ISO 9001 vs. ISO 17025 - And - Accreditation vs. Registration

J
#1
If a software provider tell you that their package will provide versatility by allowing your lab to attain iso 17025 accreditation and iso 9001 registration.... are you really benefiting since the 9001 requirements are covered mostly in the 17025 requirements? Please clarify if you can.
Thanks
 
Elsmar Forum Sponsor

Marc

Fully vaccinated are you?
Staff member
Admin
#2
What is the purpose of the software? Is it a gage tracking program? Document control program?
 
A

Al Dyer

#3
Jill,

They are 2 stand alone entities, although if you implement a quality system that encompasses all of the requirements of both, you could be audited to both at the same time and be accredited/registered to both as a combined "quality system"

I have no idea about the costs involved in such an endeavor, but you would need a registrar/auditor that is "allowed" to audit both entities.

Call a couple of registrars and see what the process would entail, they are looking for business and could be very helpful.

ASD...
 
G

Graeme

#5
Here is the key difference as I see it:
  • ISO 9001:2000 - Describe and document your commitment to quality, your processes, and procedures. (The familiar process of say what you do, do what you say, prove that you did it, show that you are improving it, and show what your customer thinks of it.)
  • ISO 17025 - if you are a testing or calibration laboratory, then in addition to the above prove that you are capable by actually doing the work and having it verified.

Software by itself is not the whole answer. Software does not do the testing or calibration. The testing or calibration process may include the software, but it also includes the environment, equipment, methods and people. All of these work together to produce a result, and one of the parts of laboratory accreditation is proving that the result is correct, at least to within your stated limits of uncertainty.

------------------
Graeme C. Payne
ASQ Certified Quality Engineer
 
Thread starter Similar threads Forum Replies Date
S Transition training for Internal Auditor from ISO 9001: 2008 to the ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
H R&D Lab ISO 9001 certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
J ISO 9001:2015 Clause 8.5.1 Control of Production and service provision - Help with Work Instruction Access ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
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
D Can an ISO 9001 Certificate have Remote Locations? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D ISO 9001 - 8.4.1 Evaluate All Suppliers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 66
Sidney Vianna ISO 9001 News ISO 9001 Quality Check - spinning facts in LinkedIn ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A ISO 9001 Internal Audits - No production right now due to furloughs Internal Auditing 5
T Do we need an SOP for ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
K ISO 9001 Auditing in a Healthcare setting Process Audits and Layered Process Audits 15
C ISO 9001:2015 8.3.2. h) Design and Development Planning - What is required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Employee Handbook in ISO 9001:2015 Section 7 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
Q ISO 9001/IATF 16949 Audit Finding Question - Document Retention IATF 16949 - Automotive Quality Systems Standard 11
Q Audit report template ISO 9001/14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Q Process matrix examples of ISO 9001 & 14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
chris1price Archiving of paper records - ISO 9001 7.5.3.1b Records and Data - Quality, Legal and Other Evidence 4
D Common practices in ISO 9001 deployment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Q ISO 9001-2015 Internal audit finding Internal Auditing 14
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
W First time being audited (ISO 9001), asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Q ISO 9001 - Reseller Exclusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
N ISO 9001 - Training business with fewer than 5 employees ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
J Opportunity in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
K Integrating ISO 9001:2015 with ISO 17025:2017 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R Remote Audits for ISO 9001 (or any other standard) General Auditing Discussions 31
T Relationship between ISO 9001 and ISO – IEC BS EN 870079- 34 2020 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Sequence of ISO 9001:2015 Implementation Steps ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
qualprod Business Continuity Planning in ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Brizilla Employee Data Privacy Policy - ISO 9001:2015 requirement(s)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S ISO 9001:2015 Internal Auditing Internal Auditing 8
Q Process: Knowledge Section 7.1.6 of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
P ISO 9001 certification with zero customers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A What must be recorded? (ISO 9001:2015, subclause 10.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
B Updated IATF 16949 - Will IATF 16949 get revised when ISO 9001:202X is released? IATF 16949 - Automotive Quality Systems Standard 4
S ISO 9001:2015 vs 21 CFR Part 211 matrix Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
S ISO 9001 implementation in a Gold exporting business ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
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
A Tips and Tricks to understand ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M ISO 9001 Major Nonconformance Internal Audit Schedule/COVID-19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
B ISO 9001 - "Remote Audit Fee" Registrars and Notified Bodies 13
John C. Abnet ISO 9001 4.4.1 "...shall determine the processes needed..." ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 72
S ISO 9001 Clause 8.2.3 - Review of the requirements for products and services in a Cafe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D ISO 9001 certificate issued by QMS International for 10 years - legit? Registrars and Notified Bodies 17
S Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
M ISO 9001:2015 and AS6081:2012 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Implementation ISO 9001: 2015 ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3

Similar threads

Top Bottom