What accreditation is required for Internal Laboratories?

E

ellie

#1
My company is a compounder with internal laboratories. Many managers are questioning if we must maintain our laboratory accreditation to ISO17025 or equivalent to be accredited per QS9000, third edition?
 
Elsmar Forum Sponsor

Stuart Andrews

Involved - Posts
#2
The way I see it is this!

If you had ISO17025 before you were/are going to be QS accredited then you must have done this for a reason. Ask yourself - what was that reason?

Even if you are ISO17025 accredited, this does not mean you will meet the requirements of lab control for QS9000 (but you probably will). You still need to meet ALL the requirements of QS9000 separately.

If one of your customers requires you to have ISO17025, they won't be impressed if you've decided to leave out ISO17025 and go for QS9000 instead.

I really think you need to keep both because QS9000 is an automotive quality management standard that gives “minimum requirements” for in-house Lab control, and I would imagine it doesn’t come close to meeting the requirements of a Lab accreditation cert. Not by a long way!!!!
 
D

D.Scott

#3
To address your managers' questions - No - there is no requirement to have accreditation to ISO17025 in order to be accredited to QS-9000. As Stuart says though, if a customer requires it - that's a different matter.
Dave
 

Stuart Andrews

Involved - Posts
#4
D.Scott, upon reading your reply I had concluded that as ellie had stated "maintain"; their company already had ISO17025. But your interpretation of the question is right, and there is no need for a QS9000 sub-contractor/supplier to have ISO17025 to become QS accredited.

I thought I'd clarify this incase ellie was confused by my first answer.

[This message has been edited by Stuart Andrews (edited 09 June 2001).]
 
Thread starter Similar threads Forum Replies Date
B EU REACH Regulation - is ISO17025 accreditation required for internal labs? ISO 17025 related Discussions 6
Jerry Eldred ISO17025 Accreditation Not Required For Compliance ISO 17025 related Discussions 1
M Is ISO 17025 accreditation required under 21 CFR 820? ISO 17025 related Discussions 6
D Who is required to hold ISO 17025 accreditation? ISO 17025 related Discussions 2
A Nadcap Accreditation Fee AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
Sidney Vianna Informational IAF and ILAC to merge. A Global Accreditation mammoth? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 1
N IATF 16949:2016 7.1.5.3.2 External Laboratory - How to approve the Testing Laboratory without accreditation scope IATF 16949 - Automotive Quality Systems Standard 1
M Informational US FDA – Frequently Asked Questions (FAQs) About the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Medical Device and FDA Regulations and Standards News 0
M Informational USFDADraft Guidance – Accreditation Scheme for Conformity Assessment (ASCA) Pilot Medical Device and FDA Regulations and Standards News 0
J GLP accreditation for mechanical tests of medical device? Other Medical Device and Orthopedic Related Topics 1
Sidney Vianna Interesting Discussion The proliferation of Accreditation Bodies in the USA ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 6
Sidney Vianna Are the Accreditation Bodies doing their job? Keeping CB's accountable Registrars and Notified Bodies 0
DuncanGibbons How does AS 9100D correlate or differ from NADCAP accreditation? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 8
Sidney Vianna World Accreditation Day 2019 - consistent accreditation? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 4
Ajit Basrur Informational Merger of PAC and APLAC to form the Asia Pacific Accreditation Cooperation (APAC) General Measurement Device and Calibration Topics 0
M IAS (USA) Accreditation with IAF for ISO 13485 Logo Confusion EU Medical Device Regulations 10
B Request for Information; Application for Accreditation Japan Medical Device Regulations 0
G ANAB ISO 17025 Accreditation - Uncertainty and systematic error? ISO 17025 related Discussions 6
S ISO 17025 - Help in Getting accreditation- Where to start from ISO 17025 related Discussions 8
R CE accreditation for EN 60601-1 ISO 13485:2016 - Medical Device Quality Management Systems 1
S Technical Steps to ISO 17025 Accreditation ISO 17025 related Discussions 1
M IAF Accreditation and CE Mark Questions EU Medical Device Regulations 24
Marc IAF (international accreditation forum) - Mandatory Documents (MD Series) ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 0
S Supplier/ Service Provider Accreditation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
H Requirements for parameter based testing scope of accreditation General Measurement Device and Calibration Topics 4
B Registration Certificate Dual Accreditation Marks (UKAS and ANAB) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
R Do I need A2LA Accreditation? General Measurement Device and Calibration Topics 2
Marc IAQG Listed AS9100 National Accreditation Bodies as of 29 June 2014 ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 7
TrivialSublime TUV Rheinland voluntarily suspending their ANAB accreditation to AS9100/AS9120. Registrars and Notified Bodies 19
M Understanding accreditation, MoUs, certifications Other ISO and International Standards and European Regulations 28
R Should transfer of certificates be better scrutinized by accreditation bodies? Registrars and Notified Bodies 5
J PT/ILC - No Approved Programs within our Scope of Accreditation General Measurement Device and Calibration Topics 2
Hershal IAS Public Accreditation Committee Meeting Feb 10, 2014 General Measurement Device and Calibration Topics 2
G Is there an OSHA Safety Accreditation? Occupational Health & Safety Management Standards 9
Jim Wynne Laboratory Accreditation Certificate with no Expiration Date General Measurement Device and Calibration Topics 5
M Does ISO/IEC 17021 Accreditation work for 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
S Which is the "Best" Registrar Accreditation Body? Registrars and Notified Bodies 3
I International Accreditation Board of Bristol, UK ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 11
P Losing Accreditation - JAS-ANZ has changed the conditions of non-conformances ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R Comparing Laboratory Scope of Accreditation against internal equipment General Measurement Device and Calibration Topics 3
B New website for AIAO-BAR - Unaccredited Accreditation Body ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 33
S Renewal of "Accreditation Certificate of Foreign Medical Device Manufacturer" Japan Medical Device Regulations 3
M Starting ISO 17025 Accreditation from scratch - Petroleum Laboratory ISO 17025 related Discussions 3
somashekar Is IAF an AB (Accreditation Body) for the ISO9k? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R Tier 2 Laboratory Accreditation IATF 16949 - Automotive Quality Systems Standard 3
Coury Ferguson BSI receives AS9104/1 ANAB Accreditation - October 2012 Registrars and Notified Bodies 0
K Bureau Veritas UKAS accreditation for ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Hershal PAC (Pacific Accreditation Cooperation) guidance on application of ISO/IEC 27000 IEC 27001 - Information Security Management Systems (ISMS) 0
Sidney Vianna Accreditation Bodies to Perform Market Surveillance Visits to Certified Organizations Registrars and Notified Bodies 2
JodiB What point does the Accreditation begin in the process? ISO 17025 ISO 17025 related Discussions 6
Similar threads


















































Top Bottom