Quality Objectives and resources

#1
We have determined resources required for our objectives - does it have to be documented on the Quality Objectives sheet - is this a nonconformance?
 
Elsmar Forum Sponsor

John C. Abnet

Teacher, sensei, kennari
Staff member
#2
We have determined resources required for our objectives - does it have to be documented on the Quality Objectives sheet - is this a nonconformance?
Good day @jaycove . The short answer is "no".
ISO 9001 prescribes very little in regards to HOW something is accomplished. The standard simply requires that resources are "considered', are determined and "provided"...etc.. The only retained information (records) are specific to ...
1- evidence of "fitness..." in regard to monitoring and measurement.
2- evidence of management reviews (which also is to "consider" resource "needs" and "adequacy".

So, no. It does not have to be documented beyond the records of consideration I mentioned above.

Hope this helps.
Be well.
 

Tagin

Trusted Information Resource
#3
While it may not be required, I do think it is helpful to create a quality objective plan with sections addressing 6.2.2a-e, even if its just one sentence per section.
 
#7
This is the text of the NC :FINDING: The organization did not provide evidence that the Objective’s Planning Actions considered the required resources. EVIDENCE: The Quality and Env. Objectives .... table did not have an entry for Resources
 

Tagin

Trusted Information Resource
#8
This is the text of the NC :FINDING: The organization did not provide evidence that the Objective’s Planning Actions considered the required resources. EVIDENCE: The Quality and Env. Objectives .... table did not have an entry for Resources
Did the auditor include the specific ISO 9001 clause for the N/C?
 

Big Jim

Super Moderator
#9
It sounds like a flakey NCR. The only element I can really relate to is 7.1.1 "The organization shall determine and provide the resources needed . . . " There is no record keeping attached to it though.
 

John Broomfield

Staff member
Super Moderator
#10
Perhaps the auditor asked “what are the processes (comprising work, resources and controls) required to fulfill this quality objective?”

...and no one knew the answer.

So, the auditor asked the CEO and still received the “rabbit in the headlights” look. The CEO then agreed this was a nonconformity in need of corrective action.
 
Thread starter Similar threads Forum Replies Date
Q Quality Objectives Not Met - Resources promised by investors ISO 13485:2016 - Medical Device Quality Management Systems 4
U Examples of Quality Objectives for a Medtech start up ISO 13485:2016 - Medical Device Quality Management Systems 4
V Quality Objectives - ISO 9001 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
I Quality Policy and Objectives examples Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 5
M Specific Values of Quality Objectives Benchmarking 7
V What plans have been put in place to achieve quality objectives? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A Objectives in Quality Policy ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
K ISO 13485 section 5.3 Quality Policy - No framework for establishing and reviewing quality objectives ISO 13485:2016 - Medical Device Quality Management Systems 2
S QUALITY OBJECTIVEs for third party garments factory inspection ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
R ISO 13485 Software validation procedure and Quality Objectives Monitoring wanted Document Control Systems, Procedures, Forms and Templates 1
F Quality Objectives - Where in the QMS Quality Objectives should be located ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Farley.0 QMS Sales Goals & Quality Objectives Manufacturing and Related Processes 22
qualprod Annual SWOT for 4.1? I plan to revise quality objectives and strategic route ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Setting Quality Objectives (for the first time) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 17
V Discussion of ISO 9001:2015 - "Quality Objectives" term ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
P Quality objectives - must they include CAPA and internal audit topic? ISO 13485:2016 - Medical Device Quality Management Systems 28
S Quality Department Objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
K Where in the quality manual do I put our Quality Objectives and our Quality Policy Quality Management System (QMS) Manuals 19
R ISO 13485:2016 - Quality Objectives Regulatory Requirement Examples ISO 13485:2016 - Medical Device Quality Management Systems 1
Q Additional KPI to Top Management beside Quality Objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
R Examples of Quality Objectives related to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 6
Q Setting Quality Objectives with a Timeframe ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Identifying Objectives & Targets for Quality Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
R 5.4.1 Quality Objectives - Nonconformity: The process was not fully effective ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 36
dubrizo If Quality Objectives are not known to employees, is it a Nonconformance? General Auditing Discussions 7
M Quality Objectives and Monitoring & Measurement of Processes - Clause 8.2.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T Corrective Action for Quality Objectives which are not Measureable Nonconformance and Corrective Action 7
T Best place in QMS to manage Quality Objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Q Quality Objectives for Quality Control and Quality Assurance functions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
T Setting Quality Objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
K Are Quality Objectives applicable on HSE Department? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
J Will these Quality Objectives cover the Product Requirements? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Presentation for tracking Quality Objectives across sites Preventive Action and Continuous Improvement 3
M Quality Objectives - Acceptable Levels and Functions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 37
H ISO 9001 Quality Objectives Scorecard or Matrix template to share ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
J Setting Quality Objectives for Service, Repair and Sales ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Understanding Quality Objectives, Metrics and KPI ISO 13485:2016 - Medical Device Quality Management Systems 15
L Changing Quality Objectives ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
G Differences between Quality Objectives and Business KPI's ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A Where to document Quality Objectives ISO 13485:2016 - Medical Device Quality Management Systems 6
J Quality Objectives for Engineering Department and R&D Quality Manager and Management Related Issues 5
A Quality Objectives 5.4.1 - KPI SOP - ISO 13485 Audit Observations EU Medical Device Regulations 6
A Are Explicit Quality Objectives Required? Quality Management System (QMS) Manuals 8
G Defining Quality Objectives for Product Realization and Design and Development AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
J Quality Objectives - Telephone Calls ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Quality Objectives for Aerospace Chemical Conversion & other Surface Treatment Plant AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
D Determining Quality Objectives for the Finance Department ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
C Looking for new Quality Objectives (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
I Are KPIs (Key Performance Indicators) considered as Quality Objectives? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Suitability and Meaning of PED (Pre-Established Dispositions) to Quality Objectives IATF 16949 - Automotive Quality Systems Standard 2

Similar threads

Top Bottom