Where to Start to Implement ISO 9001

[John Broomfield]

Re: Where to Start to Implement ISO9001

I liked what John has written about the general strategy in implementing QMS. I would like to add my little bit to this thread as follows:
My experience shows that the weakest area in an orgn. vis a vis requirements of ISO 9001 is those related to clauses 8.3 and 8.5 whereas maximum benefits through QMS to an orgn. may accrue from implementation of these clauses. So I suggest that while you plan your project, please give equal or priority status to following actions:
1. Advising process owners to identify nonconformities they come across in their processes and record how they correct them (cl 8.3) and how they take corrective action(cl 8.5.2) if they are already doing it. If they are not used to corrective action, you may have to guide them in the corrective action process in their respective areas.
2. You can also devise a nonconformity reporting proforma which could also be used to record correction of nonconformity(disposal of nonconforming product as per cl 8.3);analysis of root cause of nonconformity; and recording of corrective action including verification of effectiveness of corrective action. You can see to it that this proforma is put into use at the first stage of implemenation itself.
3. An action that deserves equal importance is to guide process owners in identifying process performance indicators(cl 8.2.3) in their respective areas and also encourage them to collect data on actual performance in terms of these indicators. This step will faciltate them to analyse data collected, define present level of performance in their respective functional areas and also subsequently arrive at measurable quality objectives(cl 5.4.1) with respect to these areas.

I agree with this although it is important for each key process to have an objective (see 4.1c).

As you analyze the key processes with the process owners you record each nonconformity as you go; another benefit of becoming a competent systems auditor first. I also describe the nonconformity in a blue note attached to the flowcharted procedure. This enables you and the process owner to resist the temptation of pretending the process fulfills all of the applicable requirements. It also quickly informs management of what they or others must change and implement (includes training) to bring the process into conformity. It also helps remove the fear of a probably new word: "nonconformity".

Employees can see managers taking responsibility for the system and the nonconformity it causes.

The certification bonus is that you start building the records early as evidence of having used the new processes, from the beginning of the system development project, for removing the root causes of both future and current nonconformity in process and product.

Your next problem will be how to get the operators, supervisors and managers to monitor and correct processes while under their control instead of waiting for an auditor to tell them it is wrong.

 

[QualityKey]

Re: Where to Start to Implement ISO9001

I have uploaded a deployment or swimlane flowchart to explain this is a different way.

John

The flowchart is excellant, it explains what you have said earlier. thanks

 

[eternal_atlas]

Re: Where to Start to Implement ISO9001

The flowchart is excellant, it explains what you have said earlier. thanks

Mr. Quality key,

Dont make a try for implementing systems just for certification. Have an experienced consultant as a guide and select a good steering team who knows the behaviour of their own processes and tailor a system suits your company not to just satisfy the certification body.

Make your management to sit in the front to drive the systems establishing by you. dont leave them.

Begin from the top management with commitment.

Suresh

 

[John Broomfield]

Re: Where to Start to Implement ISO9001

Mr. Quality key,

Dont make a try for implementing systems just for certification. Have an experienced consultant as a guide and select a good steering team who knows the behaviour of their own processes and tailor a system suits your company not to just satisfy the certification body.

Make your management to sit in the front to drive the systems establishing by you. dont leave them.

Begin from the top management with commitment.

Suresh

Suresh,

Agreed, you will notice from the flowchart that the system development project starts with the "Chief Executive Officer requiring development of the management system so it can be used and improved".

John

 

[eternal_atlas]

Re: Where to Start to Implement ISO9001

Mr. John,

Ofcourse it is in the paper, I just ask this original poster to make it realize during implementation. Otherwise,he has to end up with having a certificate hanging on the wall as a decorative one.

Tips my end is simple:

"He has to involve every employee to to run the systems with top management as the driver"

Take care Mr. Quality Key...

 

[SpongeMouse]

this is our old QP format, maybe it could help in such a way....

you can add additional/improve columns to suit your needs

 

[Don Reed]

Simply, my advice is to implement the standard in phases... according to the ISO 9001 clauses.

1) Start in clause 4: Define processes, put the doc control and record control systems in place. Write rough drafts of needed procedures and the quality manual (because they will change, but it is nice to have a rough draft before you proceed).

2) Then put the continual improvement process of clause 8 into place.

3) Then address all the "Shall" statements of clause 5 and 6 (along with the few record requirements there)

4) Do clause 7 last, because it has the most record requirements and the toughest compliance issues.

Good luck.

(I strongly agree with the comments about forming a good ISO team.)

 

[AndyN]

Don, welcome:

Taking your (novel) approach could cause some problems if folks haven't had some kind of competencies determined, early on, couldn't it?

How many people really understand what makes effective document and record control, but this wouldn't be found out until much later in the implementation, after the procedures etc have been written.

Imagine the mess - writing 6 'required' procedures' only to find out - later - that the folks who wrote them weren't competent!

I have to disagree with this approach of yours, I'm sorry to say - based on my 20+ years of implementation experience in hundreds of organizations.

 

[John Broomfield]

Simply, my advice is to implement the standard in phases... according to the ISO 9001 clauses.

1) Start in clause 4: Define processes, put the doc control and record control systems in place. Write rough drafts of needed procedures and the quality manual (because they will change, but it is nice to have a rough draft before you proceed).

2) Then put the continual improvement process of clause 8 into place.

3) Then address all the "Shall" statements of clause 5 and 6 (along with the few record requirements there)

4) Do clause 7 last, because it has the most record requirements and the toughest compliance issues.

Good luck.

(I strongly agree with the comments about forming a good ISO team.)

"Implement ISO", an "ISO team", an "ISO system" on the "I:drive" a recipe for fear and loathing of something done to get a certificate.

Instead name the management system after its owner, the company, or may be even call it a "Company Name"Teamwork System.

1. Analyze how the company gets work, does work and gets paid. This is the core process for converting customer needs into cash in the bank.

2. Determine the key processes from the core processes and those necessary to sustain and improve the core process (largely from the system standards and from common sense - such as "Recruiting and hiring".

3. Designate each key process as: As-is or New and name the person who is the expert in each key process. Some process owners may need training before owning the Problem-solving or Auditing process, for example.

4. Analyze the as-is processes with the process owner to define the controls and resources actually used to fulfill each processes' objective (obtain as-is or accuracy review comments from the process teams).

5. Design the new processes with the newly trained process owners and involve the process teams in agreeing their feasibility.

6. Nurture the new processes as they improve the system that runs the business.

7. Enable the leaders to demonstrate their commitment to requirements by helping them to understand their system and explain in their own terms to the employees. Do not allow the System Manager to do this alone.

8. Require a State-of-the-System Report from each management review so the employees know what the system does well, where it needs help and what top management is doing about it.

Avoid any reference to the ISO System.

 

[batman1056]

Don, welcome:

How many people really understand what makes effective document and record control, but this wouldn't be found out until much later in the implementation, after the procedures etc have been written.

Imagine the mess - writing 6 'required' procedures' only to find out - later - that the folks who wrote them weren't competent!

I have to disagree with this approach of yours, I'm sorry to say - based on my 20+ years of implementation experience in hundreds of organizations.

I actually favour his approach, I am qualified QMS lead auditor and working on the development of an EMS (14001) and also QMS system.

I am applying the same logic, in order to control and affect document and records, and in essence manage the process elements of the standard then the development of the record procedures is paramount.

My approach was to review what the organisations has at present, someone will be using a rudimentary form of record management (ask internal audit or Finance).
I then pulled together several templates (including some form Prince2) and had an open workshop discussing the pro's and cons of the designs.
Next stage, I carried out trials of the agreed templates in key areas and gained feedback.
Final versions were then developed.
Need to also develop associated elements - record tempaltes, naming conventions, file plans, record retention rules (legal, finance, hr, and audit should help with these).
Full record control is massive, I personally applied a modulator approach, as each section was developed, tested, updated and released.
Data Protection, Data Quality, Data Security, Record Control (ISO15489), FOI etc...

Ref: John Broomfield, nice approach - this is how I have historically managed the whole process.

Just remember:
What are our services?
Which services directly impact passenger usage?
How are these measured?
When are these measured?
Are they measured correctly?
How do we compare and manage performance?
How do we target these areas? (Strategies/ad-hoc)
What internal services affect these areas?
How are these measured?
How do we improve?
How do we know we have improved?

When I did a presentation to management about the added value of a standard (did not mention ISO at this stage) I give them this simple example:

A process operated by employees meeting defined competence requirements, specifically trained to do tasks as expected, using process controls that allow adjustment and correction to defined parameters, with product verification.

…and no document procedures