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.
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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 Viddddeo at http://www.youtube.com/watch?v=G8WI2MgyS7w
ISO 9000 Template
Quality Manual & Standard Procedures template can obtain from http://www.iso-consults.com