Revision of ISO 9000
ISO 9000 is revised by its publisher (the International Organization for Standardization "ISO") approximately every 7 years. The newest revision is called ISO 9000:2008; it was published on November 14, 2008 (the ":2008" indicates the year of revision). Important implications are:
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ISO 9000:2008 supersedes ISO 9000:2000.
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Old ISO 9000:2000 certifications remain valid up to November 13, 2010.
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New ISO 9000:2008 certifications are now being issued.
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Companies currently certified to ISO 9000:2000 can change their certification to the new ISO 9000:2008 after a successful re-certification or surveillance audit.
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ISO 9000:2008 is not expected to be revised again before the year 2015.
Note: For practical purposes, "ISO 9000" and "ISO 9001" mean the same.
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What is new in ISO 9000:2008?
ISO 9000:2008 is not a major revision. However, the requirements of the standard are clearer now and the wording has been simplified. The important changes are:
Clause 1.1 (Scope - General)
• Clarification: product also includes intermediate product – not only product intended for customer.
• Change of wording: “regulatory requirements” have been changed to “statutory and regulatory
requirements”.
• Explanation: “statutory and regulatory requirements” can also be called “legal requirements”.
Clause 4.1 (General Requirements)
• Clarification: Processes are monitored, but may not need to be measured.
• Clarification: If the company outsources a process, the company is still responsible to ensure that both
customer and legal requirements are met.
• Change of wording: “determine the processes” instead of “identify the processes”.
Clause 4.2.1 (Documentation Requirements - General)
• Clarification: Quality management system documentation also includes records.
• Clarification: One document may include the requirements of one or more procedures; the requirements of
one procedure may be covered by more than one document.
• Change of wording: Sub-clauses c), d) and e) have been restructured.
Clause 4.2.3 (Control of Documents)
• Clarification: Not all external documents have to be identified and controlled; only those needed for the
planning and operation of the quality management system.
Clause 4.2.4 (Control of Records)
• Change of wording: Records being "maintained" changed to having them "controlled".
• Explanation: Maintaining records would simply keep them in good condition. Controlling the records
means to regulate their use.
Clause 5.5.2 (Management Representative)
• Clarification: The Management Representative must be a member of the company’s own management.
• Explanation: The Management Representative position cannot be outsourced to an external consultant.
Clause 6.2.1 (Human Resources - General)
• Change of wording: Work affecting "product quality" changed to work affecting "conformity to product
requirements".
• Explanation: This is not a new requirement. Anyone performing, verifying, or managing work within the
scope of the quality management system, including supporting services, can affect conformity to product
requirements. A new note has been added to 6.2.1 to explain this point.
Clause 6.2.2 (Competence, Training, and Awareness)
• Change of wording: The title has been changed from “Competence, Awareness, and Training“ to
“Competence, Training, and Awareness”.
• Change of wording: Added "where applicable" in reference to provide training or provide other actions.
• Explanation: Training or other actions may not be necessary, since individuals may already have the
necessary competence.
Clause 6.3 (Infrastructure)
• Change of wording: Add "information systems" as an example of a supporting service.
Clause 6.4 (Work Environment)
• Explanation: A note has been added to clarify the term work environment as relating “to those conditions
under which work is performed including physical, environmental, and other factors (such as noise,
temperature, humidity, lighting, or weather).”
Clause 7.1 (Planning of Product Realization)
• Change of wording: Addition of "measurement" as one of the required activities to be determined during the
planning of product realization.
Clause 7.2.1 (Determination of Requirements Related to the Product)
• Clarification: Post delivery activities include, for example, actions under warranty provisions, contractual
obligations such as maintenance services, and supplementary services such as recycling or final
disposal.
• Change of wording: Requirements “related” to the products are now requirements “applicable” to the
product.
• Explanation: The change from "related" to "applicable" shifts from determining legal requirements that are
merely associated with the product to those that are relevant and can be applied to the product.
Clause 7.3.1 (Design and Development Planning)
• Clarification: Although review, verification, and validation have distinct goals, they can be carried out and
recorded separately or in any combination.
Clause 7.3.3 (Design and Development Outputs)
• Clarification: Additional reminder to indicate that the design output should consider product preservation,
e.g., product packaging.
• Change of wording: The outputs of design and development shall be in a form “that enables verification”
changed to “suitable for verification”.
Clause 7.5.2 (Validation of Processes for Production and Service Provision)
• Clarification: Any process output that can't be verified may result in deficiencies becoming known only after
the product is in use or the service has been delivered.
Clause 7.5.3 (Identification and Traceability)
• Clarification: Identifying the product monitoring and measurement status applies throughout product
realization, from received product to final product, including in-process product – not merely to the final
product.
Clause 7.5.4 (Customer Property)
• Change of wording: “Personal data" is now included as an example of customer property.
• Explanation: Including the example of “personal data” reminds us of the applicability to a wide spectrum of
companies, especially service companies.
Clause 7.5.5 (Preservation of Product)
• Change of wording: “As applicable” added to “preservation shall include…”
• Explanation: It is now clear that “preservation” may not necessarily include all of “the identification,
handling, packaging, storage, and protection” of the product.
Clause 7.6 (Control of Monitoring and Measuring Equipment)
• Clarification: A note was added so that software development companies may now find it easier to
understand that confirmation of software would typically include verification and configuration management.
• Change of wording: The title has been changed from “Control of Monitoring and Measuring Devices” to
“Control of Monitoring and Measuring Equipment”.
• Change of wording: "calibrated or verified" changed to "calibrated or verified, or both”.
Clause 8.2.1 (Customer Satisfaction)
• Clarification: Some examples now make it easier to find methods of monitoring customer perception. The
examples are: “obtaining input from sources such as customer satisfaction surveys, customer data on
delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims,
dealer reports.”
Clause 8.2.2 (Internal Audit)
• Clarification: Now clearer that both a documented procedure and records are required.
• Change of wording: "Actions" changed to "any necessary corrections and corrective actions".
• Explanation: Expanding from "actions" to "any necessary corrections and corrective actions" serves as a
reminder that an immediate correction might be needed before determining the cause of the nonconformity
and taking corrective action to prevent its recurrence.
Clause 8.2.3 (Monitoring and Measurement of Processes)
• Clarification: A note was added to clarify that when defining a "suitable" method for monitoring and
measuring processes the company should consider the impact on the conformity to product requirements
and on the effectiveness of the quality management system.
Clause 8.2.4 (Monitoring and Measurement of Product)
Clarification: The release of the product relates to the delivery to the customer.
Clause 8.3 (Control of Nonconforming Product)
• Clarification: Now clearer that a documented procedure is required.
• Change of wording: “Where practicable” changed to “where applicable”.
Clause 8.4 (Analysis of Data)
• Change of wording: Revision of a reference from 7.2.1 to 8.2.4 and addition of new references (8.2.3, 8.2.4,
and 7.4).
Clause 8.5.2 (Corrective Action)
• Change of wording: Added “effectiveness” to “reviewing the effectiveness of the corrective action taken”.
• Explanation: It is now clearer that the requirement for review means to determine if the action was effective
– not merely if the action was taken.
Clause 8.5.3 (Preventive Action)
• Change of wording: Added “effectiveness” to “reviewing the effectiveness of the preventive action taken”.
• Explanation: It is now clearer that the requirement for review means to determine if the action was effective
– not merely if the action was taken.
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