Do You Agree With These Interpretations?

What is your opinion on how to interpret these new requirements?

  • Are you now required to re-evaluate controlled documents on a periodic basis?
  • Will compliance require more than analyzing complaints to judge customer satisfaction?
  • Will the quality manual need to address every requirement in the standard?
  • Is equipment maintenance no longer a specific requirement?
  • Are you no longer required to evaluate the effectiveness of corrective actions?

Clause 4.2.3 (b) on Reevaluating Documents

Did you notice that clause 4.2.3 (b) states “to review and update as necessary and re-approve documents.” In ISO 9001:1994, clause 4.5.3 called for the review and approval of document changes. If a document is to be changed, both standards require it to be reviewed and approved.

However, according to ISO 9001:2000, documents must be reviewed (and updated as necessary). Therefore, in some cases, they may not need updating because they are still valid and current.

Many organizations review all their documents on a periodic basis to ensure none of them have become obsolete or need to be updated. They limit this effort by only reviewing the documents that have not been revised since the last review.

The new wording seems to imply all controlled documents must be reviewed, and updated as necessary, independent of specific change activity. What is your opinion?

Clause 8.2.1 on Customer Satisfaction

Will tracking only customer complaints satisfy the new requirement on customer satisfaction? Clause 8.2.1 states to “monitor information relating to customer perception as to whether the organization has met customer requirements.”

What is meant by customer perception? Could it involve directly asking the customer how well you are meeting their requirements? Could it mean to establish customer communication on the subject? Clause 7.2.3 requires “communicating with customers in relation to (c) customer feedback, including customer complaints.” So, feedback is expected to be more than just complaints.

The definition of customer satisfaction in ISO 9000:2000 sheds more light on the subject. Customer satisfaction is defined as the “customer’s perception of the degree to which the customer’s requirements have been fulfilled.” It doesn’t say the organization’s perception; it says the customer’s perception.

In addition, Note 1 states “customer complaints are a common indicator of low customer satisfaction, but their absence does not necessarily imply high customer satisfaction.” Note 2 states “even when customer requirements have been agreed with the customer and fulfilled, this does not necessarily ensure high customer satisfaction.”

If you agree that complaints alone may not satisfy the customer satisfaction requirement, what would? Asking for feedback through surveys would give direct information on how well customers perceive your product or service. The survey information could be gathered by an independent firm, solicited by your own sales organization, or collected by forms distributed with your offering.

Complaints are an important indicator and should not be overlooked. This information, along with other feedback, such as product returns and customer scorecards, can provide an early warning between your periodic monitoring of customer satisfaction. See the article on Monitoring Information on Customer Satisfaction in this newsletter.

Clause 4.2.2 on Quality Manual

Clause 4.2.1 of ISO 9001:1994 stated the quality manual must address all requirements of the standard. Although some registrars may have viewed the manual and its referenced procedures as the quality system definition, most registrars expected the quality manual to express the policy for each “shall” statement in the standard.

Clause 4.2.2 of ISO 9001:2000 covers quality manual requirements, but does not state explicitly that the document must address all requirements. However, it does say that any exclusions must be detailed and justified in the quality manual. This could be viewed as requiring all requirements to be addressed, otherwise the omitted requirements would appear to be exclusions without documented justification.

Our conclusion is that the quality manual should fully address the requirements of the standard to be a complete policy document for your quality management system.

Clause 7.5.1 (c) on Suitable Equipment

Clause 4.9 (b) in ISO 9001:1994 required the use of suitable equipment. This requirement is carried forward as clause 7.5.1 (c) of the new standard.

Clause 4.9 (g) of ISO 9001:1994 required equipment maintenance to ensure continued process capability. Although clause 7.5.1 (c) in the DIS version of ISO 9001:2000 required the “use and maintenance of suitable equipment”, that clause in the recently published standard omitted the reference to “maintenance” of the equipment.

Does this mean equipment maintenance is no longer a requirement? Well, clause 6.3 states the organization must “determine, provide, and maintain the infrastructure”, which according to subclause (b) includes “process equipment”.

Clause 8.5.2 on Corrective Action

Some auditors have expressed a concern that Clause 8.5.2 (f) only requires the “reviewing of corrective action taken”. They point out clause 4.14.2 (d) of ISO 9001:1994 required “application of controls to ensure that corrective action is taken and that it is effective”. Well, rest assured that corrective action must still be effective. The definition of “review” in ISO 9000:2000 is the “activity undertaken to determine the suitability, adequacy, and effectiveness of the subject matter to achieve established objectives.”

Do you agree with these interpretations? Are you unsure of other requirements? Send us an email note with your reactions and questions. We will include the most frequent comments and requests in our next e-newsletter.