ISO 9001 News ISO 9001:2025 - What should be changed in the next Edition of ISO 9001? - REVISION PROCEEDING- August 2023

Bill Levinson

Industrial Statistician and Trainer
The reference is a good one. The first item encompasses "hidden plant" although it's not mentioned. "Poor quality costs a company money in terms of productivity problems. "

Another good point: "While using less expensive parts and equipment might cut costs in the short term, the long-term effects might be far more expensive" as in "cheap is dear." The same applies to people; Henry Ford paid premium wages to attract better employees because they cost him less in the long run (due to better work quality). He also paid premiums for the best ship crews because he knew they would not linger in port (thus wasting the time of the ship and adding cycle time to whatever was in the hold).
 

Dr. IJ Arora

Involved In Discussions
It would help immensely if the term "process" was better defined or perhaps an indication of when they are talking about business processes and when they are talking about manufacturing processes.
Processes are processes, in that the high level view of how an organization provides confirming products and services. When the process is captured as a methodology of the process in a procedure documented or undocumented the process then gets systematized as that procedure. Now the procedure would be used and when required either directed by a NC or risk or during review it would be changed in specific steps. The procedure invariably leads to WI (work instructions/ SOPs). Trust it helps.
 

Big Jim

Admin
Processes are processes, in that the high level view of how an organization provides confirming products and services. When the process is captured as a methodology of the process in a procedure documented or undocumented the process then gets systematized as that procedure. Now the procedure would be used and when required either directed by a NC or risk or during review it would be changed in specific steps. The procedure invariably leads to WI (work instructions/ SOPs). Trust it helps.

It is old school thinking that processes and procedures need to be aligned. The writers of the standard never intended for that to be so. In the 2000 and 2008 versions in talking about the six topics that were required to be included in written procedures it went so far as to say in a note that each of the six could be covered in multiple procedures and that a procedure may address more than one of them. In the 2015 version the word procedure was completely removed.
 

John Broomfield

Leader
Super Moderator
It is old school thinking that processes and procedures need to be aligned. The writers of the standard never intended for that to be so. In the 2000 and 2008 versions in talking about the six topics that were required to be included in written procedures it went so far as to say in a note that each of the six could be covered in multiple procedures and that a procedure may address more than one of them. In the 2015 version the word procedure was completely removed.

Indeed an organization may choose to bundle several processes into one procedure (documented or not), for example:

Managing continual improvement (to remain competitive) could include:

- Analysing data and taking preventive action
- Controlling nonconformity and taking corrective action
- Reviewing system performance to target investment

Smaller organizations may already think and work this way.

Misunderstandings arise from our failure to carefully distinguish between process (work) and procedure (the specified way to carry out the work).

Processes are not procedures (according to the definitions we share) but thinking that processes and procedures are synonymous may be where the one to one (process to procedure) misperception comes from.
 

Gun46

Registered
I consider next update ISO 9001 should consider to classified terms of "Complaints". I think if Complaint
should be divided in 2 terms : Relevant Complaint and Not Relevant Complaints. Because each terms has different consequences, and action / countermeasure should be further taken

1.) Sequences for Relevant Complaint (Input Clause 9.1.2 --> Monitor by Clause 9.1.3 --> Determined its Relevant Complaint --> Controlling NC Output Clauses 8.7 --> Need Corrective action Clause 10.2).
2.) Sequences for Not Relevant Complaint (Input Clause 9.1.2 --> Monitor by Clause 9.1.3 --> Determined its Not Relevant Complaint --> Not required follow up)

Refer to ISO 9000:2015 : Complaints
<customer satisfaction> expression of dissatisfaction made to an organization (3.2.1), related to its
product (3.7.6) or service (3.7.7), or the complaints-handling process (3.4.1) itself, where a response or
resolution is explicitly or implicitly expected

If Organization received "Complaints", so they should review, verify if this complaint caused of significant of impact to their business process and need to be follow up as a countermeasure or not (It's organization activity to classified their Complaint as Relevant or Not Relevant Complaint)

Please corrected if I'm wrong for my perception view of Complaints
 

Dr. IJ Arora

Involved In Discussions
Indeed an organization may choose to bundle several processes into one procedure (documented or not), for example:

Managing continual improvement (to remain competitive) could include:

- Analysing data and taking preventive action
- Controlling nonconformity and taking corrective action
- Reviewing system performance to target investment

Smaller organizations may already think and work this way.

Misunderstandings arise from our failure to carefully distinguish between process (work) and procedure (the specified way to carry out the work).

Processes are not procedures (according to the definitions we share) but thinking that processes and procedures are synonymous may be where the one to one (process to procedure) misperception comes from.

The silence in the revised standard on the word procedure as also PA (preventive action), is symbolic. I think to think processes and as needed bundle them into procedures or use individually. Often procedure meant documented, it should not have. Yet it caused concern. So I agree with you procedures documented or undocumented. And of course data drives risk (which in effect is PA with a difference). Risk has the usual negative connotation, as also the positive when it offers an OFI.
 

Gun46

Registered
Example Irrelevant complaints
- Training Institution give customer satisfaction questionnaire to member. After, Training Institution review feedback of poor service complaints related to coffee time. Member want extend 15 minutes to an hour
- My flight is delayed and re-schedule for 4 hours. Based on airline procedure, they shall provide snack/meal for passenger. Then, I complaint to airline to provide my full refund because I have an urgent meeting, so I can arrange my closest flight schedule

Thanks
 
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