10 Critical Success Factors that make an ISO implementation successful

10 Critical Success Factors that make an ISO implementation successful.
They are, in order of importance:
· Management’s recognition of their crucial role in the ISO system management process
· Involvement of people at all levels in the organization
· Developing a better understanding of the organizational processes and the critical points in the process that must be controlled to satisfy customer needs & expectations
· People trained in how to do their job (including ISO Training)
· A willingness to provide the effort and self-discipline to change the system for the better
· Focusing on organizational development & improvement, not on just getting to the ISO certification finish line
· Finding the right balance between too much ISO paperwork, and not enough information to do the job consistently.
· Dedication to following the agreed procedures at all levels in the organization
· Keeping the organization focused on meeting the ISO implementation timeline
· Effective ISO Audits
· Timely management response on feedback of how the system is functioning, and how it can be improved
we can ensure that you go through each of the success factors effectively to enable your organization realize true potential of the ISO certification. Our ISO consultants ensure that you improve your process performance and achieve ISO certificate with tangible business improvement benefits.
Contact us at www.isoconsultantsdelhi.com or call us at +91 9212293916

Your Journey to ISO 9001 Certification

• Preparation

Realistically, if you are new to the ISO 9001 standard, then you are going to need some guidance. Once contact is made, we'll discuss your requirements with you and suggest the solution that best suits your needs. After assessing your needs we will give you a fixed price quotation so that you know exactly how much your registration will cost.

• Application

Once you decide to go-ahead, we'll assign a Lead Assessor to you. He or she will be your principal contact throughout the registration process and beyond. They will build-up detailed knowledge of your business and will offer you the support you need.

• Pre-Audit Assessment

Your Lead Assessor will visit you to explain the standard and ensure you are prepared for your Audit Assessment. He or she will facilitate the process to ensure that all of the correct procedures are drafted; ensuring that all documented procedures cover the requirements of the standard. Together, you will then determine the appropriate timetable for your Audit Assessment. Many organizations benefit from a pre-assessment "dry run" and your Lead Assessor will be able to advise you on this.

• Audit Assessment

Once you are ready for your formal Audit Assessment, your Lead Assessor will make the required arrangements for you. On completion, you will be informed of the Auditor's recommendation before he or she leaves your premises.

• Registration & Certificate

Following the independent Auditor's recommendation, your registration will be formally confirmed. Soon after, your certificate of conformity to the ISO 9001 standard will be issued and sent to you.

What Are the Significant Changes to ISO 9001:2000?

The ISO 9001:2000 changes include:

• Easier adaptation to a wider range of organizations
• Focus on a process approach, including a process model
• More consistent terminology
• Reduction in the amount of required documentation
• Enhanced compatibility with ISO 14000
• Less-prescriptive documentation requirements
• Linkage of Quality Management System to organizational processes
• Continual improvement of the Quality Management System
• Significant emphasis on achieving customer satisfaction

In order to conform with ISO 9001:2000 requirements your organization should realize the following steps:

• Obtain information about the ISO 9000 family
• Obtain management commitment and designate responsible persons for QMS
• Prepare Action Plan
• Conduct awareness sessions with all personnel to explain ISO 9000
• Develop Quality Policy based on Company Mission and expectations of interested parties (stakeholders)
• Establish at relevant functions and levels within the organization measurable Quality Objectives including those needed to meet requirements for products
• Identify QMS processes and bring them into conformity with ISO 9001:2000 requirements
• Identify parameters for each process that is necessary to organize control over it, for example process outputs, inputs, resources, cycle time at alias
• Identify and ensure personnel qualification and competency needs for each process be done as it was planned
• Create documented procedure required by ISO 9001:2000
• Measure, analyze and improve identified QMS processes
• Establish and maintain a Quality Manual

Are the ISO 9000 Quality System Standards only for countries that are exporting?

This is a common misconception. Any company which implements a quality system to an ISO 9000 standard stands to gain significant benefits for its operation even if the company is not involved in export. This is true regardless of its size, product or service. The ISO 9000 standards indicate basic conditions which a company must satisfy for compliance. The standards are generic, and therefore do not give specific details on how the company will attain compliance.

Facilitating successful ISO 9000 implementations since 1991

• Published 10 books on ISO 9000
• Been a monthly columnist for Quality Systems Update Magazine for over two years
• Presented at every major conference on ISO 9000 in the USA
• Been recognized as a Certified Quality Manager by the American Society for Quality
• Innovated “Quality as a Profit Center” at companies such as Dell Computer

Key topics include:

Interpreting the ISO 9001 requirements, with emphasis on auditing beyond compliance

• Understanding the audit system using the ISO 19011 guidance document
• Embracing the role of audit team leader
• Planning activities including audit program management, audit agenda planning, checklist preparation, and team management skills
• Reviewing and evaluating quality system documentation
• Conducting the audit, including interviewing skills, managing audit team members, addressing problems with the auditee, and daily reporting activities
• Reporting nonconformities in a factual, helpful manner
• Writing a summary report from your audit

Summary of ISO 9001:2000 in informal language

• Decisions about the quality system are made based on recorded data and the system is regularly audited and evaluated for conformance and effectiveness.
• Records should show how and where raw materials and products were processed, to allow
• Products and problems to be traced to the source.
• You need a documented procedure to control quality documents in your company. Everyone must have access to up-to-date documents and be aware of how to use them.
• To maintain the quality system and produce conforming product, you need to provide suitable infrastructure, resources, information, equipment, measuring and monitoring devices, and environmental conditions.
• You need to map out all key processes in your company; control them by monitoring, measurement and analysis; and ensure that product quality objectives are met. If you can’t monitor a process by measurement, then make sure the process is well enough defined that you can make adjustments if the product does not meet user needs.
  

Aims Management Consultants International Policy on Transition to other standards

Aims Management Consultants International recognises that to some Organisations, ISO 9001:2000 Registration is just a starting point for a Company’s development under International Standards.
Holders of certification to ISO 9001:2000 can extend Certification to other Standards and aims management consultants International Technical Staff would be pleased to discuss this.
As part of the ongoing surveillance process, assessment personnel will raise reports against the customers current standard(s) and will also highlight any areas for development to ensure a smooth transition to additional standards. Upon confirmation that a customer has implemented the necessary systems to acheive the standard, an aims management consultant’s International branded certificate of registration will then be awarded.

ISO 9001:2008 does not contain any new requirements

They have recognised that ISO 9001:2008 introduces no new requirements. ISO 9001:2008 only introduces clarifications to the existing requirements of ISO 9001:2000 based on eight years of experience of implementing the standard world wide with about one million certificates issued in 170 countries to date. It also introduces changes intended to improve consistency with ISO 14001:2004.

As a result of attending this briefing you will:

• Gain an understanding of the main changes embodied within the new ISO9001:2008 standard
• Be familiar with the structure of the ISO 9000:2008 suite of standards (ISO9000, 9001 and 9004)
• Be aware of the Eight Fundamental Principles on which the new standard is based
• Be aware of the responsibilities placed on 'Top Management'
• Gain a basic understanding of the 'process approach' to management systems
• Be familiar with the need to establish and describe the 'sequence and interaction of your processes'
• Understand the requirements for setting and measurement of 'Quality Objectives'
  

What is the impact of ISO 9001:2008 on certification?

One year after publication of ISO 9001:2008 all accredited certifications issued (new certifications or re-certifications) shall be to ISO 9001:2008. Twenty four months after publication by ISO of ISO 9001:2008, any existing certification issued to ISO 9001:2000 shall not be valid.

Policies, Procedures and Forms

Procedures define who does what, when, and where. Work instructions explain how a particular task within the process is performed. Forms are created, controlled, and distributed and should be re-enforced with training so that workers know how and when to use them. Completed forms create the records that capture key process data - important information needed for improvement.
This is the beginning of a quality management system. The intent of the Documentation Phase is to collect data (records) from your processes that you will employ in the next phases and lead to real improvement. To move out of the Documentation Phase you will need to chart, trend and analyze your data. Typical tools used to get out of this phase include Pareto charts, histograms, run charts, and SPC (Statistical Process Control), all critical pieces for phase three.

Read this basic ISO 9000 Implementation Overview

The ISO 9000 standard is a set of requirements on how to do business. The requirements affect virtually all aspects of a company (not only the quality control function, as some people wrongly believe).
In order to implement ISO 9000, a company must do all of the following:
a) Create numerous documents: you need to write an ISO 9000 quality manual, ISO 9000 procedures, a quality policy, quality objectives, and company-specific work instructions. This can be much easier if you use good templates (as available in our Products section) and modify them to meet your company's circumstances.
b) Implement the procedures and instructions. Unless your company has been following other quality management systems, it is very likely that your ISO 9000 procedures and work instructions require you to do some things differently. You will need to adjust business processes and train employees so that your new procedures and instructions are being followed.
c) Keep records. ISO 9000 requires you to keep many records. Well-designed forms (as available in our Products section) can be of tremendous help; they not only help you meet the record keeping requirement, but they can also serve as a step-by-step guide on how to perform a certain process (for example, the selection of your vendors).

We are an ISO 9000 Registrar committed to open lines of communication

We let you know at once what we are seeing, doing, and finding. We invite your feedback and discussion. No preconceived ideas, just open, objective minds.
The ISO 9001 audit process involves interviewing employees at all levels and reviewing records. Our purpose is to document with objective evidence the system's effectiveness. SQA holds daily wrap-up meetings to go over the events of the day and solicit further input if needed.
At the end of the assessment, SQA conducts a closing meeting where findings and recommendation status are discussed. The entire process is intended to be value-added.

What are the ISO standards?

Developed by the ISO Technical Committee 176, published in 1987 and updated approximately every five years, the standards comprise five documents whose focus is Quality Assurance Systems.
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 with 20 clauses.
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

Cost of an ISO 9001 Quality System

While operating a good ISO 9001 quality system results in significant cost savings (even after paying the periodic audit fees of about $1,000 - $2,000 per auditor day), the initial ISO 9001:2008 implementation can be expensive. Large companies often spend in excess of hundred thousand dollars, while small companies could get by with a thousand dollars. We found that small to medium size companies can achieve significant savings by implementing the ISO 9001:2008 quality system internally in-house using a good template or sample for a quality manual and quality procedures. We prefer the featured ISO 9000 starter package which includes everything you need to start ISO 9001:2008 because it provides detailed customization instructions, it is so easy to understand and easy to implement, and the resulting ISO 9001:2008 quality system is very un-bureaucratic and efficient.

MONITOR AND MEASURE YOUR QMS PROCESSES

• Select suitable methods to monitor and measure the processes that make up your organization's QMS.
• Monitor and measure your QMS processes.
• Take appropriate action whenever your QMS processes fail to achieve planned results.

A little bit of history

Traditional views of quality control and assurance methods have produced a negative legacy which ISO 9001 2000 seeks to address by its newly simple, proactive, and adaptable approach.
Its popularity has been promoted by its use as a supply chain management tool by many large industries, who quickly saw the cost benefits of requiring suppliers to be independently audited and certified to ISO 9001, rather than maintaining their own staff to carry this out.
The ISO 9000 standard is continually being revised by standing technical committees and advisory groups, who receive feedback from those professionals who are implementing the standard.

Why choose World Certification Services?

World Certification Services offer value-added assessment and registration services thanks to trained and experienced Lead Auditors with the ability to undertake their work impartially and in a friendly manner. World Certification Services has a wide scope range and has plans in place to extend these further when client needs are identified. World Certification Services is continuously assessed by UKAS and ANAB so you can be sure that high standards are maintained at all times.

International Automotive Task Force Announces New Auditor Development Process

The International Automotive Task Force (IATF) recently announced a new auditor development process for existing auditors.
The new process uses a Web-based delivery system for the training and assessment of IATF auditors. The system will be available on January 31 in English and all other IATF-translated languages on March 31.
All current IATF auditors whose credentials expire before May 31 will be extended until June 30 to allow them time to review and comply with the new process. All auditors who are affected by this extension will be required to complete both the Knowledge and Application Assessments by June 30.

Learning Objectives

• Understand ISO 9000 Quality Management Principles
• Learn the requirements and intent of the ISO 9001:2008 standard
• Know how to apply the ISO 9001:2008 requirements

HERE IS WHAT I WILL DO FOR YOU:

• Teach you about all ISO 9000 requirements and explain them in plain English
• Audit your quality system to the new ISO 9001:2008 Standard
• Write your Quality Assurance Manual to the ISO 9001:2008 format or to the latest AS9100 or API Q1 format as applicable
• Write your six ISO 9001 Required Documented Procedures and include them with your QA Manual
• Show you how to format documented procedures and provide you with easy-to-use templates
• Provide you with ongoing free telephone help as you prepare for certification
• Charge you a fee that is only a fraction of the cost that the large consulting firms want to charge you.

Identify and define all of your policies towards the Standard chosen. Record this information in the Quality Manual.

Start by setting up an implementation team that represents the experts from the various disciplines of your company's operations, i.e. Sales, Marketing, Scheduling, Manufacturing, Design, Purchasing, etc. Each individual needs to address their policies towards the requirements of the compliance Standard chosen. The policies need to be addressed/defined in the Quality Manual. In other words, you are defining your company's approach towards the requirements of the Standard by using that Standard as a guideline to define "Where and how do we meet those requirements?"

How is the Standard changed?

The good news is that the 2000 version of the standard promises benefits that will apply equally to small firms as to large organizations. These include the following:

• Written in clear language; simple to use and less bureaucratic
• Applicable to all sizes of organization and all product sectors - including service
• More emphasis on 'the processes' of a business
• Ability to reduce the scope, according to the type of organization
• Compatible with related standards, such as ISO 14001 (Environmental)
• Provides a pathway to continual improvement

Achieving Continuous Improvement

The ISO 9000 standard incorporates several processes that help a company continuously improve:

• Goals and Metrics: setting goals on various levels and using metrics to gage performance.
• Customer Feedback: measuring what customers think about the company and its products or services.
• Internal Audits: periodical evaluating if the company still meets all ISO 9000 requirements.
• Corrective Action: systematical identification of underlying causes of existing problems and then correcting these causes.
• Preventive Action: systematical search for potential problems and correcting their underlying causes before the problems can occur.
• Management Review: management’s periodical review of key business indicators and planning of improvement initiatives
  

What does this change mean for any existing certification of ISO 9001:2000?

“The International Accreditation Forum has published an official position on organizations migrating their existing certification to ISO 9001:2008,” Hunt says. “Organizations that are currently registered to ISO 9001:2000 will have 24 months after publication to update their certification to ISO 9001:2008. During the twenty-four month period, ISO 9001:2000 certificates are to be considered equal to ISO 9001:2008 certification. While this official position has been published, organizations currently certified to ISO 9001:2000 should receive information from their registrar on how they will specifically manage the change.”

Key facts about the new standard include:

• ISO 9001:2008 is an amendment with no new or deleted requirements.
• Changes to the standard relate to one of the following categories: clarifications, improve compatibility with ISO 14001, consistency within the ISO 9000 family or improved translation.
• Compliance to ISO 9001:2008 will be verified on a surveillance or recertification audit.
  
  

ISO 9001 Consultants and ISO 9001 Training

We specialize in ISO9001 training and ISO14001 training, we cover most of the UK but our ISO 9001 Consultants, ISO 9001 Training services mainly cover the 50 mile radius from Willenhall such as Wolverhampton, Dudley, Birmingham, Walsall, Tamworth, Stoke on Trent, Coventry, Shrewsbury and Nottingham. Our ISO 9001 Consultants and ISO 9001 Training services cover ISO 14001 'Environmental Management' and ISO 9001 or ISO 9001:2008 'quality management'. As an International Standard, ISO9001:2008 is the most commonly used for providing a framework for an effective QMS (Quality Management System).

ISO to Issue Comparison of 9001:2000/2008

The ISO technical committee is preparing a document which clearly shows the difference between ISO 9001:2008 and ISO 9001:2000 and when this document is approved by ISO, they will be published in the website, probably by October 2008. ISO and IAF are keen to implement a smooth transition to ISO 9001:2008 and have taken international quality system and auditor certification bodies for consultation to this effect.
It is proposed by ISO that the ISO 9001:2008 not to have any major changes but will only introduce some clarifications to the existing terms of ISO 9001:2000. It is estimated that about a million certificates have been issued for companies in about 170 countries. It has been decided by ISO that no certification will be issued to the companies till the ISO 9001:2008 is published and audit conducted in accordance with the terms of ISO 9001:2008.

AIMS MANAGEMENT CONSULTANT QUALITY POLICY

• At Aims Management Consultants , client satisfaction is an ongoing priority. In this respect, all our employees have engaged in a continuous improvement process to provide a high-quality product that fully meets the needs and expectations of our clients.
• From the first contact to the completion of a project, we spare no effort to meet the requirements of our clients.
• Our goal is excellence. Our products, technologies and processes are continually developed based on a creative and innovative approach.
• Consultation, participation, and a commitment to improvement are the foundations of our success. Our competent and motivated personnel upgrade their skills on an ongoing basis.
• The efficiency of our organization is monitored on a permanent basis to enable us to produce fully compliant goods the first time, and every time.
  

Continual improvement

“Demonstrate top management commitment to the development and improvement of the quality management system.”
“Plan and manage for continual improvement of the quality management system, including the use of quality policy and objectives and quality performance data.”
“Collect and analyze data to determine the effectiveness of the quality management system and for identifying where improvements can be made. also taking into account primarily customer feedback obtained above”

A typical transition plan would include:

• Customer Surveys
• Leadership Development
• Customer-Focused Teamwork
• Process Improvement and Problem-Solving
• Supply Chain Management
  

ISO 9004:2009: An Update

The revision to ISO 9001:2000 has held center stage in the standards arena for the last three years. Considering the number of organizations holding ISO 9001 certificates, the attention is not unwarranted

Advantages of implementing ISO 9001:2008 (Quality Management System)

• Policies and objectives set by 'top management'
• Understanding customer's requirements with a view to achieving customer satisfaction. Improved internal and external communications
• Greater understanding of the organization's processes
• Understanding how statutory and regulatory requirements impact on the organization &
• Your customers' clear responsibilities and authorities agreed for all staff
• Improved use of time and resources
• Reduced wastage
• Greater consistency and tractability of products and services
• Improved morale and motivation
  
  

BS EN ISO 9001:2008 Quality Assurance

Site Masters are ISO accredited, our latest audit was held in October 2008.The globally implemented ISO 9001:2008 standard for providing assurance is about the ability to satisfy quality requirements and to enhance customer satisfaction in supplier-customer relationships.Site Masters are Certified by a UKAS Accredited Certification Body with a scope that includes recruitment, training and consultancy.

We offer the following:

• Free initial consulting to explain the benefits of having documented processes and establish your QMS requirements.
• Develop your company procedures to reflect how you do business
• Create your customized ISO 9000 quality manual, even if registration is not intended
• Provide support for implementing documented systems
• Help your company select a registrar (if ISO 9000 registration is desire)
• Conduct a Gap Analysis to determine current status of company
• Conduct company internal audits to maintain Quality Management System Compliance
  

Changes from ISO9001-2000 to ISO9001-2008

The remit of Technical Committee 176 (who maintains ISO9001) was to align the wording of the standard with ISO14001 and to make the wording more consistent, without significantly changing the meaning of the standard.
As a result, the changes are mainly limited to moving sentences around with some clauses, adding extra notes and so on. If your current system meets ISO9001:2000, it should probably meet ISO9001:2008. But there are a few changes that may mean that you might have to make changes. These are described in the following "clause by clause" pages.

Increases Customer Satisfaction and Sales

By monitoring and reacting to Customer Satisfaction (not necessarily with questionnaires), existing Customers can be retained and new Sales can be developed. Improving efficiency can improve competitiveness, also some Customers require their Suppliers to be ISO 9000 Certified, leading to more sales.

With the ISO 9000 Compliance Procedure Pack, you can;

- Develop procedures in the six 'mandatory' areas of ISO 9001: 2000 from the tested examples provided
- Develop your own work
-flow procedures and work instructions using the many examples provided
- Learn short-cuts to certification using the robust methods demonstrated for achieving ISO
-critical functions
- Create easy-to-use, easy-to-read and easy-to-change Procedures that make sense to your colleagues as well as the assessor
- You can use this product to develop a new ISO 9001: 2000 certification for your company; or as a valuable spring-cleaning for your top level procedures after re-certification to ISO 9001: 2000, or just as a professional example of best practise.

This is a fast and inexpensive solution for:

• ISO 9001 Beginners implementing for the first time
• Organizations implementing ISO 9001
• Organizations implementing a Quality Management System without a consultant
• Consultants assisting companies with registration
• Project managers leading their companies Quality Management System implementation
• Experienced ISO 9001 professionals who would like to save on time and effort during their ISO 9001 project.

What is Document Control?

Document control means that the right persons have the current version of the documents they need, while unauthorized persons are prevented from use.
We all handle many documents every day. These documents include forms that we fill out, instructions that we follow, invoices that we enter into the computer system, holiday schedules that we check for the next day off, rate sheets that we use to bill our customers, and many more. An error on any of these documents could lead to problems. Using an outdated version could lead to problems. Not knowing if we have the latest version or not could lead to problems. And so on.
ISO 9000 gives us tools (also referred to as “requirements”) that help us control our documents. Take a look into the Quality Manual for more information and simple instructions.

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 if I am currently registered to ISO 9002?

There are significant differences between the current ISO 9003 standard and the revised ISO 9001-2000 standard, notably in the product realization activities. You should perform a gap analysis based on the draft standards to determine what areas in your organization's quality management system already comply with the revised requirements. Where your current system does not address the applicable ISO 9001-2000 requirements, development and implementation of processes to ensure compliance will need to be made.

Policy & Procedures Manual

• Centralized
• Always current: only one copy to maintain
• Each section can be controlled and updated by local administrators/management
• Revision control
• Automated notification of changes/updates
• Accessible worldwide by authorized individuals
• Rich content with flowcharts, color, schematics, etc.
• Can be updated using MS Word, WordPerfect, PowerPoint, etc.
• Intuitive menu driven system with context sensitive help
  

Major Elements of our Quality Management System include:

• Detailed policies and procedures for the service and certification of scales, balances and other weighing devices; including documentation, training, tolerances, testing, traceability and other related matters supporting ISO 9000 requirements.
• Equipment tested, calibrated and certified to N.I.S.T. (National Institute of Standards and Technology) utilizing serialized master and field service test weights. State or registered independent metrology laboratories certify these weights at regularly scheduled intervals.
• Prompt, reliable notification and scheduling of testing services to assure that equipment certification is always kept current.
• Equipment repaired, calibrated and certified by factory-trained service technicians according to documented service and testing procedures as set forth in ISO 9000 guidelines
  

Control of non-conforming product

Non-conforming product must be identified, segregated, and controlled to prevent misuse. The organisation must deal with non-conforming product by taking action to eliminate the non-conformity and either obtain authorisation for its use from the customer, or remove it from the possibility of use.
Review of the extent of non-conforming product should be part of management review to consider reduction goals and resource needs.
People carrying out the product non-conformity review and making the decision on disposition must have the competence to evaluate the total effects and the authority to agree the outcome and corrective action.
When non-conforming product is corrected for subsequent use it must be subjected to re-verification to demonstrate conformity.

ISO 9000 and the Scientific Sector

Scientific service companies (research, development, feasibility studies) would orient their choice towards the ISO 9001 or 9002 standard, depending upon the type of mandates they receive. The more they are involved with new discoveries, procedures or research protocols, the more reason they have for developing a quality assurance system conforming to the ISO 9001 standard, which encompasses conception. This would be the case for the majority of companies in this sector. All standard elements would apply, but the degree of importance of each of the elements would vary according to the scientific domain. In fact, in reference to medical research, the most important elements are identification and traceability, inspection and testing, documentation of procedures and recording results.

An ISO 9001 audit performed by a SQA, ISO 9000 auditor, which results in certification, provides:

• Public recognition that your organization is committed to producing quality products or services, providing on-time delivery and meeting customer expectations.
• Increased opportunities for new business from customers that recognize the value of ISO 9001 certification.
• External, independent validation that your quality management system conforms with the requirements of ISO 9001.
• Independent feedback to foster continual improvement.

HOW DOES TRANSITION OCCUR?

Although implementation does not require restructuring or renumbering of your quality manual, procedures and other documents to align with ISO 9001-2000, the new requirements have to be addressed. An understanding of the process management model should also be developed and specific training conducted for management, internal auditors and staff.

Why should engineers and architects be interested in ISO 9000?

The European Community has chosen to regulate certain product groups. These include medical devices, telecommunications equipment...and construction materials. For construction materials, approval of a supplier's quality system is a legal requirement. ISO certification, while not specifically required, is the method of choice to meet EC requirements.
Since most U.S. manufacturers of engineering and construction materials operate in highly competitive markets, there is constant pressure to take cost out of the product. Cost reduction does not have to mean quality reduction, but it can, especially for manufacturers without adequate quality systems. ISO certification forces manufacturers to spend more time and effort on quality. As one executive of a large building components manufacturer said recently, "It used to be, when we had a quality problem, that we could ignore it. Now, with ISO 9000, our system won't allow us to ignore it".
It is difficult for a material specifies to find the balance between a highly restrictive specification and a completely open specification. A restrictive specification often increases the predictability of quality, but generally results in higher cost. Wide-open specifications, conversely, decrease predictability of quality and generally lower cost. Therefore, Polyguard recommends that the following clause be added to all open specifications: "Manufacturers shall submit proof of current certification of its quality system to the ISO 9001 quality system standards."

What the Big Deal?

ISO 9000 registration has become a must especially for any company involved in international commerce.
Adherence to the standard is voluntary. But many companies do business exclusively with suppliers which have had their quality sytems”registered”.
A ISO 9000 certificate doesn’t warrant whether specific products are any good –ISO 9000 deals with the environment for producing goods and services, not specific products.
Purchasers of goods and services ask their suppliers to be certified to ISO 9000 because they want to be assured that suppliers are competent to conduct business. Customers don’t want to send their own inspectors to inspect how their suppliers conduct business.

How Do I Attain Registration or Compliance?

After determining on which requirements standard - ISO 9001, ISO 9002 or ISO 9003 - it should base its quality system, an organization performs two primary tasks:

• The documentation of its business processes in light of the requirements of each of the applicable 20 elements of the ISO 9000 standard.
• The implementation of these documented processes throughout the organization.

Upon completion of these two tasks, the organization then has the option of:

1.Contracting with an accredited independent third-party (usually referred to as a registrar) to obtain registration. This third-party, or registrar, audits the organization to ensure that:

• The documentation of its business processes meets all the requirements of each of the applicable 20 elements of the ISO 9000 standard.
• Actual business practices in the organization reflect these documented business practices.

2.Performing a self-registration audit. The company determines that its quality management system complies with the requirements of the chosen standard (ISO 9001, ISO 9002 or ISO 9003).

Simplified ISO 9000 System that improves your Company

The ISO 9000 Implementation Manual is specifically designed to truly improve your company's efficiency, productivity and profits:

• all processes are simple, lean and efficient,
• it is free of the excessive paperwork that is typically associated with ISO 9001 :2008,
• it eliminates the bureaucracy that often gives ISO 9001 :2008 a bad name,
• it reduces liability exposure (includes input from corporate attorneys),
• it is simple, and easy to operate and maintain, and
• It is designed, reviewed and fine-tuned with the specific goal to add value to your company.
  

What exactly are the ISO 9000 Standards? Do I need to implement them? What are the advantages of implementing the standards?

The ISO 9000 Standards were created by the International Organization for Standardization. The ISO Standards are considered a consensus on "good management practices with the aim of ensuring that the organization can time again deliver the product or services that meet the client's quality requirements" (International Organization for Standardization, 2002). In other words, the ISO 9000 standards are not quality control standards for products per se, but are instead management systems standards that help businesses assure that they are following a set system for the production of their goods and/or services.ISO 9000 standards essentially outline what requirements a good quality system will meet. Because ISO standards are implemented by individual businesses, corporations, and government organizations, the ISO 9000 "family" also provides auditing tools to make sure that you have properly implemented the standards and are meeting the quality requirements. More specific information on evaluation systems may be obtained from the ISO http://www.isoconsultantsdelhi.com/

Data elements in the ISO patents database

Each record of the database contains the following 11 data elements:

• ISO standard reference: The number of the International Standard to which the Patent Statement refers, eg: ISO/IEC 14496-10:2003.
• Domain: This indicates in certain cases e.g.: multimedia the technical area to which the International Standard belongs, eg: MPEG, JPEG etc.
• Id. Number: The identification number assigned to the Patent Statement communicated to ISO. If there were, for example, 10 Patent Statements communicated to ISO referring to ISO/IEC 8822:1994, then there would be identification numbers ranging from ISO/IEC 8822:1994-01 to ISO/IEC 8822:1994-10.
• Organization: The organization/company that holds the patent and its contact address.
• Tel. No., Fax No. and e-mail address : The contact telephone number, fax number and e-mail address of the organization/company
• URL: Web site of the organization/company.
• Patent Title: The title of a patent, if given, in an organization's communication to ISO.
• Patent Number: The number of the patent cited in the communication to ISO.
• Patent ITU reference: Used in case of common text with ITU-T (International Telecommunication Union - Telecommunication Standardization Sector).
• Patent Country: The country in which the patent has been obtained. If the patent is held in several countries, only the major country (if that can be determined) is given.

Specify the user and organizational requirements

this looks at user and organizational requirements in relation to the context of use description (1), and it should:

• Identify the range of relevant users and other personnel in the design
• Provide a clear statement of the human-centered design goals
• Set appropriate priorities for the different requirements
• Provide measurable benchmarks against which emerging designs can be tested
• Be confirmed by the users or those representing their interests in the process
• Include and statutory or legislative requirements
• Be adequately documented

What ISO 9001:2008 is not?

ISO 9001 is NOT a product standard-it contains no product requirements.
It is a series of generic requirements for quality management systems. Approval to ISO 9001 does not guarantee product or service quality. Customer focused leadership, not Standards produces satisfied customers.
Approval to ISO 9001 demonstrates that you meet the minimum requirements of quality management.

ISO 9002 and ISO 9003 became obsolete in December 2000.

ISO 9001:2008 contains all of the requirements which an organization must address within their Quality Management System (QMS) if they wish to be certified against the Standard.
The majority of these requirements would be identified by many organizations as 'common sense' topics which they would want to address in order to run their business well e.g. sales, design, purchasing, training, calibration of test equipment, control of records.
ISO 9001 is written by a committee (TC 176) and is designed for use in any type of organization. This inevitably means that there are compromises in the wording of the Standard and some interpretation is often needed.

Summary of ISO 9001:2000 in informal language

• The quality policy is a formal statement from management, closely linked to the business and marketing plan and to customer needs. The quality policy is understood and followed at all levels and by all employees. Each employee needs measurable objectives to work towards.
• Decisions about the quality system are made based on recorded data and the system is regularly audited and evaluated for conformance and effectiveness.
• Records should show how and where raw materials and products were processed, to allow products and problems to be traced to the source.
• You need a documented procedure to control quality documents in your company. Everyone must have access to up-to-date documents and be aware of how to use them.
• To maintain the quality system and produce conforming product, you need to provide suitable infrastructure, resources, information, equipment, measuring and monitoring devices, and environmental conditions.
• You need to map out all key processes in your company; control them by monitoring, measurement and analysis; and ensure that product quality objectives are met. If you can’t monitor a process by measurement, then make sure the process is well enough defined that you can make adjustments if the product does not meet user needs.
• For each product your company makes, you need to establish quality objectives; plan processes; and document and measure results to use as a tool for improvement. For each process, determine what kind of procedural documentation is required (note: a “product” is hardware, software, services, processed materials, or a combination of these).
• You need to determine key points where each process requires monitoring and measurement, and ensure that all monitoring and measuring devices are properly maintained and calibrated.
• You need to have clear requirements for purchased product.
• You need to determine customer requirements and create systems for communicating with customers about product information, inquiries, contracts, orders, feedback and complaints.

What is an ISO 9001 Compliant Quality System?

An ISO 9001 compliant quality system satisfies the requirements of the ISO 9001 standard but has not been formally assessed and registered by a third party registrar. This means that you could enjoy the benefits of an ISO 9001 Compliant Quality System without going through the expense normally associated with registration. You would be in a position to register at anytime should the need arise.

Everything you need to know about ISO 9001

Aims Management Consultants Learning offers a comprehensive programme of training courses covering every aspect of ISO 9000:2008 for:

• Participants who are new to Quality Management Systems
• Participants who need to audit and improve an existing system

Course Range

• Introduction to ISO 9001:2008
• Implementing ISO 9001:2008
• Auditing to ISO 9001:2008
• Internal Auditor ISO 9001:2008
• Auditor/Lead Auditor ISO 9001:2008
  

The Path Forward

This pragmatic path forward can be used as a guide to craft a game plan during the transition. It stresses the basic steps that your organization should consider, regardless of the maturity of your QMS.

• Obtain a copy of the ISO 9001:2008 Standard. Copies can be purchased from your national standards body ANSI in the United States at (www.isoconsultantsdelhi.com), the International Organization for Standardization (www.isoconsultantsdelhi.com), or from the American Society for Quality (www.isoconsultantsdelhi.com).
• Review Annex B, and familiarize yourself with the changes to the Standard. This Annex (Table B.1) identifies the text changes between the 2000 and 2008 versions. It’s a must read.
• Discuss the transition requirements with your registrar. Remember you have two years to make the transition. We recommend transitioning sooner than later. This is no time to procrastinate.
• Determine whether the changes impact your organization. If nothing else, it will give you and your management team a better understanding of the nuances and underlying reasons for the change

Transitioning to ISO 9001:2008

The International Organization of for Standardization and the International Accreditation Forum have agreed to a smooth transition. Both standards will remain current for two years—until November 15, 2010. Registration of conformity to ISO 9001:2008 will be issued from November 15 on, and after a routine registrar surveillance audit, or a recertification audit against the new version. Also, as of November 15, 2009, all new registrations and recertification’s must be to ISO 9001:2008.
Two years after publication of ISO 9001:2008 (November 15, 2010), any certifications that are still to ISO 9001:2000 will no longer be valid. This means that currently certified organizations in “surveillance mode” in 2008-2009 have until November 15, 2010 to be successfully certified to ISO 9001:2008. We recommend a proactive approach. If you can win in your marketplace every day—why put it off?

Contents of ISO 9001:2008

• Introduction to and overview of the ISO 9001 requirements
• The relevance of ISO 9001 to a business management system
• What is meant by Management Commitment
• Objective setting and factually based decision making
• How ISO 9001 may be used by your organization for business improvement
• The format and features of a process based management system
• The key issues for successful implementation
  

Is certification to ISO 9001:2008 better than ISO 9001:2000?

Certification to ISO 9001:2008 is not an “upgrade”, and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2008. However, certificates to ISO 9001:2000 will only remain valid until 2 years after the publication of ISO 9001:2008.

Why are customers embracing ISO 9001: 2008?

Companies who are being told to by their customers, those whose competition is doing it and Those who want to steal a march on their competition. Also those whose current customers are happy with them but know that doors are shut to them in new areas which they want to break into or quote for as well as those who want to improve their businesses. It shows your customers and prospective customers that you care about them and the service you provide;

What will happen to ISO 9001:2000?

ISO 9001:2008 will supersede ISO 9001:2000 However, noting the IAF/ISO-CASCO/ISO TC176 agreement that accredited certification to the 2000 edition should remain possible for up to 2 years after the publication of ISO 9001:2008, copies of the 2000 edition will still be available on request from ISO and the national standards bodies during that period, and possibly for even longer.

Topic coverage

• Changes in IOS 9001:2008 as compared to ISO 9001:2008 .
• Over view of ISO 9000 QMS.
• Important Areas to be focused during implementation.
• Detailed discussion and explanation of entire standard.
• Linkage of all clauses to existing department of organization.
• Introduction, need, plan &conduct of IQA.
• Terminologies used in IQA.
• Process Approach based Audit. Lastes trend in global auditing practice.
  

Validity and transition of certificates

DNV will follow the rules jointly set by ISO and the International Accreditation Forum (IAF) for the transition:

• Twenty four months after the publication of ISO 9001:2008 any certificates issued to ISO 9001:2000 are no longer valid.
• One year after publication of the new version all certifications or re-certifications will be to ISO 9001:2008.
• Certification of conformity to ISO 9001:2008 or its national equivalents will only begin after the new standard has been officially published, and after a periodic audit or re-certification audit against ISO 9001:2008

ISO / TS 16949 QMS for Automotive Sector

ISO/TS 16949 QMS defines the quality management system requirements for the design and development, production and, when relevant, installation and service of automotive related products. ISO/TS 16949 QMS technical specification is applicable to sites of the organization where customer specified parts, for production and/or service, are manufactured.
The goal of ISO/TS 16949 QMS standard 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.
ISO/TS 16949 QMS differs from other ISO standards in two important ways: it is restricted to automotive companies and their suppliers; and it requires compliance with a customer's requirements worldwide, not just regionally.
ISO/TS 16949:2002 QMS was developed by a partnership comprising the International Automotive Task Force (IATF) and the Japan Automobile Manufacturers Association (JAMA), with the support of ISO technical committee ISO/TC 176, which is responsible for the ISO 9000 family of quality management standards.

ISO 9001:2008 Explained, Third Edition

This book explains the meaning and intent of the requirements of ISO 9001:2008 and discusses the requirements as they relate to each product category. Where appropriate, it elaborates on why the requirements are important. It includes a list of typical audit-type questions that an organization may use to appraise compliance with the requirements.
New in this third edition are recommendations for implementation. While some implementation guidance was provided in earlier editions, they had focused on achieving understanding of the requirements. Each clause now has a section on tips for implementation. There is also a completely new chapter devoted to the implementation of a quality management system, as well as new chapters on auditing the process-based quality management system and sector applications.

• Written by authors with well over 100 years of experience in quality management systems deployment in a wide variety of manufacturing and service environments, both for profit and not for profit, this book addresses the needs of the following:
• Organizations seeking a general understanding of the contents of ISO 9001:2008
• Organizations desiring guidance to ensure that their ISO 9001:2000 quality management system also meets the new version
• Organizations considering the use of ISO 9001:2008 as a foundation for the development of a comprehensive quality management system
• Educators who require a textbook to accompany a training class or course on ISO 9001:2008