Quality Assurance Program

 

A quality management system is a comprehensive set of documented policies, procedures and processes that comprise management's commitment to product and service quality in all their activities. Many companies have attempted to inspect quality into their products by the use of quality control programs. It has been demonstrated through the years that a company cannot inspect quality into a product. Quality must be built into a product by the use of a quality management system that assures all activities associated with product quality (design, manufacturing, production, purchasing, quality control, packaging, handling, and storage, shipping and servicing) are appropriately managed and controlled.

What is ISO 9000?

ISO 9000 is a series of international quality standards introduced in 1987 that define a structure for a comprehensive quality management system. ISO 9000 standards apply equally to all industries and require companies seeking certification to define how their quality system meets the requirements of the standards.

ISO ("isos" is the Greek word for "equal" or "same") is a term created by the International Organization for Standardization to denote standards. Just as the name indicates, the organization's objective is to promote the development of worldwide standards, for the purpose of improved operating efficiency, improved productivity, and reduced costs. Over 100 countries are actively involved in the development of world wide standards for the purpose of improved operating efficiency, improved productivity, quality and reduced costs across international borders. The American National Standards Institute (ANSI) and the American Society for Quality (ASQ) is the member body representing the United States.

What is the difference between ISO 9001 / 9002 / 9003?

ISO 9001 is the most complete and demanding standard in the ISO 9000 series, and is designed to assure customers that the quality system is in place through the entire product delivery cycle. It covers product design, engineering, manufacturing, purchasing, marketing, sales, product storage, shipping and handling and product servicing.

ISO 9002 is the next most demanding standard in the ISO 9000 series, and is designed to assure customers that the quality system is in place from manufacturing to service. ISO 9002 does not cover product design as it is structured to be used for companies who manufacture products that have been designed by someone else.

ISO 9003 is the least demanding standard in the ISO 9000 series. It addresses only the requirements for detection and control of problems during final inspection and testing of less complex products or services.

What does it mean if a company is registered or certified to ISO 9000?

To become registered and certified to an ISO 9000 standard requires a company to submit its quality management system to an independent registrar for review, audit and acceptance as meeting the international quality standard's requirements.

These independent registrars are governed by strict international codes and agreements that dictate their operating practices, audit methods and staff qualifications to perform registration and certification. For example, a registrar cannot consult or assist a company in the development and implementation of its quality management system. It must be completely independent from the companies it reviews. This is called "third-party" auditing.

Once a company demonstrates its quality management system meets the international standard and is registered and certified, it continues to be periodically reviewed and audited by the registrar through six month or annual visits to assure the quality management system remains in place and effective for the company's customers and its management. If the standard's requirements are not met, the registrar can terminate the company's certificate.

ISO registered companies must have in place a continuous quality improvement objective if they are to meet the international standard and its objectives.

How many companies are registered or certified to the ISO 9000 series of standards?

There are approximately 250,00 companies registered and certified in the ISO 9000 series of international quality management standards. In the U.S., there are around 25,000 companies. The U.S. started very late in the adoption of the ISO 9000 series when compared to other countries. For example, Germany has approximately the same number of companies registered as the U.S. but has a total population of about 1/3 the U.S. and is only twice the size of Wisconsin.

The rapid development of ISO in Europe has been driven by their desire to have a unified market for manufacturers and to reduce the differing national product certification programs that made selling products in multiple national markets a costly undertaking.

The U.S. was reluctantly forced into adopting the ISO standards when many European countries started requiring their suppliers (many from the U.S.) to address the ISO quality management standards. Once many of the larger U.S. companies realized the benefits of having an international quality standard with third-party audit and registration requirements, they started rapidly over the last two to three years to impose the requirements on their own U.S. suppliers.

As a customer and consumer, why is it important to me that the quality management system is certified and registered to ISO 9001?

Purchasing products from a company that is ISO 9001 registered provides the customer a much stronger level of assurance that the products they receive are of high quality. What does "high quality" mean? It means that the product meets or exceeds and conforms to the regulatory, safety and customer design requirements that have been specified for the product. To put it in simpler terms, a "high quality" product should meet or exceed customer expectations and requirements.

Most companies make claims their products are high quality. ISO registered companies must do more than just claim their products are high quality. They must demonstrate it! An independent audit organization reviews the company's quality management system every six months or, as a minimum, on an annual basis. The ISO registrar is responsible under strict international and U.S. agreements to verify the registered company is meeting its commitment to quality and safety.

In addition, the ISO standards require registered companies to have an internal audit program that tells internal company management whether its quality system is effective and working satisfactorily.

An ISO 9001 company must document its product's designs and have them formally reviewed and approved as meeting applicable regulatory, safety and customer requirements. Compliance to those designs is not only verified by the required internal audit program but also by the independent registrar.

Product safety and quality are critical elements in the food and dietary supplement industry. ISO 9001 company registration demonstrates to a customer that a company is committed to assure continuous safety and quality improvement in its products.

As a manufacturer who is thinking of using products or services, why is it important that the Farms are ISO 9001?

Companies who need products or services supplied to them to incorporate into their own products have to be significantly concerned from a liability standpoint with supplied product quality and safety. ISO 9001 registered companies provide numerous benefits to product suppliers.

A manufacturer knows what the quality management system is in an ISO registered company. The opposite is true of a company that is not registered. Consequently, a manufacturer may have to perform extensive audit and continuous reviews to just determine what kind of quality program exists in a non-registered company that supplies products to them and whether the program is being maintained.

An ISO registered company is committed to meet purchase order requirements like notifying its customer of product quality problems and allowing access to its facilities for audit or review. It is required to have an extensive corrective action and audit program that not only solves quality and safety issues but also prevents their recurrence.

An ISO registered company that provides a certificate of conformance / compliance or analysis has the documented procedures and records to demonstrate the validity of the documents. This may or may not be true with an unregistered company.

As mentioned above when discussing customer and consumer needs, product safety and quality are critical elements in the food and dietary supplement industry. ISO 9001 company registration demonstrates to a supplier that a company is committed to assure continuous safety and quality improvement in its products.

A summary of some of the most important benefits that customers, consumers and supplier's get from using an ISO 9001 registered company:

• ISO certification is direct evidence of a company's financial and ethical commitment to provide high quality safe products.
• An ISO certified company must maintain a comprehensive internal audit program which is utilized to demonstrate to management and customers the effectiveness of its quality efforts.
• An ISO certified company provides a recognized effective quality management system that has been accepted for use by the U.S. and over eighty other countries around the world as an effective means to acheive product quality.
• An ISO 9001 certified company maintains documented, reviewed and approved product designs that meet applicable safety, regulatory and customer requirements.
• Many companies say their products are high quality. An ISO certified company must demonstrate it by receiving successful audits from an independent registrar. The registrar is governed by strict international codes and agreements that dictate their operating practices, their audit methods and their staff qualifications to perform company registration and certification. They must be completely independent from the company it reviews. Failure to maintain quality program requirements will lead to de-certification by the registrar.
• Using an ISO certified company to provide product needs to a supplier reduces the need for the supplier to perform extensive audit and review to determine what quality system is in place and is it being maintained.
• A certificate of analysis or certificate of conformance / compliance from an ISO certified company will be backed up by documented procedures and records that demonstrate its validity.