International Organization for Standardization has once again revised ISO 9000 standards. The changes affected the requirements for Quality Management Systems - ISO 9001 . The new edition has the following number - ISO 9001:2008 .
Key changes:
Introduction (0)
Added that in addition to other factors, "Quality management system is influenced by the business environment, changes in the environment, or risks associated with that environment ..."
Region (1.1)
Added that the term "product" applies not only to intentionally to the products or product required by the customer but also to any deliberate processes of the result release. This extends the range and include, for example, purchased products, products at an intermediate stage of production, as well as products from the processes of outsourcing. "Legislative" requirements applicable to the product have been introduced in addition to the "regulatory" requirements (it is common to the entire document).
General requirements (4.1).
Clarified in Note 1: Note: 1. Processes needed for quality management system referred to above include processes of management, providing resources, products and measurement, analysis and improvement. The term "include" instead of "recommended" emphasizes the need to define processes for all of the controls.
General requirements (4.1). (Continued)
Explained that this process of outsourcing: Note 2. The process of outsourcing - a process necessary for quality management system, but transferred to an organization outside to run. Clarified that audsorsing is not an excuse to meet the requirements of the product, as are the factors that may influence the degree and type of management outsourcing: Note 3. The warranty process management outsourcing does not relieve the organization of the responsibility for compliance with all requirements of the customer, statutory and regulatory requirements. The type and degree of control required for outsourcing processes may depend on several factors: a) the potential impact of the outsourcing process for the organization's ability to supply conforming product, b) the extent to which management of the process is carried out jointly, c) the possibility of achieving the necessary control through the application of section 7.4 .
Operating environment (6.4)
The text is supplemented examples of your work environment, which may affect the conformity of the product. NOTE. The term "operating environment" refers to the conditions of the work, including physical factors, environmental factors and others (such as noise, temperature, humidity, lighting or weather).
Determination of requirements related to a product (7.2.1)
Examples are given of the possible requirements and contractual obligations related to the activity after delivery: NOTE. Activities include after delivery, for example, actions under warranty, contractual obligations such as maintenance, and additional services such as recycling or retirement.
Product design and development (7.3.3)
Explained to the output of design and development: NOTE. Information on production and service provision can include details on the conservation of the product.
Customer satisfaction (8.2.1)
Examples are given for monitoring customer satisfaction: NOTE. Monitoring of consumer perception can include obtaining information from sources such as surveys of satisfaction of consumers of the quality of data delivered product, polls opinions, analysis of lost business, thanks, complaints of warranty, dealers report.
Corrective / preventive actions (8.5.2f/8.5.3e)
Fixed a text for a clearer understanding of the requirements and compliance with ISO 14001: Instead of editorial "analysis of the corrective / preventive actions" specified "analysis of the impact of the corrective / preventive actions."
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8 Comments
Dear Dasha! And how about the full text of the new version of the standard? Can the English language.
SW. Victor! Original in Latin, translated into Russian. Any whim for your money. :-)
Tell me please how to sign up to download the ISO 9 001 -2 008?
a registration and does not work:)
Gagarin, everything works, no problem.
2Tatyana, check the right sidebar under Archives. The inscription "Enter".
Very soon I will make the full computation ISO 9001-2008 in English with Russian translation. The file will be available to all registered.
Cool:) You must use this message for personal gain. Simply a must!
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