Where to Start to Implement ISO 9001

[pthareja]

All, Processes are about the resources of several departments interacting to add value for customers

Increasingly departments or functions understand their role is to serve the processes that run through their domains. Thankfully the siloed havens of self-interest are dissolving before our eyes.

Such is the value of business process management.

Process one; or process two-- let them interact to add value..
when at-last they've broken the barriers in departments through..
Hopefully more departments or functions understand their good role
While systems that assure process Quality get increasingly mature
However, lest the siloed havens of self-interest hide in guise..
and should continue to blind wise men right in-front of latters' eyes.

Copyright 2010, priyavrat thareja

 

[batman1056]

All,

In many organizations departments are havens for career development, wasteful politicking and rivalry with other departments. Groups of like minded people trying to keep the head of their silo happy. Such departments and wasteful departmental thinking is the enemy of process and customer service.

John

This is quoted on another website and looks like it was wrote by some academic with a grudge. In some sense I do agree, but in an era of efficiency drivers, silos are not the norm. Silos are normally created because management through the line is not effectively implemented and line managers or section managers are too busy with their own section - this can be addressed by stronger and more effective communication and direction from the department head/director.

Even the implementation of an ISO standard can still result in silo’s

These silos have become systemic in a lot of public sector organisations but they also appear in large conglomerates too.


http://needs2cash.wordpress.com/2010/10/

 

[luftkastel]

Hey everybody,

This web-site is indeed an invaluable resource which I'll try my best to tap into, and I'd like to thank you for your efforts!

Let me briefly describe my situation: I'm a simple undergraduate student and am forced to spend half of every semester in a company. The firm I've found is in the lightning-protection consultancy field and employs 12 people. They don't produce anything; rather, they just provide tailored solutions for their customers. This company has almost no competition on the market, and this is where I come in.
The management are being proactive in their thinking -- they want to have their QMS certified against ISO 9001:2008 before/if customer requirements change towards them. And I, but a student, was appointed as Head of QA.

Unfortunately, my experience is zilch when it comes to this. I've managed, however, to go through a couple of books on the subject and have acquired a copy of the standard. Also, I've read most of the general threads here and in other places that touch upon this topic.
My dilemma, though, is that I'm lost. I have some general ideas what I should do (which I will lay out here), but for the most part I feel everything beneath me is sagging.

My future approach (when I actually go to the company):

1. Find out how the customer gets what they want (i.e. map the processes that add value);
2. Draft the quality policy;
3. Get the missing procedures in place and document them;
4. Fill in the quality manual;
5. Communicate and implement the changes along the way, gradually;
6. Internal audits and management review;
7. First and second stage audits.

What I've written so far is probably non-sense, but that's why I'm turning to you.

I have some questions, though:

A. This business has been up and running successfully for the past few years, which means half of the work has already been done, am I right?
B. Many advise that a gap analysis be performed first, but others say it's not needed. What gives?
C. Should the quality manual be drafted at the beginning or should it be left for the end? If worked on at the beginning, can it serve as a gap analysis tool?
D. Should I buy some book that will guide me through the process (e.g. ISO 9001 in plain English)?

Please keep in mind that I have no set deadline, but I can work on this for a year at most. Also, consultants are a no-no.

Any advice will be greatly appreciated!

Thank you for your time and take care!

 

[John Broomfield]

luftkastel,

Seems like you are on the right track.

Some answers to your four questions:

A. Yes, probably more.
B. When you analyze the core process and the support processes you should identify the missing processes and controls (nonconformities) as you go.
C. If you write the manual around the standard (rather traditional with shalls everywhere) at the beginning it may help identify gaps but not as thoroughly as B above. It is best written in the present tense at the end to describe the system for employees (not auditors!).
D. The key is to understand the system you are developing so ensure you are trained to audit management systems so you know what questions to ask the process owners when analyzing and documenting their processes sufficient for effective planning, operation and control; and when to record the nonconformities.

I will reply privately to point you to the people>processes>system methodology for developing process-based management systems that has been used and improved since 1986.

John

 

[JaneB]

Luftkastel,
The approach you outline is reasonably sound.
My commens:

1. Find out how the customer gets what they want (i.e. map the processes that add value);
>Don't overlook those that don't directly address customers but are essetnial to support others that are.

4. Fill in the quality manual;
Haven't you already done that by now, with processes and procedures? What else is to 'fill in'?
6. Internal audits and management review;
'Managment review' should be happening from Day 1 - it doesn't wait until now! Management should be involved and active and overseeing this from the beginning.


To your questions:

A. Right. But then, you cannot ever get certification for a brand newenterprise as it wouldn't have any track record. And certain items will be missing right now anyway.

B. What gives? Different people have different views.

C. What do you mean by "the quality manual"? What contents are you envisaging here?

D. Yes - very good book.

 

[JaneB]

I will reply privately to point you to the people>processes>system methodology for developing process-based management systems that has been used and improved since 1986.

Why 'privately'? Why not share this on the Cove for everyone else?

 

[John Broomfield]

Why 'privately'? Why not share this on the Cove for everyone else?

Jane,

That may be construed as advertising.

John

 

[Stijloor]

Jane,

That may be construed as advertising.

John

Advertising? How can a possible useful approach or technique be considered advertising? Virtually all approaches, tools, techniques are all different versions of what we know or have seen already.

I would suggest, post it here for the benefit of our Members and let Marc and us Moderators decide.

Stijloor.

 

[luftkastel]

Hello again,

First things first -- thank you for your input, John and Jane!

D. The key is to understand the system you are developing so ensure you are trained to audit management systems so you know what questions to ask the process owners when analyzing and documenting their processes sufficient for effective planning, operation and control; and when to record the nonconformities.

John, to be honest, I have no knowledge or experience in auditing whatsoever. I take it that it's rather important to ask the process owners the right questions, but what would these be? Could you perhaps recommend something useful to read in that direction? I'm also pretty sure there's tons of information on that here, so I'll do my own research, too.

1. Find out how the customer gets what they want (i.e. map the processes that add value);
>Don't overlook those that don't directly address customers but are essetnial to support others that are.

I'm not sure I'm getting this straight. When addressing the first clause of the Standard, should I only lay down the core processes or should I include the supporting ones in the flowchart, too?

Haven't you already done that by now, with processes and procedures? What else is to 'fill in'?

I haven't done anything yet. I'm not supposed to go to the company until a month and a half from now. What I meant, though, was to put into words what the company has in place, for everyone to see.

'Managment review' should be happening from Day 1 - it doesn't wait until now! Management should be involved and active and overseeing this from the beginning.

I second that. But what about records? Should these reviews generate records from the very start?

C. What do you mean by "the quality manual"? What contents are you envisaging here?

I thought the QM was a required document by ISO 9001:2008 which shows to all stakeholders (external auditors included) how one's organization meets the requirements of the Standard. So in my opinion it encompasses all the clauses. And my question was whether to deal with it at the beginning or at the end. I hope I've clarified things a bit.

Thank you once more. Hopefully, I've managed to adequately get my point across.

Best regards

 

[John Broomfield]

Hello again,

John, to be honest, I have no knowledge or experience in auditing whatsoever. I take it that it's rather important to ask the process owners the right questions, but what would these be? Could you perhaps recommend something useful to read in that direction? I'm also pretty sure there's tons of information on that here, so I'll do my own research, too.

luftkastel,

Then I suggest you study and use our management system development methodology here. It is free of charge and has been used and improved 1986.

You will see that the core process flowchart determines most of the key processes in the system. You can determine most of the other key (support) processes from study of the standard and the remaining key proceses (such as recruiting) come from common sense.

Search the Cove for the keyword SIPOC to learn some of the questions to ask when analyzing process and documenting its procedure with the process owner.

You will need auditing skills sooner or later so you may as well acquire them in time to help you to develop the management system in terms of knowing what to look for and when to cite a nonconformity. Nonconformities cited during system development are either corrected (the two-week rule is useful here) or they become the system's first corrective action requests.

John