ISO 9001 Training

Understanding ISO 9001:2008
Requirements for Quality Management Systems

5.4.1 Quality Objectives  

ISO 9001 Training - Key Explanation Points and Tips:

Clause 4.1e requires you to measure and analyze QMS processes and clause 7.1 requires objectives for product. Clause 4.2.1a requires you to document it. Clause 8.2.3 and 8.2.4 require you to monitor and measure and evaluate results to your planned objectives. This clause 5.4.1 sets out specific requirements for planning of quality objectives.

Top management must provide the leadership, organization and resources to deploy and achieve planned quality objectives.

From the previous clause 5.3 we learned that the quality policy must provide the framework for establishing quality objectives in order to be consistent with it and provided examples of such consistency. In this clause, top management must ensure that specific quality objectives are established.

Use quality objectives to measure the performance of products; processes; customer satisfaction; suppliers; use of resources; and the overall performance and effectiveness of the QMS. Quality objectives may be established for all QMS processes.

Examples of quality objectives:

Product - reduction in defect rates, PPM’s (defective parts per million), scrap rates, rework; improvement in on time delivery (see clause 7.1a).

Process - objectives generally focus on improving process productivity through the elimination or reduction of variation and waste in process - inputs, outputs, conversion activity and related use of resources. Objectives may be used to monitor and improve process - productivity; reduction of cycle time, errors, omissions and failures; etc.

Examples could include objectives for - set-up time; run rates; process cycle time; yield rates; etc.

Customers - reduction in # of complaints; improvement in customer satisfaction
rating; on time delivery; service; support, etc, (see clause 8.2).

Suppliers - material defects; on time delivery; # of complaints with supplier.

Resources - (includes facility; equipment; labor; etc.) - objectives could be established based on availability; capability; maintenance; personnel competency, absenteeism; production rates; efficiency; safety; etc.

For the QMS - customer satisfaction feedback; internal audit results; # of improvement opportunities; etc.

Remember the purpose of quality objectives is to determine conformity to (customer and regulatory) requirements, and effective deployment and improvement of the QMS

Quality objectives may be set at various functional levels of the organization - top management; departments; processes; functional groups; work cells; project teams; individuals; etc. It would be useful to cover these levels as they add value and contribute to customer or organizational objectives.

Employees at all of these levels must be made aware of the importance of and how they must contribute to the achievement of these objectives.

Quality objectives must be measurable. Measurement can be done quantitatively or qualitatively. Quantitative measures are generally more objective in determining whether conformity or effectiveness has been achieved. In some situations, the use of qualitative measurements may be appropriate. Objectives based on yes/no criteria, (e.g. - develop new product by March 2006), are also acceptable.

These quality objectives must be deployed and measured (see clause 8) and top management must conduct an effective review of the measurement results. These measurement results must also be used for corrective action and continual improvement. 

The quality objectives must be achieved within a defined time period to ensure accountability. This could be determined by your customer, your management, your head office, regulatory bodies, etc. Your business or quality planning process must establish these time periods and include the communication of objectives and timelines to those responsible for achieving them.

Quality objectives may be documented in any or all of these documents - your quality manual; QMS processes; procedures; quality plans; etc.

The establishment of quality objectives should be part of the business planning or QMS planning processes. A review of the quality objectivesshould be part of your management review process (see clause 5.6). As a quality document, your documented statement of objectives must be controlled by 4.2.3 control of documents.

You must be careful not to overwhelm your organization with too many objectives as this may cause more frustration than positive results. Start with objectives that focus on meeting customer requirements and then slowly develop meaningful objectives for key processes and risk prone processes, as initial targets are achieved.