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

[AndyN]

Andy

Stating there is no value to unannounced audits is quite a sweeping generalization. And I don't think it is true. You might get less value from an announced audit over an announced audit.

Are OSHA, Fire Departments, Underwriters Laboratory in the United States completely non-value add with their unannounced audits?

I was referring to Internal audits...those you've indicated aren't!

I would suggest to you that, given internal audits are supposed to be a management tool, doing them unannounced is possibly the fastest way to make people feel they were being 'caught with their hands in the cookie jar'. Sure, maybe some small number of companies are so mature in their implementation of a QMS that an auditor can 'turn up' and do an effective audit, but those are rare, indeed.

 

[Sidney Vianna]

I have not seen the new ISO 19011 document yet, but the DIS had the following text:

except for unscheduled ad hoc audits, ensure that personnel being visited will be informed about audit scope and objectives.

ISO 17021 has requirements for short notice audits. There could be benefits for such type of audits, as long as they don't turn into a gotcha game.

Now, as for the term "surprise audits": normally, I am surprised when internal audits turn into something useful/beneficial for the business. For the most part, they are a wasted effort and time.

 

[AndyN]

I have not seen the new ISO 19011 document yet, but the DIS had the following text: ISO 17021 has requirements for short notice audits. There could be benefits for such type of audits, as long as they don't turn into a gotcha game.

Now, as for the term "surprise audits": normally, I am surprised when internal audits turn into something useful/beneficial for the business. For the most part, they are a wasted effort and time.

So 'unannounced' must equal 'surprise' then...

Otherwise, the auditee would know the scope etc beforehand...

 

[Marc]

The Future Structure of ISO Management System Standards

Also see: The Future Structure of ISO Management System Standards

 

[Sidney Vianna]

After much thought, I believe that the TC 176 must try a significant new way to promote ISO 9001 in the future. The endless discussion if ISO 9001 is a quality management system standard or a business management system standard led me to the conclusion that ISO 9001 must be sold as a standard that contains requirements for the Quality (please note the capital Q) component of Business Processes.

For example, product realization is NOT a quality process. Products will be manufactured/produced and services will be delivered IRRESPECTIVE of the organization having a formalized quality system or not. Thus, product realization is a business process, just like purchasing, sales, marketing, management, etc. ISO 9001 contains quality management requirements that need to be embedded in the business processes. Only when organizations understand that, they will realize that quality needs to be managed as part of the business and not as a side issue.

Some processes, e.g., corrective action, internal audits, etc... are NOT business processes "per se", but are part of the quality system.

So, in my view point, and in preparation for the 5[sup]th[/sup] Edition of ISO 9001, expected sometime in 2015, the TC 176 has to learn from the lessons learned and start plugging the future ISO 9001 as it fits the business processes of the organizations. The management of the organization FOR quality and not the management of quality.

The process approach should not be the management of quality related processes any longer, but the management of business processes. ISO 9001 provides a component of requirements for the business processes. ISO 14001 provides another set of requirements.

No more (quality) process approach, but business process approach. Focusing on business processes will make the integration of management system standards even easier.

 

[John Broomfield]

After much thought, I believe that the TC 176 must try a significant new way to promote ISO 9001 in the future. The endless discussion if ISO 9001 is a quality management system standard or a business management system standard led me to the conclusion that ISO 9001 must be sold as a standard that contains requirements for the Quality (please note the capital Q) component of Business Processes.

For example, product realization is NOT a quality process. Products will be manufactured/produced and services will be delivered IRRESPECTIVE of the organization having a formalized quality system or not. Thus, product realization is a business process, just like purchasing, sales, marketing, management, etc. ISO 9001 contains quality management requirements that need to be embedded in the business processes. Only when organizations understand that, they will realize that quality needs to be managed as part of the business and not as a side issue.

Some processes, e.g., corrective action, internal audits, etc... are NOT business processes "per se", but are part of the quality system.

So, in my view point, and in preparation for the 5[sup]th[/sup] Edition of ISO 9001, expected sometime in 2015, the TC 176 has to learn from the lessons learned and start plugging the future ISO 9001 as it fits the business processes of the organizations. The management of the organization FOR quality and not the management of quality.

The process approach should not be the management of quality related processes any longer, but the management of business processes. ISO 9001 provides a component of requirements for the business processes. ISO 14001 provides another set of requirements.

No more (quality) process approach, but business process approach. Focusing on business processes will make the integration of management system standards even easier.

Sidney,

Surely everything the organization does is for quality? Realizing the product must become a quality process for the organization not to waste money on sorting good product from bad product (aka inspection) due to badly designed processes.

Accordingly, I see ISO 9001 as our basic management system standard including specifications that apply to all of the processes necessary to determine and fulfill objectives and other requirements including the requirement for continual improvement.

Without the influence of any management system standard I will admit that most organizations are missing the processes necessary for continual improvement such as reporting the nature of nonconformity, stopping recurrence of nonconformity, auditing the management system and its processes for effectiveness and top management reviewing the performance of their management system. Some may be using uncalibrated measurement equipment and may not know the first thing about quality planning or controlling documented information. The commonly missing processes are not necessarily the only quality processes and these processes must be integrated instead of being separated as a "side issue" for the dying or dead QA department to address.

Therefore I do agree with you that the organization has to be managed to deliver quality (including the quality of its services to stakeholders) using its one management system. This way QA can be delivered by everyone working systematically to determine and fulfill requirements.

ISO 9001 should continue to specify the requirements for any organization's basic management system so quality is managed to reduce costs and provide long term employment by creating more successful customers.

John

 

[Ka Pilo]

I think an "Impact Analysis" should be added in the 9001:2015 Standard apart from "Root Cause Analysis."

 

[samsung]

I think an "Impact Analysis" should be added in the 9001:2015 Standard apart from "Root Cause Analysis."

I think 'impact analysis' is what we generally know as 'risk analysis' or risk assessment?

 

[Ka Pilo]

I think 'impact analysis' is what we generally know as 'risk analysis' or risk assessment?

Edit: No, the term "risk" usually more on the aspect of negativity. The term "impact," on the other hand, covers both positive and negative aspects.

 

[SeatynCB5]

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

The Quality Manager at the facility indicated that ISO 9001:2015 will integrate TS 16949 and ISO 14001 into 1 standard. If true "competency" will become more of a factor and the training facades must be abandoned in order for an organization to pass the Training, Awareness and Competency requirements that registrars have begun to stress.