SBS - The Best Value in QMS software

ISO 9001:2105 - Are OFI or Corrective actions required?

embedded

Involved In Discussions
#1
Hi All,

Our continual improvement processes cover our Corrective Action processes/records, but we have no processes in regards to Corrections or OFI (Opportunities For Improvement). We're a small company with limited resources and are relatively new to ISO so are trying to walk before we run... Are we required to have Corrections or OFI processes / records per ISO 9001:2015?
 
Elsmar Forum Sponsor

John Broomfield

Staff member
Super Moderator
#3
Don’t bother with OFIs but you may find that your colleagues would welcome a means of suggesting improvements to the system that is meant help them to do good work or even better work.

Corrections need not be recorded (they may happen as a result on monitoring a process) unless they are an essential step in corrective action.
 

John Broomfield

Staff member
Super Moderator
#7
Indeed, process corrections that don't work may eventually be reported and shared as a process nonconformity worthy of corrective action. And too common process corrections may indicate the need for system improvement but then the person knowing this will suggest an improvement perhaps to have it addressed across the organization.

Otherwise these ineffective process corrections may result in service or product nonconformity.

If this is too risky or ineffective then keep a record of the corrections provided the records are reviewed for necessary improvements.

The point at which process corrections are recorded may depend on the magnitude of the potential service or product nonconformity.
 

Randy

Super Moderator
#8
Don’t bother with OFIs but you may find that your colleagues would welcome a means of suggesting improvements to the system that is meant help them to do good work or even better work.

Corrections need not be recorded (they may happen as a result on monitoring a process) unless they are an essential step in corrective action.
How do you explain this?
10.2.2 The organization shall retain documented information as evidence of:
a) the nature of the nonconformities and any subsequent actions taken;
b) the results of any corrective action.
 

Jim Wynne

Staff member
Admin
#9
How do you explain this?
10.2.2 The organization shall retain documented information as evidence of:
a) the nature of the nonconformities and any subsequent actions taken;
b) the results of any corrective action.
I don't think it's clear at this point what was meant by "corrections" in the original post. It's possible to "correct" something before a nonconformity happens. This is somewhat at odds with common terminology, but it would be good if the OP could explain what was meant.
 

Pancho

wikineer
Super Moderator
#10
Hi All,

Our continual improvement processes cover our Corrective Action processes/records, but we have no processes in regards to Corrections or OFI (Opportunities For Improvement). We're a small company with limited resources and are relatively new to ISO so are trying to walk before we run... Are we required to have Corrections or OFI processes / records per ISO 9001:2015?
Further to Randy's comment, per 10.2.1 you must "as applicable" take action to control and correct non-conformities, and deal with their consequences. It is hard to imagine a case where you'd want to deliver (or your customer would want to receive) non-conforming product, so, yes, you should, at least, have corrections. And though the standard doesn't require it, it is good practice to record your NCs as they happen. Such record allows for better control, correction and dealing with the consequences.

NCs are valuable. They show you where your system is weak. They ARE opportunities for improvement. We use issue-handling software to record them along with other OFIs. It works great.
 
Thread starter Similar threads Forum Replies Date
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 12
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 9
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
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
J Audit Checklist for Integrated Management System for ISO 9001:2015, ISO 14001 & OHSAS18001 (IMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
G National Structural Steel Specification 7th Edition - Do I now have to be audited against ISO 3843-3 as well as ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1

Similar threads

Top Bottom