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Germany

ap-qualifizierung

Lembergstraße 17, 72766, Reutlingen, Germany

DAKKS|D-PL-20966-01-01DAKKS|D-PL-20966-01-02DAKKS|D-PL-20966-01-00ISO/IEC 17025Register refreshed 2026-09-25
Certificates
3
Scope items
9
Standards
8
Locations
1

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DAKKSRefreshed
D-PL-20966-01-01Active
D-PL-20966-01-02Active
D-PL-20966-01-00Active

Accredited standards

8

Our reading of the DAKKS scope: each standard once, with its official name where we have checked it. Click a standard to see the scope line it comes from, word for word.

EN 17141Cleanrooms and associated controlled environments - Biocontamination control
As written on the certificate · Line 2 (DAKKS D-PL-20966-01-01)

DIN EN 17141; ISO 14698-1; DIN EN ISO 14644-1; DIN EN ISO 14644-3; DIN 1946-4

As written on the certificate · Line 2 (DAKKS D-PL-20966-01-02)

DIN EN ISO 11737-2; DIN EN ISO 13485; DIN EN ISO 11737-1; DIN EN 17141

As written on the certificate · Line 4 (DAKKS D-PL-20966-01-02)

DIN EN ISO 11737-1; DIN EN ISO 11737-2; DIN EN ISO 14644-1; DIN EN ISO 14644-2; DIN EN ISO 14644-3; DIN EN ISO 14644-4; DIN EN 17141; EG-Leitfaden GMP, Anhang 1; VDI 6022 Blatt 1; T-110-SOP 2022-06-22; T-111-SOP 2022-06-22; T-112-SOP 2022-06-22; T-113-SOP 2022-06-22; T-114-SOP 2022-06-22; T-115-SOP 2022-06-22; T-116-SOP 2022-06-22

ISO 11737-1Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
As written on the certificate · Line 2 (DAKKS D-PL-20966-01-02)

DIN EN ISO 11737-2; DIN EN ISO 13485; DIN EN ISO 11737-1; DIN EN 17141

As written on the certificate · Line 4 (DAKKS D-PL-20966-01-02)

DIN EN ISO 11737-1; DIN EN ISO 11737-2; DIN EN ISO 14644-1; DIN EN ISO 14644-2; DIN EN ISO 14644-3; DIN EN ISO 14644-4; DIN EN 17141; EG-Leitfaden GMP, Anhang 1; VDI 6022 Blatt 1; T-110-SOP 2022-06-22; T-111-SOP 2022-06-22; T-112-SOP 2022-06-22; T-113-SOP 2022-06-22; T-114-SOP 2022-06-22; T-115-SOP 2022-06-22; T-116-SOP 2022-06-22

ISO 11737-2Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
As written on the certificate · Line 2 (DAKKS D-PL-20966-01-02)

DIN EN ISO 11737-2; DIN EN ISO 13485; DIN EN ISO 11737-1; DIN EN 17141

As written on the certificate · Line 4 (DAKKS D-PL-20966-01-02)

DIN EN ISO 11737-1; DIN EN ISO 11737-2; DIN EN ISO 14644-1; DIN EN ISO 14644-2; DIN EN ISO 14644-3; DIN EN ISO 14644-4; DIN EN 17141; EG-Leitfaden GMP, Anhang 1; VDI 6022 Blatt 1; T-110-SOP 2022-06-22; T-111-SOP 2022-06-22; T-112-SOP 2022-06-22; T-113-SOP 2022-06-22; T-114-SOP 2022-06-22; T-115-SOP 2022-06-22; T-116-SOP 2022-06-22

ISO 14644-1Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration
As written on the certificate · Line 2 (DAKKS D-PL-20966-01-01)

DIN EN 17141; ISO 14698-1; DIN EN ISO 14644-1; DIN EN ISO 14644-3; DIN 1946-4

As written on the certificate · Line 3 (DAKKS D-PL-20966-01-02)

DIN EN ISO 13485; DIN EN ISO 14644-1; DIN EN ISO 14644-3; DIN EN ISO 14644-2; DIN EN ISO 14644-4; VDI 6022 Blatt 1; EG-Leitfaden GMP, Anhang 1

As written on the certificate · Line 4 (DAKKS D-PL-20966-01-02)

DIN EN ISO 11737-1; DIN EN ISO 11737-2; DIN EN ISO 14644-1; DIN EN ISO 14644-2; DIN EN ISO 14644-3; DIN EN ISO 14644-4; DIN EN 17141; EG-Leitfaden GMP, Anhang 1; VDI 6022 Blatt 1; T-110-SOP 2022-06-22; T-111-SOP 2022-06-22; T-112-SOP 2022-06-22; T-113-SOP 2022-06-22; T-114-SOP 2022-06-22; T-115-SOP 2022-06-22; T-116-SOP 2022-06-22

ISO 14644-2Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
As written on the certificate · Line 3 (DAKKS D-PL-20966-01-02)

DIN EN ISO 13485; DIN EN ISO 14644-1; DIN EN ISO 14644-3; DIN EN ISO 14644-2; DIN EN ISO 14644-4; VDI 6022 Blatt 1; EG-Leitfaden GMP, Anhang 1

As written on the certificate · Line 4 (DAKKS D-PL-20966-01-02)

DIN EN ISO 11737-1; DIN EN ISO 11737-2; DIN EN ISO 14644-1; DIN EN ISO 14644-2; DIN EN ISO 14644-3; DIN EN ISO 14644-4; DIN EN 17141; EG-Leitfaden GMP, Anhang 1; VDI 6022 Blatt 1; T-110-SOP 2022-06-22; T-111-SOP 2022-06-22; T-112-SOP 2022-06-22; T-113-SOP 2022-06-22; T-114-SOP 2022-06-22; T-115-SOP 2022-06-22; T-116-SOP 2022-06-22

ISO 14644-3Cleanrooms and associated controlled environments - Part 3: Test methods
As written on the certificate · Line 2 (DAKKS D-PL-20966-01-01)

DIN EN 17141; ISO 14698-1; DIN EN ISO 14644-1; DIN EN ISO 14644-3; DIN 1946-4

As written on the certificate · Line 3 (DAKKS D-PL-20966-01-02)

DIN EN ISO 13485; DIN EN ISO 14644-1; DIN EN ISO 14644-3; DIN EN ISO 14644-2; DIN EN ISO 14644-4; VDI 6022 Blatt 1; EG-Leitfaden GMP, Anhang 1

As written on the certificate · Line 4 (DAKKS D-PL-20966-01-02)

DIN EN ISO 11737-1; DIN EN ISO 11737-2; DIN EN ISO 14644-1; DIN EN ISO 14644-2; DIN EN ISO 14644-3; DIN EN ISO 14644-4; DIN EN 17141; EG-Leitfaden GMP, Anhang 1; VDI 6022 Blatt 1; T-110-SOP 2022-06-22; T-111-SOP 2022-06-22; T-112-SOP 2022-06-22; T-113-SOP 2022-06-22; T-114-SOP 2022-06-22; T-115-SOP 2022-06-22; T-116-SOP 2022-06-22

ISO 14644-4Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up
As written on the certificate · Line 3 (DAKKS D-PL-20966-01-02)

DIN EN ISO 13485; DIN EN ISO 14644-1; DIN EN ISO 14644-3; DIN EN ISO 14644-2; DIN EN ISO 14644-4; VDI 6022 Blatt 1; EG-Leitfaden GMP, Anhang 1

As written on the certificate · Line 4 (DAKKS D-PL-20966-01-02)

DIN EN ISO 11737-1; DIN EN ISO 11737-2; DIN EN ISO 14644-1; DIN EN ISO 14644-2; DIN EN ISO 14644-3; DIN EN ISO 14644-4; DIN EN 17141; EG-Leitfaden GMP, Anhang 1; VDI 6022 Blatt 1; T-110-SOP 2022-06-22; T-111-SOP 2022-06-22; T-112-SOP 2022-06-22; T-113-SOP 2022-06-22; T-114-SOP 2022-06-22; T-115-SOP 2022-06-22; T-116-SOP 2022-06-22

ISO 14698-1Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods
As written on the certificate · Line 2 (DAKKS D-PL-20966-01-01)

DIN EN 17141; ISO 14698-1; DIN EN ISO 14644-1; DIN EN ISO 14644-3; DIN 1946-4

Scope as published by DAKKS

9 lines
DAKKS

ISO/IEC 17025

Active

D-PL-20966-01-01

View scope
DAKKS

ISO/IEC 17025

Active

D-PL-20966-01-02

View scope
DAKKS

ISO/IEC 17025

Active

D-PL-20966-01-00

View scope

Location

Lembergstraße 17, Reutlingen, 72766, DE

48.51502, 9.21892

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