SBS - The best value in QMS software

What should be changed in the ISO 9001:2015 Standard?

John Broomfield

Staff member
Super Moderator
Re: What should be changed in the ISO 9001:2014 Standard?

6 Resource management (ISO 9001:2008)

In my view, this clause needs to be re-structured to incorporate identification, possibly documentation and effective management of
a) Financial resources
b) Technology & knowledge,
c) Natural resources forming part of the process inputs, in particular &
d) other 'stakeholder controlled' resources

These resources are as significant as (may be more than) any other resource like Human and infrastructure like Equipment, means of communication etc. etc and without having access to or failing to administer effective control over such resources, I doubt, if an organization can truly ensure meeting the following intent of clause # 6.1:



I would like to hear what other members have to say.

Thanks
Samsung,

The standard requires the organization to determine the resources required.

You seem to have determined the resources required and this determination would require your system to include the controls you also specify. Why benefit your competitors by suggesting the standard prescribes such controls?

It also requires the organization to determine the processes required.

Why should the standard further prescribe all of the processes, resources and controls necessary to ensure ongoing customer satisfaction?

Is this because we do not want to determine these things for ourselves?

John
 
Elsmar Forum Sponsor
S

samsung

Re: What should be changed in the ISO 9001:2014 Standard?

Samsung,

The standard requires the organization to determine the resources required.

You seem to have determined the resources required and this determination would require your system to include the controls you also specify. Why benefit your competitors by suggesting the standard prescribes such controls?

It also requires the organization to determine the processes required.

Why should the standard further prescribe all of the processes, resources and controls necessary to ensure ongoing customer satisfaction?

Is this because we do not want to determine these things for ourselves?

John
Then why the standard talks of other resources such as Human, Equipment, supporting services etc. The clause 6 could have come to an end at 6.1 itself only by stating a single sentence 'the organization shall determine the resources required' in order to indicate that the clause implies every resource ( including competent humans) required to achieve or enhance customer satisfaction. I am sure, having guided by one sentence, the organizations still must have 'determined' even those resources described thereafter.

Ofcourse one may argue that there are separate standards to deal with finance, separate one to deal with natural resources and still another is under preparation and the like. If so, there would be another question 'why not to make it a 'COMPLETE' standard meant for effective Business Management by not incurring any loss to it's identity as Quality Management System standard.
 

John Broomfield

Staff member
Super Moderator
Re: What should be changed in the ISO 9001:2014 Standard?

Then why the standard talks of other resources such as Human, Equipment, supporting services etc. The clause 6 could have come to an end at 6.1 itself only by stating a single sentence 'the organization shall determine the resources required' in order to indicate that the clause implies every resource ( including competent humans) required to achieve or enhance customer satisfaction. I am sure, having guided by one sentence, the organizations still must have 'determined' even those resources described thereafter.

Ofcourse one may argue that there are separate standards to deal with finance, separate one to deal with natural resources and still another is under preparation and the like. If so, there would be another question 'why not to make it a 'COMPLETE' standard meant for effective Business Management by not incurring any loss to it's identity as Quality Management System standard.
Samsung,

Let us make our basic management system standard short and elegant and for me this means avoiding every duplication.

I am not sure if by using the word complete you prefer to see duplication and a prescriptive standard?

As I see it everything we do is for quality. Therefore QMS = Business Management System.

...and as shareholders also receive intended product they are customers too.

It is a shame that ISO 9001 chose to limit its focus to the intended product and as a consequence excluded unintended by-products thereby opening the door to the ISO 14000 series.

Nonetheless, we can develop and use our process-based management systems that conform to ISO 9001 to manage risk, prevent pollution and assure sustainability too.

Of course, some organizations may, for marketing reasons, also seek recognition for conformity to other system standards.

But our basic management system standard should remain as non-prescriptive as possible and therefore suitable for all organizations.

John
 
S

samsung

Re: What should be changed in the ISO 9001:2014 Standard?

Samsung,

Let us make our basic management system standard short and elegant and for me this means avoiding every duplication.

I am not sure if by using the word complete you prefer to see duplication and a prescriptive standard?

As I see it everything we do is for quality. Therefore QMS = Business Management System.

...and as shareholders also receive intended product they are customers too.

It is a shame that ISO 9001 chose to limit its focus to the intended product and as a consequence excluded unintended by-products thereby opening the door to the ISO 14000 series.

Nonetheless, we can develop and use our process-based management systems that conform to ISO 9001 to manage risk, prevent pollution and assure sustainability too.

Of course, some organizations may, for marketing reasons, also seek recognition for conformity to other system standards.

But our basic management system standard should remain as non-prescriptive as possible and therefore suitable for all organizations.

John
I have to raise certain points:

(1) I don't see any duplication by incorporating the additions I had suggested because these resources are, till now, nowhere addressed in the standard except for a brief & general requirement for determination of resources as deemed necessary.

(2) What makes me stress it again & again is the mention of some of the resources while ignoring some vital ones which leaves me believe that I need to focus on the prescribed resources only. If one thing is explicitly focused, others are naturally shadowed that would lead me not to consider them for audit & periodic review since this part is not specifically indicated in the standard.

(3) I don't consider it a prescriptive approach if it is applicable to all. (I can't think of any organization managing its affairs anyway without managing the resources in question.)

(4) Consider a hypothetical situation wherein the standard hasn't prescribed anything further to 6.1 under clause 6. How many of us would have raised the voice for inclusion of what is prescribed in clause 6.2, 6.3 & 6.4 ? Aren't these requirements a duplication of what the standard has already prescribed in 6.1 ?

(5) Organizations do demonstrate excellence in resource (finance, raw materials, human, technological know how and many more) management and Resource Use Efficiency even without ISO saying it because it is one of the key elements that sustain the businesses of whatever nature or scale.

(5) You can see at many places the standard has cited examples in the form of 'notes' for adding clarification to the stated requirement. This can also be done in a similar way and I strongly favour it to be there and believe that resources (whatever) are fundamental to every business & nothing can be achieved without effectively managing them and as I understand the business of this particular standard is to help mange the BUSINESSES effectively. The standard, therefore, should accord greater priority to resource management.

However I do agree with your statement
It is a shame that ISO 9001 chose to limit its focus to the intended product and as a consequence excluded unintended by-products thereby opening the door to the ISO 14000 series.
 

John Broomfield

Staff member
Super Moderator
Re: What should be changed in the ISO 9001:2014 Standard?

6 Resource management (ISO 9001:2008)

In my view, this clause needs to be re-structured to incorporate identification, possibly documentation and effective management of
a) Financial resources
b) Technology & knowledge,
c) Natural resources forming part of the process inputs, in particular &
d) other 'stakeholder controlled' resources

These resources are as significant as (may be more than) any other resource like Human and infrastructure like Equipment, means of communication etc. etc and without having access to or failing to administer effective control over such resources, I doubt, if an organization can truly ensure meeting the following intent of clause # 6.1:



I would like to hear what other members have to say.

Thanks
Samsung,

Back to your original points.

A and B below constitute all the resources needed to support the planning, operation, control and improvement of processes:

  • Talent, skills and knowledge = competence
  • Infrastructure, facilities and equipment

Money itself is not a resource; it can do nothing. What the investors choose to invest in is the resource. Technology is part of B above.

Data, information and materials are process inputs (to be increased in value by the work) and ISO 9001 requirements for these inputs do appear weak (except as specified in 7.3.2, 7.4.3, 7.5.4, 8.2.1, 8.3, 8.4 and 8.5.1).

In the preventive theme we perhaps should be determining the characteristics (carbon footprint?) of the input data, information and materials before inputting them to a process.

For this we could beef up clause 4.1c as follows: determine criteria and methods needed to ensure effective control over the processes' inputs and the planning and operation of these processes.

John
 
S

samsung

Re: What should be changed in the ISO 9001:2014 Standard?

Samsung,

Back to your original points.

A and B below constitute all the resources needed to support the planning, operation, control and improvement of processes:

  • Talent, skills and knowledge = competence
  • Infrastructure, facilities and equipment
Sorry, I doubt if I can plan and operate a manufacturing process without the aid of (a) mined out Raw Material & fuel (b) Electric Power generated at site or outsourced & (c) Water none of which are indicated in either of the two sets of resources mentioned above.

Skill, knowledge & competence are not 'resource' per se. These are attributes which a human resource should possess or develop.

The 'knowledge resource' I was talking about is more akin to 'information' (or instruction/know how/procedure) without which a process cannot be made to operate to achieve the desired output.

The word 'infrastructure' is understandable (or the standard has made it so) and it, nonetheless, cannot be construed to include any of the resources I referred to in my post.

'Equipment' in a manufacturing environment is generally taken to mean 'machines or tools/apparatus/appliances etc.

Let's see the definition of the term 'facility' given in the 'Concise Oxford Thesaurus' (since it is nowhere defined by the standard nor I found it in 9000:2005)
▶ noun
car-parking facilities: PROVISION, space, means, potential, equipment.
the camera has a zoom facility: POSSIBILITY, feature.
a wealth of local facilities: AMENITY, resource, service, advantage, convenience, benefit.
a medical facility: ESTABLISHMENT, centre, place, station, location, premises, site, post, base; informal joint, outfit, set-up.
his facility for drawing: APTITUDE, talent, gift, flair, bent, skill, knack, genius; ability, proficiency, competence, capability, capacity, faculty; expertness, adeptness, prowess, mastery, artistry.
I was turning out poetry with facility: EASE, effortlessness, no difficulty, no trouble, facileness; deftness, adroitness, dexterity, proficiency, mastery.
Hence it's nothing more than repetition / duplication of what it has already mentioned. It's more or less part of the so called 'infrastructure'.

Still I'm left with the resources under discussion.

Money itself is not a resource; it can do nothing. What the investors choose to invest in is the resource. Technology is part of B above.
It's again an unfair generosity of the standard to have skipped defining the term 'resource' even in it's supplementary standard 9000:2005 giving one enough liberty to interpret it in whatever way that suits ones purpose.

Data, information and materials are process inputs (to be increased in value by the work) and ISO 9001 requirements for these inputs do appear weak (except as specified in 7.3.2, 7.4.3, 7.5.4, 8.2.1, 8.3, 8.4 and 8.5.1).

In the preventive theme we perhaps should be determining the characteristics (carbon footprint?) of the input data, information and materials before inputting them to a process.
They ARE not only weak but blurry as well. The standard talks of 'communication' but itself fails to effectively communicate what it actually intends.

For this we could beef up clause 4.1c as follows: determine criteria and methods needed to ensure effective control over the processes' inputs and the planning and operation of these processes.
That makes a better sense. Clause # 4.1d also needs to be looked into
ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
What about the availability of resources very much needed for effective CONTROL and for IMPROVEMENT of these proceses. I need 'information' to 'control' the process and I do need better technology or technological know how (another resource) to effect continual improvement of the process.
 
Last edited by a moderator:

John Broomfield

Staff member
Super Moderator
Re: What should be changed in the ISO 9001:2014 Standard?

Sorry, I doubt if I can plan and operate a manufacturing process without the aid of (a) mined out Raw Material & fuel (b) Electric Power generated at site or outsourced & (c) Water none of which are indicated in either of the two sets of resources mentioned above.

Skill, knowledge & competence are not 'resource' per se. These are attributes which a human resource should possess or develop.

The 'knowledge resource' I was talking about is more akin to 'information' (or instruction/know how/procedure) without which a process cannot be made to operate to achieve the desired output.

The word 'infrastructure' is understandable (or the standard has made it so) and it, nonetheless, cannot be construed to include any of the resources I referred to in my post.

'Equipment' in a manufacturing environment is generally taken to mean 'machines or tools/apparatus/appliances etc.

Let's see the definition of the term 'facility' given in the 'Concise Oxford Thesaurus' (since it is nowhere defined by the standard nor I found it in 9000:2005)


Hence it's nothing more than repetition / duplication of what it has already mentioned. It's more or less part of the so called 'infrastructure'.

Still I'm left with the resources under discussion.



It's again an unfair generosity of the standard to have skipped defining the term 'resource' even in it's supplementary standard 9000:2005 giving one enough liberty to interpret it in whatever way that suits ones purpose.



They ARE not only weak but blurry as well. The standard talks of 'communication' but itself fails to effectively communicate what it actually intends.


That makes a better sense. Clause # 4.1d also needs to be looked into


What about the availability of resources very much needed for effective CONTROL and for IMPROVEMENT of these proceses. I need 'information' to 'control' the process and I do need better technology or technological know how (another resource) to effect continual improvement of the process.
Samsung,

I am surprised to read your implication that people standing around doing nothing are a resource. It is their talents, skills and knowledge (aka competence) being put to work that are the resource.

Likewise, infrastructure includes energy and water supply, transportation networks, sewerage, telecommunications etc...

My reference for this is BS 6143 Part 2 which describes the process model for quality costing along the lines taught by Phil Crosby*.

From this I also understand that processes (or work) should employ resources and controls to add value to inputs (data, information or materials).

The resources are: infrastructure, facilities (that is the building etc), equipment, talent, skills and knowledge.

The controls are: methods, procedures, care and coordination.

*Also used to label fishbone diagrams for root cause removal.

These definitions are very similar (but deeper) to the (5M+E) process model used by process engineers: manpower, machines, materials, money, methods and environment.

These broad definitions seem to work very well indeed when developing, using and improving process-based management systems.

BTW, isn't my "weak" and your "blurry" the same thing? If so, we are in danger of dancing on the head of a pin!

John
 
S

samsung

Re: What should be changed in the ISO 9001:2014 Standard?

Samsung,

I am surprised to read your implication that people standing around doing nothing are a resource. It is their talents, skills and knowledge (aka competence) being put to work that are the resource.

Likewise, infrastructure includes energy and water supply, transportation networks, sewerage, telecommunications etc...

My reference for this is BS 6143 Part 2 which describes the process model for quality costing along the lines taught by Phil Crosby*.

From this I also understand that processes (or work) should employ resources and controls to add value to inputs (data, information or materials).

The resources are: infrastructure, facilities (that is the building etc), equipment, talent, skills and knowledge.

The controls are: methods, procedures, care and coordination.

*Also used to label fishbone diagrams for root cause removal.

These definitions are very similar (but deeper) to the (5M+E) process model used by process engineers: manpower, machines, materials, money, methods and environment.

These broad definitions seem to work very well indeed when developing, using and improving process-based management systems.

BTW, isn't my "weak" and your "blurry" the same thing? If so, we are in danger of dancing on the head of a pin!

John
With all due regard to your interpretation, I am still of the opinion that Humans by themselves are 'resource' and putting them to work is 'deployment of resource'.

Further, the term 'infrastructure', IMO doesn't cover raw material, energy and water as also indicated in the following statements:
Infrastructure includes, as applicable,
a) buildings, workspace and associated utilities,
b) process equipment (both hardware and software), and
c) supporting services (such as transport, communication or information systems).
Moreover, when the standard provides so many examples above, what prevented the authors from including raw materials, energy etc. under infrastructure. By using the term 'as applicable', they had already acquired enough freedom to elaborate the concept without getting offended in anyway.

I am in full agreement with using the process approach w.r.t. judicious use & deployment of the required resources but, however, this wasn't the primary issue. The question was raised against the adequacy of the Clause both in terms of theory and logic as well.

Thanks for your response.

BTW, by 'blurry' I meant 'indistinct or unclear' as opposed to 'fragile or inadequate' (weak)
 
Last edited by a moderator:
S

Sorin

Re: What should be changed in the ISO 9001:2014 Standard?

Did not have time to read all the replies and just in case it was not mentioned:

Merge ISO/AS/TS...one standard to rule them all...seriously.

 

Jim Wynne

Staff member
Admin
Re: What should be changed in the ISO 9001:2014 Standard?

Did not have time to read all the replies and just in case it was not mentioned:

Merge ISO/AS/TS...one standard to rule them all...seriously.

The problem with that idea is that ISO 9001 was originally intended to be a one-size-fits-all standard, but it had barely hit the ground before it started having babies. Automotive, aerospace, telecommunications, medical devices and god knows who else decided that the standard in its raw form wasn't prescriptive enough for their "special" needs. Not only that, but the automotive industry in particular, in its disparate forms, decided that even QS 9000/TS16949 wasn't enough, and burdened it with customer-specific requirements. The whole idea behind AIAG was to normalize the requirements of the (then) Big Three so as to relieve suppliers of the burden of keeping track of each customer's requirements. Ha.
 
Thread starter Similar threads Forum Replies Date
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance document to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Sidney Vianna Interesting Discussion ISO 9001:2024 - What should be changed in the next Edition of ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 115
I Should We Notify Our Registrar - Has Our Scope Changed? IATF 16949 - Automotive Quality Systems Standard 5
C Certified Quality Manager - Do you think the Certification name should be changed Professional Certifications and Degrees 45
A Should we assign the PRRC before the date of application of MDR (26 May 2021)? EU Medical Device Regulations 0
J UDI-DI how should we interpret Device version or model to determine if a new UDI-DI is needed? EU Medical Device Regulations 0
A Should I take an online course for a career in Occupational Health and Safety? Career and Occupation Discussions 2
J Should a Class 1 medical device with an option to measure body weight be considered Class 1m? EU Medical Device Regulations 0
K Should APQP/PPAP has its own section in a QM? Quality Management System (QMS) Manuals 1
S What should i choose for "testing procedure" characteristics? (N95) General Information Resources 0
P Should eIFU link per ISO 15223-1:2016 be added to labels out of scope of Reg 207/2012? EU Medical Device Regulations 1
S Which Sampling Plan(s) Should I Use? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
A Document release vs its related training. Which should come first? ISO 13485:2016 - Medical Device Quality Management Systems 18
S Which department should prepare the control plan? could you show me a standard regarding to this matter. FMEA and Control Plans 17
J Help settle a disagreement: Should external providers of preventive maintenance be on your ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
N Master Samples - What should we be keeping? IATF 16949 - Automotive Quality Systems Standard 9
G Supplier delivered recent PPAP, should he deliver yearly layout inspection? IATF 16949 - Automotive Quality Systems Standard 4
John Broomfield Vote - Should ISO9004 Become a Requirements Standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Capability Study - in the beginning of your career what should you have known about the tool Quality Tools, Improvement and Analysis 11
J Should Loading and Unloading be Included in Cycle Times? Lean in Manufacturing and Service Industries 14
E Manufacturers should develop a testing device for covid19 Service Industry Specific Topics 0
T 510(k) submission - Which name should I use in the submission? Other US Medical Device Regulations 3
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
G Should I perform Gage R&R only at the beginning of a new project? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 6
DuncanGibbons Should the requirements FAA/EASA Part 21 be addressed within the QMS and AS9100D quality manual? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
M Should 510(k) Predicates be Actively Listed Devices? Other US Medical Device Regulations 12
B Why the Greek god Hephaestus should have done a design FMEA (DFMEA) on his giant robot APQP and PPAP 1
J On PFMEA for danger labels - Label always should be assigned severity 10 ? FMEA and Control Plans 3
H Who should be listed as the manufacturer/distributor on the box? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
M MDR, RED and LVD - Should our device comply with them? EU Medical Device Regulations 3
BeaBea How Many Processes should be created for each Department? Process Maps, Process Mapping and Turtle Diagrams 5
M Should volume of sales be factored into risk probability assessments? ISO 14971 - Medical Device Risk Management 33
MrTetris Should potential bugs be considered in software risk analysis? ISO 14971 - Medical Device Risk Management 5
S Should safety checks be included in the Control Plan? IATF 16949 - Automotive Quality Systems Standard 5
M Which incubation condition should be selected to recover both bacteria and fungus effectively Miscellaneous Environmental Standards and EMS Related Discussions 3
D Is there a specific location for PPE such as safety glass holders and glove dispensers should be mounted Occupational Health & Safety Management Standards 10
Robert Stanley Which Registrar Should I Choose for ISO 9001:2015 registration? Registrars and Notified Bodies 10
M Who should receive the bills from suppliers and vendors, account payable or procurement? Consultants and Consulting 4
V IATF 16949 8.4.1 Control of externally provided processes, products and services - Should the CB be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 10
A We are ISO 13485:2016 should we be audited to ISO 14971 ISO 13485:2016 - Medical Device Quality Management Systems 16
E Received a Major finding during IATF Surveillance audit for loss of BIQS Level 3 (more than 6 SPPS in 6 months)...how should we address SYSTEMIC CA? IATF 16949 - Automotive Quality Systems Standard 11
J Organization merger. Should we keep two separate ISO 13485 certificates? ISO 13485:2016 - Medical Device Quality Management Systems 6
S Companies that maintain your machine should be in ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
S Use of "Shall" versus "Should" in Procedures ISO 13485:2016 - Medical Device Quality Management Systems 26
D Class II medical device - When should a complaint be closed? Customer Complaints 6
Sidney Vianna IATF 16949 News Presentations from the latest IATF Stakeholder Event - Expectation that IATF 16949 certification should equate with product quality. Misguided? IATF 16949 - Automotive Quality Systems Standard 7
L Clause 0.4 of ISO 9001 and EHS - Where should I stop the inclusion of EHS in my QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Ed Panek Part 11 Self Certify Memo - What else should it cover? Qualification and Validation (including 21 CFR Part 11) 5
H Should I mention machine/Equipment password In SOP? Qualification and Validation (including 21 CFR Part 11) 4
D How long should we keep the spare parts available for our medical device, after we have stopped the production? ISO 13485:2016 - Medical Device Quality Management Systems 0

Similar threads

Top Bottom