Tag: iso9001

Templates for Quality Manuals and Forms

Using templates for ISO 9001 quality manuals, procedures and forms can have huge benefits for an organization.  Templates are usually in the form of existing and proven manuals, procedures and forms.  Follow the link for more information on the use of Templates.

 
The ISO 9000 quality manual and the ISO 9000 quality procedures are a vital part of any ISO 9001 quality system.

You can get a huge head start by purchasing a good template quality manual (a sample quality manual that you can

use as a good example and that you can modify to make it your own quality manual). There are numerous

companies that sell ISO 9000 quality manuals that you can use as templates to create your own quality manual.

We urge you to carefully evaluate them before making a purchase decision as we found the majority to be

convoluted, bureaucratic and cumbersome.


ISO 9001 quality system

The latest revision, ISO 9001:2008 – 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.


ISO 9000 – Benefits and Problems

ISO 9000 has received much publicity. Some managers see it as a prerequisite for conducting business. For others, it substitutes for the difficulties and vagaries of Total Quality Management (TQM). Some see only a needless bureaucratic boondoggle. Depending on the situation, any of these views might be correct.

Sensibly applied, ISO 9000 is a qualifier for international markets or specific domestic customers. Certification can be a valuable marketing tool. The standards are a sound blueprint for a quality system. They can lead the way to the more difficult and sophisticated approaches of Total Quality Management. ISO 9000 can improve a company’s cost structure by 5%-20%.

Approached unwisely, ISO 9000 can be costly and unproductive. It may create a quality bureaucracy which adds to the cost structure and slows product development. It can focus people on paperwork instead of customers. It can divert management concentration and energy from more vital issues.


ISO 9000

Every organization would like to improve the way it operates, whether that means increasing market share, driving down costs, managing risk more effectively or improving customer satisfaction. A quality management system gives you the framework you need to monitor and improve performance in any area you choose.

ISO 9001 is by far the world’s most established quality framework, currently being used by around 897,000 organizations in 170 countries worldwide, and sets the standard not only for quality management systems, but management systems in general.

It helps all kinds of organizations to succeed through improved customer satisfaction, staff motivation and continual improvement.

ISO 9000 series of standards

ISO 9001 is one of a series of quality management system standards. It can help bring out the best in your organization by enabling you to understand your processes for delivering your products/services to your customers. The ISO 9001 series of standards consist of:

ISO 9000 – Fundamentals and Vocabulary: this introduces the user to the concepts behind the management systems and specifies the terminology used.
ISO 9001 – Requirements: this sets out the criteria you will need to meet if you wish to operate in accordance with the standard and gain certification.
ISO 9004 – Guidelines for performance improvement: based upon the eight quality management principles, these are designed to be used by senior management as a framework to guide their organizations towards improved performance by considering the needs of all interested parties, not just customers.


QUALITY MANAGEMENT WITH ISO 9000

The methods and tools of quality management and quality assurance have evolved over many decades to a remarkable degree of perfection. From the times of early civilization up to the industrial Revolution, quality was the responsibility of the craftsman who made the product according to his own design, or that of his customers. With the beginning of the Industrial Revolution, when large numbers of workers were engaged to produce similar products in large quantities, quality progressively became the responsibility of the shop foreman or supervisor, who was usually selected from among experienced workers.

 In the 1930s, with the beginning of manufacture of interchangeable components, inspection departments started to be introduced in firms. Their function was mainly to sort good products from bad. Inspection departments represented the separation of the quality and production functions and brought to the scene specialized inspectors and sophisticated measuring and testing equipment. In the 1940s, with the dramatic increases in production due to the war, Statistical Quality Control techniques were introduced to reduce the cost of inspection work, which had become huge with the mass production of military products.

By the end of the 1950s, Quality Control Departments existed in most manufacturing companies. Their activities usually embraced the operational techniques applied to achieve quality, including both monitoring and corrective action. In the 1970s, led by the remarkable quality revolution in Japan, the concept of Total Quality Control gained very wide acceptance.

It asserted that quality was the result of a large number of interacting activities carried out by the different departments of the organization – activities that began with the identification of the needs of the customer or consumer and continued until assessments showed these needs had been satisfied.

The different stages involved constitute what is called the “quality loop”. The concept of departmentalized quality control had, by then, evolved to a broader concept: Quality Assurance, which was defined as “all the planned and systematic actions necessary to provide confidence that a product or service satisfies quality requirements”. This evolution of quality concepts led naturally, in the 1980s, to a further broadening of the quality concept.

Today we speak of Total Quality Management which can be applied in any organization, and is perceived as “the totality of management commitment to and implementation of its own self- defined quality policy”. It includes every aspect of the overall management function of an organization. In 1979 the member of  ISO and IEC for the United Kingdom, the British Standards Institution (BSI), submitted a formal proporsal to ISO that a new technical committee should be formed to prepare International Standards relating to quality assurance techniques and practices. The new technical committee was approved and given a number (ISO/TC 176), a title (Quality Assurance) a scope, and a secretariat (Canada) according to the usual ISO/IEC procedures. Twenty member countries decided to become active participants in the work (P-members) of this new committee when it was set up and another fourteen countries opted to follow the work as observers (O-members).

Today, the number of countries actively participating in ISO/TC 176 is 42 P – members and 21 O – members. There had already been a substantial base of national experience in the UK and Canada. In the UK, the BS 5750 standards were well on their way to broad acceptance and in Canada a series of national standards known as CSA Z299 were also widely used. Naturally, there were some differences in the approaches taken in the UK and Canada, and also a recognition on both sides of the Atlantic that both sets of standards could be improved. Other countries with well-developed quality management practices such as Japan were also starting to take a knee interest, so the programme of ISO/TC 176 quickly became a substantial work effort.

The first editions of the ISO 9000 standards (9000 to 9004) were completed in 1986 and published in the early part of 1987. Up to this point, one could have said that the existence of the ISO 9000 standards was not a very unsual kind of international standardization event. A new committee had been formed, it had taken about five years to produce its first major set of standards, and we would wait and see how well these standards came to be accepted.


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