SBS - The best value in QMS software

Can anybody share a sample risk assessment prepared based on ISO 17025:2017?

S

SULTHANA

#1
#1
Hi All

Can anybody share a sample risk assessment prepared based on ISO 17025:2017 accredited laboratories??
 
QMS for Medical Device Companies
Elsmar Forum Sponsor
A

AndyN

Moved On
#2
#2
Can you help us - the risk of using a lab, or risks TO a lab? A risk assessment by a lab isn't required to meet the ISO 9001:2015 option.
 
B

brucefon

Quality Coordinator - Hitachi High-Tech
#6
#6
Everything.
The 2017 edition takes time to adapt when you're so comfortable working with the 2005 standard. It's a complete reworking in the likes of 9001 from what I've read. 18 deficiencies came out of our 2-day renewal assessment to 2017. Even with 2 months to prepare it caught us by surprise. I was able to answer and fix all 18 in the 60 days but not without a lot of help from resources like Eurolab, this forum, other Cabs like ANAB, and some from ours, A2LA.
 
A

AndyN

Moved On
#7
#7
I'm currently working with an ISO/IEC 17025 accredited lab and I don't see much difference which would make that significant of a change. Yes, the section 4 and 6 requirements are different, but the rest is basic blocking and tackling (doesn't need changing much) from what was required under 2008... I'd be interested in what the 18 deficiencies were. Was it auditor bias?
 
B

brucefon

Quality Coordinator - Hitachi High-Tech
#8
#8
I would like to say half were probably assessor bias or interpretation but most were not technical in nature, rather, writing procedures that didn't exist before for many clauses related to risk this and risk that.
 
B

brucefon

Quality Coordinator - Hitachi High-Tech
#10
#10
Get ready to be impartial and identify risks to impartiality, confidentiality, and everything else. Then put it in writing.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
Y Training Plan/Schedule - Can anybody share a format or template for annual training Training - Internal, External, Online and Distance Learning 8
T Anybody could share an example of Ford PVP (production validation plan/program) APQP and PPAP 2
B Does anybody know how to get older versions of Minitab to work in Windows 10? Quality Tools, Improvement and Analysis 9
S Has anybody done IMS - Management Review Meeting ISO 14001:2015 Specific Discussions 8
I Does anybody use Detection in medical device Design FMEA? ISO 14971 - Medical Device Risk Management 18
L Does anybody have quiz's available? ISO 13485:2016 Training Material Training - Internal, External, Online and Distance Learning 2
S Can anybody help me enlighten to IATF 16949? IATF 16949 - Automotive Quality Systems Standard 7
R Due Diligence - IGC USA - Anybody know anything about them? Registrars and Notified Bodies 8
P Is anybody happy with their Notified Body? CE Marking (Conformité Européene) / CB Scheme 2
A Does anybody know in which Standard can this attached Alarm Symbol be found? Other Medical Device Related Standards 3
C Can anybody explain h.2 equation of GUM? Measurement Uncertainty (MU) 3
T Anybody been hurt by a flying triangular flapjack? Coffee Break and Water Cooler Discussions 12
R Can anybody tell me about p & np chart? Capability, Accuracy and Stability - Processes, Machines, etc. 4
S Anybody familiar with AHP Calibration Software? Calibration and Metrology Software and Hardware 3
W Is anybody familiar with IEC61010-1 Insulation Requirements? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
G Example/Sample Part 21J - "Anybody's Design Organisation Exposition" EASA and JAA Aviation Standards and Requirements 9
A Does Anybody use APIS (IQ-FMEA) Software in this forum? FMEA and Control Plans 2
P Has anybody had any experience with GM4350M? Customer and Company Specific Requirements 2
M Can anybody help me with Management Review scenario please? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
V Can anybody help me to get knowledge about API (6A) certification Oil and Gas Industry Standards and Regulations 8
S Anybody in the Education Industry? Service Industry Specific Topics 18
1 Is anybody familar with Quick Response Manufacturing? Lean in Manufacturing and Service Industries 6
6 Afghanistan - Anybody on this website working for companies in Afghanistan Immigration and Expatriate Topics 2
H Anybody miss me? Coffee Break and Water Cooler Discussions 10
Y Does anybody have any knowledge in Statistical Bin Limit (SBL)? Statistical Analysis Tools, Techniques and SPC 2
P IAQG General Assembly Forum - Anybody out there attending? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
QMMike MS-DC28, Type B, CPN 2647 - anybody have any information on this callout? Various Other Specifications, Standards, and related Requirements 1
C ISO 9001:2008 lite - Anybody heard of it before? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
QMMike Anybody familiar with SPC-PC IV Explorer? Statistical Analysis Tools, Techniques and SPC 2
S Medical Gas Pressure Regulators - Anybody had testing conducted at 450 bar? ISO 10524 Other ISO and International Standards and European Regulations 5
E Anybody knows about Steris Corporations Wave-lens Technology Misc. Quality Assurance and Business Systems Related Topics 3
A Can anybody provide a copy of ISO 9001:2008 standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
A Swimlane Diagram for Internal Auditing System - Anybody using this? Process Maps, Process Mapping and Turtle Diagrams 13
T Does anybody know about EN45014? (Replaced by ISO/IEC 17050-1) Other Medical Device Related Standards 1
M Anybody seeing negative trends with Connector manufacturers? Supplier Quality Assurance and other Supplier Issues 4
P ISO/TS 16949:2009 Status - Anybody know the target publication date IATF 16949 - Automotive Quality Systems Standard 71
5 Is anybody aware of a VDA 2 Revision which includes parts of the APQP process? VDA Standards - Germany's Automotive Standards 3
P Jishuken - Anybody familiar with this term? Lean in Manufacturing and Service Industries 19
I Anybody know about DFA (Design for Assembly) ? Design and Development of Products and Processes 1
M Does Anybody have an ISO 22000 internal audit checklist for sharing? Internal Auditing 11
Stijloor Does anybody get a job from listings in the Cove? Career and Occupation Discussions 18
L Configuration Management, Need to review ISO 10007, anybody have one? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
D Anybody have any presentation example per TS16949? IATF 16949 - Automotive Quality Systems Standard 1
N Could anybody suggest a routemap for CE marking for invitrodiagnostic medical device? ISO 13485:2016 - Medical Device Quality Management Systems 4
K Certified Project Manager - Is anybody here certified by AAPM for MPM? Professional Certifications and Degrees 4
Sidney Vianna Anybody using YackPack? If so, provide your comments. After Work and Weekend Discussion Topics 2
W Preventive 5S - Does anybody have any idea about Preventive 5S? Preventive Action and Continuous Improvement 1
J Product mix problem using excel .xls - Can anybody throw in some light? Excel .xls Spreadsheet Templates and Tools 5
M When is a system not a single device? Does anybody know of a guidance document? ISO 13485:2016 - Medical Device Quality Management Systems 11
Manix GM GP9 procedure - [email protected] - Can anybody explain the figure "% True Scrap"? Document Control Systems, Procedures, Forms and Templates 2

Similar threads

Top Bottom