Does ISO/IEC 17025:2005 require the Laboratory to have separate ISO 9001 Procedures

morteza

Trusted Information Resource
#1
Hello all
I would be so grateful if someone answer the below question.

Question:
Does ISO/IEC 17025:2005 requires the laboratory which is part of an organization certified to ISO 9001:2008, to prepare a separated set of documents in spite of those provided according to ISO 9001:2008?

Overview for this question:
In our organization which has been certified to ISO/TS 16949:2009, we have a calibration laboratory which is preparing itself to be accredited against to ISO/IEC 17025:2005. But some assessors said us that we shall have a separated set of documents for laboratory despite those we provided for our quality management system. For example, we have a documented procedure for document control (according to ISO 9001 clause 4.2.3) and our laboratory also uses this procedure for controlling its documents. Assessors believe that we shall have an independent procedure (with different identification code) for laboratory regardless of that created for QMS (including laboratory). Assessors have the same idea for other procedures such as internal audit or purchasing.
Thanks in advance.
 
Elsmar Forum Sponsor

Stijloor

Staff member
Super Moderator
#2
Re: Request for clarification

Your internal lab must have a "Scope Statement." The scope statement includes: a listing of the specific tests performed, the devices/equipment used, the applicable standards/references, and the qualifications of the lab personnel.

Hope this helps.

Stijloor.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#3
Re: Does ISO/IEC 17025:2005 require the Laboratory to have separate ISO 9001 Procedur

There is some validity to what you have been told. An ISO9001 manual by itself does not address the requirements for lab accreditation usually. Specifically, things like proficiency testing and inter-laboratory comparison (PT/ILC), traceability, specific requirements for the management review, training required for internal auditors (the auditors must be able to audit the lab operations), and some specifics in other areas like purchasing.

Typically, the lab will have a "supplemental" manual that addresses the requirements for the lab that go beyond 9K. Base as much as possible on the parent's 9K manual, but have the additional for the accreditation requirements.
 
A

ananthadd

#4
Re: Does ISO/IEC 17025:2005 require the Laboratory to have separate ISO 9001 Procedur

Hello all
I would be so grateful if someone answer the below question.

Question:
Does ISO/IEC 17025:2005 requires the laboratory which is part of an organization certified to ISO 9001:2008, to prepare a separated set of documents in spite of those provided according to ISO 9001:2008?

Overview for this question:
In our organization which has been certified to ISO/TS 16949:2009, we have a calibration laboratory which is preparing itself to be accredited against to ISO/IEC 17025:2005. But some assessors said us that we shall have a separated set of documents for laboratory despite those we provided for our quality management system. For example, we have a documented procedure for document control (according to ISO 9001 clause 4.2.3) and our laboratory also uses this procedure for controlling its documents. Assessors believe that we shall have an independent procedure (with different identification code) for laboratory regardless of that created for QMS (including laboratory). Assessors have the same idea for other procedures such as internal audit or purchasing.
Thanks in advance.
Yes Sir beyond doubt you need separate procedures to cover the technical requirements because 17025 is technical standard for calibration and testing. Cl 4 of 17025 will be a direct reflection of system requirements of ISO 9001 while cl 5 will be partly system and mostly technical.

Hope this clarifies

Best Regards

Ananth
 
B

bazboy

#5
Re: Does ISO/IEC 17025:2005 require the Laboratory to have separate ISO 9001 Procedur

It's important to remember what works best for your company and not what the assessors like to see. Having said that I would have a separate 17025 procedure that that only contains processes that are unique to 17025. Much of 17025 can be covered by your 9001 QM eg document control, auditing etc.
 
Thread starter Similar threads Forum Replies Date
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
M Does Calibration to ISO/IEC 17025 conform to Z540.3? ISO 17025 related Discussions 1
M Does ISO/IEC 17021 Accreditation work for 13485 ISO 13485:2016 - Medical Device Quality Management Systems 2
T Does anybody know about EN45014? (Replaced by ISO/IEC 17050-1) Other Medical Device Related Standards 1
A Sampling - What does it mean by Sampling in ISO:IEC 17025 ISO 17025 related Discussions 1
R Does ISO/IEC 17025 supersede ANSI/NCSL Z540 ISO 17025 related Discussions 6
A Does anybody have an audit check list for ISO/IEC 17025 to replace ISO/IEC Guide 25 ISO 17025 related Discussions 14
M Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 1
N Does anyone use SGS for ISO 13485 / CE certification Registrars and Notified Bodies 0
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 9
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A What does this sentence "this symbol shall be used in the orientation shown" mean in ISO 780:2015? Other Medical Device Related Standards 4
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 39
A EN ISO 14971:2019 does not include the Annex Zs ISO 14971 - Medical Device Risk Management 4
Watchcat Does ISO 13485 7.3 include the manufacturing process? ISO 13485:2016 - Medical Device Quality Management Systems 14
B Does EN ISO 15223-1:2016 include the graphic symbols to be added to software and IFU? Other Medical Device Related Standards 9
G Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing? Quality Management System (QMS) Manuals 14
C Does ISO 9001-2015 have a requirement for manufacturing equipment to be numbered? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A What if Contract Manufacturers does not have an ISO 13485 certificate? Where will the NB audit take place, at legal mfg. site or contract mfg. site? Other Medical Device Regulations World-Wide 3
M Does ISO 13485 or MDR require you to state the origins of customer requirements or user needs? Design and Development of Products and Processes 2
Q Does anyone have experience implementing a QMS without ISO certification? Quality Manager and Management Related Issues 2
P Why does the standard clause use the term Issues in place of Context - ISO 27001 4.1 IEC 27001 - Information Security Management Systems (ISMS) 3
Q Does our material suppliers’ supplier have to be at least ISO 9001 certified? IATF 16949 - Automotive Quality Systems Standard 3
D Where does FMEA fit in your ISO 14971 Risk Management process? ISO 14971 - Medical Device Risk Management 13
M Does ISO 9001 mandates cooking procedure for restaurants ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Tagin Does ISO 9001:2015 require a full internal audit annually? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
L Does anybody have quiz's available? ISO 13485:2016 Training Material Training - Internal, External, Online and Distance Learning 2
N Does anyone know a registrar that offers both ISO 9001 and ISO 17020? Registrars and Notified Bodies 6
Q Does ISO 9001 require CARs for all customer complaints? Customer Complaints 2
S RSL (Remote Site Location) Laboratory - Does it need to be ISO 17025 IATF 16949 - Automotive Quality Systems Standard 5
qualprod ISO 9001 Cl. 4.1 and 4.2 - What does monitoring and review mean? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Sidney Vianna ASQ apparently doesn't know ISO does not issue ISO 9001 certificates? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 4
K Does ISO 13485:2016 - 7.2.3 Customer Communication include Marketing? ISO 13485:2016 - Medical Device Quality Management Systems 1
M Does MDSAP replace ISO 13485, or do both have to be maintained? ISO 13485:2016 - Medical Device Quality Management Systems 25
M Does ISO 10993 Apply to Packaging? (e.g. Travel Case) Other Medical Device Related Standards 4
thisby_ ISO 14971 - ALARP and P2 - New ISO 14971 does not allow the concept of ALARP? ISO 14971 - Medical Device Risk Management 3
C Optic Patchcord Cables - Does 8.3 (Design) Apply Here? ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Does AS9100 require Suppliers to be Certified to ISO or AS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
A Does anyone have a comparison between ISO 9001:2015 and ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
G Does ISO 9001:2015 call for a Policy or a Statement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Q Does ISO 9001 Requirement for Document Approval (a service organization) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
J Does the word "claim" in ISO 9001 Clause 8.2.2 mean "requirement"? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S ISO 14001 Clause 4.1 Organization and its context - What does an Auditor expect? ISO 14001:2015 Specific Discussions 12
T Does your Quality Dept Control Procedures Outside the Scope of ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S ISO 9001:2008 Certification Scope does not mention "manufacturing" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Q Where does 5S technique fit into ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
L What does "conformance matrix" means in terms of ISO 9001:2008? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5

Similar threads

Top Bottom