› ISO 9001 quality system

The latest revision, ISO 9001:2000 - which has just been published - has a greater focus on how companies meet customer needs, integrate those needs into the operation and evaluate customer feedback (see sidebar after article). It is the most extensive overhaul of the standard yet and requires top-level management leadership. The new updated standard is based on eight fundamental "best practices" that all organizations should have integrated into their business if they intend to keep up with their competition.
Improved customer relations are only one of a number of benefits of adopting such a company-wide quality system. Following ISO 9001 improves communications both inside and outside the firm. It reduces rework, scrap and product returns. It builds better supplier relationships through improved communications and feedback. An ISO 9001 system helps to create a reliable system for documenting procedures, which helps set performance expectations, promote consistency and can reduce new employee training time.

The greatest obstacle to adopting an ISO 9001 quality system is understanding what compliance to the standard really means, and then implementing the requirements in a simple and easy-to-use system. Because the standard can be applied across all industries, a first step for most companies is deciding what parts of the standard apply and identifying where any system already in place needs to be improved or modified. Many companies get stuck trying to fit the standard to their situation rather than implementing the basic controls and checks/balances that ISO looks for. Here the experience of plastics professionals can help a moldmaker/molder by clarifying which requirements are needed, what areas are to be placed under document control, and the easiest methods to show evidence of quality related activities.

The Advent of Superior Quality Standard

ISO 9001 2008 was created with a view to specifying the requirements for a quality management system especially where an organization or firm needs to demonstrate its capacity to provide customers with durable products and appropriate regulatory and statutory requirements. ISO 9001 2008 and ISO 9001 2008 draft also helps enhance customer satisfaction by ensuring effective application of a system including various processes that promote continual development and assurance of product conformity for the customer. All requirements of ISO 9001 2008 are usually generic in nature and are intended to be applied in various organizations regardless of the type of product that they produce. The formal international standards and technical reports that govern ISO 9001 2008 are contained in ISO 9000 standards. The same applies to various web based documents and technical specifications that regulate ISO 9001 2008 (FAQ). Information on quality assurance of ISO 9001 2008 can be found at the Quality Information Center.

Quality Management

There are two schools of thought on quality management. One views quality

management as the management of success and the other the elimination of

failure. They are both valid. Each approaches the subject from a different

angle:

The ‘success’ school is characterized by five questions (Hoyle, David and

Thompson, John, 2001)3 :

1 What are you trying to do?

2 How do you make it happen?

3 How do you know it’s right?

4 How do you know it’s the best way of doing it?

5 How do you know it’s the right thing to do?

The ‘failure elimination’ school is characterized by five different questions

1 How do you know what is needed?

2 What could affect your ability to do it right?

3 What checks are made to verify achievement?

4 How do you ensure the integrity of these checks?

5 What action is taken to prevent a recurrence of failure?

In an ideal world, if we could design products, services and processes that

could not fail we would have achieved the ultimate goal. Success means not

only that products, services and processes fulfil their function but also that the

function is what customers’ desire. Failure means not only that products,

services and processes would fail to fulfil their function but also that their

function was not what customers desired. A gold-plated mousetrap that does

not fail is not a success if no one needs a gold-plated mousetrap!

The introductory clause of ISO 9001:1994 contained a statement that the aim

of the requirements is to achieve customer satisfaction by prevention of

nonconformities. (This was indicative of the failure school of thought.) The

introductory clause of ISO 9001:2000 contains a statement that the aim is to

enhance customer satisfaction through the effective application of the quality

management system and the assurance of conformity to customer and

applicable regulatory requirements. (This is indicative of the success school of

thought.)

In reality you cannot be successful unless you know of the risks you are

taking and plan to eliminate, reduce or control them. A unification of these

approaches is what is therefore needed for organizations to achieve, sustain

and improve quality. You therefore need to approach the achievement of

quality from two different angles and answer two questions. What do we need

to do to succeed and what do we need to do to prevent failure?

Quality does not appear by chance, or if it does it may not be repeated. One

has to design quality into the products and services. It has often been said that

one cannot inspect quality into a product. A product remains the same after

inspection as it did before, so no amount of inspection will change the quality

of the product. However, what inspection does is measure quality in a way that

allows us to make decisions on whether or not to release a piece of work. Work

that passes inspection should be quality work but inspection unfortunately is

not 100% reliable. Most inspection relies on human judgement and this can be

affected by many factors, some of which are outside our control (such as the

private life, health or mood of the inspector). We may also fail to predict the

effect that our decisions have on others. Sometimes we go to great lengths in

preparing organization changes and find to our surprise that we neglected

something or underestimated the effect of something. We therefore need other

means to deliver quality products – we have to adopt practices that enable us

to achieve our objectives while preventing failures from occurring.

ISO 9000 Video

ISO 9000 Template

Quality Manual & Standard Procedures template can obtain from http://www.iso-consults.com

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