Hello. I came from manufacturing background and had implemented ISO9001 in various manufacturing-based industries - metal stamping, electronics, etc.

Now that I've been given responsibility to help a company to implement ISO9001 - and this is a non-manufacturing industry - a property realty business, or you may consider this as 'service' and 'market' industry.

Maybe someone can give me some tips and hints on how to start on something like this. Sometimes, it may be confusing in the term 'product realization' in realty business....calibration, measurment equipment, etc etc......(which are much more easier to understand in a manufacturing firm)

Help !!

Hi, YKT! We've had a few discussions on ISO 9001 and the service sector. I suggest you do a search in the Cove. You'll get links to threads such as this thread: ISO 9001 and Service Providers Industry? What do you think? (http://elsmar.com/Forums/showthread.php?t=10889).

A review of ISO 9000:2000 Fundamentals and Vocabulary will get you the needed understanding.

Product Realization can be called 'Service' Realization. The term product, which is the result of a process (interacting activities which transform inputs into outputs) is generic and includes the category of 'services'.

"Calibration, measurement equipment," can be 'excluded'. See ISO 9001:2000 clause 1.2 Application. Unless you want to calibrate your pencil sharpeners, you can exclude items such as this (contained in clause 7) due to the nature of going about your service business pertaining to property realty.

Does this help?

In a realtor / property business your products might include some things like a sales contract, maybe research. Hmmm, interesting situation.

The bottom line is the first thing to do is to define what the product(s) are. Here's one to think about. The company essentially sells (their product is) extended warranties.

Quality Digest has an article on the growth of ISO 9001 in the Service Sector, his month.
Please note that the link will expire when the next QD issue becomes available.
http://www.qualitydigest.com/currentmag/articles/04_article.shtml

With the continual exporting of US manufacturing plants aboard, this has a significant impact.

http://www.iso.org/iso/en/commcentre/pressreleases/2006/Ref1030.html


Ref.: 1030
26 September 2006
'How to get benefits of ISO 9001:2000' – for service sector

http://www.iso.org/iso/en/commcentre/pressreleases/image2/workbook.jpgA practical method for helping service sector companies, particularly in developing countries, to implement ISO 9001:2000 quality management systems has just been published by ISO (International Organization for Standardization) and the International Trade Centre (ITC).

ISO 9001:2000: A workbook for service organizations is designed to make it easier for service providers to achieve the benefits, such as increased efficiency and effectiveness, of implementing ISO 9001:2000.
According to the World Trade Organization WTO), the value of world trade in commercial services increased in 2004 by 16 % to USD 2,10 trillion. The cross-border trade in services includes business process outsourcing and offshoring, which offers opportunities for developing countries in particular.
One way that organizations in developing countries can increase their market share in such opportunities is by ensuring competitiveness through the implementation of a quality management system based on ISO 9001:2000.
The ISO/ITC workbook targets service organizations with less than 20 employees, such as accountants, architects, engineers, lawyers and management consultants. Resolutely practical in its approach it focuses on the discussions, decisions and steps that make up a programme to implement an effective quality management system.
With the aid of questions and checklists, it guides the service company manager through the following stages: making a decision to implement ISO 9001:2000; planning an approach, designing the quality management system and managing documentation.
For those organizations that wish to go further and have their quality management system audited and certified by an independent body, there are also chapters on getting certified, and after certification. The appendices include one giving tips on working with external consultants.
Certification is not a requirement of ISO 9001:2000, which can be implemented solely for the benefits it brings internally and to the organization’s customers. At the same time, many organizations choose to pursue certification and at the end of 2005, nearly 33 % of ISO 9001:2000 certificates were held by organizations in the service sectors.
Although developed with service enterprises in developing countries in mind, the hands-on approach of ISO 9001:2000: A workbook for service organizations has something to offer for service providers in developed countries too.
The workbook is available in English (ISBN 92-9137-286-2), French ( ISBN 92-9137-294-3) and Spanish ( ISBN 92-9137-292-7), costs 64 Swiss francs and is available from ISO national member institutes (see the complete list (http://www.iso.org/iso/en/prods-services/ISOstore/memberstores.html) with contact details), ISO Central Secretariat (see below), and ITC (Web www.intracen.org (http://www.intracen.org/); e-mail itcreg@intracen.org (itcreg@intracen.org)).
ISO Store: to order
ISO 9001:2000: A workbook for service organizations (http://www.iso.org/iso/en/prods-services/otherpubs/Quality.PublicationList?CLASSIFICATION=QUALITY#096000)

Hi
In service sector you can implement ISO 9001:2000.But a major problem is your view.
If you understand service nature you can design and implement a proportionate system.
I recommend you read some book about service management.
A dimension of service quality is very different from manufacturing quality.

I am responsible to prepare / organized setup for ISO.

Importing MEDICAL DEVICES and Ware House.

Since, I have no back ground experience...need help.

How to start? from where?

Some one has templates?

Hi Madona (Paragon),

Welcome. Like the others, I believe you are on holiday also. Therefore things will be a bit slow for the next few days.

Before the crowd comes back, I'll suggest you do some preparations by carrying out the following two activities.

1. Prepare a simple flow/flowchart of how things are being done at your locality (in their correct sequence and show how they inter linked). Do not worry about mistakes cos' they are part of learning process and post it here for the others to offer their advice/suggestions.

2. Read More about ISO 9001. The easiest is to go to the top of this page and click on the 'Forum Index' - red wordings on green background. Next, under International & business standards, click on ISO 9001- Quality Management Systems. There are currently 1608 threads available. As they are listed by titles, pick and choose what you want to read.

In 2 to 3 days you should have a better understanding and be able to benefit more while participating in discussions subsequently.

Regards.

p/s Samples of manual, ppt presentations, flow-chart, forms etc are available if you click on 'more free files' or 'post attachments list'. Both are at the header bar of this page.

I am responsible to prepare / organized setup for ISO. Importing MEDICAL DEVICES and Ware House. Since, I have no back ground experience...need help. How to start? from where?

Since you are importing medical devices, apart from the ISO requirements and what Harry has rightly pointed, you need to have a look at the regulatory aspects and FDA requirements too.

Hi Madona (Paragon), Read More about ISO 9001.

It would be ISO 13485, since Paragon would be dealing with Medical Devices.

Since you are importing medical devices, apart from the ISO requirements and what Harry has rightly pointed, you need to have a look at the regulatory aspects and FDA requirements too.



It would be ISO 13485, since Paragon would be dealing with Medical Devices.


First, this post was made under the "Implementing ISO 9001 in a service industry" thread. Next, the original poster indicate that they are working on project to implement "ISO for Importing and warehousing" (refer to introduction thread) and I guess distribution - that's why she post under the service thread.

Question is, do importers and distributors of medical devices (for local consumption) need ISO 13485? Not in my country! All they need to do is meet local laws and legislation. If the purpose is to improve service, then 13485, without the customer satisfaction and continuous improvement elements is also not relevant.

However, its good to point out to the original poster as what is really needed is very much dependent on their business scope or model.