Section 1.1 General
• Again, “regulatory” has been changed to “statutory and regulatory.” a) Needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and b) Aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. • Note 1 has been expanded, and a Note 2 has been added:
Note 1 in this International Standard, the term “product” only applies to a) product intended for, or required by, a customer,
b) Any intended output resulting from the product realization process. Note 2 Statutory and regulatory requirements can be expressed as legal requirements. Section 1.2 Applications
• Again, “regulatory” has been changed to “statutory and regulatory.” Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within Clause 7, and such exclusions do not affect the organization’s ability, or responsibility to provide product that meets customer and applicable statutory and regulatory requirements. Section 2 Normative References
• ISO 9000:2000 has been changed to ISO 9000:2005, Quality Management Systems – Fundamentals and vocabulary. Section 3 Terms and Definitions
• Explanation of the terms “supplier” and “organization” have been deleted. Section 4.1 General Requirements
• In 4.1a, the word “identify” has been replaced with “determine.” a) Determine the processes needed for the quality management system and their application throughout the organization (see 1.2), • In 4.1e, “where applicable” has been added.
e) Monitor, measure (where applicable), and analyse these processes, and… What does this mean to you? It may not be possible or make sound business sense to measure all processes. The outputs of some processes, especially support processes, may best be measured in a downstream process. However, all processes still need to be monitored. • Also, in clause 4.1, controls over outsourced processes now must be defined and not simply identified: Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system. What does this mean to you? Somewhere in the management system, e.g. part of your documentation, these controls shall be defined. • There are now three notes. In Note 1, there has been an addition of “analysis and improvement,” and the word “should” has been deleted, making it mandatory for all of these types of processes to be included. Noted 2 and 3 are new. Note 1: Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization and measurement, analysis and improvement. Note 2: An “outsourced process” is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party. Note 3: Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as a) The potential impact of the outsourced process on the organization’s capability to provide product that conforms to requirements, b) The degree to which the control for the process is shared, c) The capability of achieving the necessary control through the application of 7.4. What does this mean to you? An outsourced process needs to be treated as any other purchased commodity and subjected to the...