Understanding ISO 9001:2008 Quality Management System

Understanding ISO 9001:2008 Quality Management System

Chapter 7

MEASUREMENT, ANALYSIS AND IMPROVEMENT

Author – K. R. Singhal

There are following clauses under this section:
8.1 – General
8.2 – Monitoring and measurement
8.3 – Control of nonconforming product
8.4 – Analysis of data
8.5 – Improvement

General
(Please refer to clause 8.1 of ISO 9001:2008)

The organization must plan and implement the monitoring, measurement, analysis and improvement processes needed for the following:
to demonstrate conformity to product requirements,
to ensure conformity of the quality management system, and
to continually improve the effectiveness of the quality management system.

The organization must determine applicable methods (including statistical techniques) and extent of their use.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in the requirement, however there is editorial change in the wordings. As per ISO 9001:2008, monitoring, measurement, analysis and improvement processes needed ‘to demonstrate conformity to product requirements’, instead of ‘to demonstrate conformity of the product’ (as mentioned in ISO 9001:2000 QMS Standard).


Monitoring and measurement
(Please refer to clause 8.2 of ISO 9001:2008)

There are following clauses under this clause:
8.2.1 – Customer satisfaction
8.2.2 – Internal audit
8.2.3 – Monitoring and measurement of processes
8.2.4 – Monitoring and measurement of product

Customer satisfaction
(Please refer to clause 8.2.1 of ISO 9001:2008)

The organization must monitor information relating to customer perception to know whether the organization has met customer requirements. The organization must determine methods for obtaining and using information relating to customer satisfaction. This monitoring must be done by the organization as one of the measurements of the performance of organization’s quality management system.

Note at the end of this clause clarifies that monitoring customer satisfaction can include obtaining inputs from various sources, such as:
customer satisfaction surveys,
customer data on delivered product quality,
user opinion surveys,
lost business analysis,
compliments,
warranty claims, and
dealer reports.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that in sub-clause 8.2.1 (Customer satisfaction), a note has been added that monitoring customer perception may include 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.


Internal audit
(Please refer to clause 8.2.2 of ISO 9001:2008)

The organization must conduct internal audits at planned intervals. Conducting internal audits must be done to determine whether the quality management system of the organization:
conforms to the planned arrangements,
conforms to the requirements of ISO 9001:2008 Standard,
conforms to the quality management system requirements established by the organization, and
is effectively implemented and maintained.

The organization must plan an audit programme by considering the status and importance of the processes, areas to be audited and results of previous audits. The organization must define audit criteria, scope, frequency and methods of internal audit. The organization must ensure objectivity and impartiality of the audit process in selecting internal auditors and conducting internal audits. Auditors must not audit their own work.

The organization must establish a documented procedure to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results.

The organization must maintain records of the audits and their results.

The management (of the area or department being audited) must ensure that any necessary corrections and corrective actions are taken promptly (without undue delay) to eliminate detected nonconformities and their causes.

The organization must carry out follow-up activities including verification of the actions taken and the reporting of verification results.

Note at the end of this clause states to refer to ISO 19011 for guidance.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that the requirements of this clause reworded to give more clarity. The requirements in ISO 9001:2008 is very clear that a documented procedure must be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results. It also requires that records of the audits and their results must be maintained. In Para 4 of sub-clause 8.2.2 of ISO 9001:2000 QMS Standard, before the word ‘actions’ phrase ‘any necessary corrections and corrective’ has been added in ISO 9001:2008 to give more clarity .A note at the end of sub clause 8.2.2 now refers to ISO 19011 for guidance in ISO 9001:2008, instead of ISO 10011-1, ISO 10011-2 and ISO 10011-3 as mentioned in ISO 9001:2000 QMS Standard.


Monitoring and measurement of processes
(Please refer to clause 8.2.3 of ISO 9001:2008)

The organization must apply:
suitable methods for monitoring of the quality management system processes, and
where applicable, measurement of quality management system processes.

Such suitable methods must demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, the organization must take correction and corrective action, as appropriate.

Note at the end of this clause suggests that organization should consider the type and extent of monitoring or measurement appropriate to each of its processes, when determining suitable methods, in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that in sub-clause 8.2.3 the phrase ‘to ensure conformity of the product’ has been removed as was mentioned in ISO 9001:2000. A note added at the end of sub-clause 8.2.3 now clarifies that when deciding on appropriate 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 effectiveness of the quality management system.


Monitoring and measurement of product
(Please refer to clause 8.2.4 of ISO 9001:2008)

The organization must monitor and measure the characteristics of the product to verify that product requirements have been met. This must be carried out at appropriate stages of the product realization process in accordance with the planned arrangement. The organization must maintain evidence of conformity with the accepted criteria.

The organization must maintain records indicating the person(s) authorizing release of product for delivery to the customer.

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

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there are editorial changes, some additions and deletions. Requirement to maintain evidence of conformity with the accepted criteria is in Para 2 of ISO 9001:2000 QMS Standard, and this requirement has been deleted from this Para and added to Para 1 of this sub-clause in ISO 9001:2008. In Para 2 of this sub-clause in ISO 9001:2000 requires records to indicate the person(s) authorizing release of product, and this has been made more specific now in ISO 9001:2008 and records must indicate the person(s) authorizing release of product for delivery to the customer. The phrase ‘Product release and service delivery’ in Para 3 of this sub-clause (as mentioned in ISO 9001:2000 QMS Standard) has been substituted by the phrase ‘The release of product and delivery of service to the customer’ (in ISO 9001:2008).


Control of nonconforming product
(Please refer to clause 8.3 of ISO 9001:2008)

The organization must ensure that nonconforming product (the product which does not conform to product requirements) is identified and controlled to prevent its unintended use or delivery. The organization must establish a documented procedure to define the controls and related responsibilities and authorities for dealing with nonconforming product.

Where applicable, the organization must deal with nonconforming product by one or more of the following ways:
by taking action to eliminate the detected nonconformity,
by authorizing its use, release or acceptance under concession by relevant authority and, where applicable, by the customer,
by taking action to preclude its original intended use or application,
by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.

When organization carries out correction in nonconforming product, such correction must be subject to re-verification to demonstrate conformity to the requirements.

The organization must main records of the nature of nonconformities and any subsequent actions taken, including concessions obtained.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that Para 1 of this clause has been reframed to provide more clarity. The term ‘where applicable’ is added in the beginning in Para 2 of this clause. The requirements of Para 3 and Para 4 of this clause (in ISO 9001:2000 QMS Standard) have been interchanged as Para 4 and Para 3 in ISO 9001:2008 without any change in wordings. The requirement mentioned in Para 5 of this clause (mentioned in ISO 9001:2000 QMS Standard) has been shifted in Para 3 Bullet d) with appropriate reframing of wordings (in ISO 9001:2008).

Analysis of data
(Please refer to clause 8.4 of ISO 9001:2008)

The organization must determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This must include data generated as a result of monitoring and measurement and from other relevant sources.

The analysis of data must provide information relating to:
customer satisfaction,
conformity to product requirements,
characteristics and trends of processes and products, including opportunities for preventive action, and
suppliers.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in the requirement of this clause, however, reference to clause has been changed or added. In clause 8.4 (b), reference to ‘(see 8.2.4)’ has been mentioned in ISO 9001:2008 instead of ‘(see 7.2.1)’ as mentioned in ISO 9001:2000 QMS Standard. In clause 8.4 (c), after ‘… preventive action’ the words ‘(see 8.2.3 and 8.2.4)’ have been added. In clause 8.4 (d), after suppliers the words ‘(see 7.4)’ added.

Improvement
(Please refer to clause 8.5 of ISO 9001:2008)

There are following clauses under this clause:
8.5.1 – Continual improvement
8.5.2 – Corrective action
8.5.3 – Preventive action

Continual improvement
(Please refer to clause 8.5.1 of ISO 9001:2008)

The organization must continually improve the effectiveness of the organization’s quality management system. This must be done through the use of the following:
quality policy,
quality objectives,
audit results,
analysis of data,
corrective action,
preventive action, and
management review.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in the requirement of sub-clause 8.5.1 (Continual improvement).

Corrective action
(Please refer to clause 8.5.2 of ISO 9001:2008)

The organization must take corrective action, appropriate to the effects of the nonconformities encountered, to eliminate the causes of nonconformities in order to prevent recurrence.

The organization must establish a documented procedure that defines requirements for the following:
reviewing nonconformities,
determining the causes of nonconformities,
evaluating the need for action to ensure that nonconformities do not recur,
determining and implementing action needed,
records of the results of action taken, and
reviewing the effectiveness of the corrective action taken.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in requirements, however in sub-clause 8.5.2 (Corrective action), there are editorial changes in the wordings of the requirements to give more clarity of meaning. The word ‘cause’ (as mentioned in Para 1 of sub-clause 8.5.2 in ISO 9001:2000 QMS Standard) has been substituted by the word ‘causes’ (in ISO 9001:2008). Instead of ‘reviewing the corrective action taken’ (as mentioned in ISO 9001:2000 QMS Standard), now it is mentioned ‘reviewing the effectiveness of the corrective action taken’ (in ISO 9001:2008).

Preventive action
(Please refer to clause 8.5.3 of ISO 9001:2008)

The organization must determine preventive action, appropriate to the effects of the potential problems, to eliminate the causes of potential nonconformities in order to prevent their occurrence.

The organization must establish a documented procedure to define requirements for:
determining potential nonconformities and their causes,
evaluating the need for action to prevent occurrence of nonconformities,
determining and implementing action needed,
records of the results of action taken, and
reviewing the effectiveness of the preventive action taken.

If we compare ISO 9001:2000 (old version) and ISO 9001:2008 (new version), we observe that there is no change in requirements, however in sub-clause 8.5.3 (Preventive action), there are editorial changes in the wordings of the requirements to give more clarity of meaning. Instead of ‘reviewing the preventive action taken’ (as mentioned in ISO 9001:2000 QMS Standard), now it is mentioned ‘reviewing the effectiveness of the preventive action taken’ (in ISO 9001:2008).


Questions

What are the key changes in clause 8.1 (measurement, analysis and improvement – General) in ISO 9001?
What are the key changes in clause 8.2.1 (Customer satisfaction) in ISO 9001?
What are the key changes in clause 8.2.2 (Internal Audit) in ISO 9001?
What are the key changes in clause 8.2.3 (Monitoring and measurement of processes) in ISO 9001?
What are the key changes in clause 8.2.4 (Monitoring and measurement of product) in ISO 9001?
What are the key changes in clause 8.3 (Control of nonconforming product) in ISO 9001?
What are the key changes in clause 8.4 (Analysis of data) in ISO 9001?
What are the key changes in clause 8.5 (Improvement) in ISO 9001?

Note from the author

The author of this literature has used his skills and knowledge to his best capacity to provide relevant and the latest information. Utmost care has been taken to ensure correctness and accuracy of the contents. However, omissions and errors, if any, in this literature are regretted. Reader’s suggestion for improvement is welcomed. Readers are requested to send their frank opinion, comment, criticism and assessment of this literature.

The purpose of this literature is to create awareness. Standard document ISO 9001:2008 may be obtained from International Organization for Standardization (ISO) or any member organization of ISO. Readers are advised to have ISO 9001:2008 for reference purpose.