 95% coverage probability”.
 
In cases 2 and 3 it is not possible to state compliance or non-compliance. In Case 2 it is possible to indicate “It is not possible to state compliance using a 95 % coverage probability for the expanded uncertainty although the measurement result is below the upper limit”. Only in case of a clear need for the statement of compliance/noncompliance (e.g. legal requirement), case 2 can be reported as follows “Compliance – compliance cannot be confirmed with a 95 % coverage probability for expanded uncertainty which means that the measurement result can be outside (above upper or below lower) the specification limit”, while in case 3 this can be reported as “Noncompliance – noncompliance cannot be confirmed with a 95 % coverage probability for expanded uncertainty which means that the measurement result can be inside (below upper or above lower) the specification limit”.
 
In case of a measurement result that is equal to the specification limit the procedure will follow that of case 3. If a laboratory is using a coverage probability other than a 95% coverage probability, then a statement of compliance/noncompliance with specification has to be harmonised given the used coverage probability.

Stating compliance with specification involving multiple quantities
 
If the evaluation of compliance with specification comprises more quantities, each measurement value should be evaluated independently. The result of each evaluation should be reported.
 
An overall evaluation of compliance with requirements or specification may be formulated in one of the following ways, or by combining them:

  • “All measured values comply with the specification limit(s)” or “The item/sample complies with the requirements”. This covers situations where all measurements comply with specification (Case 1 of Fig.1);
  • “For some of the measured values it is not possible to make a statement of compliance with specification”. This covers situations where some of the measurements demonstrate neither compliance nor non-compliance with specification (Case 2 and 3 of Fig.1).
  • “Some of the measured values do not comply with specifications” or “The item/sample does not comply with the requirements”. This covers situations where one or more measurements are in non-compliance with specifications (Case 4 of Fig.1).  

19th October 2012

Accepting DMDM measuring capabilities in volume calibration

We hereby inform the users that the measurement capabilities (CMC) of the Volume and Flow Group of the Directorate for Measures and Precious Metals in the field of calibration of measuring instruments of unit volume of liquids are accepted and posted on the BIPM website, a total of 13 services of measurement range of up to 5,000 L (see Annex).

Confirmation of measuring capabilities in the field of calibration enabled the traceability of standards of the Republic of Serbia to the international level, and hence the opportunity for accredited laboratories to ensure traceability of calibration results as documented in the ATS Rules.

Published measuring capabilities for other areas of calibration of the Directorate for Measures and Precious metals can be found in the database of the International Bureau of Weights and Measures (BIPM)

7th June 2012

At the regional conference on accreditation that was held in Aranđelovac, Serbia, on 11th and 12th May 2012 and organised by the Accreditation Body of Serbia (ATS) as part of the EU regional IPA 2011 Project entitled “Quality Infrastructure in the Western Balkans and Turkey” it was decided that ATS should compose a uniform list of accredited calibration laboratories from the region that would then be uploaded onto the websites of the regional ABs.

31st May 2012

Any extension of the measuring range in case of calibration laboratories is considered as extension of the scope of accreditation and in accordance therewith the Accreditation Body of Serbia will undertake appropriate activities. A laboratory shall submit an application for the extension of the scope of accreditation that will be accompanied by all the necessary information.

When reviewing the application for the extension of the scope the Accreditation Body of Serbia will, depending on the scope to be extended, carry out an on-site assessment and the necessary witnessing or it will only perform a documentary review thereof. If the change in the measuring range significantly affects the calibration and measurement capability (СМС), the assessment will be carried out together with a mandatory on-site witnessing.

Accredited calibration laboratories are recommended to carry out such extensions as part of regular surveillance assessments.

 

topobzor.info/meizu-pro-6-plus/

maxformer.com

viagra-on.com