Why is ISO 9001:2008 Certification Important?

Why is ISO 9001:2008 Certification Important?

First of all it provides a system for managers and organizations to achieve excellence and opens the door for American manufacturers and/or service organizations seeking a larger role in both international trade and with other American organizations. Many organizations require their suppliers to be certified or at a minimum to be working toward certification on ISO 9001:2008 to do business.

Consider the facts (source MORI/SGS-ICS) that with ISO 9001 certification:

• 83% realized improved management control
• 82% realized improved customer satisfaction
• 62% said it improved the ability to win work
• 61% stated a more motivated workforce
• 60% realized improved productivity
• 60% saw reduced waste
• 52% stated it improved marketing
• 50% had reduced costs
• 49% realized increased market share

ISO 9000 AND THE CONSTRUCTION INDUSTRY

ISO 9000 AND THE CONSTRUCTION INDUSTRY

A formal quality management system has the potential to change attitudes, cultures, and work procedures at any construction firm in a way the organization has never experienced before. In most cases, in order to set up a

formal quality management system at a construction firm, there has to be direct demands from their customers, whose requirement for quality is essential for doing business. Most of the construction organizations will not enter into the cost and allocation of resources to implement a quality management system unless they will be compensated. There is a general movement towards making implementation of a quality management system a contractual requirement. Small to medium sized organizations can always argue that they ‘operate to a quality system’ although this is not formalized. However, since the existence of such ‘informal’ quality systems are

difficult to justify, the International Standards Organization, (ISO) has come up with ISO 9001 series of standards that are applicable to all organizations irrespective of size or nature of business.

ISO 9000 refers to a set of quality management standards. Standards present an opportunity for an organization to develop a quality management system that meets the requirements specified by ISO 9001:2000, which are

recognized internationally, making the organization competitive. ISO 9001 family of standards is undeniably the most prolific of all formal standards. This could be due to the worldwide applicability standardization and

flexibility with which the standards are associated, even though there are some experts that still question the standards’ applicability in the construction industry. It is important to note that ISO 9001:2000 has replaced ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994, while the old ISO 9002 and ISO 9003 standards have been discontinued.

A formal quality management system has the potential to change attitudes, cultures, and work procedures at any construction firm in a way the organization has never experienced before. In most cases, in order to set up aformal quality management system at a construction firm, there has to be direct demands from their customers,whose requirement for quality is essential for doing business. Most of the construction organizations will not enterinto the cost and allocation of resources to implement a quality management system unless they will becompensated. There is a general movement towards making implementation of a quality management system acontractual requirement. Small to medium sized organizations can always argue that they ‘operate to a qualitysystem’ although this is not formalized.

However, since the existence of such ‘informal’ quality systems aredifficult to justify, the International Standards Organization, (ISO) has come up with ISO 9001 series of standardsthat are applicable to all organizations irrespective of size or nature of business. ISO 9000 refers to a set of quality management standards. Standards present an opportunity for an organization todevelop a quality management system that meets the requirements specified by ISO 9001:2000, which arerecognized internationally, making the organization competitive. ISO 9001 family of standards is undeniably themost prolific of all formal standards. This could be due to the worldwide applicability standardization andflexibility with which the standards are associated, even though there are some experts that still question thestandards’ applicability in the construction industry. It is important to note that ISO 9001:2000 has replaced ISO9001:1994, ISO 9002:1994 and ISO 9003:1994, while the old ISO 9002 and ISO 9003 standards have been discontinued.

ISO’s logo

ISO’s logo

ISO will not authorize the use of its logo in connection with material publicizing an ISO 9000 or ISO 14000 certification –some examples of such uses are in company letterheads, marketing leaflets, advertisements, and so on. The ISO logo is a registered trademark. ISO does not authorize its logo to be used, either by quality system certification bodies, or by the companies to which the latter issue ISO 9000 certificates. The same applies to ISO 14000 certifications, as these become more widespread. Allowing the ISO logo to be used would give the false impression that ISO carries out certification activities, or has approved or authorized the organization using its logo. These activities are not business functions of ISO.

ISO is not an auditor, assessor, registrar, or certifier of either quality systems or environmental management systems – or, for that matter, of materials, products and services – nor does it endorse any such activities performed by other parties. ISO develops International Standards but, at present, operates no scheme for assessing conformance with them.

Allowing the use of our logo in advertisements or other publicity material would give the impression that ISO has “approved” such a certification – or even carried it out. For the reasons given above, such an impression would be totally misleading.

ISO 9001 and occupational health and safety

ISO 9001 and occupational health and safety

Adopting ISO 9001 might lead to improvements in occupational health and safety in a variety of ways. In the process of formally documenting procedures, for example, managers can identify and eliminate hazardous practices and add safety precautions. Moreover, by fostering more focused attention to detail,ISO 9001 adoption can reveal new “win-win” opportunities to improve quality or efficiency and occupational health and safety that were previously obscured by indirect and distributed costs and benefits.

Additionally, processes that provide warning signals and prompt corrective action can forestall serious accidents. Finally, routine auditing and corrective action procedures required by ISO 9001 to address management system failures encourage root-cause analysis that can identify problematic work practices that might otherwise precipitate not only quality failures, but occupational health and safety concerns.

Departments charged with managing quality sometimes also manage health and safety, and companies are increasingly implementing integrated management systems that incorporate all these considerations. Occupational health and safety can be improved by applying the tools of continuous improvement associated with ISO 9001 certification. Employees who know how to identify root causes of quality problems, for example, also have the skills to identify root causes of safety problems.

The high rates of repetition and increased monitoring implicit in the emphasis of ISO 9001 on routinization and standardization of tasks can increase stress and repetitive motion injuries, potentially worsening the safety records of plants with quality program. Moreover, to the extent that the higher equipment utilization associated with ISO 9001 adoption translates into reduced employee downtime, employee fatigue, a major cause of injuries, might be expected to increase. Additionally, new quality management procedures implemented in association with ISO 9001 that add inspection tasks to work processes optimized for production can occasion poor ergonomic conditions that leave employees susceptible to injuries.

Process Approach In ISO 9001 Standards

Process Approach In ISO 9001 Standards

The ISO 9001 International Standard 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 determine and manage numerous linked activities. An activity or set of activities 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”.

An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.

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

Six Sigma Vs ISO 9000

Six Sigma Vs ISO 9000

The debate over whether or not to choose Six Sigma over ISO 9000 is getting more interesting with each passing day. In an attempt to determine which of these is the better of the two, it is highly pertinent to discuss that in the context of applicability of them to industries. And there exists a huge amount of difference between the approaches of these two methodologies in tackling the issues.

Six Sigma – A Critical View

Six Sigma utilizes a multi-faceted approach to doing business with total improvement of the end product being the goal. In doing so, Six Sigma defines and analyzes the processes critically almost always focusing on process improvements. The statistical tools used in Six Sigma help not just in the adoption of processes but are also critical tools of Six Sigma implementation.

Process Development Stages

Let us examine the above statement as applicable to a process for easier understanding. While working on process improvement, the Black Belts break up the original sequence of different events that comprise the entire process and each event is further subdivided internally. This enables the “belts” to take an entirely different view of the process via the entire process as a whole. The powerful statistical tools employed at this stage of evaluation make the picture clearer and help the “belts” to arrive at decisions about the value additions those made to the process by different events.

This principle obviously goes beyond standardizing the processes and setting the pathway for being vigilant about adherence to the Six Sigma methodology. Useless values which have lost meaning make way for more meaningful events and eventually more robust and comprehensive processes. In a Six Sigma environment, customer demands will assume a key role in driving the processes towards aligning all activities with the vision of the leader of the company. The approach is “how to” rather than “what to” deliver.

The ISO 9000 Approach

The ISO approach towards quality management concentrates on standardization of the activities of production. The eight quality principles of ISO 9000, along with its twenty-four requirements outline business processes. The emphasis here is on the control of events in each aspect of doing business by documenting evidence and reports. The eight principles of ISO 9000 include prioritizing customer data, purchasing and quality systems, among other critical aspects. ISO 9000 recognizes each process, whose end goals are the same, as an independent entity. Documented quality requirements typically decide, based on set rules, whether or not a particular process adhered to that standard.

Document and Process Control

Maintenance of quality is achieved by adhering to key process and document control. Operating procedures and process control documents restrict deviations outside the concepts of what you should be doing in every process. What-you-should-be-doing is given emphasis under standard conditions rather than dealing with process improvement.

Stalwarts in industry are examining the possibility of merging the best practices of the two. Several industry leaders have already acknowledged the benefits of using both methodologies to compliment each other. Another view is that, as Six Sigma implementation is what you do within your company (unlike the certification in ISO) the company does not get recognition for achieving successful Six Sigma implementation. However, as long as the culmination of a business activity is defined by both methodologies as retaining and improving the customer base along with maximizing the bottom line, rejection of one in favor of other will be hard to justify.

The Environment For A Healthy Business In ISO 14001 Standards

The Environment For A Healthy Business In ISO 14001 Standards

Growing scrutiny toward industry’s effects on the environment has made conformance with ISO 14001:2004 – a voluntary, internationally recognized Environmental Management Systems (EMS) standard – more important than ever. As more companies pursue ISO 14001 certification to demonstrate environmental commitment to their customers, shareholders and government agencies, many are discovering the benefits of partnering with Intertek. As one of the first accredited certification bodies, Intertek offers expertise, experience and know-how that no one else can deliver. Your certified EMS can help you reap the benefits of:

Improved overall performance
Your ISO 14001 certified EMS can help make your business more efficient and productive. Lower energy and raw materials use, reductions in waste and pollution, and mitigated risks of accidents and emergency situations translate into greater profitability and productivity.

Expanded market access
Your company’s environmental credibility and commitment to quality are established from day one. It will take less time to demonstrate the effectiveness of your EMS and earn your prospective customers’ trust and confidence, and you’ll enjoy access to markets you might not otherwise penetrate.

Improved corporate image
Your certification demonstrates your company’s commitment to environmental responsibility, fostering improved relationships with the community, shareholders, and governmental and environmental organizations.

Enhanced competitiveness
While helping you to operate more efficiently and profitably, your ISO 14001 certified EMS can instill additional confidence in shareholders, investors, insurers and your customers – making your business the clear choice in a highly competitive market.
Plus, you can maximize your human and financial resources by using your existing Quality Management System (QMS) as a basis for your EMS, taking advantage of the synergies between ISO 9001 and ISO 14001.

Introduction to ISO 9001 Standard Certification

Introduction to ISO 9001 Standard Certification

Certification is a way to attest, by the intermediary of a third-party certifier, to a company’s ability to provide a service, product or system in accordance with client requirements and regulation requirements. ISO and IEC give the following definition:
Procedure by which a third party gives written assurancethat a product, process or service complies with the requirementsspecified in a benchmark.The ISO 9000 family of standards corresponds to all the management best practices benchmarks as regards quality, which are defined by ISO (the International Organisation for Standardization).
ISO 9000 standards were originally written in 1987, with revisions taking place in 1994 and 2000. Thus, the 2000 version of the ISO 9001 standard, which is part of the ISO 9000 family, is written “ISO 9001:2000?. The ISO 9001:2000 standard mainly focuses on the processes used to produce a service or product, whereas the ISO 9001:1994 standard was mainly focused on the product itself. Here is an overview of all the different standards in the ISO 9000 family:
ISO 9000: “Quality Management Systems – Basic Principles and Vocabulary”. The ISO 9000 standard describes the principles of a quality management system and defines the terminologyISO 9001: “Quality Management Systems – Requirements”. The ISO 9001 standard describes the requirements relative to a quality management system either for internal use or for contractual or certification purposes. Therefore, this standard is a group of requirements that companies must followISO 9004: “Quality Management Systems – Guidelines for Improving Performance”. This standard, which is intended for internal use and not for contractual purposes, focuses particularly on continually improving performanceISO 10011: “Guidelines for auditing quality management and/or environmental management systems”.

Business benefits of ISO 14001 Standards

Business benefits of ISO 14001 Standards

Any manager will try to avoid pollution that could cost the company a fine for infringing environmental legislation. But better managers will agree that doing only just enough to keep the company out of trouble with government inspectors is a rather weak and reactive approach to business in today’s increasingly environment-conscious world.
There is a better way. The ISO 14000 way. The ISO 14000 standards are practical tools for the manager who is not satisfied with mere compliance with legislation – which may be perceived as a cost of doing business. They’re for the proactive manager with the breadth of vision to understand that implementing a strategic approach can bring return on investment in environmentrelated measures. Implementing an ISO 14000-basedenvironmental management system, and using other tools from the ISO 14000 family, will give you far more than just confidence that you are complying with legislation.
The ISO 14000 approach forces you to take a hard look at all areas where your business has an environmental impact. And this systematic approach can lead to benefits like the following:
a. Reduced cost of waste managementb. Savings in consumption of energy and materialsc. Lower distribution costsd. Improved corporate image among regulators, customers and the publice. Framework for continuous improvement of your environmental performance.
The manager who is “too busy managing the business” to listen to good senseabout environmental management could actually be costing the business plenty. Just think, for example, of the lost opportunities for achieving benefits like those above.
The ISO 14000 standards are management tools that will help your businessachieve environmental goals that go way beyond acquiring a mere “green sheen”.

The ISO 9001 & ISO 14001 Standards and the environment

The ISO 9001 & ISO 14001 Standards and the environment

The ISO 14000 family of International Standards on environmental management is a relative newcomer to ISO’s portfolio – but enviroment-related standardization is far from being a new departure for ISO.

In fact, ISO has two-pronged approach to meeting the needs of business, industry, governments, non-governmental organizations and consumers in the field of the environment.

On the one hand, it offers a wideranging portfolio of standardized sampling, testing and analytical methods to deal with specific environmental challenges. It has developed more than 350 International Standards (out of a total more
than 12000) for the monitoring of such aspects as the quality of air, water and soil. These standards are means of providing business and government with scientifically valid data on the environmental effects of economic activity.

They also serve in a number of countries as the technical basis for environmental regulations.

ISO is leading a strategic approach by developing environmental management system standards that can be implemented in any type of organization in either public or private sectors (companies, administration, public utilities). To spearhead this strategic approach, ISO establish a new technical commitee, ISO /TC 207, Environmental management, in

1993. This followed ISO’s successful pioneering experience in management system standardization with the ISO 9000 series for quality management.

ISO’s direct involvement in environmental management stemmed from an intensive consultation process, carried out within the framework of a Strategic Advisory Group on Environment (SAGE),set up in 1991, in which 20 countrie, 11 international organizations and more than 100 environmental experts participated in defining the basic requirements of a new approach to environment-related standards.

This pioneering work was consolidated with ISO’s commitment to support the objective of “sustainable development” dicussed at the United Nations Conference on Environment and Development in Rio de Janeiro in 1992.

Today, delegations of business and government experts from 55 countries have participate actively within TC 207,

and another 16 countries have observer status. These delegations are chosen by the national standars institute concerned and they are required to bring to TC 207 a national consensus on issue being addressed by the commitee.

This national consensus is derived from a process of consultation with interested parties.

From its beginning, it was recognized that ISO/TC 207 should have close cooperation with ISO/TC 176, Quality management and quality assurance, in the areas of management systems, auditing and related terminology. Active efforts are under way to ensure compatibility of ISO environmental management and quality management standards, for the benefit of all organizations wishing to implement them.

ISO 9000 Series and Six Sigma

ISO (International Organization for Standardization) 9000 series standards were first published in 1987, revised in 1994, and re-revised in 2000 by the ISO. The 2000 revision, denoted by ISO 9000:2000, has attracted broad expectations in industry.

As of the year 2001, more than 300,000 organizations world-wide have been certified to the ISO 9000 series standards. It embodies a consistent pair of standards, ISO 9001:2000 and ISO 9004:2000, both of which have been significantly updated and modernized. The ISO 9001:2000 standard specifies requirements for a quality management system for which third-party certification is possible, whereas ISO 9004:2000 provides guide- lines for a comprehensive quality management system and performance improvement through Self-Assessment.

The origin and historical development of ISO 9000 and Six Sigma are very different. The genesis of ISO 9000 can be traced back to the standards that the British aviation industry and the U.S. Air Force developed in the 1920s to reduce the need for inspection by approving the conformance of suppliers’ product quality. These standards developed into requirements for suppliers’ quality assurance systems in a number of western countries in the 1970s. In 1987 they were amalgamated into the ISO 9000 series standards.

Independent of ISO 9000, the same year also saw the launch of Six Sigma at Motorola and the launch of Self-Assessment by means of the Malcolm Baldrige National Quality Award in USA. Both Six Sigma and Self-Assessment can be traced back to Walter A. Shewhart and his work on variation and continuous improvement in the 1920s. It was Japanese industry that pioneered a broad application of these ideas from the 1950s through to the 1970s. When variation and continuous improvement caught the attention of some of the American business leaders in the late 1980s, it took the form of the Malcolm Baldrige National Quality Award, on a national level, and of Six Sigma at Motorola.

Some people are wondering if the ISO 9000:2000 series standards make Six Sigma superfluous. They typically refer to clause 8 of ISO 9001: “Measurement, analysis, improvement.”

It requires that companies install procedures in operations for the measurement of processes and data analysis using statistical techniques with the demonstration of continuous improvement . They also partly refer to the ISO 9004:2000 standards that embody guidelines and criteria for Self-Assessment similar to the national quality awards.

The author firmly believes that Six Sigma is needed regardless of whether a company is compliant with the ISO 9000 series. The two initiatives are not mutually exclusive and the objectives in applying them are different. A Six Sigma program is applied in organizations based on its top-line and bottom-line rationales. The primary objective for applying the ISO 9000 series standards is to demonstrate the company’s capability to consistently provide conforming products and/or services. Therefore, the ISO 9000 series standard falls well short of making Six Sigma superfluous.

The ISO 9000 series standards have from their early days been regarded and practiced by industry as a minimum set of requirements for doing business. The new ISO 9000:2000 stan

dards do not represent a significant change to this perspective. Six Sigma on the other hand, aims at world-class performance, based on a pragmatic framework for continuous improvement.

The author believes that Six Sigma is superior in such important areas as rate of improvement, bottom-line and top-line results, customer satisfaction, and top-level management commitment. However, considering the stronghold of ISO 9000 in industry, Six Sigma and ISO 9000 are likely to be applied by the same organization, but for very different purposes.

Improve your performance management with new version of ISO 9001

A quality management system enables you to manage your business processes effectively:

it is much more than a set of rules and procedures. When properly implemented and maintained, a QMS addresses the needs of your organisation and delivers tangible business benefits.

The new version of ISO 9001 has recently been published. One of the main aims of ISO 9001:2008 is to facilitate integration with other standards. Although there are no new requirements as such, there are some key clarifications to be taken into account.

There are three main objectives to the new standard:

Detail, clarify, improve the understanding of ISO 9001:2000 (previous version)

Improve compatibility with ISO 14001:2004 Simplify the way in which ISO 9001 can be integrated with other management system standards (such as OHSAS 18001)

There are no new requirements in the new standard:

The title, scope, and structure of the standard are unchanged

The process approach is confirmed

Compatibility with the latest revision of ISO 14001:2004 is maintained and improved upon

Preservation of the quality management principles included in ISO 9000:2000

There are five main areas to note. The relevant sections of the standard are noted in brackets.

1. A reinforcement of the notion of product conformity

2. Compatibility with other standards is evolving

3. A better understanding of outsourced processes

4. An editorial clarification of some requirements – for instance;

A reinforcement of the notion of product conformity2.3.4.

An editorial clarification of some requirements – for instance;A better understanding of outsourced processesCompatibility with other standards is evolving

• (6.4) work environment, including an explanatory note on work environment giving examples,

to help meet product conformity requirements

• (8.2.1) measurement of customer satisfaction, including a note broadening the scope beyond

satisfaction surveys to include other channels such as customer feedback5.

• (Introduction) the notion of risk

• (5.5.2) appointment of a management représentative

• (6.2.2) assessing the effectiveness of achieving compétence

• (8.5.2 et 3) assessing the effectiveness of corrective and preventive actions?

Some additional explanations regarding the requirements of the standard;An editorial clarification of some requirements – for instance;A better understanding of outsourced processesCompatibility with other standards is evolvingA reinforcement of the notion of product conformity

ISO 9001 Standards Certification

ISO 9001 Standards Certification

When an organization chooses not to pursue ISO 9001 certification or not to retain the ISO 9001 certificate, it should make no difference to the way the organization is managed. It’s similar to the man who chooses not to take the course examination. He still has the knowledge he has acquired whether or not he takes the exam and gets a certificate. What he cannot do is demonstrate to others that he has reached a certain level of education without having to prove it every time. People who know him don’t care that he didn’t take the exam. It is only those who don’t know him that he will have difficulty convincing.

Audit Of Electronic Documents In ISO 9001 Standards

Audit Of Electronic Documents In ISO 9001 Standards

Electronic documents that establish management system policies and procedures can be in a variety of file formats depending on the software applications that are utilized by the organization to generate the documents. Electronic file formats include, Text, HTML, PDF, etc. Spreadsheets and databases formats are also considered to be electronic “documents” subject to the control elements of the management system to being audited.

Given the relative ease with which users can now create electronic spreadsheets and other electronic documents, auditors (either internal or external) should ensure that policies governing the controls that apply to management system documentation in-general are also employed for electronic documents through appropriate procedures.

Organizations need to employ suitable and effective methods within the electronic environment for ensuring the adequate review, approval, publication and distribution of its management system documentation. These should be consistent with the methods for the development and modification of electronic documents.

In many cases document control measures may also be standard features of software applications used for their creation. Therefore auditors should understand these application-specific controls to the degree that these are utilized as a basis for conformance to the applicable management system standard.

Given the increased capacity to modify, update, reformat and otherwise improve documents within an electronic-based management system, auditors should pay particular attention to control elements such as document identification and document revision level.

As electronic media facilitates an increased rate of document modifications, auditors should verify that the controls being employed for the management of obsolete documents are considered within the organizations’ document control policies and procedures.

Auditors should verify that electronic-based documentation exists to provide orientation to users with regard to the functional and control aspects associated with electronic documents. Additionally, “Point-of-use” requirements associated with the applicable management system standards will typically be addressed in part by the organization’s document access policies. Auditors should understand the organization’s policies and procedures regarding user privileges as these become important factors for properly realizing the organization’s processes.

External electronic communication with suppliers, customers and other interested parties may involve the exchange of documents. Given that these external documents may contain key parameters that specify the functioning of the organization’s processes, auditors should verify the degree to which these documents are formally introduced and controlled within the electronic-based management system.

Different Between Quality Assurance & Quality Control

QA: Quality Assurance is the process which are having their eyes on the process to provide the assurity of the quality. like doing the testing at the time of development, giving the review comments and forced the developers to fixed the defects of the requirement, designed, coding and testing phase is the Quality Assurance.

Quality Control: Before delivering the product to make sure that all the documentation are provided, product has meet with the requirement criteria, all the SDLC phase are met with the exit criteria is the Quality control.

Difference between Quality Control and Quality Assurance? Quality Control Quality Assurance Definition QC is about checking at the end of some development process (e.g. – a design activity) that we have built quality in i.e. that we have achieved the required quality with our methods. QA is about having an overall development and management process that provides right environment for ensuring quality of final product. Description QC is like testing a module against requirement specification or design document, measuring response time, throughput etc. QA gives us added assurance that the whole producing or checking process is properly planned and executed and thus maintaining high quality. What it does To check that the modern methods of software development are largely designed to ensure right quality is achieved. QC checks that these methods are in place and to discover where they are not then corrections are to be made. It gives us added assurance that the while producing / checking process is being properly planned and executed and hence is keeping high our chances of producing software of required quality. Stages Define features and levels Define feature check procedure Carrying out the check procedure Record the result take and record any corrective action taken. 1. Determination of quality policy through Quality Management System 2. Checking that predetermined Quality control activities are being properly taken care off. Best carried out on QC is best carried out on products QA is best carried out on process. Phase of implementation QC should take place at every stage of SDLC. QA should be done at end of every SDLC i.e. when product building is complete. Technique Structured walkthrough, Fagan Techniques are some of QC techniques. Quality policy defined and generally implemented in the form of Quality Management System is used to carry out QA.

As per ISO 9000 Standards:

Quality Control means – The Operational Techique and activities that are used to fullfill requirements of Quality,

Quality Assurance means – All Those planned and systematic activites implemented already , to provide adequate confidence that an entity will fulfillrequirements of Quality.

The following table can explain in detail:

QC QA

Product Process

Reactive Pro-active

Line Function Staff Function

Find the defects Prevent the defects

e.g.

QC QA

Walkthrough Quality Audit

Testing Defining Process

Inspection Selection of tools

Checkpoint Review Trainings

Step by Step: Leading your company to Successful ISO 9001:2008 Registration

Step by Step: Leading your company to Successful ISO 9001:2008 Registration

1. ISO 9000 Introduction, a Process approach.

2. Gap Analysis: Schedule the Gap Analysis, Conduction and ISO 9001 Gap Analysis.

3. Prepare a Project Plan: The Team approach, Steering Team, Task Teams.

4. Train employees on ISO 9001: Mamagement Overview, Employee awareness, Keeping them informed.

5. Document your system: How much Documentation do you need, Importance of Documentation control

6. Implement the QMS in your Organization:Training on new procedures, Training of internal auditors.

7. Audit your QMS: Train internal Auditors, Conduct Internal Audits.

8. ISO 9001:2008 Registration Audit: Selecting a Registrar and then go ahead with registration.

Document Review In ISO 9000 Standards

Document Review In ISO 9000 Standards

The ISO 9000 Standard requires that documents be reviewed.
Previously the implication was that the review was a check by potential users that the document was fit for purpose before it was offered for approval. It
could be construed that for a document to receive approval it must be checked and therefore review and approval in this context are one and the same
and the requirement is in this instance enhanced rather than relaxed.
A review is another look at something. Therefore document review is a task that is carried out at any time following the issue of a document.
This requirement responds to the Continual Improvement principle.
Reviews may be necessary when:
- Taking remedial action (i.e. Correcting an error)
- Taking corrective action (i.e. Preventing an error recurring)
- Taking preventive action (i.e. Preventing the occurrence of an error)
- Taking maintenance action (i.e. Keeping information current)
- Validating a document for use (i.e. When selecting documents for use in connection with a project, product, contract or other application)
- Taking improvement action (i.e. Making beneficial change to the information)
Reviews may be random or periodic. Random reviews are reactive and arise from an error or a change that is either planned or unplanned. Periodic reviews
are proactive and could be scheduled once each year to review the policies, processes, products, procedures, specification etc. for continued suitability. In
this way obsolete documents are culled from the system. However, if the system is being properly maintained there should be no outdated information
available in the user domain. Whenever a new process or a modified process in installed the redundant elements including documentation and equipment
should be disposed of.