ISO 9001:2000 - Required Procedures or minimum required number?

[Pancho]

In my experience, more than six procedures is crap.

Wow, Chris! That's quite the inductive jump even if you've had some or many bad experiences with documentation. I'll not try to convince you otherwise, but for the benefit of folks that read this forum and may not have so much experience as you, I'd like to point out:

The standard does not say "document only the 6 procedures". Section 4.2.1d of ISO 9001 charges the organization with documenting what they deem necessary to plan, operate and control its processes effectively. Achieving consistent quality requires documenting how an organization's processes and activities should be carried out. The standard applies to all types and sizes of organizations. It would be impossible to list the required documents for all those types and sizes. For all but maybe one-man shows, the documentation required to achieve consistent quality is substantially more than "the 6 procedures".

Having detailed documentation of your processes is the only way to control them effectively when more than one person does the process, or when the person doing the process changes, or when you do them intermittently, or nearly in every other real circumstance.

Documentation is also truly effective way to improve your processes. Improvements are recorded in the documents, compelling any required changes from even operators very experienced in older ways of doing things, and as importantly, capturing those operators' knowledge so others can do it as well as them. I'd be very skeptical of the effectiveness of a continuous improvement system without documented procedures on which to reflect acquired knowledge.

So all in all, maybe all you do need to frame a certificate are indeed the 6 procedures and a myopic auditor.

But to put out quality, you need to document your processes.

 

[Stijloor]

In my experience, more than six procedures is crap. There are 21 records identified and the focus of your ISO system should be on the 21 records and not on 42 procedures.

More procedures do not make for a more stable ISO system. Most people don't read, understand, or follow the procedures in the first place. Having more procedures just creates more audit findings, more documents to control, and more documents to update.

What you want your people doing is measuring and monitoring processes by collecting transaction data (records) to understand product and process nonconformances. These records should then be analyzed in run charts or pareto charts in order to take corrective or preventive action. That is why you need the six required procedures and nothing else.

Once you get rid of those other procedures you can start focusing on the effectiveness of the system instead of blindly following (or not) procedures.

You are responding to a post that is 11 years old.

The OP's last visit was on 3rd March 2011, so I do not know if he will get your message.

Stijloor.

 

[Chris_Anderson]

Wow, Chris! That's quite the inductive jump even if you've had some or many bad experiences with documentation. I'll not try to convince you otherwise, but for the benefit of folks that read this forum and may not have so much experience as you, I'd like to point out:

The standard does not say "document only the 6 procedures". Section 4.2.1d of ISO 9001 charges the organization with documenting what they deem necessary to plan, operate and control its processes effectively. Achieving consistent quality requires documenting how an organization's processes and activities should be carried out. The standard applies to all types and sizes of organizations. It would be impossible to list the required documents for all those types and sizes. For all but maybe one-man shows, the documentation required to achieve consistent quality is substantially more than "the 6 procedures".

Having detailed documentation of your processes is the only way to control them effectively when more than one person does the process, or when the person doing the process changes, or when you do them intermittently, or nearly in every other real circumstance.

Documentation is also truly effective way to improve your processes. Improvements are recorded in the documents, compelling any required changes from even operators very experienced in older ways of doing things, and as importantly, capturing those operators' knowledge so others can do it as well as them. I'd be very skeptical of the effectiveness of a continuous improvement system without documented procedures on which to reflect acquired knowledge.

So all in all, maybe all you do need to frame a certificate are indeed the 6 procedures and a myopic auditor.

But to put out quality, you need to document your processes.

I was reacting to the post that suggested that six procedure is worthless. For more perspective, six procedures is sufficient for small organizations sure, but small to me means 100 employees or more too. I could see how very large organizations with multiple locations, geographies, and thousands of employees would need more than six. Yet, I have worked with large organizations with 300 procedures and their people still do not use the procedures effectively. Procedures do not drive conformance. So, more procedures do not drive more performances. Procedures are like inventory. If you are suffering from stock outs then carrying more inventory will not protect you from stock outs. In my experience, more procedures drives more audit findings.

For the benefit of folks that read this forum and may not have so much experience as you, I'd like to point out that having detailed documentation of your processes is NOT the only way to control them effectively. You have to think outside the box. The focus is on outcomes not documents. Visual signals and active feedback provide control. Not procedures. Just about everything you do in life is done without a written, documented procedure. When you drive your car, do you have detailed documentation or a series of visual signals? The signals provide the control not a procedure. The only way to control process effectively is with feedback not procedures. At least when I studied engineering, process control was all about feedback.

 

[Jim Wynne]

In my experience, more than six procedures is ****. There are 21 records identified and the focus of your ISO system should be on the 21 records and not on 42 procedures.

More procedures do not make for a more stable ISO system. Most people don't read, understand, or follow the procedures in the first place. Having more procedures just creates more audit findings, more documents to control, and more documents to update.

What you want your people doing is measuring and monitoring processes by collecting transaction data (records) to understand product and process nonconformances. These records should then be analyzed in run charts or pareto charts in order to take corrective or preventive action. That is why you need the six required procedures and nothing else.

Once you get rid of those other procedures you can start focusing on the effectiveness of the system instead of blindly following (or not) procedures.

I realize I might be talking to an empty chair here, but for the benefit of others...

First of all I agree that more emphasis should be put on process operation and desired outcomes. That doesn't mean, however, that the value of documentation is diminished as a result. A false dichotomy is created when you say that there is a binary choice involved--more documents means less emphasis on process operation.

Before processes will run in an optimal fashion, they must be designed. Too often processes are allowed to design themselves on the fly, which inevitably results in results that are less than optimal. If you do go to the trouble of designing processes such that you understand the variation in them and have taken conscientious steps to control it, it would be foolish not to document what you've done.

In this sense, a document can be both a procedure and a record--a record of process design. The standard allows the organization to decide what documents are necessary beyond the 6+21 that are explicitly required, but there should be very few organizations that would not benefit from having more, even if the documentation isn't used regularly. Like anything else it's possible to overdo it, but that's a different problem.

 

[Big Jim]

I'd like to point out that having detailed documentation of your processes is NOT the only way to control them effectively. You have to think outside the box. The focus is on outcomes not documents. Visual signals and active feedback provide control. Not procedures. Just about everything you do in life is done without a written, documented procedure. When you drive your car, do you have detailed documentation or a series of visual signals? The signals provide the control not a procedure. The only way to control process effectively is with feedback not procedures. At least when I studied engineering, process control was all about feedback.

The devil is in the details. Finding the right balance of needed written procedures and those that don't need to be written is the challenge then isn't it?

 

[JaneB]

Before processes will run in an optimal fashion, they must be designed. Too often processes are allowed to design themselves on the fly, which inevitably results in results that are less than optimal. If you do go to the trouble of designing processes such that you understand the variation in them and have taken conscientious steps to control it, it would be foolish not to document what you've done.

Yes, I agree.

Very often, the act of capturing it, has a value as an activity in itself. Often, the actual documenting of a process (mapping it/flowcharting it/describing it etc) is a very useful way to get an understanding of how it operates now and also to be able to stand back and look at something objective (ie, the map, flowchart whatever) and decide how one wants it to look in the future, or find duplication, apparently wasted steps, etc etc.

A single example from a process mapping workshop: when the 'now' process was mapped on a whiteboard, a number of things became very clear to senior management. Particuarly, they realised that their end users weren't being communicated with enough - after they submitted their original application, they got almost no information back for a lengthy period of time. Resulted in a number of positive changes.