SCESm Directory Accreditation number: SCESm 0001 · Federal Department of Economic Affairs, ......

Federal Department of Economic Affairs,

Education and Research EAER

State Secretariat for Economic Affairs SECO

Swiss Accreditation Service SAS

SCESm Directory Accreditation number: SCESm 0001

25.06.2018 / BU geh/zej 0001scesmvz_engl 1/13

International standard: ISO/IEC 17021-1:2015

Swiss standard: SN EN ISO/IEC 17021-1:2015

Swiss Association for Quality and Management Systems (SQS) Bernstrasse 103 3052 Zollikofen

Head: René Wasmer

Responsible for MS: Felix Müller

Telephone: +41 58 710 35 35

E-Mail: mailto: [email protected]

Internet: http://www.sqs.ch

Initial accreditation: 21.07.1992

Current accreditation: 12.08.2017 to 11.08.2022

Scope of accreditation see: www.sas.admin.ch (Accredited bodies)

Scope of accreditation as of 25.06.2018

Certification body for management systems in the domain of quality, environment and security

Standards Approved technical scopes Remarks

ISO 9001:2008 ISO 9001:2015

Already granted certificates ac-cording to the standard ISO 9001:2008 keep their validity until 14.09.2018, at the latest.

IAF Code

Agriculture, fishing 1

Mining and quarrying 2

Food products, beverages and to-bacco

3

Textiles and textile products 4

Leather and leather products 5

Wood and wood products 6

Pulp, paper and paper products 7

Publishing companies 8

mailto:[email protected]

http://www.sqs.ch/








ISO 9001:2008 ISO 9001:2015

Printing companies 9

Manufacture of coke and refined petroleum products

10

Manufacture and processing of nu-clear fuel

11

Chemicals, chemical products and fibres

12

Pharmaceuticals 13

Rubber and plastic products 14

Non-metallic mineral products 15

Concrete, cement, lime, plaster etc.

16

Basic metals and fabricated metal products

17

Machinery and equipment 18

Electrical and optical equipment 19

Shipbuilding 20 Code NACE 35-12 pleasure and sporting boats

Aerospace 21

Other transport equipment 22

Manufacturing not elsewhere clas-sified

23

Recycling 24

Electricity supply 25

Gas supply 26

Water supply 27

Construction 28

Wholesale and retail trade; repair of motor vehicles, motorcycles and personal and household goods

29

Hotels and restaurants 30

Transport, storage and communi-cation

31








ISO 9001:2008 ISO 9001:2015

Financial intermediation, real es-tate, renting

32

Information technology 33

Engineering services 34

Other services 35

Public administration 36

Education 37

Health and social work 38

Other social services 39

ISO 14001:2004 ISO 14001:2015

Already granted certificates ac-cording to the standard ISO 14001:2004 keep their validity until 14.09.2018, at the latest.

IAF Code




3








10


11


12

Pharmaceuticals 13










ISO 14001:2004 ISO 14001:2015


16


17



Shipbuilding 20 Code NACE 35-12 pleasure and sporting boats

Aerospace 21



23

Recycling 24


Gas supply 26

Water supply 27

Construction 28


29



31


32



Other services 35


Education 37










ISO 45001:2018 BS OHSAS 18001:2007

Already granted certificates ac-cording to the standard BS OHSAS 18001:2007 keep their validity until 11.03.2021, at the lat-est.

IAF Code




3








10


11


12

Pharmaceuticals 13




16


17



Shipbuilding 20

Aerospace 21










23

Recycling 24


Gas supply 26

Water supply 27

Construction 28


29



31


32



Other services 35


Education 37



ISO 50001:2011 Energy Management Systems - Industry – light to medium - Industry – heavy - Mining - Energy supply - Buildings - Building complexes - Transport

Agriculture

The certification body fulfils the re-quirements of the standard ISO 50003:2014

AQAP 2110: 2003 NATO-QS-Requirements

Same scope as ISO 9001:2000 Only in combination with a certifi-cation according to ISO 9001

eduQua:2012 Education Corresponds to IAF Code 37

ISO 29990:2010 Provider of learning services for non-formal education and training








SVOAM-2010 Measures of the employment mar-ket

ISO 22000:2005 Food safety management systems for the clusters (according to ISO/TS 22003)

The certification body satisfies the requirements according to ISO/TS 22003:2013 for the sectors

Cluster

2. Food and Feed Processing

(C + D)

C Food Manufacturing

D Animal Feed Production

3. Catering (E) E Catering

4. Retail, transport and storage

(F + G)

F Distribution

G Provision of Transport and

Storage Services

5. Auxiliary Services (H + I + J) H Services

I Production of Food Packaging

and Packaging Materials

J Equipment Manufacturing

6. (Bio) Chemicals (K) K Production of (Bio) Chemicals

ISO 22000:2005 ISO/TS 22002-1:2009

Inclusive additional FSSC 22000 requirements version 4

Food Safety System Certification 22000 (FSSC 22000) for the cate-gories:

Including ISO/TS 22003:2013

CI Processing of perishable ani-mal products

CII Processing of perishable plant products

CIII Processing of perishable ani-mal and plant products (mixed products)

CIV Processing of ambient stable products (ambient temperature)

DII Production of Pet Food for dog and cat

ISO 22000:2005

ISO/TS 22002-6:2016


DI Production of Feed

DII Production of Pet Food for other pet than dog and cat

Inclusive ISO/TS 22003:2013

ISO 22000:2005

ISO/TS 22002-2:2013


E Catering Inclusive ISO/TS 22003:2013








ISO 22000:2005

PAS 221:2013


FI Retail/Wholesail


ISO 22000:2005

NEN/NTA 8059:2016


GI Provision of Transport and Storage Services for Perisha-ble Food and Feed

GII Provision of Transport and Storage Services for Ambient Stable Food and Feed.


ISO 22000:2005

ISO/TS 22002-4:2013


I Production of Food Packaging and Packaging Material


ISO 22000:2005 ISO/TS 22002-1:2009


K Production of food and feed additives, vitamins, minerals, bio-cultures, flavourings, en-zymes and processing aids,

(Excluded: pesticides, drugs, fertilizers, cleaning agents)


FAMI-QS:2014

Version 5.1, February 2014

European Code of Practice for Feed Additives and Premixture Operators

Production of feed additives and premixes for the feed industry

Including ISO/TS 22003:2013

DIN EN 15593:2008 Packaging - Management of hy-giene in the production of packag-ing for foodstuffs. Requirements.

ISO/IEC 20000-1:2011 IT Service Management

ISO/IEC 27001:2013 Information Security Management Systems ISMS

The certification body fulfils the re-quirements of the standard ISO/IEC 27006:2015

ODPC - (SR 235.13) including the directives of the Swiss Federal Data Protection and Information Commissioner (FDPIC) with re-spect to the minimum require-ments for a data protection man-agement system and its Appendix (Guidelines for the Management of Data Protection)

Data Protection Management Sys-tems (DPMS) in accordance with Article 4 ODPC: Certification of Or-ganization and Procedures

Based on Swiss Federal Data Protection Law (SR 235.1) including special legal data protec-tion regulations Ordinance on the Swiss Federal Data Protection Law (SR 235.11)

Management system certification (all international standards of the series ISO 13485)








ISO 13485:2003

SN EN ISO 13485:2012

SN EN ISO 13485:2016

MD 0000 Non Active Medical Devices

Only certification according to standard ISO 13485 without re-quirements of MDO and 93/42/EEC

ISO 13485:2003

SN EN ISO 13485:2012

SN EN ISO 13485:2016

MD 0100 General non-active, non-implantable medical de-vices


MD 0101 Non-active devices for anaesthesia emergency and inten-sive care

MD 0102 Non-active devices for injection, infusion, transfusion and dialysis

MD 0103 Non-active orthopaedic and rehabilitation devices

MD 0104 Non-active medical de-vices with measuring function

MD 0105 Non-active ophthalmolo-gic devices

MD 0106 Non-active instruments

MD 0108 Non-active medical de-vices for disinfecting, cleaning, rinsing

MD 0110 Medical devices for in-gestion

ISO 13485:2003

SN EN ISO 13485:2012

SN EN ISO 13485:2016

MD 0200 Non-active implants Only certification according to standard ISO 13485 without re-quirements of MDO and 93/42/EEC

MD 0202 Non-active orthopaedic implants

MD 0203 Non-active functional im-plants

MD 0204 Non-active soft tissue implants

ISO 13485:2003

SN EN ISO 13485:2012

SN EN ISO 13485:2016

MD 0300 Devices for wound care









MD 0301 Bandages and wound dressings

MD 0302 Suture material and clamps

MD 0303 Other medical devices for wound care

ISO 13485:2003

SN EN ISO 13485:2012

SN EN ISO 13485:2016

MD 0400 Non-active dental de-vices and accessories


MD 0401 Non-active dental equip-ment and instruments

MD 0402 Dental materials

MD 0403 Dental implants

ISO 13485:2003

SN EN ISO 13485:2012

SN EN ISO 13485:2016

MD 1000 Active Medical Devices Only certification according to standard ISO 13485 without re-quirements of MDO and 93/42/EEC

ISO 13485:2003

SN EN ISO 13485:2012

SN EN ISO 13485:2016

MD 1100 General active medical devices


MD 1101 Devices for extra-corpo-ral circulation, infusion and hae-mopheresis

Limitation: MD 1101 without heart lung machine

MD 1102 Respiratory devices, de-vices including hyperbaric cham-bers for oxygen therapy, inhalation anaesthesia

Limitation: MD 1102 only respira-tory protection apparatus/device

MD 1103 Devices for stimulation or inhibition

MD 1104 Active surgical devices

MD 1105 Active ophthalmologic devices

MD 1106 Active dental devices

MD 1107 Active devices for disin-fection and sterilisation

MD 1108 Active rehabilitation de-vices and active prostheses

MD 1111 Software








MD 1112 Medical gas supply sys-tems and parts thereof

ISO 13485:2003

SN EN ISO 13485:2012

SN EN ISO 13485:2016

MD 1200 Devices for imaging Only certification according to standard ISO 13485 without re-quirements of MDO and 93/42/EEC

MD 1201 Imaging devices utilising ionizing radiation

MD 1202 Imaging devices utilising non-ionizing radiation

ISO 13485:2003

SN EN ISO 13485:2012

SN EN ISO 13485:2016

MD 1300 Monitoring devices Only certification according to standard ISO 13485 without re-quirements of MDO and 93/42/EEC

MD 1301 Monitoring devices of non-vital physiological parameters

MD 1302 Monitoring devices of vi-tal physiological parameters

ISO 13485:2003

SN EN ISO 13485:2012

SN EN ISO 13485:2016

MD 1400 Devices for radiation therapy and thermo therapy


MD 1404 Devices for (extracor-poral) shock-wave therapy (litho-tripsy)

ISO 13485:2003

SN EN ISO 13485:2012

SN EN ISO 13485:2016

MDS 7000 Specifics of Medical Devices


MDS 7004 Medical devices refer-encing the Directive 2006/42/EC on machinery

MDS 7006 Medical devices in ster-ile condition

MDS 7009 Medical devices utilis-ing biological active coatings and/or materials or being wholly or mainly absorbed

MDS 7010 Medical devices with build-in and/or employed software and/or with application of software








ISO 15378:2015 Primary packaging materials for medicinal products – Particular re-quirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2015)

Certification combined with ISO 9001

Good Medical Practice ®:2009 General practitioner's practices

Health Maintenance Organization (HMO) – group medicine

Certification of management sys-tem for medical practices – quality label for medical practices

RQS:2004 Reference document for Hospital Pharmacies developed by GSASA and APEQ

EN 9100:2009 AS 9100D

Management Systems for Aero-space industry

The body satisfies the require-ments of EN 9104-001:2013 and since the 25.07.2017, the body satisfies the requirements of AS 9101F.

Already granted certificates ac-cording to the standard EN 9100:2009 keep their validity until 15.09.2018, at the latest.

EN 9120:2010 AS 9120B

Management Systems for Aero-space industry / requirements for stockist distributors

The body satisfies the require-ments of EN 9104-001:2013 and since the 25.07.2017, the body satisfies the requirements of AS 9101F.

Already granted certificates ac-cording to the standard EN 9120:2010 keep their validity until 15.09.2018, at the latest.

Quality requirements for fusion welding of metallic materials

Combined with a certification on the base of ISO 9001

SN EN ISO 3834-2:2006 Comprehensive quality require-ments

SN EN ISO 3834-3:2006 Standard quality requirements

SN EN ISO 3834-4:2006 Elementary quality requirements

SR 930.114 Regulation on the

safety of pressure equipment (Pressure Equipment Ordinance)

(EC Pressure Equipment Directive

2014/68/EU)

Quality assurance production

Quality assurance products

Quality assurance production

Quality assurance products

Complete quality assurance with-out draft examination and surveil-lance of the final verification

Annex lll – module D1

Annex lll – module E1

Annex lll – module D

Annex lll – module E

Annex lll – module H








Notified Body EU identification number NB 1250 according to

2014/68/EU

Indication

The modules A2, B, C2, F, G and module H1 without quality assur-ance are covered by SCESp 0049.

Ordinance on the safety of lifts, SR 930.112

Directive 2014/33/EU on the har-monisation of the laws of the Member States relating to lifts and safety components for lifts ("Lift Safety Directive")

Lifts Lift Safety Directive 2014/33/EU - Annex X (Module E) - Annex XI (Module H1) - Annex XII (Module D)

Explicitly excluded are design ex-aminations according to

Lift Safety Directive, Annex XI (3.3)

Abbreviation Signification

APEQ Agence pour la promotion et l’évaluation de la qualité dans les institutions sanitaires

IAF Code IAF ID1, Informative Document for QMS and EMS Scopes of Accreditation

eduQua Certification body for quality management system in adult training institutes. Ref. www.eduqua.ch

FAMI-QS FAMI-QS European Feed Additives and Premixtures Quality System, Brussels, Actual version of the standard document http://www.fami-qs.org/

GSASA Gesellschaft Schweizerischer Amts- und Spitalapotheker

MDO Swiss Medical Device Ordinance of the 17 October 2001 (state of 28 December 2001), SR 812.213

ODPC Ordinance on Date Protection Certification

ref. 93/42/EEC Council Directive 93/42/EEC of the 14 June 1993 on medical devices

SVOAM Swiss association of the organizers of measures of the employment market

* / * / * / * / *

http://www.eduqua.ch/

http://www.fami-qs.org/

SCESm Directory Accreditation number: SCESm 0001 · Federal Department of Economic Affairs, ......

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