Ch-4 ISO (Quality Management Systems)

CH-4
Quality Management Systems
Quality Circles
Is a small group employees in the same work area or doing a similar type of work who voluntarily meet regularly for about an hour every week to identify, analyze and resolve work-related problems, leading to improvement in their total performance and enrichment of their work life.
Copyright 2010, G Nagalingappa, Manjunath V S
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Total Quality Management
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Features of QC
Small group of employees Belong to same work area Voluntary participation Meet regularly every week Identify analyze and resolve work related problems They contribute to better performance They aim at enrichment of work life
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What QCs are not

Are not just for quality problems Not substitute for task forces, product committees, joint plant councils & quality assurance groups. Do not change the existing structure of the organization Not means for the management to unload all their problems Not a forum for grievances Are not a panacea for all ills of an organization
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QC Benefits
Team sprit development Change in the attitude Self development
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Chapter
4
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Introduction
A QMS can be defined as "A set of co-ordinated activities to direct and control an organisation in order to continually improve the effectiveness and efficiency of its performance."
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The Benefits of a QMS

1. The customers' requirements confidence in the ability of the organisation to deliver the desired product and service consistently meeting their needs and expectations. 2. The organisation's requirements both internally and externally, and at an optimum cost with efficient use of the available resources materials, human, technology and information.
Cont.
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QMS and Business Growth
Organizations Business
Progress
QMS
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A good QMS will

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Set direction & meet customers expectation. Improve process control Reduce wastage Lower costs Increase market share Facilitate training Involve staff Raise morale
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Different ISO Standards

ISO 9001:2008 gives the requirements for quality management systems. Certification to the standard is used in global supply chains to provide assurance about suppliers' ability to satisfy quality requirements and to enhance customer satisfaction in supplier-customer relationships. ISO 14001:2004, which gives the requirements for environmental management systems, retains its global relevance for organizations wishing to operate in an environmentally sustainable manner.
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ISO/TS 16949:2009 gives the requirements for the application of ISO 9001:2008 by suppliers in the automotive sector. ISO 13485:2003 gives quality management requirements for the medical device sector for regulatory purposes.
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ISO/IEC 27001:2005 gives the requirements for information security management systems. ISO 22000:2005 gives the requirements for food safety management systems. ISO 50001:2011 gives the requirements for energy management systems.
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What is ISO 9000?

The International Organization for Standardization (ISO) was founded in 1946 in Geneva, Switzerland. The objective of this organization is to promote the development of international standards to facilitate free exchange of goods and services across the globe. ISO 9000 defines quality system standards.
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Achieve, maintain & seek to continuously improve product quality & after sales services in relationship to requirements. Improve the quality of operations to continuously meet customers stakeholders' stated & implied needs. Provide confidence to internal & other stakeholders that quality requirements are being achieved in the delivered products.
ISO 9000 objectives:
Provide confidence that quality system requirements are fulfilled.

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Benefits of ISO 9000 Certification

1. 2. 3. 4. 5. 6. 7. Achievement of international standard quality Higher productivity Increased customer satisfaction Higher profitability Higher employee morale Reduction in customer complaints Increased market share
8.
9.
Acceptability of the product in other countries, leading to increased export sales

Improved corporate image of the organization
10. Reduced need for inspection

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ISO 9000: 2000 Series of Standards

ISO 9000: 2000 standards focus on developing, documenting and
implementing procedures to ensure consistency of operations and

performance in production and service delivery processes. ISO 9000: 2000 consists of three series of standards:
1.
ISO 9000: 2000 Quality Management Systems (QMS): fundamental &
vocabulary discuss fundamental concepts to QMS & provides terminology used in other standards. 2. ISO 9001: 2000 Quality Management Systems (QMS): standard used
Cont.
for registration by documenting conformity of the QMS to customer, regulatory & organization requirements.
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3. ISO 9004: 2000 Quality Management Systems (QMS): guidelines for performance improvements provide guidelines that an organization can use to establish a QMS focused on improving performance. Note: ISO 9000 standards revised in 2008, known as ISO 9000:2008.
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ISO 9000: 2000 Quality Management Principles 1. 2. 3. Principle of customer focus Principle of Leadership Principle of involvement of people
4.
5. 6. 7. 8.
Principle of process approach

Principle of systems approach to management Principle of continuous improvement Principle of factual approach to decision-making Principle of mutually beneficial supplier relationship
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Principle of customer focus: organization should understand clear present & future customer needs, & strive continuously for exceeding the customer expectation. Principle of leadership: most important part of quality management. Create an internal environment in which employees can perform & involve fully in the process of achieving organization quality goals.
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Principle of involvement of people: HR are key components of the organization & success of an organization depends on its employee involvement in quality management efforts. Employees full involvement helps organization in achieving its objective.
Principle of process approach: ISO 9000 calls for process

approach as good process automatically leads to good output. Hence organization must focus on better and standard process which can prevent defects rather than focusing corrective actions.
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Principle of systems approach to management: organizations are made of interrelated components in the form of various functional groups & department with coordinated efforts. Hence identifying understanding, & managing interrelated process as s system contributes to the organizations
effectiveness & efficiency.

Principle of continuous improvement: organizations should focus continuous improvement of existing products, services & process. Continuous improvements of organizations overall performance should be the permanent of the organization.
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Principle of realistic approach to decision-making: Data is the most important for any decision-making. Hence collection of
reliable data is very important & effective decisions are made

on the analysis of accurate data. Principle of mutually beneficial supplier relationship: Quality products & services depends on quality of the inputs hence suppliers are the key for getting best quality inputs. An organization are interdependent and mutually beneficial relationship enhances the ability of both to created value.
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ISO 9001 Requirements 1. 2. 3. 4. 5. Scope Normative Reference Terms and Definitions Quality Management Systems (QMS) Management Responsibilities
6.
7. 8.
Resource Management
Product realization Measurement, analysis and improvement
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1.Scope: the organization to demonstrate its ability to provide a product that meets customer & regulatory requirements & achieve customer satisfaction. 2.Normative Reference: ISO 9000: 2000 QMSFundamental & Vocabulary are normative reference that provide applicable concepts & definition. 3.Terms & Definition: for the purposes of this standard the terms & definitions given in ISO:2000 apply. In addition, the supply chain is defined as:
Supplier-------Organization-------Customer
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4.Quality Management System

(i) General Requirements: the organization shall establish,
document, implement & maintain QMS & continually improve its effectiveness. (a) identify needed process such as management activities, provision for resource, product realization & measurement. (b) Determine their sequence & interaction. (c) Determine criteria & methods for effective operation & control of these process. (d) Ensure the availability of resources & information necessary to support & monitor these processes. (e) Monitor, Measure, & analyze these process. (f) Implement actions to achieve planned results & continuous improvement of theses processes.
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4.Quality Management System

(ii) Documentation: includes quality policy, quality manual, documented procedures, operation & Control of processes etc.
Quality manual shall be established & maintained & it must contain interactions among QMS processes. All the records must be established & maintained to provide evidence of conformity. Records must be legible, readily identifiable & retrievable.
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5. Management Responsibilities
(i) Management Commitment (ii) Customer focus (iii) Quality Policy (iv) Planning (v) Responsibility, authority, & Communication (vi) Management Review
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6. Resource Management
I. Provision of resources
II. Human Resources

III. Infrastructure IV. Work environment
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7. Product realization
i. ii. Planning of product realization Customer related processes
iii. Design & development iv. Purchasing v. Production & Service provision
vi. Control of monitoring & measuring devices
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8. Measurement, analysis and improvement

Conduct internal audit at planned interval to identify the nonconformance. determine, collect & analyze appropriate data to demonstrate the suitability of QMS. Improve the effectiveness of QMS through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.
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Implementation
The process of implementing ISO 9000 depends on:
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Step 1: Top Management Commitment Step 2: Establish Implementation Team Step 3: Start ISO 9000 Awareness Programmes Step 4: Provide Training Step 5: Conduct Initial Status Survey Step 6: Create a Documented Implementation Plan Step 7: Develop Quality Management System Documentation
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Step 8: Document Control Step 9: Implementation Step 10: Internal Quality Audit Step 11: Management Review Step 12: Pre-assessment Audit Step 13: Certification and Registration Step 14: Continual Improvement
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Step 1: Top Management Commitment
Communicating the importance of customer as well as statutory & regulatory requirements. Defining quality policy & making this known to every employees. Ensuring that quality objectives are established at all levels and functions Ensuring the availability of resources required for the development & implementation of the QMS. Appointing a management representative (MR) to coordinate QMS activities Conducting management review. 1. 2. 3.
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The management should also consider action such as Leading the organization by example, Participating in improvement projects. Creating an environment that encourages the involvement of people.
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Step 2: Establish Implementation Team
Establish team & appoint a management representative (MR). MR is coordinator to plan and oversee implementation. Team should contain, all functional department: Marketing, design & development, planning, production, quality control etc.,
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Step 3: Start ISO 9000 Awareness Programmes

Arrange the awareness programme about, the QMS , the advantage it offers to
employees, customers & the organization.

The awareness programme should emphasize the benefits that organization expects to realize through its ISO 9000 quality management system.
The programme should also stress the higher levels of participation & self-direction
that quality management system renders to employees. The programme could be conducted by implementation team or by experts hired to
educate all levels of employees.
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Step 4: Provide Training

The training should cover the basic concepts of QMS & standards & overall impact on the strategic goals of the organization, the changed processes, likely work culture implication s of the system.
Training is also necessary for writing the quality

manual, procedures, work instruction, auditing
principles, techniques of laboratory management,

calibration, testing procedures, etc,
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Step 5: Conduct Initial Status Survey

Ascertain and establish the following What is the present operation/process? What already exists? Analyze the relevant sections of the quality standards-ISO 9001:2000: What is actually required? If necessary, supplement and change operational arrangement in accordance with the standard, develop documents and records and describe operations/processes. What is desired operation/process?
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Step 6: Create a Documented Implementation Plan

The implementation plan should through & specific 1. Quality documentation to be developed
2. Objective of the system

3. Pertinent ISO 9001: 20000 section 4. Person or team responsible 5. Approval required 6. Training required 7. Resources required 8. Estimated completion date
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Step 7: Develop Quality Management System Documentation

Documentation of the QMS includes 1. Documented statements of a quality policy & quality objectives. 2. A quality manual 3. Documented procedures & records required by the standard ISO 90001: 2000, 4. Documents needed by the organization to ensure the effective planning, operation and control of its processes.
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Step 8: Document Control

Should include 1. approval for adequacy by authorized person before issue, 2. Review, updating & re-approval of documents by authorized person 3. Identification of changes and of the revision status of documents 4. Availability of relevant versions of documents at points of use 5. Identification and control of documents of external origin
6. Assurance of legibility and identifability of documents, and prevention of

unintended use obsolete documents.
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Step 9: Implementation
QMS being documented as documentation is developed.
In smaller companies the QMS can be implemented all at once throughout.

The implementation progress should be monitored to ensure that the QMS
is effective & conforms the to the quality.

The activities include internal quality audit, formal corrective action and management review.
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Step 10: Internal Quality Audit

Check regularly internal quality audits to verify the installed QMS. 1. Conforms to the planned arrangements, to the requirements of the ISO:2000 & to the QMS requirements established by the
organization.
2. Is effectively implemented & maintained. 3. Internal audits should be planned and performed as part of an ongoing strategy.
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Step 11: Management Review

The management review include information on: 1. Results of audits 2. Customer feedback 3. Process performance and product conformity
4. Status of preventive and corrective actions

5. Follow-up actions from previous management reviews 6. Changes that could affect the QMS and 7. Recommendations for improvements.
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Step 12: Pre-assessment Audit

If no nonconformance exists normally time to apply for the certification A pre-assessment audit should be arranged with an independent and qualified auditors. The pre-assessment audit would provide a degree of confidence for formally going ahead with an application for
certification.
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Step 13: Certification and Registration

Once QMS has been operation for few months & stabilized. The formal application for certification could be made to selected certification agency. If the documents conform to the requirements of the quality standard , then on-site audit is carried out. If certification bodies find the system to be working satisfactory, it awards the organization a certificates for period of 3-years.
During this 3-year period, it will carry out surveillance audits to ensure that the system is continuing to operate satisfactorily.
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Step 14: Continual Improvement

organization should continually seek to improve the effectiveness & suitability of the QMS through the use of:
1. Quality policy 2. Quality objective 3. Audit results 4. Analysis of data 5. Corrective & preventive actions 6. Management review ISO 9004:2000 provides a methodology for continual improvement.
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ISO 9001:2008 Standard

The ISO 9000 standard contains requirements affecting virtually all aspects of any company. Because ISO 9000 is designed for any company of any size and in any industry, the requirements are rather broad and hard to read.
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ISO 9001:2008 Standard

The ISO 9001:2008 requirements fall into the following sections: Section 1: Quality Management System Section 2: Management Responsibility Section 3: Resource Management
Section 4: Product Realization

Section 5: Measurement, Analysis and Improvement
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Section 1: Quality Management System

ISO 9001: 2008 standards outlines the necessary steps to implement the ISO 9001 QMS: 1. Identify the process needed for the QMS. 2. Determine the sequence & interaction of these processes. 3. Determine how these process are effectively operated and controlled. 4. Ensure all information is available to support the operation & monitoring of these processes.
5. Measure, monitor & analyze these processes, & implement action necessary to correct the process and achieve continual improvement.
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Section 2: Management Responsibility

Top management commitment to quality is important.
Requires a quality policy, objective, reinforces the

involvement of top management with customer requirement.
Top management has to establish responsibilities & authorities

within the company, including Management Representative.
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Section 3: Resource Management

Determine the requirements, provide in timely
manner, resources needed to implement and

improve the processes of QMS and address
customer satisfaction.
Including employee training as well as for the physical facilities and work enviornment
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Section 4: Product Realization

Defined as that sequence of processes and sub-processes required to achieve the product. This section also contains various requirements for the design of products and for the planning of processes, projects and services.
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Section 5: Measurement, Analysis and Improvement
Measurement & monitoring activities include internal audits and monitoring of customer perception as to whether the company has fulfilled customer requirements. All these activities must be defined, planned and implemented. Measuring and monitoring allows the company to manage by fact, not by guess.
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What is ISO 9001 Certification?

ISO 9001 certification is also known as ISO 9001 registration, ISO 9000 registration, ISO 9001:2008 certification or ISO 9001:2008 registration. All of these refer to an independent certification body attesting that a
company's
ISO
9001
quality
management
system
meets
all
requirements of the ISO 9001 2008 standard.
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What are the changes in ISO 9000:2008

ISO 9000: 2008 only introduces clarifications to the existing requirements of ISO 9000:2000. Reasons for limited changes are A key factor in the development of ISO 9001:2008 was to limit the impact of changes on users.
Changes & Benefits are: Easier to use Clearer language Easier to translate into the other languages Better compatibility with the environmental management standard ISO 14001:2004.
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Problems Related to ISO 9000

Problem 1: Management Attitude and Purpose Problem 2: Implementation by Consultants Problem 3: ISO 9000 Management Representative without Power Problem 4: Insufficient Resources Problem 5: Lack of Improvement Problem 6: Making it Complicated
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Problem 1: Management Attitude and Purpose
Goal should be clear defined
Not for customer requirement Not for attracting the business
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Problem 2: Implementation by Consultants

Consultants promise to write quality manual, quality procedures and other documents & provide training. Consultant is unfamiliar with the business, the company & its culture resulting system does not fit the company. For fees tires to set an overly complicated & complicated quality system. Consultant is not flexible.
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Problem 3: ISO 9000 Management Representative without Power
MR who is desperately trying to improve company while top management pays mere lip service to ISO 9001.
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Problem 4: Insufficient Resources

MR should be trained
Management allocation enough time

Financial resources Availability of documents
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Problem 5: Lack of Improvement

Common misconception that an QMS needs to
be implemented, certified & thats it.

System must constantly evolve as the company changes, as the market conditions change & as technologies improve.
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Problem 6: Making it Complicated

Processes System Unfair practices Overly bureaucratic
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ISO 14000
ISO 14000 is environmental management system, to protect environment and to prevent pollution while taking into account the economic needs of the
society.
The standard based on the principles of continuous
improvement in environmental performance of a

company.
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CH-4 Benefits of EMS

1. 2. 3. 4.
Assuring customers about environmental commitment of the organization Maintaining good public image and relations Increased brand image and market share Competitive advantage
5.
6. 7.
Conservation of scarce resources

More exports No legal harassments
8.
9.
Increased compliance to statutory requirements

Protection to human health
10. Cost effectiveness.

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Requirements of ISO 14001

In order to effectively implement and benefit from an ISO 14001 EMS, it is important to have an understanding of the standard's requirements. Policies ISO 14001 requires that the organization have a policy statement to drive the EMS. Planning Environmental Aspects Legal and Other Requirements Objectives and Targets
Cont.
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Policies
A policy statement to drive the EMS. May be short, one page or less documents & simply affirm the commitments. for example: we are committed to prevention of pollution. The policy must be clearly endorsed by top management and be available to the public & employees.
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Planning:
Not only aspects & impacts, determination of significance. Company has to determine significance.
Legal & other Requirements:

Explains how organization obtains information regarding its legal & other requirements & that information known to key functions.
Objectives & Targets:

Only the objectives & targets be documented. It is does require that certain items be considered in developing the objectives such as legal requirements & prevention of pollution.
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Implementation and Operation

Environmental Management Programmes (EMP) Structure and Responsibility
Training Awareness and Competence

Communications EMS Documentation Document Control Operations Control Emergency Planning and Response
Cont.
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Checking and Corrective Action

Monitoring and Measurement Non-conformance, Corrective, and Preventive Action
Records
EMS Audit
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Integrating ISO 14000 and ISO 9000

Implementing ISO 14000 requires huge efforts and it can consume a lot of time an organization. But organizations which have successfully implemented ISO 9000 previously may find it easy and this is due to the fact that many requirements for ISO 14000 would have already in place.
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Relationship with Health and Safety ISO 14000 is an environmental management system which aims at improving environmental management system and it results in improved work environment. Improved work environment will always result increased health and safety to the employees.
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The Capability Maturity Model (CMM)

The original Capability Maturity Model (CMM) was developed at the Software Engineering Institute (SEI) at Carnegie Mellon University to support improvements in the reliability of software development organizations, i.e., their ability to develop quality software on time and within budget. It was designed to help developers to select process-improvement strategies by determining their current process maturity and identifying the most critical issues to improving their software quality and process. The CMM includes a number of key concepts: maturity levels, key process areas, key practices and common features. CMM is a software process maturity model. This model attempts to quantify a software organisations capability to consistently and predictably produce high-quality software products.
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The Capability Maturity Model (CMM)

CMM is a development model created after study of data collected from organizations that contracted with the U.S. Department of Defense, who funded the research. The term "maturity" relates to the degree of formality and optimization of processes, from ad hoc practices, to formally defined steps, to managed result metrics, to active optimization of the processes.
The model's aim is to improve existing software-development processes, but it can also be applied to other processes.
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There are five levels defined along the continuum of the model and, according to the SEI: "Predictability, effectiveness, and control of an organization's software processes are believed to improve as the organization moves up these five levels.
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1. Initial (disorganized, ad hoc, individual heroics) - the starting point for use of a new or undocumented repeat process. 2. Repeatable - the process is at least documented sufficiently such that repeating the same steps may be attempted. 3. Defined - the process is defined/confirmed as a standard business process, and decomposed to levels 0, 1 and 2 (the last being Work Instructions). 4. Managed - the process is quantitatively managed in accordance with agreed-upon metrics. 5. Optimizing - process management includes deliberate process optimization/improvement.
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Within each of these maturity levels are Key Process Areas which characterize that level, and for each such area there are five factors: goals, commitment, ability, measurement, and verification. These are not necessarily unique to CMM, representing as they do the stages that organizations must go through on the way to becoming mature. The model provides a theoretical continuum along which process maturity can be developed incrementally from one level to the next. Skipping levels is not allowed/feasible.
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Quality Management Systems

Copyright 2010, G Nagalingappa, Manjunath V S

Total Quality Management

Text and Cases

Quality Management Systems

Copyright 2010, G Nagalingappa, Manjunath V S

Total Quality Management

Text and Cases

Quality Management Systems

What QCs are not

Total Quality Management

Text and Cases

Quality Management Systems

Copyright 2010, G Nagalingappa, Manjunath V S

Total Quality Management

Text and Cases

Quality Management Systems

Quality Management Systems

Copyright 2010, G Nagalingappa, Manjunath V S

Total Quality Management

Text and Cases

Quality Management Systems

Copyright 2010, G Nagalingappa, Manjunath V S

Total Quality Management

Text and Cases

Quality Management Systems

The Benefits of a QMS

Total Quality Management

Text and Cases

Quality Management Systems

QMS and Business Growth

Time 4-8 Total Quality Management

Quality Management Systems

A good QMS will

Copyright 2010, G Nagalingappa, Manjunath V S

Quality Management Systems

Different ISO Standards

Total Quality Management

Text and Cases

Quality Management Systems

Different ISO Standards

Copyright 2010, G Nagalingappa, Manjunath V S

Total Quality Management

Text and Cases

Quality Management Systems

Different ISO Standards

Copyright 2010, G Nagalingappa, Manjunath V S

Total Quality Management

Text and Cases

Quality Management Systems

What is ISO 9000?

Copyright 2010, G Nagalingappa, Manjunath V S

Total Quality Management

Text and Cases

Quality Management Systems

ISO 9000 objectives:

Provide confidence that quality system requirements are fulfilled.

Copyright 2010, G Nagalingappa, Manjunath V S

Quality Management Systems

Benefits of ISO 9000 Certification

Acceptability of the product in other countries, leading to increased export sales

10. Reduced need for inspection