ISO 9001 - Understanding ISO 9001 Requirements

1. SCOPE
1.1 General
This Standard specifies requirements for your QMS to:

a)demonstrate your ability to consistently provide product that meets customer and regulatory requirements

b)enhance customer satisfaction by:
Þeffective application of your QMS
Þcontinual improvement of your QMS
Þproviding assurance of conformity to customer and applicable regulatory requirements

Note: The term “Product” applies to product intended for or required by a customer

Key Explanation Points and Tips:
ÞYour QMS must do two things - 1. Meet requirements consistently and 2. Enhance customer satisfaction in three different ways (see above).

ÞAbility refers to the capability of your organization to - determine your customer needs and requirements; design and develop product; know-how and capacity to manufacture product; package product; deliver on time; provide service and support; etc;

ÞConsistency is being able to repeat your capability within specified parameters for quality as defined by customers, your own organization or regulatory bodies. Can you consistently make conforming product or service, day in day out?

ÞTo achieve and demonstrate your capabilities, you must effectively plan, operate and control the processes, within your organization that provide them. These processes collectively form the scope of your quality management system (QMS).

ÞThe effectiveness application of your QMS can be determined by - how well QMS activities and results measure up to planned performance indicators.

ÞContinual improvement of the QMS is achieved by - increasing the ability of the QMS to meet requirements through raising the performance indicators and more efficient use of resources.

ÞAssurance of conformity to requirements may be achieved by providing confidence that requirements will be fulfilled. This confidence may be achieved through - implementing prevention based controls; conducting internal/external audits; 3^rd party certification of your QMS; etc.

ÞThis standard provides specific requirements to effectively plan, operate, control and improve your QMS processes. These requirements focus on prevention based controls and to a lesser extent detection based controls, as well as continual improvement of your QMS.

ÞIt is important to note that the ISO 9001 standard does not specify requirements for product. The focus of all ISO 9001 requirements is on your QMS and its processes. By effectively controlling and continually improving your QMS processes, there will obviously be a positive impact on product quality performance.

ÞDon’t overlook regulatory requirements applicable to your organization. These requirements may come from your customer; the industry you are in; from within your own organization; or state or federal organizations. You may need to apply regulatory requirements to your suppliers and outsourced processes (subcontractors).

ÞYour ultimate objective is to enhance customer satisfaction. You achieve this by planning, operating and improving your QMS to effectively meet customer and regulatory requirements.



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