SBS - The best value in QMS software

Quality Objectives - Is this an audit nonconformity?

Is there an audit nonconformity in the situation described?


  • Total voters
    40
  • Poll closed .
J

JaneB

#61
So set against the op, it seems to me many have lost sight of the reason to be in business........
While I know that the majority of organisations getting certified are commercial, not all of them are. Nor is the Standard restricted only to commercial organisations.

Making $ is NOT the only purpose, nor raison d'etre!
 
Elsmar Forum Sponsor

Randy

Super Moderator
#62
While I know that the majority of organisations getting certified are commercial, not all of them are. Nor is the Standard restricted only to commercial organisations.

Making $ is NOT the only purpose, nor raison d'etre!
:topic: Please forgive my rudeness but I gotta say it....

Are you serious? Money or profit is the prime motivator of business, THE PRIME MOTIVATOR! Without it the doors close. No ifs, ands, or buts. Business isn't in business to give people a warm fuzzy, create jobs or to just have something to spend spare time on.

Business's are created to generate revenue, income, dollars, dinero, yen, pounds sterling, geld, Euro's, rubles and all that neat coin of the realm stuff.

Sorry to get off topic Craig, again this has been a great exercise. It justs frosts my fanny when "professionals" refuse to acknowledge the simplist of facts. Until "FSP's" (Functional Specific Professionals) can and will start talking the language of business and are able to relate their function in business language they will continue to struggle for acceptance and organizational stature above that of a drone.:soap:

I shall now take a deep breath, calm down, and wait, and again please forgive my rudeness.
 
G

Greg B

#63
I'm a bit concerned that this is turning out to be another version of "Say what you do, do what you say". That's not what ISO 9001 is about, never was, isn't and shouldn't be.........I'd like to meet the person who coined that particular phrase one dark night.............;)
Damn...I may have to look overmy shoulder LOL

The whole idea is that the organization should understand the position it will take/has in the marketplace (customers' viewpoint). Then, management should set policy and objectives to provide the overall 'direction' towards the customers' viewpoint. Then, the processes are established to meet the customers' needs and the product and process measured against those objectives. Actions are identified if the results fall short, or improved if the customers are happy! Finally, a review and adjustment of poicy and objectives occurs, the cycle repeated.

So set against the op, it seems to me many have lost sight of the reason to be in business........ Andy
WHY??? There is a lot I want to respond to in this thread but this post, being at the end, caught my eye. When I write my Objectives
I write them to benefit my company not the customer. I don't understand how we could write an objective in this fashion. If we did everythign our customer wanted we would never make a profit!!!
 
J

JaneB

#64
Randy,

I was referring to the fact that ISO 9001 can also be applied to organisations that are not commercial - ie, nonprofit organisations. (That's what we call them here). In such cases, $ is not their key driver: meeting the terms of their charter is. Example: a professional organisation is dedicated to meeting the needs of their members, and is not permitted to generate profit in the terms of its constitution & by its tax-exempt status. But they can & have still become certified to ISO 9001.

Business's are created to generate revenue, income, dollars, dinero, yen, pounds sterling, geld, Euro's, rubles and all that neat coin of the realm stuff.
Absolutely agree with you completely. No $, no business, and zero else! No argument from me whatsoever on that point, so please don't let your fanny get frosted - it sounds uncomfortable.
 
J

JaneB

#65
That (above) is not what I said or implied.
I'm going to disagree with you then. Regarding observations, you said:
Observations aren't taken seriously.
and again:
Maybe you missed my point? To clarify... The organization may not take the observation serious regardless of how it is explained to them. Unless there is a nonconformity identified (with good reason), the organization has the option to do absolutely nothing. As an auditor, it is also my duty to promote their continuous improvement/effectiveness of their QMS.
I don't see this as interpreting an inference, but was responding to your statements (above).
 
G

Greg B

#66
I am the odd-girl out I guess. I disagree with everyone and I'd write 'em up. I thought about the quality policy and that I would need to see it, but if the policy falls in line with the 5 objectives then it still does not meet the intent of clause 5.3, 5.4.1, and 7.1. JMHO. :bigwave:

The Requirement: The organization has committed itself to improving the company and environment, not the product, quality system, etc. IMO.
My Finding: The organization has defined objectives and a quality policy that do not meet the full intent of Clauses 5.3, 5.4.1, and 7.1. (Ex. quality objectives needed to meet requirements for the product.)
Note: Improved sales/profits are not always an indication of product requirements that have been met. IMO
How do the Objectives not meet 5.3.1, 5.4.1 and 7.1?

I don't believe that these are 'quality' objectives (maybe the reduced rework). Apart from anything else, they aren't customer oriented! So, like Randy, I'd want to see the 'Quality Policy' and what it said too. It's unlikely, in my experience, that the policy would be appropriate either. Andy
Where does it say they have to be customer oriented?

I didn't vote for the following reason.
I have only been presented with one quality objective (in itself this could be a non compliance as the standard calls for "quality objectives" i.e. more than one, but hey, I'm being picky).
The process of assessing objectives is not a digital / yes - no activity but a series of questions against the requirements of ISO.
In order to assess the effectiveness of the objective setting process I need to understand what the key measures of QMS effectiveness are for this particular widget making business.
  • If the rework percentage is appropriate then conformance
  • If there is a more appropriate quality measure such as customer returns, PM, customer satisfaction then non conformance
Is the objective established at relevant functions and levels?
  • If it covers a range of areas then conformance
  • If it is an isolated objective in one particular department then non conformance
Why is only one of them a Quality Objective?

If Craig had posted the list without the rework objective then it's a stone cold NC for me. Not that I disagree with the other business objectives - just that they haven't any evidence to satisfy 5.4.1. Major at that!
All of the objectives can meet 5.4.1. Why do you dismiss them?


To one and all: In ISO9000:2000 Fundamentals and Vocabulary, there is nowhere that it mentions the customer or their concerns. The main gist of the clause is all about CONTINUAL IMPROVEMENT!!!! The objectives help to improve the company.

Quality Policy and quality objectives are established to provide a focus to direct the organization. Both determine the desired results and assist the organization to apply its resources to achieve these results. The quality policy provides a framework for establishing and reviewing quality objectives. The quality objectives need to be consistent with the quality policy and the commitment to continual improvement, and their achievement needs to be measurable. The achievement of quality objectives can have a positive impact on product quality, operational effectiveness and financial performance and thus on the satisfaction and confidence of interested parties.


ISO 9000:2004, 5.5 states 'Top management should use the quality policy as a means of leading the organization toward improvement of its performance...'
5.4.1 goes on to say 'The organizations strategies planning and the quality policy provide a framework for the setting of quality objectives....' sure, it does go on to mention 'markets served' and 5.3 did briefly mention considering 'customer satisfaction'...but there is nowhere that it expressly says that we should write our objectives based on customer requirements!

In my company, Our Quality objectives ARE our business objectives. We do not look at Quality objectives as those that pertain only to our Quality system but rather convey a bigger picture of where our company is headed. We aim to reduce costs, risks etc to make us more viable because if are not competitive then we are dead in the water. Our Quality System is our Business System!!!!

For the record I voted 'NO'. There is not enough info but based on the fact that they are 'measurable and achivebale' then it is the company's business WHAT THEY CHOOSE!!
 
P

potdar

#67
Randy has a point. Businesses are necessarily meant to generate money as their primary purpose.

But I agree more with Jane. The standard is written for organisations, not businesses. All organisations are not necessarily business.

Of late, we hear regularly about schools, colleges, hospitals, coroner's office, crematoriums, police, municipal services like water supply, waste water and garbage disposal, even churches and temples getting certified. I am not covering here any trusts or NGOs. Do all of these work for making money?

For the organisation under scanner though, the business objectives can very well serve as quality objectives.
 
J

JaneB

#69
No worries, Randy. And yes, a great discussion.

I hope that ass has returned to a comfortable temperature... :lol:
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#70
I'm a bit concerned that this is turning out to be another version of "Say what you do, do what you say". That's not what ISO 9001 is about, never was, isn't and shouldn't be.........I'd like to meet the person who coined that particular phrase one dark night.............;)

The whole idea is that the organization should understand the position it will take/has in the marketplace (customers' viewpoint). Then, management should set policy and objectives to provide the overall 'direction' towards the customers' viewpoint. Then, the processes are established to meet the customers' needs and the product and process measured against those objectives. Actions are identified if the results fall short, or improved if the customers are happy! Finally, a review and adjustment of poicy and objectives occurs, the cycle repeated.

So set against the op, it seems to me many have lost sight of the reason to be in business........

:2cents:
Andy
The main focus is that the standard requires that objectives be documented, measured, and monitored. It does not specifically ask to document what you do, just how you do business. So, the point that "document what you say and do what you documented" has no bearing on the topic of Objectives. Objectives are exactly what they are defined as and that is goals within the organization. If money or sales are part of the organizations desires or goals, then so be. In my opinion.
 
Thread starter Similar threads Forum Replies Date
P Quality objectives - must they include CAPA and internal audit topic? ISO 13485:2016 - Medical Device Quality Management Systems 28
A Quality Objectives 5.4.1 - KPI SOP - ISO 13485 Audit Observations EU Medical Device Regulations 6
E Audit of Exclusions et.al. - Quality Policy, Planning (including objectives), Etc. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Audit Findings: The quality objectives have not been quantified ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Quality Objectives and resources ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
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
Q Quality Objectives Not Met - Resources promised by investors ISO 13485:2016 - Medical Device Quality Management Systems 4
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
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 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

Similar threads

Top Bottom