ISO 9000-2008

  ISO 9000 has been revised in November 2008.  The name of the newest revision is ISO 9000-2008; it supersedes ISO 9001-2000 which is now being phased out.

Here we answer your questions:

- How does the 2008 revision affect me?

- What are the changes in ISO 9000-2008?

 

 

     ISO 9000 Certification Issues

 
  • Old ISO 9000:2000 certifications became invalid as of November 13, 2010.

  • Only ISO 9000:2008 certifications are now being issued.

  • 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.

     

 


ISO 9001:2008 Certificates

Companies currently certified to ISO 9001:2000 will receive a new ISO 9001:2008 certificate after they successfully pass a surveillance or re-certification audit.

 

     ISO 9000 Documentation Issues

 
  • If you are certified to ISO 9000:2000, you are not required to change your documentation.  However, you may want to consider an update based on ISO 9000's requirement for continuous improvement.  There is one provider who offers the so-called "Streamlining Manual" which is a template designed to improve any existing ISO 9000 system (see www.9001simplified.com for details)

  • If you are currently in the process of implementing ISO 9000 and you are using older ISO 9000-2000 templates, we suggest you contact your template provider for an update.

  • If you haven't decided on templates for your ISO 9000 documentation, you may want to consider a template supplier that offers not only ISO 9000-2008 compliance but also incorporates the new and simplified language of ISO 9000-2008 and the latest interpretations.  We are listing the best in our Resources

 

 

 

     The Details - Changes in ISO 9000-2008

 


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.