All the risk assessments - ISO 9001:2015 requirements

Moncia

Quite Involved in Discussions
#1
Hello

I am due to start working on the 2015 revision
Scared out of my mind - still dont quite understand what's going on

All the risk assessments

Who's gone through the re-certification already and can share some pointers???



Much appreciated
Moncia
 
Elsmar Forum Sponsor

Kronos147

Trusted Information Resource
#2
If you have implemented all the new requirements into your system, and the system is processes based, and process owners are training in RTB, and the employ this in their processes, a good Risk Assessment activity is to conduct and internal audit on all the processes.

What, you are already doing an internal audit on all the processes?

Wow, it looks as if you already are employing RTB in your system.

Now, the trick is to explain that (PLAN), and to capture the activities (DOCUMENTED INFORMATION).

Don't over think it. You do it all already, I'll bet.
 

RoxaneB

Super Moderator
Super Moderator
#3
Hello

I am due to start working on the 2015 revision
Scared out of my mind - still dont quite understand what's going on

All the risk assessments

Who's gone through the re-certification already and can share some pointers???



Much appreciated
Moncia
Moncia, is your organization already ISO 9001:2008? If so, it would probably not be too resource-intensive to do a gap analysis to the new requirements - even if only a 'table-top' exercise with senior management. This approach would have them become familiar with the new standard and could serve as one way to demonstrate their commitment.

That said, we have discussed the risk assessments/management in this thread - perhaps your concerns have already been addressed. :)
 

Moncia

Quite Involved in Discussions
#4
yes
we are ISO 2008

but from what i heard - you have to pretty much re-write all you procedures

i might be mistaken

like i said - i am just getting started

not really sure where to start from :frust:
 
Thread starter Similar threads Forum Replies Date
M Should volume of sales be factored into risk probability assessments? ISO 14971 - Medical Device Risk Management 33
S Excipient Manufacturers - Supplier Risk Assessments when they refuse Customer Audits Supplier Quality Assurance and other Supplier Issues 5
R Risk Assessments, Packaging Qualification and Equipment Modifications Manufacturing and Related Processes 3
C Own Brand Labellers Manufacturer's Products (Class I and IIa) and Risk Assessments EU Medical Device Regulations 3
P ISO27001 - Risk Assessments Other ISO and International Standards and European Regulations 5
T Software Supplier Risk Assessments General Auditing Discussions 0
R Risk assessment on IT containers and the information they contain IEC 27001 - Information Security Management Systems (ISMS) 4
B Threat/Vulnerability Catalogue for risk assessment IEC 27001 - Information Security Management Systems (ISMS) 4
R Opportunity For Improvement vs Opportunity (Positive Risk) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
R FOD Risk Assessment - What tools would you recommend for assessing FOD risk? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
A ISO 14971 PFMEA Manufacturing Risk ISO 14971 - Medical Device Risk Management 2
Q Example of the Risk Template Document Control Systems, Procedures, Forms and Templates 1
K Overall residual risk according to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 5
A Risk Number for each software requirement IEC 62304 - Medical Device Software Life Cycle Processes 7
A IEC 60601 11.2.2.1 Risk of Fire in an Oxygen Rich Environment, Source of Ignition IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
D Importing a general wellness low risk product Other US Medical Device Regulations 3
C Quantifying risk in choosing the number of parts, operators and replicates in a GR&R Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
R AQL, Consumer Risk and MA Statistical Analysis Tools, Techniques and SPC 2
M Risk managment report of Surgical Mask Example ISO 14971 - Medical Device Risk Management 14
M Risk Analysis Flow - Confusion between ISO 14971 and IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 8
R ECG Risk Analysis Standards ISO 14971 - Medical Device Risk Management 2
N Device Labeling - Medtronic Ventilator Files (Risk Management documents) Coffee Break and Water Cooler Discussions 2
A 5 x 5 Risk Matrix - Looking for a good example Manufacturing and Related Processes 2
F Risk for Quality Assurance Department in a Hospital - Hospital Incident Reporting ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T How do you define your Hazards? <a Risk Management discussion> ISO 14971 - Medical Device Risk Management 16
adir88 Documenting Risk Control Option Analysis ISO 14971 - Medical Device Risk Management 8
B Risk Assessment Checklist for Non product Software IEC 62304 - Medical Device Software Life Cycle Processes 1
MrTetris Should potential bugs be considered in software risk analysis? ISO 14971 - Medical Device Risk Management 5
K Identification of hazards and Risk file IEC 62366 - Medical Device Usability Engineering 7
S Risk based internal auditing Internal Auditing 6
Robert Stanley I'm @ RISK of not showing my RISKS! ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
M Estimating the benefit-risk ration under MDR EU Medical Device Regulations 1
adir88 Information of safety can reduce risk now? ISO 14971 - Medical Device Risk Management 12
G Any good examples of CAPA forms that include a risk based approach? ISO 13485:2016 - Medical Device Quality Management Systems 8
adir88 MDR requirement: Risk Management Plan for "each device" ISO 14971 - Medical Device Risk Management 5
M Has anyone heard of Run at Risk? Manufacturing and Related Processes 15
Tagin Is SARS-CoV-2/COVID-19 on your risk register? Misc. Quality Assurance and Business Systems Related Topics 11
D IEC 62304 Risk Classification - With and without hardware control IEC 62304 - Medical Device Software Life Cycle Processes 2
J ISO 14971 applied to ISO 13485? Low risk class 1 devices ISO 13485:2016 - Medical Device Quality Management Systems 3
DuncanGibbons Classification of aerospace parts depending on their risk and criticality etc. Federal Aviation Administration (FAA) Standards and Requirements 3
D Performance specification as a Risk Control Measure, EN 14971 ISO 14971 - Medical Device Risk Management 7
M Risk Classification For Supplier - Clinical Research Organisation (CRO) Supply Chain Security Management Systems 3
Sidney Vianna IAQG SCMH explains "positive risk"..........but does it? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
MrTetris Unacceptable risk and information for safety ISO 14971 - Medical Device Risk Management 16
M IATF 16949 (6.1.1 - Planning and Risk Analysis for a remote site) Process Maps, Process Mapping and Turtle Diagrams 5
D Risk Analysis & Technical File - What detail goes in the Risk Management Report ISO 14971 - Medical Device Risk Management 5
C AS9100 Rev D 8.1.1 & APQP - Operational risk management process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
B ATP 5-19 "Risk Management" Misc. Quality Assurance and Business Systems Related Topics 2
D Reduction of software class based on multiple external risk controls IEC 62304 - Medical Device Software Life Cycle Processes 5

Similar threads

Top Bottom