1. Standards and Legislation
overview
Geert Appeltans
Feb. 1st, 2013

2. Standards and Legislation overview
Automotive
Medical devices
Aerospace
Health & Safety
Environment
Basis ISO9001:2008

3. Explanation of Standards and
legislation – Automotive (1/2)
ISO/TS16949:2009
Golden Standards Guidelines
ISO/TS 16949:2002_
implementation guide
ISO 9004: 2009
Worldwide
Automotive
International
Standards
Legislation
Legislation (Pink Book)
Harmonized Standards
Directives EC
Possible to be certified for
ISO9001:2008
Forum IATF_International Automotive Task Force
Regulations
(# Product Group)
Eg. Pressured parts
Tyres
Fuel tanks
..
Not possible to be certified for

4. Explanation of Standards and
legislation – Automotive (2/2)
European Committee content of Pink Book: eg.

5. Explanation of Standards and
legislation – Medical devices (1/3)
ISO 9001: 2008
ISO 13485: 2003
Golden Standards Guidelines
ISO 14971: 2007 Risk Management
ISO 14155 Clinical Trials
ISO 10993 Biocompatibility
GxP (ICH)
ISO 14969: 2004
ISO 9004: 2009
EU
Medical
Devices
International
Standards
Legislation
Directives
Regulations
MDD - MEDDEV
Harmonized Standards
Directives
Regulations
Annex  How?
Articles  What?
93/42/EEC MD
Possible to be certified for Not possible to be certified for
(# Product Group)
Forum GHTF_Global Harmonization Task Force

6. Explanation of Standards and
legislation – Medical devices (2/3)
US
Food
and
Drug
Administration
-
FDA
21 CFR part 820
21 CFR part 11
21 CFR part 803-804
21 CFR part 4
Quality System Regulation and associated
guidance documents
Electronics Records and Electronic Signitures
MDR Compliance and Recall Analysis
cGMP
Forum GHTF_Global Harmonization Task Force

7. Explanation of Standards and
legislation – Medical devices (3/3)
Rest of the world
Possible accreditations:
UKAS – United Kingdom Britain
Belacs – Belgium
..
Canada – CMDCAS ISO13485 (Canadian MD Regulation)
Australia – ISO13485 (Australian Register of Therapeutic Goods)
Taiwan – TCP Partner-ROC Taiwan ISO13485
Japan – JPAL-Japanese MHLW Ordinance #169 ISO13485
Hong Kong – MD control office CAB-ISO13485
.. Also there are differences in classification for different countries:
-Class A and B in Singapore
-Class I and II in Taiwan
-etc..

8. Explanation of Standards and
legislation – Aerospace (1/7)
ISO 9001: 2008
AS/EN/JISQ 9100: 2009
AS/EN/JISQ 9110: 2005
AS/EN/JISQ 9120: 2010
AS/EN/JISQ 9133: 2004
Golden Standards Guidelines
In compliance with EN 9104:2006
Requirements & Registration
programs
EN9101:2011 Audit requirements
ISO 14971: 2007 Risk Management
ISO 9004: 2009
EU
Aerospace
International
Standards
Legislation
Directives
Regulations
EASA Part 21_Section A/B_
Subpart G – (JAA)
BCAA (be)
EC1702/2003
Amendements
Appendices  Forms
Articles
Local legislation
Possible to be certified for Not possible to be certified for
Annex
Forum ICAO_Next Generation of Aviation
Professionals Taskforce
Replaced by EC 748/2012
Based on
ISO9002:1994
Based on
ISO9001:2000

9. Explanation of Standards and
legislation – Aerospace (2/7)
US
Federal
Aviation
Administration
-
FAA
FAR
Quality System Regulation and associated
guidance documents
14 CFR
Federal Aviation Regulations

10. Explanation of Standards and
legislation – Aerospace (3/7)
Rest of the world
Possible accreditations:
UK – UKAS EN9100 (EASA)
US – ANAB AS9100 (FAA)
France – COFRAC EN9100 (DGAC)
..
Japan – JISQ9100
..

11. Explanation of Standards and
legislation – Aerospace (4/7)
Organisations
Non-profit
Legislation
Accreditation Legislation:
-FAA (US)
-EASA_JAA (EU)
-BCAA (BE)
-.. (ROW)
Standardisation for EU:
-CEN
-CENELEC
-ETSI
Others:
-ASD-STAN
-ABNT (Brazil)
-..
ICAO
General:
ISO
IEC
Aerospace:
IAQG
-SAE
-EACMA/ASD
-SJAC
AFAQ
BVQI
AENOR
DQS
BSI
SGS UK
LRQA
TüV
ASD-CERT
..
Certifications:
-ISO9001
-AS/EN/JISQ9100
-AS/EN/JISQ9110
-AS/EN/JISQ9120
-AS/EN/JISQ9133
In compliance with
EN9104
Accreditations:
-UKAS
-ANAB
-COFRAC
-JISQ
..
-QPL www.aecma-ease.org
-PQ
-OASIS www.sae.org/oasis
Certificate of Quality Management System for
Aviation
Production
Organisation
Approval
Certificate
Part 21G
BE.21G.xxxx
POA
compliance
checklist

12. Explanation of Standards and
legislation – Aerospace (5/7)

13. Explanation of Standards and
legislation – Aerospace (6/7)
Difference between IAQG (non profit organisation) and EASA (European Aviation and Safety Agency):
See EASA issued decision ED 2005/01/CF, where was decided to establish internal certification working procedures.
Input from:
• It is not the intent of the Competent Authority (EASA) to issue
approvals to manufacturing firms that perform only sub-contract
work for main manufacturers of products and are consequently
placed under their direct surveillance.
See white paper: Difference between AS/EN9100 and Part 21G

14. Explanation of Standards and
legislation – Aerospace (7/7)
Abbreviations:
FAA Federal Aviation Authority
FAR Federal Aviation Regulations
CFR Code of Federal Regulation
EASA European Aviation Safety Agency
BCAA Belgium Civil Aviation Authority
EC European Committee
JAA Joint Aviation Authorities
JAR Joint Aviation Requirements
EN European Norm
CEN Comité Européen de Normalisation
CENELEC Comité Européen de Normalisation Electrotechnique
ETSI European Telecommunication and Standardisation Institute
ISO International Organisation for Standardisation
IEC International Electrotechnical Commission
JISQ Japanese Industrial Standard Q
ICAO International Civil Aviation Organisation
IAQG International Aerospace Quality Group
AECMA Association Européenne des Constructeurs de Materiel Aérospatial
ASD Aerospace and Defence Industries Associations of Europe
SAE Society of Automobile Engineers
SJAC Society of Japanese Aerospace Companies
GEBECOMA Belgium Aerospace Industries Association
QPL Qualified product list
QP Production Qualification Certification
OASIS Online Aerospace Supplier Information System
DOA Design Organization Approval
POA Production Organization Approval
MOA Maintenance Organization Approval
*9100 design, development, production,
installation and maintenance
*9110 maintenance organisations
*9120 dealers and stockists
*9101 Audit requirements
*9133 Qualification Procedure for
Aerospace Standard Parts
*9104 requirements under the Aerospace
Quality Management System series of
standards
*Part 21G Production Organization
Approval
References:

15. Explanation of Standards and
legislation – Health & Safety (1/1)
OHSAS 18001:2007
Golden Standards Guidelines
EU-Belgium
Health
&
Safety
International
Standard
Belgium
Legislation
ARAB-CODEX
AREI
Directives FOD WASO
Possible to be certified for
Forum CPBW

16. Explanation of Standards and
legislation – Environment (1/3)
ISO14001: 2004
Golden Standards Guidelines
Belgium
Environment
International
Standard
Belgium
Legislation
Vlarem 1 - 2
Vlarea - Vlarebo
Directives
Environmental
Coördinator-
OVAM
Possible to be certified for

17. Explanation of Standards and
legislation – Environment (2/3)

18. Explanation of Standards and
legislation – Environment (3/3)
REACH covers the production and use of chemical substances, its 277 pages took seven years to pass. It has
been described as the most complex legislation in the history of E.U. and the most important in 20 years. It is
the strictest law to date regulating chemical substances and will impact industries throughout the world. Since it
came into force in June 2007 REACH requires all chemicals of 1,000 kilograms or more in volume that are
manufactured in or imported into the European Union each year to be tested for health and safety and registered
with a new central European authority – the European Chemicals Agency located in Helsinki, Finland. REACH
also applies to all chemicals that are considered of very high concern to human health or the environment -
regardless of volume.
ROHS: The Directive on the restriction of the use of certain hazardous substances in electrical and electronic
equipment 2002/95/EC. Restriction of Hazardous Substances Directive or RoHS was adopted in February 2003 by the
European Union. The RoHS directive took effect on 1 July 2006, and is required to be enforced and become law in each
member state. This directive restricts the use of six hazardous materials in the manufacture of various types of electronic and
electrical equipment. It is closely linked with the Waste Electrical and Electronic Equipment Directive (WEEE) 2002/96/EC
which sets collection, recycling and recovery targets for electrical goods and is part of a legislative initiative to solve the
problem of huge amounts of toxic waste.