ISO 9001:2009 – Clause 8 Changes

In previous newsletters, I have reviewed the proposed changes for clauses 4, 5, 6, and 7 of the draft ISO 9001:2009 standard. This month, we’ll look at the suggested changes for clause 8, Measurement, Analysis, and Improvement. Please note that only the new or changed sections are discussed below. Unaffected text has not been included.

8.2.1 Customer Satisfaction

As one of the measurements indicators of the performance of the quality management system, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. 

Monitoring customer satisfaction is viewed as more of an “indicator” of performance than the “measurement” of performance.

8.2.2 Internal Audit

A documented procedure shall be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results.

The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure. 

The requirement above has been edited to emphasize the need for a documented procedure (by placing it first in the sentence). Also, “establishing records” has been moved ahead of “reporting results” in the list of topics to be defined in the procedure. Records are being captured throughout the audit and should be listed before the reporting of results. The reference to 4.2.4 for record control was moved to the new text below.

Records of the audit and its results shall be maintained (see 4.2.4). 

The new text above highlights the need to maintain records of the audit and its results.

NOTE: See ISO 19011 ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance. 

The reference to the withdrawn ISO 10011, Guidelines for Auditing Quality Systems, has been replaced with a reference to ISO 19011, Guidelines for Quality and/or Environmental Management Systems Auditing.

8.2.3 Monitoring and Measurement of Processes

When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product

Clause 8.2.3 requires applying suitable methods for monitoring and measuring processes to demonstrate their ability to achieve planned results. For some supporting processes, these results are only indirectly related to product conformity. Therefore, the reference to product conformity has been moved to the new Note below.

NOTE: When determining suitable methods, the organization should consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system. 

What is a “suitable” method for monitoring and measuring processes? The Note above says to consider the type and extent of monitoring or measurement based on the impact of the process on product conformity and system effectiveness.

8.2.4 Monitoring and Measurement of Product

The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1). Evidence of conformity with the acceptance criteria shall be maintained. 

The requirement to maintain evidence of conformity with acceptance criteria has been moved from the paragraph below to the paragraph above.

Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product for delivery to the customer (see 4.2.4).

The release of product release and service delivery to the customer shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and, where applicable, by the customer. 

The requirement above has been edited slightly and clarifies that the release of product and service delivery is to the customer.

NOTE: Evidence of conformity with acceptance criteria can be a record or as otherwise specified in the planned arrangements. 

The Note above clarifies that evidence of conformity can be a record or as otherwise specified in the planned arrangements, e.g., test procedure. There must be proof that product test results indicate conformity with the acceptance criteria.

8.3 Control of Nonconforming Product

A documented procedure shall be established to define Tthe controls and related responsibilities and authorities for dealing with nonconforming product. shall be defined in a documented procedure. 

The sentence above has been edited to begin with (instead of end with) the requirement for a documented procedure.

Where practicable, the organization shall deal with nonconforming product by one or more of the following ways: 

The requirement now begins with “where practicable”, meaning where feasible or possible, deal with nonconforming product in one or more of the four ways listed.

d) when nonconforming product is detected after delivery or use has started, by taking action appropriate to the effects, or potential effects, of the nonconformity 

The new entry above in the list of ways to deal with nonconforming product is text that has been moved from the last sentence in clause 8.3 to become part of the list.

Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4). 

The deleted text above wasn’t actually deleted, it was just moved below the next sentence.

When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.

Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4).

When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity. 

This deleted text was moved to entry (d) in the list of ways to deal with nonconforming product.

8.5.2 Corrective Action

A documented procedure shall be established to define requirements for

f) reviewing the effectiveness of the corrective action taken. 

I’ve heard people complain that only “reviewing” a corrective action isn’t sufficient. You must instead verify that the action taken was effective in preventing recurrence of the detected nonconformity.

If these people had read the definition of “review” in the ISO 9000:2005 Fundamentals and Vocabulary, maybe they wouldn’t be as concerned.

ISO 9000:2005, 3.8.7, states that a review is the activity undertaken to determine the suitability, adequacy, and “effectiveness” of the subject matter to achieve the established objectives.

So, the proposed clarification shouldn’t be necessary, but if people are misinterpreting the word “review”, then adding “effectiveness” should help avoid any confusion.

8.5.3 Preventive Action

A documented procedure shall be established to define requirements for

e) reviewing the effectiveness of the preventive action taken. 

See the 8.5.2 explanation for the reason behind this 8.5.3 change. The additional 8.5.3 text should help clarify that the action taken must be effective in preventing the potential nonconformity.