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ISO 9001 Quality Objectives

What is the purpose of quality objectives?

The purpose of quality objectives is to determine conformity to (customer and regulatory) requirements, and facilitate the effective deployment and improvement of the quality management system (QMS).  

What are the specific requirements in ISO 9001 for quality objectives?
The requirements (clause 5.4.1) for quality objectives are:

Establish quality objectives at relevant functions and levels
Include objectives to meet product requirements
Quality objectives must be measurable
Keep these quality objectives consistent with the quality policy
Make all personnel aware of the importance of the objectives and how they
  can help to achieve them (clause 6.2.2d).

Where should quality objectives originate from?

Quality objectives must orginate from the organization’s quality policy. Developing a QMS must be a strategic business decision and therefore top management must provide the necessary direction and leadership, starting with establishing the quality policy and objectives.

Your quality policy provides top management’s vision on quality management for the organization. It provides the organization with focused direction, i.e. high level goals and objectives for quality management.

Besides your own organization, requirements for quality policies and objectives (e.g., for product as well as product realization processes) may also come from the customer, regulatory bodies and industry standards or codes.

Your quality policy and objectives must be consistent with the scope of your QMS and must complement other business objectives of your organization such as those related to growth, finance, profitability, the environment and occupational health and safety. Aggressive sales or marketing strategies must not be at the expense of quality management.

The goal of an organization should be to integrate the various management systems (including quality management) used to achieve its strategic business goals and objectives. It is unfortunate that many organizations choose to dis-associate quality management from operational management.

What are these other strategic business goals and objectives?

Top management must integrate and keep quality management policies and objectives consistent with strategies, policies and objectives for other business, areas such as:

· Markets: share and growth, customer base and diversification, competitor information, pricing, sales, etc.

Organization: size, structure, responsibilities and accountability, etc.

Product: quality, performance, reliability, maintainability, design technology and innovation, demand, mix, packaging, pricing, warranty, support, etc.

Processes: facility, capability, capacity, technology, reliability, quality

Supplier management: quality, delivery, price, consistency, flexibility

Workforce: labor availability, competence, mix, utilization, compensation, health and safety, etc.

Capital: sourcing, availability, cost, prioritization of use, return, etc.

· Other: environment, regulatory issues, governmental policies, communications, etc.

What should an organization state in its Quality Policy?

Clause 4.1.a - requires that you document your quality policy and clause 5.3.c requires that you specify your commitment to ‘meet requirements’ and ‘continually improve the effectiveness of your QMS’. Clause 1 specifies requirements for the scope of your QMS. Therefore, it would be logical and useful to use the wording in clause 1 to define your quality policy?

The wording of the quality policy should preferably specify what requirements are being complied with (e.g., customer, regulatory, ISO 9001, etc.). It must also clearly state your commitment to continually improve the effectiveness of the QMS.

Beyond that, you may state other complementary and important policies (business growth; product or manufacturing technology; workforce competence; business flexibility, etc.)

How do quality objectives flow from the Quality Policy?

What you state in your quality policy, must lead to establishing quality objectives, e.g. if you state in your quality policy that you will “meet customer requirements”, then from this, you might derive customer focused objectives for - product defects; customer complaints and returns; on time delivery, etc.

Similarly, for the phrase -“meet ISO 9001 requirements”; from this you might derive process objectives for effectively using ISO 9001 requirements to manage and control your QMS processes to achieve conformity to the standard.

Stating that you will “continually improve the effectiveness of your QMS” in your quality policy - can lead to a number of objectives, as your QMS is comprised of many processes each with related risks; so it is possible to have one or more improvement objectives for each process.

Thus, we can see that each statement in your quality policy may result in one or more quality objectives. These quality objectives do not need to be stated in your quality policy, but top management must clearly be involved in providing direction, establishing and reviewing these objectives.

Who should be involved in setting quality objectives?
Top management must provide the leadership and direction for quality management within an organization. The establishment of quality objectives should be part of the business planning or QMS planning processes.

Top management must establish the organizational structure and internal environment that motivates personnel to achieve the organization's quality management goals and objectives. They must provide adequate resources to develop, implement, maintain and improve 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. In determining quality objectives, top management must obtain input from these sources. Top management must also ensure that quality objectives from all sources are consistent with each other as well as other business objectives such as sales growth and profitability.

They must ensure also buy-in and ownership of all quality objectives to facilitate their deployment and achievement. The Quality management representative can play a significant role in coordinating the development and deployment of quality policies and objectives.

Input from customers and regulatory authorities must also be considered.

Can you provide some examples of quality objectives for an organization?

Quality objectives may be established 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; etc.

Customers - # and $ value of product returns; reduction in # of complaints; improvement in customer satisfaction rating; % on time delivery; # and $ value of service or support issues/delays; etc, (see clause 8.2).

Suppliers - # and $ value of 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 and results of improvement opportunities; etc.

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