Standards and Legislation overview

Geert Appeltans

Feb. 1st, 2013

Standards and Legislation overview

Automotive

Medical devices

Aerospace

Health & Safety

Environment

Basis ISO9001:2008

Explanation of Standards and legislation – Automotive (1/2)

ISO/TS16949:2009

Golden Standards Guidelines

ISO/TS 16949:2002_ implementation guide

ISO 9004: 2009

Worldwide

Au

tom

otiv

e

Inte

rnat

iona

l S

tand

ards

Leg

isla

tion

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 partsTyresFuel tanks..

Not possible to be certified for

Explanation of Standards and legislation – Automotive (2/2)

European Committee content of Pink Book: eg.

Explanation of Standards and legislation – Medical devices (1/3)

ISO 9001: 2008

ISO 13485: 2003

Golden Standards Guidelines

ISO 14971: 2007 Risk ManagementISO 14155 Clinical Trials

ISO 10993 BiocompatibilityGxP (ICH)

ISO 14969: 2004ISO 9004: 2009

EU

Med

ical

Dev

ices

In

tern

atio

nal

Sta

ndar

ds

Leg

isla

tion

Dir

ecti

ves

Reg

ulat

ions

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

Explanation of Standards and legislation – Medical devices (2/3)

US

Foo

d an

d D

rug

Adm

inis

trat

ion

- F

DA

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

Explanation of Standards and legislation – Medical devices (3/3)

Rest of the world

Possible accreditations:

UKAS – United Kingdom BritainBelacs – Belgium..

Canada – CMDCAS ISO13485 (Canadian MD Regulation) Australia – ISO13485 (Australian Register of Therapeutic Goods)Taiwan – TCP Partner-ROC Taiwan ISO13485Japan – JPAL-Japanese MHLW Ordinance #169 ISO13485Hong 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..

Explanation of Standards and legislation – Aerospace (1/7)

ISO 9001: 2008

AS/EN/JISQ 9100: 2009AS/EN/JISQ 9110: 2005AS/EN/JISQ 9120: 2010AS/EN/JISQ 9133: 2004

Golden Standards Guidelines

In compliance with EN 9104:2006 Requirements & Registration

programsEN9101:2011 Audit requirements

ISO 14971: 2007 Risk ManagementISO 9004: 2009

EU

Aer

osp

ace

Inte

rnat

iona

l S

tand

ards

Leg

isla

tion

Dir

ecti

ves

Reg

ulat

ions

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

Explanation of Standards and legislation – Aerospace (2/7)

US

Fed

eral

Avi

atio

n A

dmin

istr

atio

n -

FAA

FAR

Quality System Regulation and associated guidance documents

14 CFR

Federal Aviation Regulations

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..

Explanation of Standards and legislation – Aerospace (4/7)

OrganisationsNon-profit

LegislationAccreditation Legislation:-FAA (US)-EASA_JAA (EU)-BCAA (BE)-.. (ROW)

Standardisation for EU:-CEN-CENELEC-ETSI

Others:-ASD-STAN -ABNT (Brazil)-..

ICAO

General:ISOIEC

Aerospace:IAQG -SAE -EACMA/ASD -SJAC

AFAQBVQIAENORDQSBSISGS UKLRQATüVASD-CERT..

Certifications:-ISO9001-AS/EN/JISQ9100-AS/EN/JISQ9110-AS/EN/JISQ9120-AS/EN/JISQ9133In 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

ProductionOrganisationApprovalCertificatePart 21GBE.21G.xxxx

POA compliance checklist

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

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

Explanation of Standards and legislation – Aerospace (7/7)

Abbreviations:

FAA Federal Aviation AuthorityFAR Federal Aviation RegulationsCFR Code of Federal RegulationEASA European Aviation Safety AgencyBCAA Belgium Civil Aviation AuthorityEC European CommitteeJAA Joint Aviation Authorities JAR Joint Aviation RequirementsEN European NormCEN Comité Européen de NormalisationCENELEC Comité Européen de Normalisation ElectrotechniqueETSI European Telecommunication and Standardisation InstituteISO International Organisation for StandardisationIEC International Electrotechnical CommissionJISQ Japanese Industrial Standard QICAO International Civil Aviation OrganisationIAQG International Aerospace Quality GroupAECMA Association Européenne des Constructeurs de Materiel AérospatialASD Aerospace and Defence Industries Associations of EuropeSAE Society of Automobile EngineersSJAC Society of Japanese Aerospace CompaniesGEBECOMA Belgium Aerospace Industries Association QPL Qualified product listQP Production Qualification CertificationOASIS Online Aerospace Supplier Information SystemDOA Design Organization ApprovalPOA Production Organization ApprovalMOA 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:

Explanation of Standards and legislation – Health & Safety (1/1)

OHSAS 18001:2007

Golden Standards Guidelines

EU-Belgium

Hea

lth

& S

afet

y In

tern

atio

nal

Sta

ndar

d

Bel

gium

Leg

isla

tion

ARAB-CODEX

AREIDirectives FOD WASO

Possible to be certified for

Forum CPBW

Explanation of Standards and legislation – Environment (1/3)

ISO14001: 2004

Golden Standards Guidelines

Belgium

En

viro

nm

ent

Inte

rnat

iona

l S

tand

ard

Bel

gium

Leg

isla

tion

Vlarem 1 - 2

Vlarea - VlareboDirectives

EnvironmentalCoördinator-OVAM

Possible to be certified for

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

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.