ISO 9001:2008 Forum

HOW DO YOU BUILD A QMS FROM SCRATCH?

Tue, 10 Nov 2009 03:01:22 CST

by ANTHONY OFILI.

SINCE I JOINED THIS SITE I HAVE GAINED A LOT OF KNOWLEDGE ABOUT QMS.

THIS IS STILL NEW WHERE I AM FROM, DO ANYONE HAVE A SUGGESTION ON HOW TO START A QMS WHERE NON EXISTED IN THE FIRST PLACE?

internal& external audits

Tue, 10 Nov 2009 00:38:44 CST

by sureshmurali radhakrishnan.

internal audits are those which are done within the organisation for continuous monitoring of the company's operations, processes and activities. The aim of the internal audits is also to ensure that corrective and preventive actions are in place if any defects are found. External audits are those which are done by an outsider who is not, usually a part of the organisation. They work mainly on a monthly or yearly basis on behalf of the clients and the board of directors and just give their opinion on the (financial) status of the organisation.

Re: ISO 9001:2008 and CMMI Development

Mon, 09 Nov 2009 23:36:02 CST

by Kumar Subramaniam.

CMMI basically categorizes the organization into different levels based on the performance.

Emphasizes more on Competency building, Intergroup co-ordination and approach is based on Key Process Areas.

Continuous improvement has to be inculcated into the Organization's culture to establish "maturity".

Re: Management Commitment

Mon, 09 Nov 2009 08:23:16 CST

by lydia indrasari.

ISO can not sustain without Management Commitment. From my point of view, we better not start ISO, if there is no Management Commitment. Because, we will have lack of resource (Management do not want to provide any or enough resource , i.e human resource, training, or other resource). They also will not support the Management Representative to communicate / socialize the importance of customer requirement (or any other requirement). The Quality Policy will also only as a wall decoration, not as a guidance for company strategy deployment.

In a short sentence, ISO without Management Commitment, will only make the Management Representative suffer as a Management Black Sheep.

Re: Checklist of a Quality Assurance Manager.

Mon, 09 Nov 2009 08:14:13 CST

by lydia indrasari.

Quality Management Calender is always my 1st priority to begin incoming years. Usually in beginning of December, we have already proposed QM Calender included schedule for :
1. Internal Audit (frequency is based on our procedure 2 times a year)
2. External Audit (based on Certification Body periodical schedule)
3. Management Review (usually we planned after the internal audit)
4. Customer Satisfaction Surveys (frequency based on Management Commitment during Management Review).
5. Training (ISO & Quality basic for new employee, refresh for Internal Auditor etc).
6. Supplier / Subcontractor / Outsourcing Audit (based on management priority)

Above is the must do plan. The others subject is usually based on company need as result of Management Review (output), Finding / Observation from External Audit (Certification Body or Customer) & many others source.

Re: What should we do in audit, if there is no documented procedure ?

Mon, 09 Nov 2009 07:27:22 CST

by Norman Huston.

It is my understanding if they have a drawing or a Manual/tech data that they are working to, it would be ok.. However, if they have nothing to show...... I would think it is a major finding/non conformance. I am not aware of a rule of thumb, they either have procedures/tech documentation or they don't.

Re: Timeframe for implementation

Mon, 09 Nov 2009 01:23:49 CST

by Jitendar Kumar.

Time frame of 3 months is not mandatory. further, when the customers are hospitals, it is very necessary to let them know of a probable implementation for any proposed/ expected quality change/ implementation . Even slightly more time needed may put pressure on hospital for want of supplies. Hospital detergent determines the sterility of the hospitals without which no hospital can survive (function).

Ideal time for this work depends the average cycle time your consumers need to exhaust your previous supply so that while maintaining supplies for one or more complete consumption cycle at the consumer's end, the change process is started and before this supply gets over at the consumer's end, product which is the output of ISO implemented production is at consumers hand.

Speaking practically, you can follow the following steps:
1. You must first determine the time period at the end of which a quantitative bulk supply leaves your end to reach customer's end. Lets call this 'X'
2. You must then estimate how many production- supply-usage cycle time you will take depending upon the changes in infrastructure, raw materials and their availability, skill up-gradation etc. This will depend upon the demand of your detergents, the factory size etc. Lets call this 'Y'
3. Your answer would be X multiplied by Y.

Re: World Economy and Quality

Mon, 09 Nov 2009 00:25:37 CST

by Jitendar Kumar.

If we talk about the current world economy, we are bound to give a definite percentage of its cause of unrest to the quality decline. This includes lack of professional purity, purity of intention, motives and methods. When we talk of quality lets give a big attention to ETHICS- for this one word determines all the rest of quality and put both professional and other aspects of an economy and its behavior & effects on the right track.

Certainly , tools used for the measurement & improvement in quality may be many, which may include both statistical & 'status' - tical , but as long as the direction leads to a stage of improvement in purity of goal and methods, most certainly economy would be stronger.

In present senerio, QUALITY would be pushed to the forefront in all transactions and economic tie up.

Different of 7.3.4 - 7.3.5 - 7.3.6

Sat, 07 Nov 2009 15:03:08 CST

by lydia indrasari.

I have a difficulty to understand what is the real different of :
7.3.4 : D& R Review : evaluate the ability of the result of D&D to meet requirement.
7.3.5 : D&D verification : ensure the D&D output have met the D&D input requirement.
7.3.6 : D&D validation : ensure the resulting product is capable of meeting requirement for....
From my point of view, all above action is somewhat similar. Can anyone help me (maybe w' actual example) what is the real difference action ?
thanks

What should we do in audit, if there is no documented procedure ?

Sat, 07 Nov 2009 14:52:08 CST

by lydia indrasari.

Differ from ISO 9001:1994, in ISO 9001:2000, there is only 6 must have procedure. What should we do if when we do Audit, we have different opinion about the need of documented procedure with the auditee. Is there any "Rule of Thumb" , how to check & validate when we can raised the NCR for lack of documented procedure.

Re: ISO 9001:2008 and CMMI Development

Sat, 07 Nov 2009 00:08:11 CST

by Himansu Bhusan Mohapatra.

Hello,

Here is what I understand.

ISO focuses mainly on broader issues of quality within an entire enterprise or company. Executives of these organizations are often interviewed. The main product of ISO is the creation of a quality manual that discusses quality initiatives to be implemented throughout the enterprise.

The CMM takes a much more limited view. The CMM focuses on only software-intensive projects. It does not look at an entire enterprise or company. It describes an organization (admittedly, ambiguously)
as several projects managed under one director (an example). Interviews may include an executive manager or two, but mostly focus on project managers and their team members.

Any comments or a bit to add to this?

Thanks!

Himanshu

Checklist of a Quality Assurance Manager.

Fri, 06 Nov 2009 12:32:25 CST

by Asad Baig.

I cannot live with a checklist that tells me every time the things I have to do (MBO) . Similarly, I always prepare a calender for the Quality Management System for up coming year.

Please tell me what are the things to be looked into that can be included in my calender?

Re: customer satisfaction

Fri, 06 Nov 2009 00:43:50 CST

by Sapna Srivastva.

to meet the customer requirement will lead the Customer Satisfaction.
and If customer will be satisfied with the deliverable, it lead the customer to leave the good feedback.

Difference between CMMI and ISO

Fri, 06 Nov 2009 00:39:48 CST

by Sapna Srivastva.

what is the difference between CMMI and ISO?

Management Commitment

Wed, 04 Nov 2009 23:37:09 CST

by Sanjay Sinha.

the benefit of management commitment

Re: A World without Quality

Wed, 04 Nov 2009 14:41:30 CST

by Charles Eldredge.

A world without quality is definitely a scary thought. Even with quality, many things are missed that endanger an individual's welfare. In the Northeast right now (I live in CT), there is a massive beef recall going on for meat that was sold in BJ's Wholesale Clubs and a few other select outlets. It seems that the meat was tainted with e-coli and so far has cause three deaths and around 18 cases of illnesses just in the Northeast region. Of course, I read about this recall on Monday after having eaten some of this meat just last Friday evening, so I was a little unsettled (I have been blessed with no ill effects as of now) by the report.

With the high standards of quality placed on the meat industry something like this is unusual, but I don't even want to imagine if the industry without quality.

Re: customer satisfaction

Wed, 04 Nov 2009 11:35:22 CST

by Gregory Airapetyan.

I work for two car dealers and we use telephone interview with around 6 questions not to make it too long for customers. Clients are called after 7 days of purchase or service and this method seems to be the best, since it gives quick answers and you can solve problems right away. Car manufacteres usually send a detailed questionar, by mail or email, but I noticed that few anwer to that... (usually the ones that are not satisfied..)

Re: customer satisfaction

Tue, 03 Nov 2009 14:10:34 CST

by Charles Eldredge.

There are many ways to have the customer provide feedback. It really depends on whether you are looking for immediate feedback (after service provided) or feedback from a longer period. In my organization, we have found that by issuing an annual survey to all of our customers (tailor for nuclear and non-nuclear customers) we can get feedback about our performance over the cousre of several projects and can get an impression of how our customer sees us overall. In addition, at the completion of each job we do for a nuclear customer, our VP of Nuclear Sales and Marketing will call each customer and ask a) what are your thoughts about the way this project went?; b) did we meet your expectations?; and c)what can we do to improve for the next project? - these questions allow us to get a better handle on how our projects have gone and gives us better access to the customers point of view.

I would recommend using both methods, if possible, to ensure that you have a clear and concise picture of current performance and still see long term performance.

How ISO 9001:2008 be effective in quality measurement

Tue, 03 Nov 2009 13:01:10 CST

by Sanjay Sinha.

what are the procesure?

What is diffrence between iso 9001:2000 and 9001:2008

Tue, 03 Nov 2009 12:57:20 CST

by Sanjay Sinha.

this is most imp parameter to evaluate.