The process of implementation international standard ISO/IEC 17065:2012

With the aim to form unified technical policy in the work of NAAU and to provide implementation of international standard ISO/IEC 17065:2012 “The Plan of ISO/IEC 17065:2012 Implementation” was established by NAAU Decree No.5 dated January, 18 2013.

In correspondence with the abovementioned plan the following activities were held:

  • The clients were informed of the ISO/IEC 17065:2012 issuance by official NAAU web-site;
  • The translation of ISO/IEC 17065:2012 was provided;
  • The Accreditation technical committee was informed and did approve the standard translation (official minutes of Accreditation technical committee № 34 dated 14.06.2013);
  • The translation was uploaded to NAAU web-site;
  • Tuition for staff was provided.

Inner tuition:

  • 09.12.2013 (Decree No.287 dated 31.10.2013), lecturer – V. Krasyuk;
  • 10.02.2014 (Decree No.62 dated 25.01.2014), lecturer – O. Hromenko;
  • 28.04.2014 (Decree No.175 dated 30.03.2014), lecturer – V. Krasyuk;
  • 29.01.2015 (Decree No.494 dated 23.12.2014 ), lecturer – O. Hromenko.

Outer tuition:

  • SE «UkrNDNC» on 20.09.2013 (Decree No.195 dated 29.08.2013), lecturer – V. Krasyuk.

As of 06.05.2015 27 employees of NAAU as well as 35 outer experts attended tuitions. Among NAAU staff there are 16 chief auditors who are authorized to provide assessment against ISО/IEC 17065:2012 as assessment team leaders.

Additional activities:

  • Necessary changes to NAAU management system were made in order for it to comply with ISO/IEC 17065:2012;
  • Decree No.35 dated 17.01.2014 was adopted “Regarding implementation of ISO/IEC 17065:2012 requirements in NAAU activities”;
  •  Decree No.35 dated 17.01.2014  “Regarding implementation of ISO/IEC 17065:2012 requirements in NAAU activities”, was approved by the Accreditation technical committee;
  • Decree No.35 dated 17.01.2014 “Regarding implementation of ISO/IEC 17065:2012 requirements in NAAU activities” was uploaded to NAAU web-site.

In correspondence to the abovementioned Decree:

Starting from 01.01.2015 only applications for accreditation against ISO/IEC 17065:2012 are accepted. Activities according to applications for accreditation against ДСТУ EN 45011-2001 for CABs, that are already accredited, shall be treated as reaccreditation.

Starting from 01.01.2015 all ongoing CAB assessments against ДСТУ EN 45011-2001, shall be finished as those against ISO/IEC 17065:2012.

Starting from 01.02.2014 on the condition of receiving a letter from CAB stating that the mentioned CAB is ready to implement ISO/IEC 17065:2012, the assessment shall be conducted against ISO/IEC 17065:2012 with the following decision to reissue the certificate.

Starting from 01.01.2015 surveillance for CABs that were accredited against ДСТУ EN 45011-2001 shall be provided against ISO/IEC 17065:2012 only, with all the new requirements. Implementation of all corrective actions towards nonconformities must be finalized by 15.09.2015. The changes to accreditation are to be made in case of successful conformity assessment without changing validity of accreditation.

During 2014-2015 NAAU received 15 applications for accreditation against ISO/IEC 17065:2012:

No.

Application No.

Client’s name

1

1О280

Limited Liability Company “ECOSERT”

2

1О283

Limited Liability Company “Testing Center “OMEGA”

3

1О285

The certification body for road-building materials, construction elements of roads and artificial structures of State Enterprise “Center of scientific and technical support for road works and certification of Road products” (SE “Dorcenter”)

4

1О284

Limited Liability Company “CENTER OF CERTIFICATION AND COMPETENCE “TUV CERT Ukraine”

5

1О288

Conformity assessment body of “SRC “VNDIKHIMPROEKT” “Sertpobuthimkosmetyka” LLC

6

1О290

SE “Scince and Research Institute of Metrology and Control Systems” (SE SRC “Systema”)

7

1О291

CB SE «SRI «MASMA»

8

1О292

«Medical Center for conformity assessment» of SE «Ukrainian Institute of Pharmacy Quality»

9

1О293

 «Testing and Research Center “UKRSTANDART” LLC

10

1О294

 «TAIRUM» Product certification body

11

1О295

«Kyivteststandart» LLC

12

10296

“Sertis-center” LLC

13

10297

Ukrainian State Research Institute of Nanobiotechnologies and Resource

14

10298

Орган з сертифікації продукції “Ukrainian institute of development and information and communication infrastructure” Diprozv’yazok” JSC

15

10299

“Mikos-Met” PE

During 2014-2015 NAAU received 10 applications for initial accreditation against ISO/IEC 17065:2012:

No.

Application No.

Client’s name

1

1О280

“ECOSERT” LLC

2

1О283

“Testing Center “OMEGA” LLC

3

1О284

“CENTER OF CERTIFICATION AND COMPETENCE “TUV CERT Ukraine” LLC

4

1О254

Certification body of State enterprise  “Zhitomir scientific and production center of standardization, metrology and certification”

5

1О290

State Enterprise Ltd. «Common Ukrainian – German Company «Technical supervision Dieks»

6

1О291

CB SE «SRI «MASMA»

7

1О292

«Medical Center for conformity assessment» of SE «Ukrainian Institute of Pharmacy Quality»

8

10296

“Sertis-center” LLC

9

10285

The certification body for road-building materials, construction elements of roads and artificial structures of State Enterprise “Center of scientific and technical support for road works and certification of Road products” (SE “Dorcenter”)

10

10297

Ukrainian State Research Institute of Nanobiotechnologies and Resource

During 2014-2015 NAAU received 11 applications for reaccreditation against:

No.

Application No.

Client’s name

1

1О114

Certification body of DP «Chercasystandartmetrology» State enterprise «Chercasy scientific- production center of standardization, metrology and certification»

2

1О194

Сertification body of “Testing certification center “Pivdentest”, Ltd

3

1О102

Product certification body of LLC “PROMELEKTRONSERT”

4

1О208

Private enterprise “POLITOKS”

5

1О120

State enterprise “Inter-regional scientific-engineering center for certification of quality systems, pipes, bulbs and other metal production “VNITI-TEST”

6

1О190

Certification body of State enterprise «Rivne scientific and production center of standardization, metrology and certification»

7

1О183

Certification and conformity assessment body of «PROMTEST», ltd

8

1О207

Certification body of State enterprise  “Zhitomir scientific and production center of standardization, metrology and certification”

9

1О153

Product certification body of LLC “Zhitomirautostandard”

10

10207

Certification body of State enterprise  “Zhitomir scientific and production center of standardization, metrology and certification”

11

10213

“Ukrainian center for medical certification and prognostication”, Ltd.

During 2014-2015 11 accreditations against ISO/IEC 17065:2012 were finalized:

No.

Application No.

Client’s name

1

1О283

Limited Liability Company “Testing Center “OMEGA”

2.

1О139

Сertification body „UkrBUDSERT” of “Rakurs LTD”

3

1О053

Power supply certification body of the Transport Systems and Technology Institute of the National Academy of Science of Ukraine “Transmag”

4

1О102

Product certification body of LLC “PROMELEKTRONSERT”

5

1О114

Certification body of DP «Chercasystandartmetrology» State enterprise «Chercasy scientific- production center of standardization, metrology and certification»

6

1О194

Сertification body of “Testing certification center “Pivdentest”, Ltd

7

1О101

State enterprise „Ukrainian certification medical center”

8

1О190

Certification body of State enterprise «Rivne scientific and production center of standardization, metrology and certification»

9

1О207

Certification body of State enterprise  “Zhitomir scientific and production center of standardization, metrology and certification”

10

1О254

State Enterprise Ltd. «Common Ukrainian – German Company «Technical supervision Dieks»

11

1О292

«State Enterprise Medical Center» DP «Ukrainian Institute of Pharmacy Quality»

During 2014-2015 8 CABs were transferred from ДСТУ EN 45011-2001 to ISO/IEC 17065:2012 as a result of surveillance:

No.

Application No.

Client’s name

1

1О223

Conformity assessment body of “PROMSTANDART”, Ltd.

2.

1О023

Product conformity assessment body of State enterprise ”Ukrmetrteststandart”

3

1О095

Certification Body “Standard-Service” of Research-and-production joint enterprise “Standard-Service”

4

1О096

Product Certification body of

State enterprise Scientific and technical of conformity assessment in construction „BudCenter”

5

1О119

Product conformity assessment body of State enterprise “Kharkiv regional scientific and production center for standartization, metrology and certification”

6

1О227

“TESKO”, Ltd.

7

1О267

Limited Liability Company “Trade House “SAG”

8

1О080

Production certification body of carriage engineering of National enterprise «Ukrainian research institute of carriage engineering »

Therefore, as of 06.05.2015 19 CAB are accredited against ISO/IEC 17065:2012.

Provision of ISO/IEC 17065:2012 was evaluated by EA assessment team without any nonconformities stated.