APAS Document D178

advertisement
APAS Document D178
How to become a local supplier of overseas
manufactured APAS Approved Products.
Editorial: This version of the document clarifies
accreditation requirements (clause 1) and corrects
contact fax number p6.
This document should be read in
conjunction with APAS Documents;
¾ D188 "An explanation of APAS", and
¾ D192 “The APAS Approved Product
System”.
Both documents may be obtained from
the APAS web site:
http://www.apas.gov.au
1.
SCOPE
This document applies to Australian
based distributors of overseas manufactured
products intended for sale in Australia.
2.
HOW APAS OPERATES
(i)
APAS
registers
satisfactory
manufacturing units by issuing them
"Recognition" which identifies them as
having;
¾ the business control systems to
consistently manufacture products to
a defined quality standard, and
¾ the technical competence to routinely
test products and a system which
safeguards on-going product quality,
and
¾ a manufacturing process that is at, or
near, world’s best practice.
In order to comply, applicant organisations
need to be able to demonstrate that they
hold current accreditation against ISO 9001
(business management) and ISO 17025
(technical competence).
D178 Revision no. 9
8 November 2005
The overseas quality control laboratory
must be accredited against ISO 17025 by
an
organisation
having
a
Mutual
Recognition Agreement (MRA) with the
National Association of Testing Authorities
(NATA) laboratory accreditation scheme
(http://www.nata.asn.au).
This is an important requirement
because quality management systems such
as ISO 9001 say nothing about technical
competence. Their focus is on quality
management procedures and processes.
ISO 17025 laboratory accreditation ensures
the
technical
competence
of
the
organisation is achieved and maintained to
best practice standard.
(ii)
The "Recognised Manufacturing
Unit” (RMU) applies for Product Approval on
the basis of compliance with one or more
APAS specifications.
Approval is granted on the basis of the
evidence provided, subject to the
concurrence, where required, of APAS's
technical experts.
Note 1: The local distributor of the product may make
application direct to APAS provided the application
complies with all the requirements of APAS
Document D192 clause 3.5, 3.6 or 3.7 as
appropriate.
(iii)
Approved products are listed in the
“APAS List of Approved Products”, which is
circulated to all government users and other
subscribers. Manufacturers are encouraged
to market their "approved product" status
both by identification on cans and in general
promotions.
(iv)
Representatives of Federal, State
and Local Government departments that
are users of coatings, be they protective
coatings or architectural, are Members of
Authorised by Executive Officer, APAS
© Copyright APAS 2005
page 1 of 6
APAS. They use the Scheme by calling, in
tender documents and specifications, for
products that comply with the APAS
specifications. Manufacturers and suppliers
are voluntary Participants, rather than
Members and they use the Scheme to
access this market segment.
(v)
RMU’s are required to advise APAS
of relevant technical or administrative
changes and are inspected by APAS (or
one of its nominees) at regular intervals,
usually two years. Any user complaints or
defects identified during inspection visits or
audit testing are followed up by APAS until
resolved.
(vi)
APAS is governed by a Board,
comprised of representatives of Federal and
State
government
departments
and
instrumentalities. The main function of the
Board is to set policy, adjudicate on
contentious matters and to receive the
report of the Executive Officer.
Daily administration of APAS is vested
in CSIRO Manufacturing & Infrastructure
Technology PO Box 56 Highett Victoria
3190.
3.
3.2
Requirements for the Overseas
Manufacturer
In order to achieve full recognition;
(i)
Study and become familiar with this
document and the other documents
mentioned.
(ii)
When satisfied that the parent
(manufacturing) company will meet the
requirements outlined in this document,
write to or fax APAS and include the
completed "Application Form" at the end of
this document and evidence of compliance
to the aforementioned standards.
(iii)
APAS
acknowledges
your
application and forwards a questionnaire to
obtain basic information regarding the
company and its products.
(iv)
APAS reviews your completed
questionnaire and advises you of any
obvious shortcomings which may impede
"Recognition".
(v)
Overseas manufacturing company
provides evidence that they are accredited
to ISO 9001.
HOW TO JOIN THE SCHEME
3.1 General Requirements
Local
distributors
of
overseas
manufactured products normally apply for
APAS participation in order to gain access
to local markets.
Where full recognition is not achievable
eg. due to the absence of one of the key
requirements such as ISO 9001 or
ISO17025 accreditation, partial approval
may be an acceptable alternative. See
section 4 below.
D178 Revision no. 9
8 November 2005
(vi)
Overseas manufacturing company
provides evidence that their quality control
laboratory has laboratory accreditation
complying with ISO 17025 and granted by a
certifying authority recognised by the
National Association of Testing Authorities
(NATA). Refer Appendix 1 for a list of
organisations.
(vii) Once a prima facie case is
established that applicant is likely to be
ready for "Recognition", the Executive
Officer
arranges
for
local
APAS
representatives to visit the manufacturing
unit at a mutually convenient time at the
company's cost to examine constancy of
formulation,
general
manufacturing
standards and other key parameters that
APAS may deem appropriate.
Authorised by Executive Officer, APAS
© Copyright APAS 2005
page 2 of 6
Subsequent audit visits shall be
performed at intervals not exceeding 2
years. (At the discretion of APAS, these
audits may be conducted by a locally based
product certifying organisation deemed
acceptable by APAS).
(viii) The Assessment Visit is conducted
and at the completion of the visit, the
Assessment Team indicates to the applicant
the substance of their recommendations to
APAS.
(If an audit is subsequently performed
by an independent product certifying
organisation on behalf of APAS, the
assessment report shall first be provided to
APAS before being communicated to the
company).
(ix)
Corrective actions are taken by the
applicant as necessary, to the satisfaction of
APAS. This may in some instances
necessitate a further visit depending on the
nature of the corrective actions needed.
3.3 Requirements for the Local Distributor
(i)
The Australian distributor of the
products must demonstrate that they have a
working quality management system which
is accredited by a recognised third-party
accrediting body as complying to ISO 9001
requirements. (This would normally require
an audit visit by APAS to the distributor, at
least every 2 years at the cost of the
distributor).
Having complied with the requirements
of 3.1 and 3.2 above, and having paid the
appropriate fee, the APAS Executive Officer
advises the APAS Board of the
"Recognition" of the new organisations and
issues their Recognition certificates.
Once "Recognition" is granted by
APAS, products may be submitted for
approval
against
relevant
product
specifications as explained in APAS
Document D192.
D178 Revision no. 9
8 November 2005
4. ALTERNATIVES TO RECOGNITION
Sometimes,
full
manufacturer
recognition is not warranted or possible due
to the absence of one of the key APAS
requirements. It is then up to the specifier,
end user or asset owner to make a risk
assessment whether any approval or
product qualification other than full APAS
approval would suffice.
It may be decided that it is an
acceptable risk to use a product that has
only been partially confirmed by APAS as
providing a defined level of protection
(performance).
Such products are called Level 2
approved products. Details on how to
achieve Level 2 approval can be found in
APAS Document D192 clause 3.7
Appendix 1
Current NATA Mutual Recognition
Agreement (MRA) Network
Austria
Bundeministerium fur wirtschaftliche
Angelegenheiten (BMwA)
Belgium
Ministere des Affaires economiques
Service Accreditation (BELTEST)
Belgium Calibration Organisation (BKOOBE)
Brazil
Directoria de Credenciamento e
Qualidade / Instituto Nacional de
Metrologia Normalizacao e Qualidade
Industrial (INMETRO)
Canada
Standards Council of Canada (SCC)
China, People's Republic of
China National Accreditation Committee
for Laboroatories (CNACL)
Czech Republic
Czech Accreditation Institute (CAI)
Denmark
Dansk Akkreditering (DANAK)
Authorised by Executive Officer, APAS
© Copyright APAS 2005
page 3 of 6
Finland
Finnish Accreditation Service Centre for
Metrology and Accreditation (FINAS)
France
Comite
Francais
d'Accreditation
(COFRAC)
Germany
Deutsche Akkreditierungsstelle Chemie
GmbH (DACH)
Hong Kong
Hong Kong Laboratory Accreditation
Scheme (HOKLAS)
India
National Accreditation Board for Testing
and Calibration Laboratories (NABL)
Ireland
The Irish National Accreditation Board
(NAB)
Indonesia
Komite Akreditasi Nasional (KAN)
Italy
Sistema
Nazionale
per
L'Accreditamento di Laboratori (SINAL)
Servizio di Taratura in Italia (SIT)
Japan
Japan
Accreditation
Board
for
Conformity Assessment (JAB)
Japan National Laboratory Accreditation
System (JNLA)
Korea, Republic of
Korea Laboratory Accreditation Scheme
(KOLAS)
Netherlands
Raad voor Accreditatie (RvA)
New Zealand
International Accreditation New Zealand
(IANZ)
Norway
Norwegian Accreditation (NA)
Portugal
Instituto Portugues da Qualidade (IPQ)
Singapore
Singapore Accreditation Council Singapore Laboratory Accreditation
Scheme (SAC-SINGLAS)
South Africa
South African National Accreditation
System (SANAS)
D178 Revision no. 9
8 November 2005
Spain
Entidad Nacional de Acreditacion
(ENAC)
Sweden
The Swedish Board for Accreditation
and
Conformity
Assessment
(SWEDAC)
Switzerland
Swiss Accreditation Service (SAS)
Taipei, Chinese
Chinese
National
Laboratory
Accreditation (CNLA)
United Kingdom
United Kingdom Accreditation Service
(UKAS NAMAS)
USA
American Association for Laboratory
Accreditation (A2LA)
ICBO Evaluation Service Inc (ICBO)
National
Voluntary
Laboratory
Accreditation Program (NVLAP)
Vietnam
Vietnam
Laboratory
Accreditation
Scheme (VILAS)
Note 2: An up to date listing of current MRAs can be
obtained from the NATA web site at
http://www.nata.asn.au
Authorised by Executive Officer, APAS
© Copyright APAS 2005
page 4 of 6
FAX MESSAGE
TO
ATTENTION
Page
Fax
Tel.
email
Australian Paint Approval
Scheme
Ken LOFHELM
Executive Officer
1 of 2
+61 (3) 9252 6011
+61 (3) 9252 6307
kenneth.lofhelm@csiro.au
FROM
(name)
Company
or
orgnist’n
Fax.
Tel.
email
CONFIDENTIALITY NOTICE FOR RECIPIENTS OUTSIDE THE APAS MEMBERSHIP
The information contained in this facsimile is intended for the named recipient only. It may contain privileged and confidential information. If you are
not the intended recipient, you must not copy, distribute or disclose any details of the facsimile to any other person, company or organisation.
If you have received this facsimile in error, please notify us immediately and return the original to us by mail. We will reimburse you all reasonable
costs you may incur in notifying us and returning the original facsimile to us.
MESSAGE:
APPLICATION FOR OVERSEAS APAS RECOGNITION
We have examined the necessary APAS documents and believe we will comply with the detailed requirements for
Recognition. Could you please forward a Recognition Questionnaire to facilitate our assessment visit? Basic
information regarding our Company and product is as detailed below;
DETAILS OF MANUFACTURING ORGANISATION
Name of
manufacturing
company .
Postal Address
Manufacturing site
address
Contact Details
ISO 9001 in place?
Name of Auditors
ISO 17025 in place?
Name of Auditors
Brief Description of
product range:
D178 Revision no. 9
Name:
Tel.
Title:
Fax.
Email:
Web site:
YES / NO
Date of last audit:
YES / NO
Date of last audit:
8 November 2005
Authorised by Executive Officer, APAS
© Copyright APAS 2005
page 1 of 2
DETAILS OF DISTRIBUTING ORGANISATION
Name of distribution
company.
Postal Address
Site address
Contact Details
Name:
Tel.
Title:
Fax.
Email
ISO 9000 in place?
Name of Auditors
Brief Description of
market segment:
YES / NO
Date of last audit:
Signed:
.....................................................
Print Name:
……………………………………
D178 Revision no. 9
8 November 2005
Date:
Authorised by Executive Officer, APAS
© Copyright APAS 2005
page 2 of 2
Download