Continual Improvement Using ISO 9001

Improvement loop advances quality but needs more work

by Sandford Liebesman

One of the key additions to ISO 9001:2000 is a subclause 8.5.1 requirement for continual improvement. This requirement is a definite advance over ISO 9001:1994, which relied only on corrective and preventive action to improve the quality management system (QMS).

Subclause 8.5.1 requires the organization to "continually improve the effectiveness of the QMS through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review." If fully implemented, this plan-do-check-act cycle should result in iteration after iteration of improvement. First, let's look at each of the elements of this improvement loop.

Policy and objectives

Top management must ensure the quality policy (subclause 5.3) "provides a framework for establishing and reviewing quality objectives." Thus the policy must be translatable into measurable objectives (subclause 5.4.1) that include the ones needed to meet product requirements while being consistent with the quality policy. Top management's goals must be put into practice using measurable objectives to stimulate improvement.

Audit results

The next element in the improvement loop is the "results of audits" step performed by the organization. This element includes internal audits defined in subclause 8.2.2, peer audits, second- and third-party audits and other audits performed by the organization. Audit results provide one tool for understanding the status of the QMS. The other key tool is the analysis of data.

Data analysis

Subclause 8.4 requires the organization to "determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the QMS." The data must also be used to evaluate where the effectiveness of the QMS can be improved.

The analysis must "provide information relating to customer satisfaction, conformity to product requirements ... and suppliers." The information must also relate to "characteristics and trends of processes and products" and should result in "opportunities for prevention action."

Note this requirement identifies the need to translate data into information, which leads to preventive action improvement opportunities.

Preventive and corrective actions

Preventive actions (subclause 8.5.3) are aimed at eliminating the cause of potential nonconformities. The information from the data analysis should result in identification of potential root causes of future problems. Corrective action (subclause 8.5.2), on the other hand, uses information to eliminate causes of identified actual nonconformities and prevent their recurrence.

Both actions are key to continual improvement in the organization, but may result only in local, not global, changes. Top management should make the improvements global during the management review process.

Management review

Management review (subclause 5.6) is where the elements of the improvement process are brought together. The review is aimed at ensuring "continuing suitability, adequacy and effectiveness" of the QMS. It should result in opportunities for improvement and may lead to changes in the QMS, including the quality policy and objectives.

Inputs to management review include audit results and the status of preventive and corrective actions. Other required inputs are information on customer feedback, process performance and product conformity, previous management review follow-up actions, changes to the QMS and recommendations for improvement.

Mandatory outputs of the review are decisions and actions that should result in improvements in the effectiveness of the QMS, its processes and the organization's products. Management review is therefore the tool to assure improvement across the entire organization. The results of management review should start the next iteration of the improvement loop.

Ancillary requirements

Other requirements that play an important role in effective continual improvement include planning, communication, and monitoring and measurement activities. Without fulfillment of these requirements, the effectiveness of the improvement process may be less than desired.

Planning requirements. Subclause 5.4.2 requires top management to ensure planning is carried out to meet the requirements in subclause 4.1, which includes continually improving the effectiveness of the QMS. Planning should be aimed at ensuring effective operation and control of the organization's processes.

Communication. Requirements for top management and the management representative to communicate the status and importance of continual improvement are included in subclauses 5.1, 5.5.2 and 5.5.3.

In subclauses 5.1 and 5.5.3, top management must communicate its commitment to continually improve the effectiveness of the QMS. The requirement in subclause 5.5.2 is for the management representative to report the performance of the QMS to top management and identify the need for improvement.

Monitoring and measurement. The analysis of data is one of the elements of the improvement loop. Where should the data come from? Subclause 8.1 requires the organization to "plan and implement measurement, analysis and improvement processes ... to continually improve the effectiveness of the QMS." Subclauses 8.2.1, 8.2.3 and 8.2.4 require monitoring and measurement of customer satisfaction data, processes of the QMS and the organization's products.

Improvement loop problems

Although the improvement loop is itself an improvement, there are three problems with it as defined in ISO 9001:2000:

1. No process is required. Subclause 8.5.1 states "the organization shall continually improve the effectiveness of the QMS." As an auditor I ask, how is this done without a process to specify the methodology?

2. Specifying "the organization" as responsible for the improvement loop is a vague statement ignoring the real responsibility for improvement that lies with top management. I contend the improvement loop belongs in clause 5, close to the management review process.

3. How do you measure improvement in the effectiveness of the QMS? Effectiveness is defined in ISO 9000:2000 as the "extent to which planned activities are realized and planned results achieved." Without a requirement for a process and associated ownership of it, the measurements may be inconsistent and possibly even meaningless.

The telecommunications industry recognized the need to formalize the improvement loop. The latest version of its standard, TL 9000, includes a requirement to "establish and maintain a documented quality improvement program." But the TL 9000 handbook does not identify top management as being responsible for the program.¹

Finally, it is difficult to audit the requirements of subclause 8.5.1 if an organization has not developed a process and identified responsibilities. The results under these circumstances will certainly be inconsistent from organization to organization.

Revision suggestion

ISO Technical Committee 176 is starting the process of revising the ISO 9000 family of standards. I think the committee should rethink the improvement process to make it more consistent and effective.

Subclause 8.5.1 should be moved to clause 5 and should be a management responsibility. Top management should understand how the improvement loop is working. The management representative could be responsible for its effective operation. The current requirement to communicate the status of the QMS and the need for improvement would provide the direct link to top management.

REFERENCE

1. TL 9000 Quality Management System Requirements, release 3.0, QuEST Forum/ASQ Quality Press, 2000.

SANDFORD LIEBESMAN, a standards consultant and auditor, is former ISO manager for corporate quality and customer satisfaction at Lucent Technologies. He is a member of ISO Technical Committee 176 and the QuEST Forum. Liebesman is also a Registrar Accreditation Board certified lead auditor, a certified TL 9000 lead auditor, author of Using ISO 9000 To Improve Business Processes and co-author of the ASQ Quality Press book TL 9000: A Guide for Measuring Excellence in Telecommunications.