Examples of Risk and Opportunities based on ISO 9001:2015

Y

yoosuf

Starting to get Involved
#1
#1
Hi,

Could anyone please help me to understand,

Whether all identified risks are associated with opportunities?

and

quote couple of examples please.


Many thanks
 
Elsmar Forum Sponsor
Q

QAMTY

#3
#3
An example, you detected a risk, lack of training in some people,well an opportunity, could be along with this effort, to train additional people.

Yo detected a risk in one machine, and defined one action, well, do the same in machines in other areas.

Hope this helps
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
G Any good examples of CAPA forms that include a risk based approach? ISO 13485:2016 - Medical Device Quality Management Systems 8
B Risk Requirements to meet the explicit Risk Based Approach of ISO 13485:2016 Examples ISO 13485:2016 - Medical Device Quality Management Systems 21
A AS 9100 - Risk Management Procedure and Flow Chart examples AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
V Examples of Risk Assessment (FMEA) through the Life Cycle of the Product Development ISO 14971 - Medical Device Risk Management 16
D Types and Examples of Risk Analysis FMEA and Control Plans 2
R DFA & DFM - Examples for Design for assembly and design for manufacturability Lean in Manufacturing and Service Industries 1
E Non-GMP examples in Pharmaceutical industry Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 2
I Quality Policy and Objectives examples Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 4
Y Examples of TRB Reports for MIL-PRF-31032 Qualification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
I ISO 22000:2018 - Operational Prerequisite Program Examples Food Safety - ISO 22000, HACCP (21 CFR 120) 2
S Examples of software changes that required a 510k US Food and Drug Administration (FDA) 2
W SOP examples wanted - Soil, Concrete and Asphalt testing ISO 17025 related Discussions 3
M Where can I find examples of PPAP? APQP and PPAP 6
O Examples of Critical process parameter (CPP) and Critical quality attribute (CQA) Manufacturing and Related Processes 2
S AS9100D PEAR - Examples for organization's method for determining process results? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
L IATF 16949 8.3.3.2 FCA (Fiat Chrysler) Specific Requirements - Examples of AQR and MPFMEA Service Industry Specific Topics 1
L IATF 16949 Warranty Management System examples IATF 16949 - Automotive Quality Systems Standard 0
A Examples of Pre-Sub, SRD, PMA Shells and Templates Other US Medical Device Regulations 3
S IAF Codes - Examples of what falls under each code General Information Resources 2
R Examples of inherent safety by design ISO 14971 - Medical Device Risk Management 83
O Examples of the external and internal issues and their risks and opportunities IATF 16949 - Automotive Quality Systems Standard 2
M Medical Device Traceability Matrix - Examples EU Medical Device Regulations 7
P Examples of Nonconformance, Corrective Action Requests, and Root Cause Analysis Nonconformance and Corrective Action 2
Ajit Basrur Looking for examples of "User Training" - ISO 13485 section 7.2.1 d) ISO 13485:2016 - Medical Device Quality Management Systems 6
S Manufacturing Work Instruction examples that include process pictures Manufacturing and Related Processes 3
G Uncertainty Budget Examples for Caliper, Micrometer and Dial Gauge Measurement Uncertainty (MU) 3
Albert G. What are general examples of audit findings with ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
Q Risks Examples in Top Management ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
R ISO 13485:2016 - Quality Objectives Regulatory Requirement Examples ISO 13485:2016 - Medical Device Quality Management Systems 1
Sidney Vianna Blockchain Technology - Any examples of practical application? The Reading Room 21
Z SAP Validation for Part 11 Compliance - Examples (executed protocols) Qualification and Validation (including 21 CFR Part 11) 3
M How to Document Internal & External Communications - Suggestions/examples pls IATF 16949 - Automotive Quality Systems Standard 3
R Examples of Quality Objectives related to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 6
M CAAC-145 Manuals - Looking for examples of MOM's, MMM's Capability Lists, etc. Federal Aviation Administration (FAA) Standards and Requirements 13
D Seeking Corrective Action Process Examples Nonconformance and Corrective Action 3
pammesue ISO 9001:2008 Design and Development Process & Forms examples wanted Design and Development of Products and Processes 3
K AS9100 5.3 Authorities (Looking for examples) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
F ISO 14001:2015 EMS Procedures and Form Examples wanted ISO 14001:2015 Specific Discussions 10
K EN ISO 15223-1:2012 Clarification or Examples on when to use Safety Symbols Other Medical Device Related Standards 3
A SIPOC (Suppliers Inputs Process Outputs Customers) examples wanted Quality Manager and Management Related Issues 1
A Aseptic Sampling Procedure Examples (Syringe and Dipper) wanted Manufacturing and Related Processes 1
S Customer Scorecard Analysis Templates and Examples IATF 16949 - Automotive Quality Systems Standard 3
H Root Cause Corrective Action Examples Nonconformance and Corrective Action 4
S Seeking examples of Nonconforming Materials Nonconformance and Corrective Action 5
C Need examples for Controlled Shipping I and II (CSL) IATF 16949 - Automotive Quality Systems Standard 3
E Good Warehousing Practices - Examples? Manufacturing and Related Processes 3
somashekar Industry examples of Significant Beneficial Environmental Impacts Miscellaneous Environmental Standards and EMS Related Discussions 3
S OHSAS 18001 Typical Input and Output Examples Occupational Health & Safety Management Standards 4
P What should a Quality Plan Include and Examples Misc. Quality Assurance and Business Systems Related Topics 3
H Corrective and Preventive Actions Process Examples IATF 16949 - Automotive Quality Systems Standard 2

Similar threads

Top Bottom