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QUALITY NEWS
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World
Accreditation Day 9 June 2010
World Accreditation Day 2010 – “Global
Acceptance”
This year marks the 10th anniversary of the ILAC
Mutual Recognition Arrangement (MRA) and the 12th anniversary of the IAF
Multilateral Recognition Arrangement (MLA). The principle aim of these
arrangements is as relevant today as it was when they were first established,
and that is to support the freedom of world trade by eliminating technical
barriers to trade. The creation of an international network among accreditation
bodies removes the need for suppliers to have their products or services
re-evaluated in each country they enter on a commercial basis. The key to the
arrangements is that the results of accredited organisations are recognised as
equivalent by signatory accreditation bodies. In this way, certificates issued
by accredited organisations can therefore be accepted throughout the world.
‘Global Acceptance’ is therefore an apt theme for
World Accreditation Day 2010, a worldwide initiative jointly established by the
International Accreditation Forum (IAF) and the International Laboratory
Accreditation Cooperation (ILAC) to raise awareness of the importance of
accreditation-related activities. June 9th 2010 will mark the day, which will
see major national events and press campaigns carried out in more than 60
countries.
Internationally-agreed standards and
accreditation play an important role in the support of competitive markets and
cross-border trade. This is increasingly important as supply chains are
ever-extending to new overseas markets as businesses seek to lower costs or
satisfy contract terms, whilst maintaining a level of confidence that products
are technically compatible, to specification, and safe.
In such complex markets, reassurance in the
measurements, tests, inspections, and certification performed in another
jurisdiction is essential. Without these standards, the free exchange of goods
and services would be hampered by technical barriers, thereby increasing costs
for importers and consumers.
Global acceptance of accredited certificates is a
central pillar of accreditation as the harmonization of assessment requirements
and processes at a worldwide level, provides businesses and regulators with
confidence that products entering the market conform to specification, meet
national legal and regulatory requirements, and will therefore serve to protect
public interests in general.
Key Differences in ISO/TS 16949:2009
ISO/TS 16949:2009 introduces no new or changed
requirements. The incorporated ISO 9001:2008 standard is based on clarifications
or amendments to ISO 9001:2000 and those intended to improve consistency with
ISO 14001:2004.
ISO/TS 16949 incorporates text from the ISO 9001 standard
within boxed sections. The text unique to ISO/TS 16949 is included outside the
boxed ISO 9001 sections. Most of the differences in ISO/TS 16949:2009, beyond
those in the boxed ISO 9001:2008 text, were to:
| 1. |
Change from "product quality" to
"conformity to product requirements" in multiple places for consistency
with the same change made in ISO 9001:2008. |
| 2. |
Change from "regulatory" requirements to
"statutory and regulatory" requirements in multiple places for
consistency with the same change made in ISO 9001:2008. |
| 3. |
Modify the titles for clauses 6.2.2 and
7.6 to match the changed titles in ISO 9001:2008. |
| 4. |
Replace "ISO 9001:2000" with "ISO
9001:2008" and "ISO 9000:2000" with "ISO 9000:2005". |
| 5. |
Add new references in the Bibliography
section and remove the withdrawn standards. |
ISO, ILAC and IAF Streamline Quality
Management Requirements for Medical Laboratories
Medical laboratories accredited to ISO 15189:2007
are recognized as meeting the management system principles of ISO 9001:2008.
The move was announced in a joint communique by ISO,
ILAC and IAF in September 2009. The ISO-IAF-ILAC communique was issued to
address the misconception in the market that medical laboratories accredited to
ISO 15189:2007 do not operate a recognized management system.
Until now, accredited medical laboratories were
often requested by their customers to undertake the additional step of
certification to ISO 9001:2008 to demonstrate that they are in full control of
their processes. Based on the new procedures, medical laboratories accredited to
ISO 15189 will now be recognized as meeting the management system principles of
ISO 9001:2008. Accredited medical laboratories that are part of a larger
organization certified to ISO 9001 should only need to be assessed once
according to ISO 15189, and these results should be accepted as meeting the
principles of the management system requirements (ISO 9001:2008).
This recognition will reduce redundant, costly
and time-consuming audits, at the same time, enable medical laboratories to
better meet their customers' needs.
Tips on Applications of ISO/IEC 17025 Requirements
What is considered an "equivalent measure" for
avoiding loss or change of original data that is stored electronically per
Section 4.13.2.3?
"Electronic records" are considered to be records
that exist in electronic form such as data stored on a computer hard drive,
network or other storage media. Appropriate measures are to be implemented by
the laboratory that safeguard against loss or change of the originally recorded
data. Such measures may include:
- Preventing the overwriting of an existing
record, but saving a revision of the original record which includes the
corrected or altered data;
- Retaining a register of changes/revisions in
electronic records that detail the changes made;
- Limiting write access to electronic records
to only authorized individuals;
- Using revision control features of the
application that is used to generate the electronic record (e.g. "track
changes" in MS Word)
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