Session 1 Concepts of Qms

Confederation of Indian Industry

Lead Auditor/Auditor Course for Quality Management Systems

ISO 9001:2008

IRCA Registration No. : A17392NABET Registration No. : LQ81 102

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CONTENTS

Concepts of QMS

Purpose, content & interrelationship of ISO 9000 family of standards

Terminology of QMS

Requirements of ISO 9001:2008

Documentation for ISO 9001 : 2008

Certification and Accreditation

Role of IRCA & Auditor Certification and Competence & Evaluation Of Auditors

Introduction to Auditing

Audit Responsibilities

Audit Programmes & Planning of Audit

Checklists

Opening Meeting

On-site auditing and Audit Skills

Audit Reporting

Closing meeting

Audit Follow up

qms Auditor/Lead Auditor Training Course

Session 1 – Concepts of QMS

0Overview

This session introduces the participants to the fundamental and underlying principles of a Quality Management System. The Year 2000 revisions to the ISO 9000 family of standards had brought in key conceptual inputs into the QMS, eg. the Process Model, the P-D-C-A approach and the eight Principles of Quality Management. These approaches have continued in the latest revision published as ISO 9001:2008

1Purpose

Quality management systems can assist organizations in enhancing customer satisfaction.

Customers require products with characteristics that satisfy their needs and expectations. These needs and expectations are expressed in product specifications and collectively referred to as customer requirements Customer requirements may be specified contractually by the customer or may be determined by the organization itself. In either case, the customer ultimately determines the acceptability of the product. Because customer needs and expectations are changing, and because of competitive pressures and technical advances, organizations are driven to improve continually their products and processes.

The quality management system approach encourages organizations to analyse customer requirements, define the processes that contribute to the achievement of a product which is acceptable to the customer, and keep these processes under control. A quality management system can provide the framework for continual improvement to increase the probability of enhancing customer satisfaction and the satisfaction of other interested parties. It provides confidence to the organization and its customers that it is able to provide products that consistently fulfill requirements

2Requirements for QMS and requirements for products

The ISO 9000 family distinguishes between requirements for quality management systems and requirements for products.

Requirements for quality management systems are specified in ISO 9001. Requirements for quality management systems are generic and applicable to organizations in any industry or economic sector regardless of the offered product category. ISO 9000 itself does not establish requirements for products.

Requirements for products can be specified by customers or by the organisation in anticipation of customer requirements, or by regulation. The requirements for products and, in some cases, associated processes can be contained in, for example, technical specifications, product standards, process standards, contractual agreements and regulatory requirements.

3Quality management systems approach

An approach to developing and implementing a quality management system consists of several steps including the following:

a)determining the needs and expectations of customers and other interested parties;

b)establishing the quality policy and quality objectives of the organization;

c)determining the processes and responsibilities necessary to attain the quality objective;

d)determining and providing the resources necessary to attain the quality objectives;

e)establishing methods for monitoring, measurement and analysis of these processes ;

f)applying these measures to determine the effectiveness and efficiency of these processes;

g)determining means of preventing nonconformities and eliminating their causes;

h)establishing and applying a process for continual improvement of the quality management system.

Such an approach is also applicable to maintaining and improving an existing quality management system.

An organization that adopts the above approach creates confidence in the capability of its processes and the quality of its products, and provides a basis for continual improvement. This can lead to increased satisfaction of customers and other interested parties and to the success of the organization.

4Process Model and P-D-C-A Approach

ISO 9001 : 2008 promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.

For an organization to function effectively, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next.

The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach”.

A major advantage of the process approach, when compared to other approaches, is in the management and control of the interactions between these processes and the interfaces between the functional hierarchies of the organization

When used within a quality management system, such an approach emphasizes the importance of

a)understanding and meeting requirements,

b)the need to consider processes in terms of added value,

c)obtaining results of process performance and effectiveness, and

d)continual improvement of processes based on objective measurement.

The model of a process-based quality management system which is an integral part of ISO 9001, illustrates the process linkages presented in clauses 4 to 8. This illustration shows that customer play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model covers all the requirements of ISO 9001 but does not show processes at a detailed level.

In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes. PDCA can be briefly described as follows:

Plan:establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization’s policies.

Do:implement the processes.

Check:monitor and measure processes and product against policies, objective and requirements for the product and report the results.

Act:take actions to continually improve process performance.

5Eight Quality Management Principles

To lead and operate an organization successfully, it is necessary to manage it in a systematic and visible manner. The use of Quality Management Principles is considered to provide direction. The eight quality management principles have been adopted and incorporated by the ISO 9000 standards, for use by Top Management to lead the organization towards current and future performance.

A Quality Management Principle is a comprehensive and fundamental rule or belief, for leading and operating an organization, aimed at continually improving performance over the long term, by focussing on customers while addressing the needs of all the stakeholders.

The eight Quality Management Principles are discussed below

Principle 1 – Customer-Focused Organisation

“Organisations depend on their customers and therefore should understand current and future customer needs, meet customer requirements and strive to exceed customer expectations”.

Applying the principle of customer-focused organisation leads to the following actions:

•understanding the whole range of customer needs and expectations for products, delivery, price, dependability, etc.

•ensuring a balanced approach among customers’ and other stakeholders’ (owners, people, suppliers, local communities and society at larger) needs and expectations.

•communicating these needs and expectations throughout the organisation,

•measuring customer satisfaction and acting on results, and

•managing customer relationships

Principle 2 – Leadership

“Leaders establish unity of purpose and direction of the organisation.
They should create and maintain the internal environment in which people can become fully involved in achieving the organisation’s objectives.”

Applying the principle of leadership leads to the following actions:

•being proactive and leading by example,

•understanding and responding to changes in the external environment,

•considering the needs of all stakeholders including customers, owner, people, suppliers, local communities and society at large,

•establishing a clear vision of the organisation’s future,

•establishing shared values and ethical role models at all levels of the organisation,

•building trust and eliminating fear,

•providing people with the required resources and freedom to act with responsibility and accountability,

•inspiring encouraging and recognizing people’s contributions,

•promoting open and honest communication,

•educating, training and coaching people,

•setting challenging goals and targets, and

•implementing strategy to achieve these goals and targets,

Principle 3 – Involvement of People

“People at all levels are the essence of an organisation and their full involvement enables their abilities to be used for the organisation’s benefit”

Applying the principle of involvement of people leads to the following actions by the people:

•accepting ownership and responsibility to solve problems,

•actively seeking opportunities to make improvement,

•actively seeking opportunities to enhance their competencies, knowledge and experience,

•freely sharing knowledge and experience in teams and groups,

•focusing on the creation of value for customers,

•being innovative and creative in furthering the organisations objectives,

•better representing the organisation to customers, local communities and society at large,

•deriving satisfaction from their work, and

•be enthusiastic and proud to be part of the organisation.

Principle 4 – Process Approach

“A desired result is achieved more efficiently when related
resources and activities are managed as a process.”

Applying the principle of process approach leads to the following actions:

•defining the process to achieve the desired results,

•identifying and measuring the inputs and outputs of the process,

•identifying the interfaces of the process with the functions of the organisation,

•evaluating possible risks, consequences and impacts of processes on customers, suppliers and other stakeholders of the process,

•establishing clear responsibility, authority, and accountability for managing the process,

•identifying the internal and external customers, suppliers and other stakeholders of the process, and

•when designing processes, consideration is given to process steps, activities, flows, control measures, training needs, equipment, methods, information, materials and other resources to achieve the desired result.

Principle 5 – Systems Approach to Management

“Identifying, understanding and managing a system
of interrelated processes for a given objective improves the
organisation’s effectiveness and efficiency”

Applying the principle of system approach to management leads to the following actions:

•defining the system by identifying or developing the processes that affect a given objective,

•structuring the system to achieve the objective in the most efficient way,

•understanding the interdependencies among the processes of the system,

•continually improving the systems through measurement and evaluation, and

•establishing resource constraints prior to action.

Principle 6 – Continual Improvement

“ Continual improvement should be a permanent
objective of the organisation.”

Applying the principle of continual improvement leads to the following actions:

•making continual improvement of products, processes and systems an objective for every individual in the organisation,

•applying the basic improvement concepts of incremental improvement and breakthrough improvement,

•using periodic assessments against established criteria of excellence to identify areas for potential improvement,

•continually improving the efficiency and effectiveness of all processes,

•promoting prevention based activities,

•providing every member of the organisation with appropriate education and training, on the methods and tools of continual improvement such as:

–the Plan-Do-Check-Act cycle,

–problem solving,

–process re-engineering, and

–process innovation,

•establishing measures and goals to guide and track improvements, and

•recognizing improvements.

Principle 7 – Factual approach to decision making

“Effective decisions are based on the
analysis of data and information.”

Applying the principle of factual approach to decision making leads to the following actions:

•taking measurements and collecting data and information relevant to objective,

•ensuring the data and information are sufficiently accurate, reliable and accessible,

•analysing the data and information using valid methods,

•understanding the value of appropriate statistical techniques, and

•making decisions and taking action based on the results of logical analysis balanced with experience and intuition.

Principle 8 – Mutually beneficial supplier relationships

“ An organisation and its suppliers are interdependent,
and a mutually beneficial relationship enhances
the ability of both to create value.”

Applying the principle of mutually beneficial supplier relationship leads to the following actions:

•identifying and selecting key suppliers,

•establishing supplier relationships that balance short-term gains with long-term considerations for the organisation and society at large,

•creating clear and open communications,

•initiating joint development and improvement of production and processes

•jointly establishing a clear understanding of customer’s needs,

•sharing information and future plans, and

•recognizing supplier improvement and achievements.

6Product

The result of a process is a product.

There are 4 generic product categories as follows:-

1.Hardware (example - engine, mechanical part)

2.Processed materials (example - lubricant)

3.Software (example - computer programme)

4.Services (example - transport)

The classification of the product depends on the dominant element. For example, automobile consists of hardware (tyres, engine, drive, etc), processed materials (fuel, cooling liquid), software (engine control software), service (operating instructions given by salesman). The dominant component is however, hardware.

7Benefits

The application of quality management principles and systems not only provide direct benefits but also make an important contribution to managing costs and risks. Benefit, cost and risk management considerations are important for the organization, its customers and other interested parties. These considerations on overall performance of the organization may impact:

–customer loyalty,

–repeat business and referral,

–operational results such as revenue and market share,

–flexible and fast responses to market opportunities,

–costs and cycle times through effective and efficient use of resources,

–alignment of processes which will best achieve desired results,

–competitive advantage through improved organizational capabilities,

–understanding and motivation of people towards the organization’s goals and objectives, as well as participation in continual improvement,

–confidence of interested parties in the effectiveness and efficiency of the organization, as demonstrated by the financial and social benefits from the organization’s performance, products life cycle, and reputation,

–ability to create value for both the organization and its suppliers by optimization of costs and resources as well as flexibility and speed of joint responses to changing markets.

Documentation for a QMS process

8Process Approach

For organizations to function effectively, they have to identify and manage numerous interrelated and interactive processes. Often, the output from one process will directly form the input with the next process. The systematic identification and management of processes employed within an organization and the interactions can be referred to as “Process approach”.

9Types of QMS processes

The Types of Processes in an organization can be classified as under:

a)Processes for management of an organization - These include processes relating to strategic planning, establishing policies, setting objectives, providing communication, ensuring availability of resources needed and management reviews.

b)Processes for managing resources - These include all those processes for the provision of the resources that are needed for the processes for managing an organization, for realization, and for measurement.

c)Realization processes - These include all processes that provide the intended output of the organization.

d)Measurement, analysis and improvement processes - These include those processes needed to measure and gather data for performance analysis and improvement of effectiveness and efficiency. They include measuring, monitoring and auditing processes, corrective and preventive actions and are an integral part of the management, resource management and realization processes.

10Process Documentation

A typical process documentation includes the following:

a)Identification of inputs

b)Identification of resources

c)Identification of desired outputs

d)Activities and their sequence

e)Monitoring and controls

f)Measurements

g)Records required to give evidence

11Types of process documents

The ISO 9001 Standard brings in a flexibility in the organisation’s documentation in clause 4.2.1(d). The requirement specifies documents needed by the organisation to ensure effective planning, operation and control of its processes. This would mean that documents, in any manner, which comply with this requirement will be acceptable. In practical terms, this would cover procedures, work instructions, process sheet, flow charts, quality plan, checklists, and many similar documents.

The format of document would be as appropriate to suit the purpose. The format could be in text form with proper headings or it could be in a tabular form. The format could also be as process diagrams graphical representations, visual media, or electronic methods or any other suitable form.

In all the types mentioned or in a combination of these, the essential features of a process, identified in 10 above, need to be made evident.

12Benefits of process approach to documentation