Managing Processes In ISO 9000 Standards

Managing Processes In ISO 9000 Standards

The ISO 9000 Standard requires the organization to manage the identified processes in accordance with the requirements of ISO 9001.

The first stage in managing a process is to establish what it is you are trying to achieve, what requirements you need to satisfy, what goals you are aiming at; then establish how you will measure your achievements. The next stage is to define the process you will employ to deliver the results. Managing the process then involves managing all the inherent characteristics of the process in such a manner that the requirements of customers and interested parties are fulfilled by the process outcomes. This means:

Managing the process inputs

Managing the work

Managing the physical resources

Managing the financial resources

Managing the human resources

Managing the constraints

Managing the outputs

Process management is therefore much more than managing activities and therefore when describing processes, one needs more than a flow chart of activities. The chart is a diagrammatical representation of a process but only one aspect. One can also add numerical data to the charts to indicate resources, cycle times, delays, costs etc. but the intangible factors of the human environment cannot be reduced to numerical data to add to the charts.

The notes to clause 4.1 of ISO 9001 need some explanation. It is stated that the processes needed for the management system include management activities, provision of resources, product realization and measurement. This note could cause confusion because it suggests that these are the processes that are needed for the management system. It would be unwise to use this as the model and far better to identify the processes from observing how the business operates. The term provision of resources should be Resource Management, which is the collection of processes covering financial, human and physical resources.

Product realization is also a collection of processes such as design, production, service delivery, etc. Measurement is not a single process but a sub-process within each process. Grouping all the measurement processes together serves no useful purpose except it matches the standard – a purpose of little value in managing the organization.

The second note refers to outsourcing processes although it is difficult to imagine that management activities, product realization or measurement would be outsourced in its entirety. It is likely that market research; design, product verification, equipment calibration and other specialized services may be outsourced. While outsourcing comes under purchasing, it is correct to point out that the organization should control any outsourced processes. The supplier of the process is usually referred to as a subcontractor because they provide services to the organization’s requirements not their own. Control of subcontractors is covered by clause 7.4 but in meeting clause 7.4.3, you need to treat suppliers and subcontractors differently.

ISO 9000 Standards – Conducting Management Reviews

ISO 9000 Standards – Conducting Management Reviews

The ISO 9000 standards requires that top management conduct

management reviews.

The term review is defined in ISO 9001 as an activity

undertaken to ensure the suitability, adequacy, effective-

ness and efficiency of the subject matter to achieve

established objectives. The addition of the term manage-

ment means that the management review can be

perceived as a review of management rather than a

review by management, although both meanings are conveyed in the standard.

The rationale for this is that the examples given in ISO 9000 such as design

review and nonconformity review clearly indicate it is design and non-

conformity that is being reviewed. If the system was to be reviewed then the

action should be called a system review. It is no doubt unintentional in the

standard but, if the management system is perceived as the way in which the

organization’s objectives are achieved, a review of management is in fact a

review of the way achievement of objectives is being managed because the

organization exists to achieve objectives and so both meanings are correct.

Top management will not regard the management review as important unless

they believe it is essential to running the business. The way to do this is to treat

it as a business performance review. This is simpler than it may appear. If the

quality policy is now accepted as corporate policy and the quality objectives

are accepted as corporate objectives, any review of the management system

becomes a performance review and no different to any other executive

meeting. The problem with the former management reviews was that they

allowed discussion on the means for achieving objectives to take place in other

management meetings leaving the management review to a review of errors,

mistakes and documentation that no one was interested in anyway. The

management system is the means for achieving objectives therefore it makes

sense to review the means when reviewing the ends so that actions are linked to

results and commitment secured for all related changes in one transaction.

The requirement emphasizes that top management conduct the review – not

the quality manager, not the operational manager – but top management – those

who direct and control the organization at the highest level. In many ISO 9000

registered organizations, the management review is a chore, an event held once

each year, on a Friday afternoon before a national holiday – perhaps a cynical

view but nonetheless often true. The reason the event has such a low priority

is that management have not understood what the review is all about. Tell

them it’s about reviewing nonconformities, customer complaints and internal

audit records and you will be lucky if anyone turns up. The quality manager

produces all the statistics so the others managers are free of any burden. By

careful tactics, these managers may come away with no actions, having

delegated any in their quarter to the quality manager.

In order to provide evidence of its commitment to conducting management

reviews, management would need to demonstrate that it planned for the

reviews, prepared input material in the form of performance results, metrics

and explanations, decided what to do about the results and accepted action to

bring about improvement.

The ISO 9000 standards requires that top management conduct management reviews.

The term review is defined in ISO 9000 Standards as an activity undertaken to ensure the suitability, adequacy, effectiveness and efficiency of the subject matter to achieve established objectives. The addition of the term management means that the management review can be perceived as a review of management rather than a review by management, although both meanings are conveyed in the standard.

The rationale for this is that the examples given in ISO 9000 Standards such as design review and nonconformity review clearly indicate it is design and non-conformity that is being reviewed. If the system was to be reviewed then the action should be called a system review. It is no doubt unintentional in the standard but, if the management system is perceived as the way in which the organization’s objectives are achieved, a review of management is in fact a review of the way achievement of objectives is being managed because the organization exists to achieve objectives and so both meanings are correct.

Top management will not regard the management review as important unless they believe it is essential to running the business. The way to do this is to treat it as a business performance review. This is simpler than it may appear. If the quality policy is now accepted as corporate policy and the quality objectives are accepted as corporate objectives, any review of the management system becomes a performance review and no different to any other executive meeting. The problem with the former management reviews was that they allowed discussion on the means for achieving objectives to take place in other management meetings leaving the management review to a review of errors, mistakes and documentation that no one was interested in anyway. The management system is the means for achieving objectives therefore it makes sense to review the means when reviewing the ends so that actions are linked to results and commitment secured for all related changes in one transaction.

The requirement emphasizes that top management conduct the review – not the quality manager, not the operational manager – but top management – those who direct and control the organization at the highest level. In many ISO 9000 registered organizations, the management review is a chore, an event held once each year, on a Friday afternoon before a national holiday – perhaps a cynical view but nonetheless often true. The reason the event has such a low priority is that management have not understood what the review is all about. Tell them it’s about reviewing nonconformities, customer complaints and internal audit records and you will be lucky if anyone turns up. The quality manager produces all the statistics so the others managers are free of any burden. By careful tactics, these managers may come away with no actions, having delegated any in their quarter to the quality manager.

In order to provide evidence of its commitment to conducting management reviews, management would need to demonstrate that it planned for the reviews, prepared input material in the form of performance results, metrics and explanations, decided what to do about the results and accepted action to bring about improvement.

ISO 9000 Standards – Quality Management Principles

ISO 9000 Standards – Quality Management Principles

A quality management principle is defined by ISO/TC 176 as a comprehensive and fundamental rule or belief, for leading and operating an organization, aimed at continually improving performance over the long term by focusing on customers while addressing the needs of all other interested parties. Eight principles have emerged as fundamental to the management of quality.

All the requirements of ISO 9001:2008 are related to one or more of these principles. These principles provide the reasons for the requirements and are thus very important. The quality management principles can be listed as below:

1. Customer focus
Organizations depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations.
The customer focus principle is reflected in ISO 9000 Standards through the requirements addressing:
a. Communication with the customer
b. Care for customer property
c. The determination of customer needs and expectations
d. Appointment of a management representative
e. Management commitment

2. Leadership
Leaders establish unity of purpose and direction for the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.
The leadership principle is reflected in ISO 9000 Standards through the requirements addressing:
a. The setting of objectives and policies
b. Planning
c. Internal communication
d. Creating an effective work environment

3. Involvement of people
People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.
The involvement of people principle is reflected in ISO 9000 Standards through the requirements addressing:
a. Participation in design reviews
b. Defining objectives, responsibilities and authority
c. Creating an environment in which people are motivated
d. Internal communication
e. Identifying competence needs

4. Process approach
A desired result is achieved more efficiently when related resources and activities are managed as a process.
The process approach principle is reflected in ISO 9000 Standards through the requirements addressing:
a. The identity of processes
b. Defining process inputs and outputs
c. Providing the infrastructure, information and resources for processes to
function

5. System approach to management
This principle is expressed as follows:
Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.
The system approach principle is reflected in ISO 9001 through the requirements addressing:
a. Establishing, implementing and maintaining the management system
b. Interconnection, interrelation and sequence of processes
c. The links between processes
d. Establishing measurement processes

6. Continual improvement
This principle is expressed as follows:
Continual improvement of the organization’s overall performance should be a permanent objective of the organization.
The continual improvement principle is reflected in ISO 9000 Standards through the requirements addressing:
a. Improvement processes
b. Identifying improvements
c. Reviewing documents and processes for opportunities for improvement

7. Factual approach to decision making
This principle is expressed as follows:
Effective decisions are based on the analysis of data and information.
The factual approach principle is reflected in ISO 9000 Standards through the requirements addressing:
a. Reviews, measurements and monitoring to obtain facts
b. Control of measuring devices
c. Analysis to obtain facts from information
d. Records for documenting the facts
e. Approvals based on facts

8. Mutually beneficial supplier relationships
This principle is expressed as follows:
An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
The mutually beneficial supplier relationships principle is reflected in ISO 9000 Standards through the requirements addressing:
a. Control of suppliers
b. Evaluation of suppliers
c. Analysis and review of supplier data