DEVELOPING ISO QMS FOR CERTIFICATION:Process approach

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Total Quality Management MGT510

Lesson # 22

DEVELOPING ISO QMS FOR CERTIFICATION

DEVELOPMENT, IMPLEMENTATION AND REGISTRATION

The ISO 9000 standards originally were intended to be advisory in nature and to be used for two-party

contractual situations (between a customer and supplier) and for internal auditing. However, they

quickly evolved into criteria for companies who wished to "certify" their quality management or

achieve "registration" through a third-party auditor, usually a laboratory or some other accreditation

agency (called a registrar). This process began in the United Kingdom. Rather than a supplier being

audited for compliance to the standards by each customer, the registrar certifies the company, and this

certification is accepted by all of the supplier's customers.

The registration process includes document review by the registrar of the quality system documents or

quality manual; pre-assessment, which identifies potential noncompliance in the quality system or in the

documentation; assessment by a team of two or three auditors of the quality system and its

documentation; and surveillance, or periodic re-audits to verify conformity with the practices and

systems registered. During the assessment, auditors might ask such question as (using management

responsibility as an example): Does a documented policy on quality exist? Have job descriptions for

people who manage or perform work affecting quality been documented? Are descriptions of functions

that affect quality been documented? Are descriptions of functions that affect quality available? Has

management designated a person or group with the authority to prevent nonconformities in products,

identify and record quality problems, and recommend solutions? What means are used to verify the

solutions?

Re-certification is required every three years. Individual sites not entire companies must achieve

registration individually. All costs are borne by the applicant, so the process can be quite expensive.

Perspectives on ISO 9000:2000

ISO 9000 provides a set of good basic practices for initiating a quality system, and is an excellent

starting point for companies with no formal quality assurance program. In fact, it provides detailed

guidance on process and product control. Thus, for companies in the early stages of developing a quality

program, the standards enforce the discipline of control that is necessary before they can seriously

pursue continuous improvement. The requirements of periodic audits reinforce the stated quality system

until it becomes ingrained in the company. Thus, using ISO 9000 as a basis for a quality system can

improve discipline, process, productivity, decrease costs, and increase customer satisfaction.

ISO 9000 as a Quality Journey and not as a Destination

How to get started is always an issue for organizations just beginning their total quality journey.

The ISO 9000 development effort will benefit by having the following components: an executive-level

steering committee, a vision with the guiding principles, a set of broad objectives, baselines on

employee and customer satisfaction, an objective view of the organization's strengths and weaknesses,

and an indication of which employees at all levels can be counted on for support during the

implementation. In addition, the organization will have a well thought out means of communicating

with employees and all other stakeholders to keep them apprised of the changes taking place, why they

are happening, and what they will mea to everyone.

The development and implementation of an organization's quality management system is influenced by

its varying needs, its particular objectives, the products it provides, and the processes it employs. It is

not the purpose of this ISO to imply uniformity of quality management systems.

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The selection of the appropriate quality related processes described in this ISO Standard and the extent

to which these processes are adopted and applied by an organization depends upon factors such as its

size and structure, the market being served and the resources available.

The purpose of an organization is:

To identify and meet the needs and expectations of its customers and other interested parties

(i.e. employees, suppliers, owners, society), to achieve competitive advantage, and to do this in

an effective and efficient manner;

To achieve, maintain, and improve overall organizational performance and capabilities.

The application of quality management principles not only provides direct benefits but also makes an

important contribution to managing costs and risks. Benefit, cost and risk considerations are important

for the organization, its customers and other interested parties. These considerations on overall

performance may impact on the following:

Revenue (turnover), profits and market share; these may be increased by such aspects as

leadership, increased efficiency, improved employee performance, and employee and customer

satisfaction;

Costs due to resources needed for business; inadequate resource funding is likely to cause losses

and be a competitive disadvantage through the sale of deficient products.

Process approach

The ISO-9001(2000) Standard encourages the adoption of a process approach to quality management.

Any activity which receives inputs and converts them to outputs can be considered as a process. For

organizations to function effectively, they have to identify and manage numerous inter-linked processes.

Often the output from one process will directly form the input into the next process. The systematic

identification and management of the processes employed by an organization, and the interactions

between such processes, may be referred to as the 'process approach'.

Following Figure is a conceptual illustration of one of the process approach. The model recognizes that

customers and other interested parties play a significant role in defining inputs. Monitoring the

satisfaction of customers and other interested parties is necessary to evaluate and validate whether the

requirements of customers and other interested parties have been met. This model does not reflect

processes at a detailed level, but covers all the contents of the ISO Standard.

The purpose of ISO 9001 is to define the minimum Quality Management System requirements needed

to achieve customer satisfaction by meeting specified product requirements. Compliance with ISO 9001

may be used by an organization to demonstrate its capability to meet customer requirements.

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CONTINUAL IMPROVEMENT OF THE

QUALITY MANGEMENT SYSTEM

Management

Responsibility

Resource

Measurement,

analysis

Management

improvement

Product

Input

Output

realization

Product

Terms and definitions

For the purposes of this ISO 9001(2000) International Standard, the terms and definitions given in ISO

9000:2000, are applied in following way.

Supplier --------- >Organization ---------- >Customer (Interested Parties)

The term "organization" replaces the previously used term "supplier", to mean the unit to which

this International Standard applies. The term "supplier" is now used instead of the previous term

"subcontract". The changes have been introduced to reflect the vocabulary used by

organizations.

Product as a result of a Process

There are four agreed generic product categories as per ISO-9000:

Hardware,

Software,

Services,

Processed materials.

Most products are combinations of some of the four generic product categories.

Whether the combined product is then called hardware, processed material, software or service depends

on the dominant element.

Following is one of the model methodology which can be used to develop the documentation for QMS

and to get ready for certification by implementing clause by clause requirements (in the box) as given in

ISO 9001(2000) as the minimum requirement for certification and one can also take help from the

guidelines given in ISO-9004(2000) as presented below after the boxes.

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ISO Quality Management System Requirements/Guidelines

ISO 9001:2000 - Quality management systems -.Requirements

General requirements

The organization shall establish, document, implement, maintain a quality management and continually

improve its effectiveness in accordance with the requirement of this International Standard.

The organization shall:

Identify the processes needed for the quality management system and their application

throughout the organization (see 1.2)

Determine the sequence and interaction of these processes;

Determine criteria and methods needed to ensure that both the operation and control of the

processes are effective,

Ensure the availability of resources and information necessary to support the operation and

monitoring of these processes;

Measure, monitor and analyze these processes, and

Implement action necessary to achieve planned results and continual improvement these

processes.

These processes shall be managed by the organization in accordance with the requirements of this

International Standard.

Where an organization chooses to outsource any process that affects product conformity with

requirements, the organization shall ensure control over such processes.

NOTE Processes needed for the quality management system referred to above should include processes

for management activities, provision of resources, product realization and measurement.

Quality management system guidelines

Managing systems and processes

Leading and operating an organization successfully requires managing it in a systematic and visible

manner. Success should result from implementing and maintaining a management system that is

designed to continually improve performance by addressing the needs of all interested parties.

Managing an organization encompasses quality management, among other management disciplines.

The quality management system of an organization is an important part of the overall management

system. Organizations should define their systems and the processes contained within them to enable the

systems and processes to be clearly understood, managed and improved. Management should ensure

effective operation and control of processes and the measures and data used to determine satisfactory

performance. The management of the organization should closely monitor the movement toward

performance improvement. The activities and processes that can lead to performance improvement

should be described and defined by the management. In general, to fulfill the requirements of ISO

standard;

First, Company should state (write/document) what do they want to do

Second, do the work as was stated and documented

Third, check them, weather the work is being carried out as was stated. See if there are any gaps .

Fourth, Show and prove to an external auditor that work is really being done as was stated in the first

place.

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So what in terms of documentation required is a manual altogether in one volume to be called as ISO

9000 QMS Manual or can be separated into following manuals:

Quality Policy Manual

Quality Procedures Manual

Quality Work Instructions

Quality Records Manual or Quality Data Collection Manual

Documentation and records may be in any form or in any media suitable for the needs of the

organization.

Requirements for documentation and records may arise from

contractual requirements from the customer or other interested parties,

acceptance of international, national, regional and industry sector standards,

relevant statutory and regulatory requirements, or

decisions by the organization.

ISO 9001:2000 Quality management systems -Requirements

Documentation Requirements

General

The quality management system documentation shall include:

Documented statements of a quality policy and quality objectives

A quality manual

Documented procedures required by this International Standard;

Documents needed by the organization to ensure the effective planning, operation and control

Use of quality management principles

ISO 9001:2000 Quality management systems -Requirements

Documentation Requirements

Quality Manual

The organization shall establish and maintain a quality manual that includes

The scope of the quality management system, including details of and justification for any

exclusions (see 1.2),

The documented procedures established for the quality management system, or reference to

them, and

A description of the interaction between the processes of the quality management system.

Control of Documents

Documents required by the quality management system shall be controlled. Records are a special type

of document and shall be controlled according to the requirements given in 4.2.4.

A documented procedure shall be established to define the controls needed.

to approve documents for adequacy prior to issue,

to review and update as necessary and re-approve documents,

Total Quality Management MGT510

to ensure that changes and the current revision status of documents are identified,

to ensure that relevant versions of applicable documents are available at points of use,

to ensure that documents remain legible and readily identifiable,

to ensure that documents of external origin are identified and their distribution controlled,

and

to prevent the unintended use of obsolete documents, and to apply suitable identification to

them if they are retained for any purpose.

Control of Records

Records shall be established and maintained to provide evidence o conformity to requirements and of

the effective operation of the quality management system. Records shall remain legible, readily

identifiable and retrievable. A documented procedure shall be established to define the controls needed

for the identification, storage, protection, retrieval, retention time and disposition of records.

Documentation and Records

Management should define the documentation needed to support the quality management system. The

nature and extent of the documentation should support the needs of tile organization. The defined

documentation should provide for implementation, maintenance and improvement of the system.

This documentation typically includes

policy documents including the quality manual

documentation for control of processes,

work instructions for defined tasks,

standard formats for collection and reporting of data and

quality records.

The primary purpose of quality documentation is to express the quality policy and to describe the

quality management system. This documentation serves as the basis for implementation and

maintenance of the system. Suitable documentation should be available to achieve the effective

operation of the quality management system.

Documentation control should be defined and implemented to ensure that correct documents arc used.

All obsolete documents should be promptly removed from all points of issue and use, or otherwise

prevented from unintended use.

Documents to be retained, and records of quality performance, should be controlled, maintained and

protected.

The organization should ensure that sufficient records be maintained to demonstrate conformance to

requirements and verify effective operation of the quality management system. These records can also

provide know1edge for maintenance and improvement of the quality management system.

Quality records should be analyzed to provide inputs for corrective and preventive action, and process

improvements. Analysis of records may also provide information for use in the improvement of the

Quality management system.

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