Information of Special Importance to Medical Laboratories

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.

22nd July 2014

The Accreditation Body of Serbia produced the document entitled “Table of Correspondence between SRPS ISO 15189:2008 and SRPS EN ISO 15189:2014” to present the requirements of SRPS EN ISO 15189:2014 (EN ISO 15189:2012) Medical laboratories - Requirements for quality and competence that were not presented or were only partially presented in the previous version of SRPS ISO 15189:2008  (ISO 15189:2007).

This document is intended for medical laboratories that were granted accreditation as per SRPS ISO 15189:2008 to achieve easier harmonisation with the new version of SRPS EN ISO 15189:2014.

The document will be posted under Guides/Medical Laboratories.

Moreover, the document entitled ATS-UP 11, Requirements to Be Met by Medical Laboratories Accredited to SRPS ISO/ IEC 17025:2006 in order to Get Accredited to SRPS ISO 15189:2008 was withdrawn.

31st March 2014

On 28th February 2014 the Institute for Standardization of Serbia published SRPS ISO/IEC EN ISO 15189:2014, Medical laboratories - Requirements for quality and competence. This edition of the standard repeals and replaces SRPS ISO 15189:2008.

Hence the International Laboratory Accreditation Cooperation (ILAC) made a decision that a transitional period for the application of the new edition of EN ISO 15189, should be over by 1st March 2016, whereas accreditations granted as per the previous edition of the standard should no longer be valid.

ATS planned all activities and carried out all of them (change in the management system documents, training of assessors and persons participating in decision-making) in order to harmonise the accreditation procedure for medical laboratories as per SRPS EN ISO 15189:2014.

ATS will commence performing assessments as per SRPS EN ISO 15189:2014 on 1st September 2014, whereas ATS shall not accept new applications for accreditation as per SRPS ISO 15189:2008 from this date onwards. Laboratories which have already started the assessment procedure as per SRPS ISO 15189:2008 will be given a possibility to choose the edition of the standard to be used for the finalisation of the assessment procedure.

Transitional period for accredited medical laboratories (accredited as per SRPS ISO 15189:2008):

  • assessments of accredited medical laboratories in terms of transition/approximation/harmonisation with the new edition of the standard will be carried out during regular surveillance assessments or reassessments;
  • all medical laboratories accredited as per SRPS ISO 15189:2008 must prepare the SRPS ISO 15189:2014 transition plan that will define the activities to be implemented and changes in time period needed for the implementation thereof. The plan has to be sent to ATS for the purpose of efficient planning of regular surveillance assessments or assessments for the purpose of reaccreditation. With that end in view ATS will harmonise its assessment activities with each accredited medical laboratory;
  • a 1st August 2015 deadline is set for these assessments to be carried out when ATS will no longer carry out assessments as per SRPS ISO 15189:2008.

After 1st March 2016 all accreditations granted as per SRPS ISO/IEC 15189:2008 will no longer be valid. Accreditations granted to those medical laboratories, which failed to adapt to the new edition of the standard by the said deadline, will be suspended and/or withdrawn. The ATS procedures prescribe that the suspension period shall last up to 6 months maximum.

14th August 2013

New edition of ISO 15189

New edition of ISO 15189, ISO 15189:2012 Medical laboratories - Requirements for quality and competence, was published at the end of 2012.

Hence the International Laboratory Accreditation Cooperation (ILAC) made a decision that a transitional period for the application of the new edition of ISO 15189 should be over by 1st March 2016.

This edition of the standard (third one) repeals and replaces the second edition (ISO 15189:2007) the technical review of which was carried out. Furthermore, this edition provides a basis for continuous approximation to the requirements of ISO/IEC 17025. The relationship between these two editions is presented in Annex B, ISO 15189:2012.

Management system requirements in Chapter 4, ISO 15189:2012, were explained in the language that is of importance to the operation of medical laboratories and that fulfils the principles of ISO 9001:2008, Quality management systems – Requirements, and that are in keeping with relevant requirements of this standard. The relationship between the clauses and sub-clauses of this edition of ISO 15189 and those of ISO 9001:2008 and ISO/IEC 17025:2005 is presented in Annex A of this international standard.

It is important to emphasise that this edition of ISO 15189 provides general explanation of environmental protection issues related to the activities of medical laboratories.

By the end of 2013 the Institute for Standardization of Serbia (ISS) will publish the Serbian (SRPS) version of ISO 15189, whereas this edition of the standard will repeal and replace SRPS ISO 15189:2008.

The Accreditation Body of Serbia (ATS) will plan all activities and carry out all of them (change in the management system documents, training of assessors and persons participating in decision-making) in order to harmonise the accreditation procedure of medical laboratories to mirror the new edition of the standard, whereas ATS will consider the date of issuance of the Serbian version of the standard.

Assessments of accredited medical laboratories in terms of transition/approximation to/harmonisation with the new edition of the standard will be carried out during regular surveillance assessments or reassessments. Hence ATS will harmonise its assessment activities in case of all accredited medical laboratories.

After 1st March 2016 accreditations granted as per SRPS ISO/IEC 15189:2008 shall no longer be valid.

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.

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.

March 2009

The Accreditation Body of Serbia produced the document entitled ATS-UP 11, Requirements to Be Met by Medical Laboratories Accredited to SRPS ISO/ IEC 17025:2006 in order to Get Accredited to SRPS ISO 15189:2008. The said document is intended for medical laboratories accredited as per SRPS ISO/IEC 17025:2006 and for those medical laboratories seeking accreditation as per SRPS ISO 15189:2008.

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