Do we need to the requirements listed under the heading NOTE

A

amanbhai

#1
Do we need to comply with the requirements listed under the heading NOTE in the ISO/IEC 17025:2005?
DO we need to take it as it is or is there any ways we can avoid it or some of its part?
:thanks:
 
Elsmar Forum Sponsor
C

crendfrey

#2
Greetings Amanbhai,

In my humble opinion, the notes are used as an explanation and guideline.
Especially in section 4.
In Section 5 our auditor liked our procedures to accommodate them.
When reading the standard, remember that it is a “one size fits all” standard for testing and calibration. You must make it fit your company.
There will be things that just don’t apply for which you must write an exclusion.
Don’t forget about the secondary key words found in the notes like “at a minimum”.
We found that rational, practical explanations, mostly written in our procedures but some verbal clarifications geared to our specific business, were accepted.
17025:2005 is a monumental task involving much “discussion” :argue: regarding “what does this mean?” and more importantly “what does this mean for us?”
Hope this helps a little bit.
 
D

Dave Dunn

#3
amanbhai said:
Do we need to comply with the requirements listed under the heading NOTE in the ISO/IEC 17025:2005?
DO we need to take it as it is or is there any ways we can avoid it or some of its part?
:thanks:
Check toward the introduction of the manual. If it's anything like the PPAP manual from AIAG, you might find something similar to their application, "Paragraphs marked 'NOTE' are for guidance in understanding or clarifying the associated requirement. The word 'should' appearning in a NOTE is for guidance only."

Remember as always, requirements are "shall" or "must", suggestions are "should" or "may".
 

howste

Thaumaturge
Super Moderator
#4
As Dave said, notes do not contain requirements. Here's a quote from ISO 17025:2005:
1.3 The notes given provide clarification of the text, examples and guidance. They do not contain requirements and do not form an integral part of this International Standard.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#5
Amanbhai,

In general, the notes are not requirements.....however, your accrediting body may choose to elevate them to requirements BASED on circumstances and other relevant factors that are applicable to your lab.

Since you are in Canada, check with SCC and obtain their view on this.

www.scc.ca

Hershal
 
Thread starter Similar threads Forum Replies Date
P UDI-PI requirements on reusable surgical device, do we need serialisation? ISO 13485:2016 - Medical Device Quality Management Systems 0
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
L Turkish Requirements - Does the Software need to be translated? CE Marking (Conformité Européene) / CB Scheme 2
M Do you need an Applicable general safety and performance requirements Checklist? EU Medical Device Regulations 2
Q Need clarification on requirements.... Class i, gmp & 510(k) exempt Medical Device and FDA Regulations and Standards News 12
Ajit Basrur Need help to understand HIPAA requirements ISO 13485:2016 - Medical Device Quality Management Systems 17
D Do you need requirements for a Design FMEA FMEA and Control Plans 1
T Production line requirements for IATF 16949 - Need to have dedicated lines? IATF 16949 - Automotive Quality Systems Standard 3
N Do new requirements always need a validation? IEC 62304 - Medical Device Software Life Cycle Processes 5
S Certificate of Need (CON) and FDA Requirements US Food and Drug Administration (FDA) 6
A Need Clarity on AS9100 Lead Auditor Certification Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 19
R Does dental unit need to meet the requirements of clause 14 (PEMS)? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
D Lacking Documentation of Customer Requirements, what do I need? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
P ISO13485 Clause 7.2.1 (d) Additional Requirements - Need advise ISO 13485:2016 - Medical Device Quality Management Systems 2
L Do 21 CFR 820 Requirements need to be considered when deploying ISO 13485 in the UK ISO 13485:2016 - Medical Device Quality Management Systems 18
B Language requirements in Malaysia - What language the IFUs need to be in ISO 13485:2016 - Medical Device Quality Management Systems 6
GStough Need Advice: Regulatory Requirements Audits ISO 13485:2016 - Medical Device Quality Management Systems 6
MarilynJ6354 Preventive Action Requirements - Do we need a written requirement? Preventive Action and Continuous Improvement 19
D Do I need a Procedure on Legal Requirements? Regulated Insurance Sector ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
T Software Requirements - Need SRS tools like Telelogic Doors and ARTS by Goda ISO 13485:2016 - Medical Device Quality Management Systems 4
S Need solution to AS9100 signature requirements on the plans, and/or changes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
J Need to find past DCX Customer Specific Requirements Customer and Company Specific Requirements 9
S Do outprocessors need ISO 9001 certification by TS 16949 requirements? IATF 16949 - Automotive Quality Systems Standard 2
D Non-sector specific requirements: Do I need to write a physical procedure IATF 16949 - Automotive Quality Systems Standard 3
A Need help in determining Pull testing requirements - Personalized earplugs ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
C Need advice on the competency requirements of Laboratory Personel IATF 16949 - Automotive Quality Systems Standard 4
A ISO 14001 Calibration Requirements: Do ALL measuring devices need to be calibrated? ISO 14001:2015 Specific Discussions 5
D Following AS9102 for FAI Requirements - Does EVERY Component Need Its Own FAI? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 40
M Do we really need to meet the Supplier Laboratory Requirements (4.10.6)? General Measurement Device and Calibration Topics 3
K Change the way we need to document our work - Copies of requirements? QS-9000 - American Automotive Manufacturers Standard 2
J Need a contract monitoring Tool General Information Resources 0
J Need Help with FPY Data in Assembly Process Manufacturing and Related Processes 7
W 17025 and NIST handbook relationship (need advice) ISO 17025 related Discussions 8
lanley liao Does all of the suppliers need to integrated into the supplier list qualified of the company? Oil and Gas Industry Standards and Regulations 2
K Need procedure for D&D inputs? ISO 13485:2016 - Medical Device Quality Management Systems 4
S Need help on "Country of Origin" Medical Device and FDA Regulations and Standards News 0
Ed Panek Immediate need for 80601-2-56 Consulting expert. PM me for details Career and Occupation Discussions 0
Tagin You're Gonna Need a Bigger Root Cause Coffee Break and Water Cooler Discussions 12
M PSA Suppliers - CSR matrix and need the quality manual of PSA APQP and PPAP 2
M Need Help With Information Security Asset Risk Register IEC 27001 - Information Security Management Systems (ISMS) 2
K "World Class Product" based QM. I need advice. Quality Management System (QMS) Manuals 14
I Do I need to sign off my annual audit calendar? Internal Auditing 2
P Do we need to retrospectively use the "MD" symbol (indicating device is a medical device) on labels, e.g. finished devices within expiration date? EU Medical Device Regulations 2
M Do I need separation in my circuit with a medical charger? IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
V Certified Auditor - Need of additional certification specific to industry ( GMPs) ASQ vs ECA vs others Professional Certifications and Degrees 1
D Low risk IVD study in the UK, do I need MHRA approval? UK Medical Device Regulations 1
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
J Records Control - Does each individual record need to be numbered? Records and Data - Quality, Legal and Other Evidence 2
N Is there a need for clinical test of Class IIa products (for MDR)? EU Medical Device Regulations 2
J Do Software Subcontractors need to be ISO13485 compliant in the EU? EU Medical Device Regulations 3

Similar threads

Top Bottom