The International Organization for Standardization, (ISO) is a worldwide organization that develops many different kinds of Standards.
ISO 9000 is a series of documents that define requirements for the Quality Management System Standard. ISO 9001 is one of the documents in this set; it contains the actual requirements an organization must be in compliance with to become ISO 9001 Registered.
ISO 9001:2008 is the current version of the Standard. It was called ISO 9001:2000 until it was revised in the year 2008,. Past versions of ISO 9000 included ISO 9002 and ISO 9003, but those are no longer in use. Companies are now only Registered to ISO 9001.
ISO Course Descriptions
Once a company has set up their ISO 9001 Quality System then there is a need for regular Internal Audits, to ensure that the newly implemented system is being effectively applied.
ISO 9001:2000 Internal Auditor course is designed to give better Understanding of the Quality system structure, Audit Methodology & Techniques.
Course Outline
Section 1:
- Introduction
- Major Changes in ISO 9001:2000
- The Quality Management Principles
Section 2:
- Evolution of the standard
- ISO 9000:2001 Basic Structure
- Open Ended Requirements
Section 3:
- Steps in the Process Management Approach
- Key QMS Processes
- Phases & Types of Process Management
- Design and Redesign the Process
Section 4:
- Audit Preparation and Planning
- How to conduct an Audit and Audit Checklist
- Audit Reporting and Audit Closure
NOTE: Each section is followed by a quiz and in the end a final exam need to be cleared with minimum 70% score. Furthermore, some of the sections will have interactive exercises which will be time bound.
This course introduces the ISO 9001:2000 standard by presenting a brief history of the standard and then discussing the advantages this international model provides to any organization desiring to develop a quality management system built upon identifying the processes within a business, developing consistent production plans for that business and implementing structured improvements to succeed in today’s competitive marketplace
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.
Internal effectiveness and productivity benefits
Other organizations implement an ISO 9001 QMS because it has proven over the years that it leads companies to better operations, improved performance, and improved profitability
What do we need to do to become ISO 9001 Registered?
Learn about ISO 9001
You will need to get some general training on ISO 9000 so you understand what you need to do in your company to meet the requirements of the standard.
Develop and document your ISO 9001 Quality Manual and Procedures
The biggest portion of the project is looking at your current processes, and redesigning them to address all of the requirements in the standard. Once you have modified or developed processes to meet the standard, you will need to control those processes. Documenting the processes as Quality System procedures is part of this control.
Use and improve your QMS
Once your system is developed and documented, employees will follow the procedures collect records and make improvements to the system. For approximately three months or more, your organization will run the QMS, collecting records. This prepares the organization for an Audit by a Registrar.
Achieving Registration
To get your Registration, you will need to select a Registrar and they will come and perform your registration audit, and then regular surveillance audits. During these audits, the Auditor will be looking at your QMS to make sure that it meets the requirements of the standard. If they find that there are pieces of your QMS that do not meet the requirements, they will document a "Nonconformance". Your registration will be dependant on your correcting any nonconformances that are found.
ISO 9001
ISO 9000 is a family of standards for quality management systems. ISO 9000 is maintained by ISO, the International Organization for Standardization and is administered by accreditation and certification bodies. Some of the requirements in ISO 9001 (which is one of the standards in the ISO 9000 family) include
•
a set of procedures that cover all key processes in the business;
a set of procedures that cover all key processes in the business; •monitoring processes to ensure they are effective;
monitoring processes to ensure they are effective; •keeping adequate records;
keeping adequate records; •checking output for defects, with appropriate and corrective action where necessary;
checking output for defects, with appropriate and corrective action where necessary; •regularly reviewing individual processes and the quality system itself for effectiveness; and
regularly reviewing individual processes and the quality system itself for effectiveness; and •facilitating continual improvement
facilitating continual improvement A company or organization that has been independently audited and certified to be in conformance with ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO 9001 registered". Certification to an ISO 9000 standard does not guarantee any quality of end products and services; rather, it certifies that formalized business processes are being applied. Indeed, some companies enter the ISO 9001 certification as a marketing tool.
Although the standards originated in manufacturing, they are now employed across several types of organization. A "product", in ISO vocabulary, can mean a physical object, services, or software.
•"ISO 9000 Certified" is technically incorrect as ISO 9000 does not have requirements.
•"ISO 9001 Certified" means an organization has met the requirements in ISO9001. It defines an ISO 9000 Quality Management System (QMS).
•ISO 9001:2000 was replaced by ISO 9001:2008 in the year 2008. (ISO 9001:2000 is now obsolete)
ISO 9001:2008 is focused on meeting customer expectations and delivering customer satisfaction so you must pay attention to the customer.
•ISO9001 evaluates whether your quality management system is appropriate and effective, while forcing you to identify and implement improvements.
•Continuous improvement assures your customers benefit by receiving products/services that meet their requirement, and that you deliver consistent performance.
•Internally, the organization will profit from increased job satisfaction, improved morale, and improved operational results (reduced scrap and increased efficiency).
•Meeting legal and regulatory requirements benefit the community.
ISO 9001 does NOT define the actual quality of your product or service. The standard helps you achieve consistent results and continually improve the process. Thus, if you can make a good product most of the time, this helps you make it all of the time. It's just good business practices.
What is ISO 9000?
An overview
ISO9000 is an international quality certification that defines minimum requirements for a company's Quality Management System (QMS). A company's QMS comprises the organization's policies, procedures and other internal requirements that ensure customer requirements are met with consistency resulting in customer satisfaction. Some of the areas of the company within the scope of ISO9000 include:
Customer contracts
- Hiring and employee training
- Design and development of products and services
- Production and delivery of products and services
- Selection and managing of suppliers
- Management responsibility
- Internal quality audits
- Monitoring and measuring
- Continual improvement
- Corrective and preventive action
To receive an ISO9000 certification a company must put the required QMS processes and controls in place, monitor performance of its processes and demonstrate continual improvement. Most companies hire an experienced consulting firm to assist with these preparations. Once the QMS is in place, a registrar (or certification body) is hired to audit the company's compliance with ISO9000 requirements. If discrepancies are found during the audit, they must be corrected before the ISO9000 certificate is issued. The ISO9000 certification must be maintained through regular audits (bi-annual or annual) conducted by the selected registrar.
Benefits of ISO 9000Organizations that implement an ISO 9000 compliant QMS usually realize important benefits, including a more organized operating environment, a greater number of customers and a higher level of satisfaction among those customers. Whether you are planning a QMS in response to direct market requirements or want to increase the productivity of your organization, you will experience the following benefits:
Process Improvements
As you implement your QMS, you have the opportunity to improve your processes. You will outline the current process, add the requirements of the standard and then optimize the process with input from the process users. After achieving certification, you will likely see continual process improvements. A recent survey of 100 registered firms reported the average improvement in operating margin at 5% of sales. These firms also reported faster turnaround times, and a reduction in scrap and overtime.
Increased Quality Awareness
During implementation, quality awareness will increase, since all staff must be trained on ISO 9000. Staff will be required to take "ownership" of processes that they are involved in developing and improving. The QMS will also have built-in systems to report on key quality indicators, which will significantly reduce the reoccurrence of problems. This helps develop a strong quality culture, where the staff recognizes problems such as systems or process issues and works on fixing them, rather than placing blame with an individual. The result is increased confidence in workmanship and a more confident staff.
Consistency in Operations
With ISO 9000 certification, your operation will run more smoothly, as the QMS promotes consistency in how work is performed and recorded. This helps new employees learn processes more quickly and reduces misunderstandings with customers. If a problem does occur, it is traced to its root cause and fixed, saving the organization from "re-correcting" it every time it happens.
Market Advantages
ISO 9000 certification is becoming a requirement to do business in many markets. A recent survey of ISO 9000 certified companies shows that 41% were asked to achieve certification by a client. Considering that it can take 6 months or longer for some organizations to achieve certification, already having a compliant QMS in place can be a distinct advantage.
ISO 9001 Requirements
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This is a summary of the ISO 9001:2008 Standard Requirements - i.e. the items spelled out in the ISO 9001 document. Your Quality Management System must address each of these requirements.
Read Steps to ISO 9001 Certification to learn how to become ISO 9001 certified.
Detailed clause by clause review: ISO 9001 Requirements Explained (by L. Whittington)
Detailed list of 2008 changes: Changes to ISO 9001:2008 (by L. Whiittington)
ISO 9001 Presentation to review the complete standard with your organization.
Section 1: Scope Talks about the standard and how it applies to organizations and:
•the importance of a process approach
•you need to include regulatory requirements of your products & services
•you need to have processes in place for continual improvement.
•Learn: What is ISO 9001?
Section 2: Normative Reference
•References ISO 9000:2005 which should be used along with the standard. It outlines the
Quality Management Systems-Fundamentals and Vocabulary
Section 3: Terms and Definitions
•Gives definitions used in the standard
Section 4: General Requirements Gives requirements for the overall Quality Management System
•Documentation Requirements, including:
◦Quality Manual with Scope of the QMS
◦Required Procedures
◦Required Forms & Records
◦Control of Documents
◦Control of Forms
Section 5: Management Responsibility Gives requirements for Management's role in the QMS
•Management Responsibility
•Quality Policy & Objectives
•Customer Focus & Customer Satisfaction
•Management Review
Section 6: Resource Management Gives requirements for resources including:
•Personnel & Training
•Resource Management
Section 7: Product Realization Gives requirements for:
•the production of the product or service
•Planning
•customer related processes and Customer Feedback
•Design
•Purchasing
•Process control
•Identification and Traceability
•Customer Property
Section 8: Measurement, Analysis and Improvement
•Gives requirements on monitoring processes and improving those processes
•Customer Satisfaction
•Internal Audits
•Control of Non-Conforming Product
•Corrective and Preventive Action
ISO 9001
States Served:
ISO, ISO 9001, ISO 9001 2000. ISO training. ISO standards. ISO 9001 online training classes. ISO auditor training
ISO, ISO 9001, ISO 9001 2000. ISO training. ISO standards. ISO 9001 online training classes. ISO auditor training
ISO 9001:2008 Quality Management Systems Requirements
ISO 9001:2008 is intended for use in any organization regardless of size, type or product (including service). It provides a number of requirements which an organization needs to fulfill to achieve customer satisfaction through consistent products and services which meet customer expectations. It includes a requirement for continual (i.e. planned) improvement of the Quality Management System, for which ISO 9004:2000 provides many hints.
This is the only implementation for which third-party auditors can grant certification. It should be noted that certification is not described as any of the 'needs' of an organization as a driver for using ISO 9001 (see ISO 9001:2000 section 1 'Scope') but does recognize that it may be used for such a purpose (see ISO 9001:2000 section 0.1 'Introduction').
ISO 9000 Essentials
This section concisely describes the essential features of the ISO 9000 family.
The ISO 9000 family of standards represents an international consensus on good quality management practices. It consists of standards and guidelines relating to quality management systems and related supporting standards.
ISO 9001:2008 is the standard that provides a set of standardized requirements for a quality management system, regardless of what the user organization does, its size, or whether it is in the private, or public sector. It is the only standard in the family against which organizations can be certified – although certification is not a compulsory requirement of the standard.
The other standards in the family cover specific aspects such as fundamentals and vocabulary, performance improvements, documentation, training, and financial and economic aspects.
Why an organization should implement ISO 9001:2008
Without satisfied customers, an organization is in peril! To keep customers satisfied, the organization needs to meet their requirements. The ISO 9001:2008 standard provides a tried and tested framework for taking a systematic approach to managing the organization's processes so that they consistently turn out product that satisfies customers' expectations.
How the ISO 9001:2008 model works
The requirements for a quality system have been standardized - but many organizations like to think of themselves as unique. So how does ISO 9001:2008 allow for the diversity of say, on the one hand, a "Mr. and Mrs." enterprise, and on the other, to a multinational manufacturing company with service components, or a public utility, or a government administration?
The answer is that ISO 9001:2008 lays down what requirements your quality system must meet, but does not dictate how they should be met in any particular organization. This leaves great scope and flexibility for implementation in different business sectors and business cultures, as well as in different national cultures.
Checking that it works
The standard requires the organization itself to audit its ISO 9001:2008-based quality system to verify that it is managing its processes effectively - or, to put it another way, to check that it is fully in control of its activities.
In addition, the organization may invite its clients to audit the quality system in order to give them confidence that the organization is capable of delivering products or services that will meet their requirements.
Lastly, the organization may engage the services of an independent quality system certification body to obtain an ISO 9001:2008 certificate of conformity. This last option has proved extremely popular in the market-place because of the perceived credibility of an independent assessment.
The organization may thus avoid multiple audits by its clients, or reduce the frequency or duration of client audits. The certificate can also serve as a business reference between the organization and potential clients, especially when supplier and client are new to each other, or far removed geographically, as in an export context
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