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1)  All our materials are 100% compliant with the latest revision of the ISO 9001 standard (ISO 9001:2008).
2)  All our materials are 100% applicable to all countries worldwide.

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Revision of ISO 9001

The ISO 9001 family of standards is revised by its publisher (the International Organization for Standardization "ISO") approximately every 7 years.  The current revision is called ISO 9001:2008; it was published on November 14, 2008 (the ":2008" indicates the year of revision).  Important implications are:

• ISO 9001:2008 supersedes ISO 9001:2000.

• Old ISO 9001:2000 certifications became invalid as of November 13, 2010.

• Only ISO 9001:2008 certifications are being issued.

• Companies that have an ISO 9001:2000 quality management system can upgrade to ISO 9001:2008 after a successful re-certification.

• ISO 9001 will not be revised until the year 2015 or later.

Fully ISO 9001:2008 Compliant All our templates, forms and guides have been reviewed and revised to ensure that they are fully ISO 9001:2008 compliant.  All our materials not only meet all requirements of the ISO 9001-2008 but they also integrate the new and simplified wording.   Upgrade to ISO 9001:2008 If your company has an older ISO 9001:2000 quality system and you are not satisfied with it, why not take ISO 9001:2008 as an opportunity to implement a non-bureaucratic, no-nonsense ISO 9001:2008 quality system that really adds value to your business?    Our Streamlining Manual would be the ideal solution!

What has changed in ISO 9001:2008?

ISO 9001:2008 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.