A Beginners Guide to ISO9001 2000

What is it?

 

A system of controls used by some million companies world wide as a synthesis of good management practice.

Who does it and why?

Companies who are being told to by their customers

Those whose competition is doing it

Those who want to steal a march on their competition

Those whose current customers are happy with them but know that doors are shut to them in new areas which they want to break into or quote for

Those who want to improve their businesses

It shows your customers and prospects that you care about them and the service you provide

What does it consist of?

The old 1994 standard had 20 points in it. The new one has only 5 but guess what all of the old 20 are still there within the new 5 but with two more added.

They are as follows

Management responsibility   

A policy and regular reviews of where are we and how can we get better

A Quality System

Consists of a Quality Manual showing for each point whether it applies to you, who is responsible, and pointing at the procedures and processes you have in place to actually control what you do.

Sales

How do you make sure you understand your customers’ needs?

Document Control

Control of your manuals and any key documentation within the system Eg Method Statements etc

Purchasing

How do you make sure you get what you need and get it when you want it

Design

Only applies to companies who do design but if you do, how do you control the design process – planning review testing etc

Customer property

How do you look after customer data or property

Identification and Traceability

How do you identify goods and who carried out services – particularly certified items and how do you provide whatever traceability required by customers

Process

How do you control whatever it is you actually do Work Orders, Method statements, Client Folders etc

Inspection and Test

How do you inspect and test incoming goods, in process inspections and final inspections before handover to your customer. How do you check your service process has met the customer’s requirements?

Inspection and Test Status

How can you see how far a product has progresses and ensure uninspected or faulty goods are not used….not always relevant for service companies.

Inspection and measuring equipment

Is measuring equipment calibrated correctly, again not always relevant.

 

Nonconforming product  

Do you isolate faulty goods to prevent use

Corrective and Preventive action

If faults occur how do you manage them and how do you prevent them happening again. Also what planning do you do to prevent problems in the first place?

Handling and Storage

How do you look after stock, pack it and deliver it? How do your store and protect your data?

Quality records

What records do you keep to prove you have done all the things you say you do?

Auditing

This is not financial auditing. Rather it is checking that you are following your laid down processes and looking for improvements.

Training

You need to prove that people carrying out work are qualified to do so and that you have training reviews for additional training in place

Servicing

If you carry out service work how do you control it?

Statistics

Analysis of key data for improvement as well as SPC data within factories

The two new ones are:

 

 

Customer feedback 

Find out what your customers think of you and use it as a tool for improvement at Management reviews (see management responsibility above)

Internal improvements  

Obtain base data about each of your processes and decide what you could improve. Then set actions to do so again report to the Management review

 

           

That in essence is what ISO9000 is about – controlling what you do and getting better!

What is the process?

 

You need to develop a Quality Manual and Procedures or Process Manual. When you have written

What you do. You then assess what else you need to do to meet what the standard requires. This is

usually a period where you identify what improvement can be made in the business. You then

implement these changes.

 

Management Reviews are held to evaluate improvements (measurable) based on internal improvements and customer feedback.

 

You then carry out audits to see that you are doing what you say you do. – And re-audits when you find you are not!

 

You are the ready for assessment. This is normally in two stages:

 

1.       Document review by the Assessment body to see that what you say you do complies with the standard – They may come back with suggested improvements which you need to address

2.       On site review to see you do what you say you do.

Can I do it myself?

 

Of course you can but you may find that if you do not have an ISO9000 expert in the company using a consultant will save you time and heartache.

 

What are the benefits?

 

Hard to say in general terms but it invariably helps the controls within a business and also allows the business to grow with customers who would not use you without it.

Take an example

If you could grow your business by £100000 per year and have a profit rate of 10% you could get £10000 extra profit per year. So if you can get it done for less than that it is worth considering.

Getting Activa on your side should ensure your system will make you money.

 

How long does it take?

 

Because you need to implement changes , obtain customer feedback, get data internally on performance, set improvement plans and measure their effectiveness the shortest elapsed time that is practical is normally about 6 months. Many companies take longer so budget on 8 to 9 months.

 

How much?

 

That depends on how many people in the company, how complicated your processes are and what you actually do.

 

So to discuss it further give us a ring on 01270 663397 or 01799 506151 or E-mail us and we will be pleased to discuss your particular circumstances further.

 

Copyright Activa Consulting Ltd 2003

 

 

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