Background to ISO 9000 standards

ISO 9000 has revolutionized the quality domain It controls quality, saves money, customers expect it, and savvy suppliers use it. ISO 9000 can be applied to all kinds of organizations. It helps both product- and service- oriented institutions attain unprecedented improvements in quality. It can be implemented in small, medium and large-scale organizations, and it is applicable to organizations in the industrial, software and service sectors.
The needs of modern businesses are numerous and manifold. The ISO 9000 standards are applicable to all areas of the international business, because they are international in scope. Furthermore, ISO 9001:2000's new focus on customer satisfaction ensures that supplier product precisely meets the needs of the customer. The revised standards will be of specific help to organizations wishing to go beyond simple compliance with Quality Management System requirements for the sake of certification.

Essential Changes to the ISO 9000 Series

In order to reflect modern management approaches and to improve organizational practices, structural changes were necessary. ISO has taken care to maintain the essential requirements of the past ISO 9000 standards.
The ISO 9000 family contained more than 20 standards and documents. This proliferation of standards was a particular concern of ISO 9000 users and customers. To respond to this concern, the ISO 9000:2000 family was narrowed down to four primary standards supported by a considerably reduced number of supporting documents (guidance standards, brochures, technical reports, technical specifications). To the extent possible, the key points in the past documents were integrated into the four primary standards, and sector needs addressed while maintaining the generic nature of the standards. The four primary standards are:

• ISO 9000: Quality management systems - Fundamentals and vocabulary
• ISO 9001: Quality management systems - Requirements
• ISO 9004: Quality management systems - Guidance for performance improvement
• ISO 19011: Guidelines on quality and/or environmental management systems auditing (To be published)

Why do companies want ISO 9001?

Many organizations decide to Implement ISO 9001 and obtain registration because it assures customers that the company has a good Quality Management System (QMS) in place. An organization with an effective QMS will typically meet customer expectations better than an organization that does not have an effective QMS. Many organizations require their suppliers to have ISO 9001 Registration.

Disadvantages of Templates for Quality Manuals and Forms

The disadvantages of using templates can be summarized in two categories:
Bad Templates: There is a significant danger in using bad templates. Not only could you lose many of the above listed benefits, the result of bad templates could even be the opposite of those benefits. We recommend that you carefully chose your templates. Please see our reviews section for reviews of numerous ISO 9000 templates on the market.
Bad Usage: No matter how good the templates, they will always require customization. Templates that are blindly adopted as one's own quality manual or forms could be a liability as they may not fit the company. In addition, the customization process of templates provides valuable benefits as it allows the user to focus on improving their own company's processes. Skipping the focus on customization is a missed opportunity for improvement.

How does ISO 9000 interact with other standards?

ISO 9000 is the standard for a quality management system that closely resembles many other management systems. These other systems, based on health, safety, the environment, and business continuity, can be integrated into an overarching business management system. Benefits of this system include aligned interests, reduced costs, and improved efficiency. With one of these systems in place, it is easier to implement any of the others; many documents required for a different standard are already prepared, and personnel are already accustomed to the audit process. Using multiple standards will not only increase the efficiency of an organization, but increase the integrity of its operations.

What are ISO and BS standard?

ISO is the International Standard Organization. It is essentially a federation of national standards bodies from around 150 different countries.
Established in 1947, it is non-governmental organization, with a mission broadly to promote the development of standardization with the objective of facilitating international trade. ISO standards are of course prefixed with 'ISO' (eg: ISO 9000).
BSI is the British Standards Institute. This is the oldest standards body in the world, stemming from a meeting of various industrial institutes in 1901. It alone currently publishes over 20, 00 standards and has operations in over 100 countries. The prefix for its standards is BS (e.g.: BS7799).

To which standard is my organization to be registered/certified?

As the currently existing ISO 9001,ISO 9002, and ISO 9003 standards have been replaced by the revised ISO 9001 standard, the choice is clear and simple: all organizations will be registered/certified to ISO 9001-2000. The scope of registration/certification will need to reflect clearly the activities covered by the organization's Quality Management System, and any exclusions to non-applicable requirements of the standard (through clause 1.2 "Application") documented and justified in the quality manual.

How to implement the requirements of CS ISO 9001:2000 in my organization?

As a minimum you should familiarize yourself not only with the requirements of CS ISO 9001:2000 but also with the content and philosophies given in CS ISO 9000:2000, CS ISO 9004:2000 and the Quality Management Principles. You have to clearly understand your organization’s activities and processes and appropriately interpret the requirements of the standards. Implement the requirements in the various activities and processes adding value to these processes and activities. For training programmes on general awareness on the requirements, content and philosophies of the CS ISO 9000 standards, The Department of Industrial Standards of Cambodia (ISC) may be contacted.

What will happen to the ISO guide for small business?

The "Guide for Small Businesses" was published by ISO in 1996 and was intended to provide guidance from ISO/TC176 for the 1994 versions of ISO 9001, ISO 9002, and ISO 9003. ISO 9001-2000 applies a more generic approach, devoid of the hardware and manufacturing bias of the current standard, and is designed to be much more user-friendly for smaller organizations. It has recently been decided to withdraw the 1996 edition in favor of developing a new guide, which is intended to be released sometime during the first half of 2001.

What are the differences between the final published standards and the previously circulated final drafts?

The differences between the final published versions and the final drafts of ISO 9001 and ISO 9004 are only slight -- the changes are editorial in nature, to improve the clarity of the documents. ISO 9000 has been substantially modified in the area of defining auditing. These changes have been made in light of the current work being done to update ISO 19011, Guidelines on Quality and/or Environmental Management Systems Auditing.

ISO GLOBAL STANDARDS

Representatives from nearly 30 countries worked together to develop an International Standard (ISO) for market research.
The ISO 20252 norm for market, opinion and social research was approved in February and launched in May this year. 22 member countries sat on the technical committee and their national ISO institutions unanimously voted in favour of its adoption. Countries involved in developing the norms represent around 90% of the global market research market.

ISO 8601

This category is for sites with information and comments about International Standard ISO 8601, the Date and Time Standard now officially adopted in nearly every country of the world. This standard defines various formats based on Year-Month-Day for Dates, and Hours:Minutes:Seconds for Time, as well as covering the numbering of Days within the Year, Months and Weeks within the Year, and Days within the Week. Click the ISO 8601 link above to access this reference section and the further links to various other ISO 8601 information sites.

Official source of the standard

THE STANDARDS
The standards themselves are now most commonly procured in the form of downloads, usually in PDF format. The major two standards, ISO 14001 and ISO 14004, along with the audit standard ISO 19011, can be obtained via the ISO 14000 Download Page at BSI's Standards Direct outlet.
MANUAL, PROCEDURES, TEMPLATES
There are many commercial offerings of templates and tools to assist in the implementation and understanding of these environmental management standards. One of the most straight forward and widely used of these is the ISO 14000 and ISO 14001 Toolkit. This offers a wide range of fundamental items and forms targeted specifically at the standards.

What do the standards apply to ?

This is primarily for the company to decide, and to clearly document the extent of coverage. However, limiting coverage to a small [inconsequential] area may provide competitors with an ideal marketing opportunity!. There does not appear to be a limit to the coverage of the environmental management system in that it can include the organization's products, services, activities, operations, facilities, transportation, etc.From a slightly different viewpoint, all of the elements in the previous sentence should be considered for environmental impact resulting from current practices, past practices and future practices, and should further be reviewed for their impact under normal, abnormal and emergency conditions.

Consultancy

Aims management consultant’s takes pride in having an expert and skilful team of consultants. They come with years of experience of regulated industries such as healthcare & aviation. They would not only understand your needs better but would also be instrumental in helping you make a decision about a quality management system.
Aims management consultants offers a free and open discussion between clients and consultants. Our consultants will provide guidance through the entire process. So, whether you want assistance to install our system or still thinking, please call our consultants to take advice on compliance related issues. We will not only offer you a free onsite / online demonstration of our systems, but also steer you through the entire process.

The benefits of ISO 14000 certification

The benefits of acquiring ISO certification go beyond the satisfaction of doing a good deed. Adhering to the standard may result in better conformance to environmental regulations, greater marketability, better use of resources, higher quality goods and services, increased levels of safety, improved image and increased profits.
The environmental awareness and the documentation that are required by the ISO 14000 standards assist a company in conforming to environmental regulations. This means that a company, by diligently adhering to the standard, is less likely to violate environmental regulations and is always ready for inspection by a regulatory agency. In addition, the certification and documentation may aid a company in acquiring capital, in defending itself during environmental litigation and in receiving insurance or per mits.
A wider market for a company's goods and services may result from certification. Many corporations and governments will be looking for suppliers that are ISO 14000 certified in order to maintain their own certification and environment-friendly image. Al though the European Union claims that ISO 9000 certification is not required to do business in Europe that was the message received by many non-European firms and lead to the amazing success of that standard. If ISO 14000 is similarly successful, the co mpanies who are already ISO 14000 certified will have an advantage in global markets. Also, producers of consumer goods may find that many consumers not only try to purchase goods from environment-friendly companies, but will spend a little more if they feel they are helping the environment. In order to reap this benefit, a company must make their environmental efforts known through advertising and labeling.

AS 9100:2001 Aerospace Standards

When the aerospace industry realized that it was necessary to supplement the ISO quality management system model to satisfy internal, government and regulatory requirements for the aerospace industry, AS 9100 was established. This standard comprises the ISO 9001:2000 requirements augmented by aerospace industry requirements. It was the result of an international effort by aerospace companies with a common goal of establishing a quality management system for use within the aerospace industry.
To assure customer satisfaction, aerospace industry organizations must produce, and continually improve safe, reliable products that meet or exceed customer and regulatory requirements. The globalization of the aerospace industry, and the resulting diversity of regional/national requirements and expectations, has complicated this objective. End-product organizations face the challenge of assuring the quality of, and integration with, product purchased from suppliers throughout the world and at all levels within the supply chain. Aerospace suppliers and processors face the challenge of delivering product to multiple customers having varying quality expectations and requirements.

QS/TS 16949:2002 Automotive Quality Management System

QS/TS 16949 is an enhanced version of ISO 9000 that reflects the needs of the automotive industry. The title is indicative of the current transition status from QS 9000 to TS 16949. This certification is required for all first-tier suppliers of the Big Three automakers.
The goal of ISO TS 16949 is the development of a quality management system that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain.
This specification together with applicable customer-specific requirements, defines the fundamental quality management system requirements for those subscribing to it.It is intended to avoid multiple certification audits and provide a common approach to a quality management system for automotive production and relevant service part organizations. It can be applied throughout the automotive supply chain.

Manage Your Documentation/Implementation Project

some companies prefer that the project be lead by an expert in ISO compliance. For those companies, we provide a project manager, who is on site one day per week for three months. With the support of your company's management staff, the project manager:

• Organizes the work
• Assigns responsibilities
• Develops and monitors schedules
• Supervises activities

These five documents are:

A) ISO 9000
Quality Management and Quality Assurance Standards- Guidelines for selection and use.
B) ISO 9001 Quality systems –Model for quality assurance in design, production, installation and servicing. This is the most comprehensive standard.
c) ISO 9002
Quality systems – model for quality assurance in production and installation. This standard has 18 clauses.
d) ISO 9003
Quality systems –Model for quality assurance in final inspection and test, Requires conformity with 12 clauses.
e) Quality management and quality system elements -Guidelines

Easy ISO 9001 Implementation with our templates

High quality ISO templates are the fastest, easiest and most cost efficient way to implement ISO 9001:2008

• Good ISO 9001 templates provide many advantages to you.
• The ISO 9000council recommends our templates.
• Our ISO 9001 quality templates have unique feature that make the very best for you and your company.

Remember that the quality of the ISO 9001 templates has a large impact on your ISO 9001 implementation project and the efficiency of your business operations.

Benefits of ISO/TS 16949

• Fosters improved product & process quality.
• Incorporates the best lessons learnt from the global automotive realm
• Provides additional confidence for global sourcing.
• Ensures a global quality system approach in the supply chain for supplier/subcontractor service consistency.
• Reduces variation, waste & improves the overall efficiency in production levels.
• Provides a common platform to address world wide quality system requirements.
• Formatted to allow easy conversion to ISO 9001/2000.
• Advantageous to the up gradation of existing quality systems,
  

About ISO 13485:2003

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001All requirements of ISO 13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.

The Cost of ISO 9001 Certification?

Though there are costs incurred in attaining ISO 9001, the exercise should really be used as a means to apply more efficient business practices and lift performance across the organisation with the aim of increasing customer value, revenue and profit. With this approach it should be possible for ISO 9001 to virtually pay for itself. There are THREE basic cost elements to gaining ISO 9001; the external costs of using a consultant, the cost of the external assessment and registration, and the generally less defined costs related to the time and effort expended by the organisation's own people. There may also be some training requirements (e.g. Internal Auditing), but this can sometimes be included within the consultancy work. Below is a breakdown and some examples of these costs.

Attaining ISO 9001 certification

once the systems are in place and you have undertaken a number of internal audits and have embedded the key management review process, an application for assessment can be made with one of a number of Certification Bodies who should ideally be UKAS accredited.
The assessment process is now carried out across two stages, or visits, with Stage 1 intended to ensure that all of the required systems and processes are in place, and the assessor may make any recommendations at this point. The Stage 2 visit will follow about four weeks later and is the actual audit of the management system against the ISO 9001 standard.

What will ISO do for me?

Because DRL operate a management system that applies the principles of ISO 9001, our customers can be confident that we will deliver solutions that meet your requirements consistently, and that we are committed to improving our customer experience.
Direct Response customers can thus rely on our proven management structure. They can expect consistency from all levels of management and immediate senior management involvement should you feel that there is a problem. You can be sure that you will be fully informed about product development and that fault handling is treated as a matter of urgency.

What Are ISO 27001 and ISO 27002?

ISO 27002 is of course based upon the 17799 standard, and is described as a set of information security controls describing "best practices in information security". These controls are intended to be selected from whilst implementing a security strategy. The document was originally published by the DTI in the United Kingdom as a 'code of practice', and later went on to be published as BS7799-1. This was later republished as ISO17799 (which was again updated in 2005). This in turn became ISO 27002 in 2007.

An ISO17025 FAQ

The ISO 17025 Quality Management System Model provides structure using the industry standard ISO 9001 approach. It embraces trusted methods and frameworks to help provide a stable quality environment. To enhance understanding, and provide a little more detail, we have created our own FAQ:

Other ISO14000 Series Standards

Other standards in the series are actually guidelines, many to help you achieve registration to ISO 14001. These include the following:

• ISO 14004 provides guidance on the development and implementation of environmental management systems
• ISO 14010 provides general principles of environmental auditing (now superseded by ISO 19011)
• ISO 14011 provides specific guidance on audit an environmental management system (now superseded by ISO 19011)
• ISO 14012 provides guidance on qualification criteria for environmental auditors and lead auditors (now superseded by ISO 19011)
• ISO 14013/5 provides audit program review and assessment material.
• ISO 14020+ labeling issues
• ISO 14030+ provides guidance on performance targets and monitoring within an Environmental Management System
• ISO 14040+ covers life cycle issues

COMPLYING WITH THE STANDARDS

ISO 14001 is the only standard intended for registration by a third party (along the lines of ISO 9001 or QS 9000). All the others are for guidance.
Whether seeking formal certification or not, the start point is often difficult: What is required? Where can I get ISO 14001 Policies? Where do I learn about ISO 14000? What about procedures?. The list of questions is long.
Fortunately, there are resources available to help. The one recommended by this portal is The ISO 14000 Toolkit. This offers outstanding value, and includes a number of substantial and quality components: an ISO 14001 policy manual, a set of procedures, a comprehensive ISO 14000 training presentation, an audit checklist, a significant number of data collection forms, etc

A bout ISO

Since 1971, ISO has been a leading source of information about risk.
We supply data, analytics, and decision-support services for professionals in many fields, including:

• Property/casualty insurance
• mortgage lending
• Healthcare
• Government Human resources

We also offer information for risk managers in all industries.
To serve our clients, we draw upon our vast experience in data management and security and our expertise in predictive modeling. We analyze data and present information in formats our customers can use. And we develop practical tools that integrate into our customers’ workflow.
In the United States and around the world, our products help customers protect people, property, and financial assets.

Social Responsibility

ISO, the international organization for standardization, has decided to launch the development of an International Standard providing guidelines for social responsibility (SR).
The guidance standard will be published in 2010 as ISO 26000 and be voluntary to use. It will not include requirements and will thus not be a certification standard.
There is a range of many different opinions as the right approach ranging from strict legislation at one end to complete freedom at the other. We are looking for a golden middle way that promotes respect and responsibility based on known reference documents without stifling creativity and development.
Our work will aim to encourage voluntary commitment to social responsibility and will lead to common guidance on concepts, definitions and methods of evaluation.
The need for organizations is both public and private sectors to behave in a socially responsible way is becoming a generalized requirement of society. It is shared by the stakeholder groups that are participating in the WG SR to develop ISO 26000: industry, government, labor consumers, non governmental organizations and other, in addition to geographical and gender based balance.

The ISO 20000 Alignments and Certification Roadmap

• Alignment and certification - roadmap
• Requirements for certification, in terms of people, process , technology and Management commitments
• Challenges, Approach, critical success factors
• A brief case study

Required Prerequisites

Participants are expected to have some prerequisite knowledge of information security and ISO/IEC 17799 /BS 7799 standards, or must have been exposed to other Management System Standards such as ISO 9000 or ISO 1400 series. As implementers or consultants”.

Getting an ISO certification

All requirements of ISO are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Companies need to define, document and implement the requirements of the standard ISO 9001:2000 in order to get certified.
Companies that decide to go for an ISO certification first need to consult an individual quality auditor or a firm of quality consultants who are well versed in ISO matters. They need to seek a detailed orientation for understanding and thereby adequately meeting the requirements of the quality system standards.
The top brass of an organization planning to go in for ISO certification should first identify under what ISO category their organization falls viz: ISO 9001, 9002 or 9003. They need to share the commitment to seeking ISO certification with all levels of management, choose an ISO representative and also decide whether to use a consultant or not.

Quality Management

Certification to the requirements of quality management systems standards, such as ISO 9001:2000, is recognised as a tried and tested way of improving company performance and productivity and is a benchmark for working towards and achieving business excellence.
Not only are you able to use quality management systems as an effective management tool to add value to your product or service offering, but you can demonstrate to your customers, supply chain and the community at large that you minimise risk and reduce wastage. Increasing customer confidence is critical to your profitability and market edge, achieved through clearly defined objectives and a buy-in from the whole organisation.
ISO 9001:2000 is suited to any sector of industry, type or size of organisation you operate, its guiding principals are suited to you.
With the ability to streamline your systems and processes, together with the opportunity to integrate these with those you have already identified in your business plan you are now in a better position to run your business more efficiently and effectively. Not only are you able to cut out unnecessary duplication of work but more importantly the amount of time and effort spent doing this will be significantly.

The standard combines generally recognized key elements to ensure food safety along the food chain,including:

• Interactive communication
• System management
• Control of food safety hazards through pre-requisite programmes and HACCP plans
• Continual improvement and updating of the food safety management system
  
  

Aims management consultants company information

Aims management consultants operate nationwide successfully servicing all 9001, 14001, 18001, SIA - Quality, Health, Safety & Environmental requirements.
From sole proprietor to large nationals & institutions we have successfully applied the same RESULT DRIVEN practical approach to gaining ISO 9000/9001, ISO 14000/14001 & OHSAS 18001 registration.
We deliver comprehensive programmes - fixed fee, guaranteeing UKAS approved registration within a given time-scale.
Our process of achieving ISO 9001, 14001, 18001 or integrated system Certification is not “quick-fix” but adds robustness to your management activities, - concise systems encouraging “buy-in” from both management & staff alike.

How satisfied are our Customers?

• Very satisfied! Virtually all customers are happy withour products and our expert customer support.
• Less than 0.2% of our customers have had a complaint (and any complaint is swiftly addressedby our customer service team).
  

Three Keys to Continuous Improvement

How can a company ensure that it is leveraging its ISO system to create an environment where dramatic innovation can occur? The ISO 9001 Quality Management System framework has a built-in process intended to bring about continuous improvement. However, without proper attention to Management Reviews, Internal Audits, and the Corrective/Preventive Action Process, you may not be getting the biggest bang for your buck. This presentation will discuss, using case studies, how these three important elements of an ISO system provide the keys to continuous improvement. Mr. Anton helps companies improve profitability by applying and integrating proven strategies such as ISO 9001, MRP/ERP, and Lean Enterprise. As a speaker, he injects frequent examples from his years of hands-on manufacturing experience and consulting work.

Value-added Consultancy:

At Olive, our business analysts, technical consultants and software engineers will analyse your competition and revenue models; define your requirements; and develop strategic e-business solutions and business intelligence tools to re-engineer and optimise business processes. Olive develops integrated, interoperable and fully scalable e-business solutions that function in a complex, distributed environment with heterogeneous platforms and evolve with business growth, while requiring minimum maintenance/support.

Quality Certification like ISO -9001, TQM

We offer Quality Certification services that helps in effective management control, marketing advantage, international acceptance and competitive advantage in quality & market-hold.
· Assistant on getting quality certifications
· Providing Training on ISO 9001 : 2000 Standard
· Providing Training on the Statistical Training
· Refresher Training on the Statistical Technique
· Refresher Training to the Company's Internal Quality Auditors on the requirement of the new standard. Internal QMS audit under the revised standard (to verify the effectiveness of implementation of QMS documentation and recording the finding

Overview of the standards

Quality management system: This section details the general and documentation requirements that are the foundation of the management system. The general requirements ask you to look at the processes of the management system, how they interact with each other, what resources you need to run the processes; and how you will measure and monitor the processes. The second part of the section then sets out the requirements for the documentation needed to effectively operate the system and how the documentation should be controlled.
Management responsibility: The management of the systems is the responsibility of the “top management” at a strategic level in the organization. The “top management” must know customers’ requirements at a strategic level and make a commitment to meeting these as well as statutory and regulatory requirements. “Top management” must also set policies; and to achieve these policies set objectives through planning how the objectives will be met.“Top management” should also ensure that there are clear internal communications and that the management system is regularly reviewed.
Resource management: This covers the people and physical resources needed to carry out the processes. People should be competent to carry out their tasks and the physical resources and work environment need to be capable of ensuring that the customers' requirements are met.

Profile

We are a team of professional engineers having rich industrial experience, practically involved in development, implementation and monitoring of various systems and “Total Quality Management’ in organizations, committed to provide consultancy / training in the field of Quality / Environment Management Systems, Shop-floor improvement practices and other emerging trends in the industries for the overall improvement and growth of manufacturing and service sectors.

ORGANISATIONAL RESPONSIBILITIES:

Special invitee in the Board of Directors of the Hospital since its inception.
Management Representative in ISO 9001 : 2000 programme.
Member of the National Committee on Health and Family Planning, CII.
Member of Committee on HIV/AIDS Trust, CII.
Chairman of Selection Panel of State Chapter of BYST, and autonomous trust of CII.
Founder of Rotaract(Youth wing of Rotary International) at AIIMS.