What are the things which need to be considered during the implementation of

ISO 9001.
Balakumar P
Senior Manager - Product delivery
Top Contributor
Management responsibility is the first requirement, here most of the companies witness failure due to
improper support from management during implementation.
Sherri Gallagher
Quality and Industrial Engineering Consultant at Technacon Company Inc
I think we need to expand on that to the company culture. Management must be in favor of ISO 9001 as a
good business investment, but so must the unofficial leaders of the workforce. Not only does
management need to see value in it but so must the employees. You must be able to answer the age old
question, "What is in it [ISO9001] for me?".

At this point you then need to get a clear determination of the true customer requirements. That is
frequently more unclear than most people would think.

Once the culture and customer requirements are understood then it is time to look at resources and map
the process from the first customer contact to the delivery and you are on your way to a great deal more
work.

I hope it goes well for you.
Dave Brown
Owner / Consultant at Revitalize Solutions
A GAP Analysis identifying what you are already doing that is in compliance with ISO 9001 will be greatly
beneficial. There is no sense in spending time "re-inventing the wheel". If you already have a successful
company with satisfied customers, you are most likely already following many ISO principles. The less
you have to change to achieve your ISO certification, the greater chance for buy-in you will receive from
employees and management.
Jacqueline van der Lee
Technical Services Officer Beverage at BROWNES FOODS OPERATIONS PTY LTD., Australia
Management commitment is very important. No point implement the management system if you don't get
the top most management support. If you can convince the CEO or MD of the company to be the chair
person for all the management review meeting, your implementation will go smoothly. Otherwise you will
struggle with all the resources. Good luck
Vincent O'Donnell MCQI CQP
Quality Consultant at D.N.O. Kurdistan
Top Contributor
Determine what management's goals are for gaining certification, or implementing a documented QMS.
Like one of the posts stated, if you are in a successful business meeting customer requirements, you may
already comply with of ISO 9001 requirements.

You need to identify the scope of your company's business, what processes are involved, how they
interlink, what procedures are required to control each process, identify if by implementing an ISO 9001
you intend to improve the efficiency of your QMS and ultimately your company's business. Are they
wasting money on fruitless operations?
S Anand
Master Trainer 3rd Party Automotive & Aerospace CB Auditors
Top Contributor
Section 0.1 of ISO9001 clearly lays down that "The adoption of a QMS should be a strategic decision of
an organization. The design and implementation of an organization's QMS influenced by Org
environment, its needs, objectives and its size". This statement is not ready by most of the QMS
implementation teams. If the top management is made to read this statement, their commitment should
become almost mandatory. If they decide to miss out this portion of ISO9001, then they should be ready
to face legal complications as and their organisation gets caught on the wrong foot. That settles the
involvement of Top Management. Once they are involved, availability of Resources shall become easier.

Once this done, we could follow the steps given below. The order could be changed as per the need and
requirement of an organization.

1. Gap Analysis to get an answer to "Where are we as on today.
2. Arrange ISO9001 awareness program for all the Executive and other staff in a planned manner.
3. I would prefer using Process Turtle across the organization. This is a single sheet process control and
has the power of getting people involved right to the bottom most rung
4. Clause 6.2.2 (d) demands that its personnel must be aware of the relevance and importance of their
job and their contribution towards meeting the Process Objectives.
5. Meanwhile Top Management takes a vision and spells it out in the Quality Policy and distributes to
Process Owners for deployment across the plant.
6. MR should coordinate all activities and keep the Top Managment fully aware of the QMS
Implementation status
7. Get a couple of personnel trained for Internal Audit.
8. Trainer auditors perform Internal audit and analyses the causes of poor performance.
9. Management Review follows and actions planned for continual improvement.
10. Select a CB and arrange audit at the earliest. Post this External audit, NCs are closed with the help of
Corrective action where needed. If CB finds the status acceptable, they should recommend the
organization to be certified by their CB.
Jane Bennett
Quality Management Consultant; DIY ISO 9001 Kit author
Top Contributor
Listen to what Miguel says, and do it. Step 1 is make sure you have someone who really does know &
understand the Standard! Without that, it's like setting off on an ocean voyage to another continent,
without any maps, pilot or anyone who can navigate... and about as productive.
Asking such a very, very broad question in a forum like this is likely to get the following responses:
- none or very few (because it's so broad that it either cannot be answered or needs a book to answer it,
and who has time to write that much?)
- anyone and everyone telling you their approach or how they did it once perhaps, because they're
wanting to help
- the 'drum-beaters' who have a single pet topic and will grab the opportunity to give you a diatribe on
their pet topic because they're single-minded about it.
- perhaps a few (if you're lucky) giving sound advice.
The problem is, without any knowledge at all, you'll find it very hard to sort the wheat from the chaff, and
may end up either utterly overwhelmed, or listening to very poor advice. The only way to avoid these
pitfalls is - get knowledge, as Miguel says, whether external or internal.