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 Using an outdated version could lead to problems.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