ISO 9001(2000) QMS MANAGEMENT RESPONSIBILITY:Issues to be Considered

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Lesson # 23

ISO 9001(2000) QMS MANAGEMENT RESPONSIBILITY

MANAGEMENT RESPONSIBILITY - REQUIREMENTS

ISO 9001:2000-QUALITY MANAGEMENT SYSTEMS -REQUIREMENTS

MANAGEMENT COMMITMENT

Top management shall provide evidence of its commitment to the development and implementation of

the quality management system and continually improving its effectiveness by:

Communicating to the organization the importance of meeting customer as well as statutory and

regulatory requirements;

Establishing the quality policy,

Ensuring that quality objectives are established,

Conducting management reviews; and

Ensuring the availability of resources.

Needs and expectations of interested parties

Management responsibility Guidelines

General guidance

Top management should establish policies and strategic objectives consistent with the purpose of the

organization. Leadership, commitment and the involvement of the top management are essential for

developing and maintaining an effective and efficient quality management system to achieve benefits

for all interested parties. The key to achieving benefits for interested parties is to sustain and increase

customer satisfaction. The deployment of the policies and implementation of plans to achieve the

objectives are the responsibility of management. Management should involve everyone in the

organization in these actions. Top management responsibilities include

setting policies and objectives and leading the organization,

provision of organization structure and resources,

maintenance of current performance, and

achievement of continual improvement.

Top management should define an approach for measurement of the organization's performance in order

to verify that strategic objectives are achieved. This approach could include

financial measures,

measures of process performance, and

assessment of satisfaction level of customers and other interested parties.

This performance information should be used as input to management review in order to ensure that

continual improvement is the driver for organizational development.

Issues to be Considered

Issues to consider when developing, implementing and managing the organization's quality management

system include the use of the quality management principles outlined in 4.3.

Based on these principles, the following activities should be considered:

promoting policies and objectives to increase awareness, motivation and involvement of people,

identifying realization processes which add value for the organization,

planning for the future of the organization and management of change,

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setting and communicating directions related to achieving satisfaction of interested parties.

The quality management system should be appropriate for the organization's size and structure. It should

be focused on the achievement of the organization's quality objectives.Top management should

consider its approach to performance improvement through both continual improvement and radical

change. It should consider the resources and communication needed to ensure that the quality

management system is maintained and developed as the organization structure changes.

Top management should identify the organization's rea1ization processes, as these are directly related to

the success of the organization. Top management should also identify those support processes that affect

the efficiency of the realization processes or the needs of other interested parties.

To ensure all processes operate as an efficient network, the organization should analyze how all the

processes interact. Consideration should be given

To ensuring that the sequence and interaction of processes are designed to achieve the desired

results,

To ensuring inputs, activities and outputs are dearly defined and controlled,

To managing risks and opportunities.

To monitoring inputs and outputs to verify that individual processes are linked and operate

effectively and efficiently. and

To establishing data analysis that facilitates continual improvement across ail processes.

It is useful to define a process owner with full responsibility and authority to manage each process, and

to achieve process objectives.

ISO 9001:2000 Quality Management Requirements

Customer focus

Top management shall ensure that customer requirements are determined and are met with the aim of

enhancing customer satisfaction (see 7.2.1 and 8.2.1)

NOTE When determining customer needs and expectations, it is important to consider obligations

related to product, including regulatory and legal requirements.

General

Every organization has several categories of interested parties, each with needs and expectations.

For quality management purposes, interested parties include

customers and end users

people in the organization,

owners/investors, including shareholders, individuals or groups, including the public sector, that

have a specific interest in the organization.

· suppliers and partners, and

· society in terms of the community and the public affected by the organization.

T o meet the needs and expectations of all interested parties, organizations should consider

identification of the needs and expectations of all interested parties.

maintenance of a balanced response to interested parties needs and expectations,

translation of those needs and expectations into requirements,

communication of those requirements to all levels of the organization, and

improvement of all processes to create value for the interested parties.

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Needs and Expectations

The success of the organization depends on understanding and satisfying current and future needs and

expectations of customers (including end-users), and other interested parties. The management should

endeavor to exceed the expectations of all interested parties.

Examples of product concerns from customers and end-users include

conformance,

dependability,

availability,

delivery,

post-realization activities, and

price and life-cycle costs.

To define customer and end-user needs and expectations, an organization should

identify its customers, including potential customers,

determine key product characteristics for the customers and end-users,

identify and assess competition in its market,

identify opportunities, weaknesses and future competitive advantages.

The organization should also identify people's needs and expectations for recognition, work satisfaction,

competencies and development of knowledge. Such attention helps to ensure that the involvement and

motivation of people are as strong as possible. The organization should also define financial and other

results which satisfy the identified needs and expectations of owners and investors. Management should

consider the potential benefits of establishing partnerships with suppliers to the organization, in order to

create value for both parties. A partnership should be based on the definition of a joint strategy, sharing

knowledge, risks and profits.

When establishing partnerships, an organization should

identify key suppliers, contractors and distributors as potential partners,

jointly establish a clear understanding of customers' needs and expectations,

jointly establish a clear understanding of the partners' needs and expectations, and

set goals to secure opportunities for continuing partnerships.

In considering its relationships with society, the organization should .demonstrate responsibility for

health and safety,

consider environmental impact, including conservation of energy and natural resources,

identify applicable statutory and regulatory requirements,

identify the current and potential impacts on society in general, and the local community in

particular, of its products, processes and activities, and

· define the needs and actions for improvement in these areas

Statutory and Regulatory Requirements

Management should ensure that the organization has knowledge of the statutory and regulatory

requirements that apply to its products, processes and activities.

The response to relevant statutory and regulatory requirements should not prohibit the organization from

meeting its quality objectives.

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Consideration should also be given to

benefits to interested parties from exceeding compliance,

the role of the organization in the protection of community interests, and

the promotion of ethical interpretation and effective compliance with current and prospective

requirements.

ISO 9001:2000 Quality Management Systems -Requirements

Quality policy

Top management shall ensure that the quality policy:

is appropriate to the purpose of the organization;

includes a commitment to comply with requirements and continually improve the effectiveness

of the quality management system,

provides a framework for establishing and reviewing quality objectives;

is communicated and understood within the organization, and

is reviewed for continuing suitability.

Quality policy

An organization's quality policy should be consistent witl1 the organization's overall business policies.

In establishing the quality policy, top management should consider

the expected level of customer satisfaction,

the needs of other interested parties,

opportunities and needs for continual improvement.

resources needed, and

contributions of suppliers and partners.

An effectively formulated and communicated quality policy should

be consistent witl1 a vision of the organization's future,

make quality objectives understood throughout the organization.

demonstrate top management commitment to quality and the provision of adequate resources

for its achievement,

promote a commitment to quality at all levels of the organization, with clear leadership by top

management, and

address continual improvement and customer satisfaction.

The quality policy should be periodically reviewed and revised as necessary.

ISO 9001:2000 Quality Management Systems -Requirements

Planning Quality objectives

Top management shall ensure that quality objectives, including those needed to meet requirements for

product are established at relevant functions and levels within the organization. The quality objectives

shall be measurable and consistent with the quality policy.

Planning Quality objectives

The organization's objectives should be established during the planning process. They should be

consistent with the quality policy and capable of being measured. When establishing these objectives,

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management should consider the current and future needs of the organization and the markets served.

Consideration should also be given to output from management reviews, current product and process

performance, and to the levels of satisfaction of all interested parties. Objectives should be deployed

throughout the organization with defined responsibility for their achievement and be clearly

communicated to all relevant people. People should be able to translate these objectives into their

individual contributions.

1SO 9001:2000 -Quality Management Systems -Requirements

Quality Management System Planning

Top management shall ensure that

The planning of the quality management system is carried out in order to meet the requirements

given in 4.1, as well as the quality objectives, and

The integrity of the quality management system is maintained when changes to the quality

management system are planned and implemented.

Quality Management System Planning

Management should implement quality planning for the activities and resources needed to satisfy the

quality policy, objectives and requirements. Quality planning is an integral part of the quality

management system.

Primary inputs for quality planning include

needs and expectations of the customers and other interested parties,

performance of the products,

performance of the quality management system processes,

lessons learned from previous experiences- .opportunities for improvement, and

risk assessment and mitigation.

1S0 9001:2000 - Quality Management Systems -Requirements

Responsibility, Authority and Communication

Responsibility and Authority

Top management shall ensure that responsibilities and authorities are defined and communicated within

the organization.

Management Representative

Top management shall appoint a member of management who, irrespective of other responsibilities,

shall have responsibility and authority that includes.

Ensuring that processes needed for the quality management system are established,

implemented and maintained.

Reporting to top management on the performance of the quality management system and any

need for improvement, and

Ensuring the promotion of awareness of customer requirements throughout the organization.

NOTE The responsibility of a management representative can include liaison with external parties on

maters relating to the quality management system.

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Responsibility, Authority and Communication

General

Management should define and implement a quality management system in order to provide confidence

that the organization can satisfy the needs and expectations of interested parties. The quality

management system should be consistent with the organization's size, culture and products.

Outputs of quality planning can also identify

the responsibility and authority for execution of improvement plans,

the skills and knowledge needed,

improvement approaches, methodology and tools, .the resources needed,

alternative planning needs,

indicators for performance achievement, and

the need for documentation and records.

Quality planning outputs should be reviewed regularly (as changes in the organization's situation occur}

and revised as necessary. To develop the quality management system, the management should address

· strategic objectives,

· quality policy and quality objectives,

· needs and expectations of interested parties,

· relevant statutory and regulatory requirements, .process approach,

· communication,

· structure of the organization and the environment in which it exists,

· resources,

· other management systems,

· improvement.

Top management should define and communicate responsibility and authority in order to implement and

maintain the quality management system effectively and efficiently.

All people should be given authority and responsibilities to enable them to assist in the achievement of

the quality objectives. This assignment of authority and responsibility helps to establish involvement

and commitment of people throughout the organization.

Management Representative

Management representative(s) should be appointed and given authority by top management to manage,

monitor, evaluate and coordinate the quality management system processes. The goal of the

appointment is to enhance effective and efficient operation of the quality management system.

The representative(s) should report to top management and communicate with customers and other

interested parties on matters pertaining to the quality management system.

ISO 9001:2000 - Quality Management Systems -Requirements

Internal communication

Top management shall ensure that appropriate communication processes are established within the

organization and that communication takes place regarding the effectiveness of the quality management

system.

Internal COMMUNICATION

Management should define and implement processes for the communication of quality requirements,

objectives and accomplishments. Providing this information becomes a resource for improvement and

the involvement of people in achieving quality objectives.

Examples of tools for communication include

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team briefings and other meetings,

notice-boards, in-house journals/magazines,

audio-visual and electronic media.

ISO 9001:2000 - Quality Management Systems - Requirements

Management Review

General

Top management shall review the organization's quality management system, at planned intervals, to

ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing

opportunities for improvement and the need for changes to the quality management system, including

the quality policy and quality objectives. Records from management reviews shall be maintained

Review Input

The input to management review shall include information on

Results of audits;

Customer feedback;

Process performance and product conformity;

Status of preventive and corrective actions;

Follow-up actions from previous management reviews;

Changes that could affect the quality management system, and

Recommendations for improvement.

Review Input

Management Review

General and Review Input

Top management should establish a process to review the quality management system at periodic

intervals to evaluate its effectiveness and efficiency and verify that quality policy and objectives are

being satisfied. In addition, the management review process should analyze current activities that may

require change and consider opportunities for improvement of the quality management system.

Inputs for tile management review should include

results from audits of the quality management system including internal, customer and third

party audits,

· measurements of satisfaction of the needs and expectations of interested parties,

· performance of processes,

· analysis of product conformance,

· status of corrective and preventive actions,

· status of action items from previous reviews, and

· changes in original assumptions (for example, those arising from new technologies, outputs of

research and development, quality concepts, financial, social, environmental conditions and

relevant statutory and regulatory changes).

Additional inputs to consider include

status and results of improvement activities,

results of self-assessment of the organization,

customer satisfaction measurements,

market place evaluation, including the performance of competitors,

results of benchmarking activities,

performance of suppliers,

opportunities for improvement

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status of partnership initiatives,

financial effects of quality related activities,

impact of changes to relevant statutory and regulatory requirements.

ISO 9001:2000 - Quality Management Systems - Requirements

Review Output

The outputs from the management review shall include any decisions and actions related to:

Improvement of the effectiveness of the quality management system and its processes;

Improvement of product related to customer requirements; and

Resource needs.

Results of management reviews shall be recorded. ]

Review Output

Management review activity should be set in a context of the organization's strategic planning cycle.

This placement helps to ensure quality objectives and requirements are integral to the organization's

overall objectives and requirements.

Results of management review should, for example, focus on

· adding value for interested parties,

· improved performance of products and processes,

· suitability of organizational structure and resources,

· ability to introduce new product on time in the market,

· managing risks.

· compliance with relevant statutory and regulatory requirements, and

· planning for future resources.

Observations, recommendations, conclusions and decisions for actions should be recorded to facilitate

monitoring of progress, and used as input to subsequent reviews.

The management review process should be evaluated for effectiveness and improved when necessary.

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