What is ISO 9000?
ISO is derived from a Greek word meaning equal.
ISO 9000 is an international standard intended to equalize Quality Systems between countries.
ISO 9000 is the offspring of the International Organization for Standardization, organization. It is a non-governmental, worldwide federation of national standards bodies from some 140 countries.
Quality systems between countries and between companies are equalized with ISO 9000. It is a quality system designed to be applied to any product or service anywhere in the world.
The standard addresses how an entire organization assures the quality of its products and services. ISO 9000 is not just for the quality assurance department; it is a management system standard that looks at almost all functions in the organization.
The ISO Mission
To develop and promote common standards worldwide to foster the international exchange of goods and services.
Since the 1994 ISO 9000 revision, not only has the millennium changed, but so has the worldwide need for a different emphasis toward a quality management system.
Many organizations did not link their processes together for a unified business approach with the 1994 revision. The structure of the new year 2000 revision of ISO 9000 has changed from functional or by department management to process management.
Processes are present in all organizations and necessary to producing products and services. Since organizations with linked processes can better see the whole picture for satisfying the customer; they are more likely to be competitive, innovative and profitable.
The new ISO 9001 standard places more importance on continuous improvement and customer satisfaction. Organizations will need to demonstrate continual quality system improvement and the ability to meet customer requirements.
The international exchange of goods and services are further advanced by this revision.
From Quality Assurance to Quality Management Systems:
The focus of ISO 9000:2000 has been broadened from “Quality Assurance” to “Quality Management Systems.” This indicates a more holistic approach that encompasses how the entire operation contributes to quality.
The ISO 9000:1994 standard has three editions companies can choose to be certified to: ISO 9001, which includes a product design control element; ISO 9002, which has no design control element; and ISO 9003, used typically by inspection companies, with only 16 of the 20 elements. ISO 9001 and 9002 are the most common.
ISO 9001 now replaces those three editions with a single requirements standard, ISO 9001.
Like the ISO 9000:1994 version, ISO 9001 now continues to allow organizations to tailor their quality management system to their individual needs. Rules on the structure and format of the quality management system are not imposed, provided the requirements of the ISO 9001 standard are met.
ISO 9000:2000 was published in the December 2000. Companies registered to prior ISO 9001 are given time to upgrade to the new ISO 9001 standard revision. Studying books like our ISO 9001 Survival Guide and the ISO 9001 standards themselves will enable companies to keep an eye on the future while improving their quality management systems.
Why should my company pursue ISO 9001 registration?
Companies are showing a commitment to quality through ISO 9001:2008 registration.
Registration helps companies achieve the following:
- Ensures that a company has a quality management system in place and is using that system.
- Provides the foundation for a total quality management program.
- Creates a competitive edge.
- Provides access to additional markets because increasing numbers of purchasers are looking for suppliers who are registered.
- Increases customer confidence that your company has a sound quality management system in place.
- Protects existing markets. If one of your customers were to require ISO 9001 registration from all suppliers, that requirement would already be met and the existing relationship not affected.
- Reduce the number of customers’ supplier audits. ISO 9001 gives the benefit of an objective, third-party evaluation of the quality management system.
Irwin Publishing (now part of McGraw-Hill Companies) completed a survey to which 1,880 ISO 9001 certified companies responded. The companies were questioned on their most significant external benefit realized from certification. These were the results:
Percentage of companies
|Higher Perceived Quality|
|Reduced Customer Quality Audits|
|Improved Customer Demand|
|Increased Market Share|
Since companies that have obtained registration have an image of better quality with current and potential customers, market your registration!
Even before obtaining registration, let your customers know that you are working on it. If possible, wait to order printed materials until after certification. Then, put the registrar logo and “ISO 9001 Certified” on letterhead, shipping labels, invoices, business cards, and sales literature. Have stickers made to add to any existing literature.
In that same Irwin Publishing/ McGraw-Hill survey, the companies responded that their most significant internal benefit realized was:
Percentage of companies
|Greater quality awareness by employees|
|Increased operational efficiency / productivity|
|Enhanced Intercompany communications|
|Reduced scrap / rework|
Since 50% of the companies said they had improved documentation, use ISO 9001 as an opportunity to improve your company’s documentation. Good documentation is key to improving operations, solving problems and staying efficient.
ISO 9001 will also result in greater quality awareness among your employees. Involve employees, and implementation and subsequent surveillance audits will be easier.
Use an internal marketing effort with your employees. Generate enthusiasm with the company newsletter, promotional coffee cups, key rings, bulletin boards, enclosures with paychecks, or a display case of finished customer products.
How does my company go about getting ISO 9000 certification?
Your company’s steps to ISO 9001:
- Create a plan and establish a timeline (When planning, take into consideration employee time, availability, and expertise, and whether to use an outside resource.)
- Educate management, then all employees
(Copies of the ISO 9001 Standard for management to study can be ordered from:ASQ at 800-248-1946, or on-line at: http://www.qualitypress.asq.org. For larger quantities, reprint permission is available.)
- Develop the quality system documentation based on what your company does and what ISO 9001 requires.
- Implement the quality management system
- Begin the Internal Audit function
- Registrar’s review of quality management system documentation
- Pre-assessment of the quality management system
- Audit and registration by the Registrar
How do we educate management and employees?
All employees should know and understand your company’s Quality Policy or Mission Statement.
This helps employees to understand why the company is making the commitment to ISO 9001 and serves as a guide to your company’s values, mission and objectives.
|AEM Consulting Group’s Mission Statement|
AEM is committed to:
What are the steps to implement ISO 9000?
Use the following ISO 9001 process steps to develop and document the procedure for each of the ISO 9001:2008 sections.
- Identify the people who need to be involved, including a project (element or section) leader.
- Review or formulate the element/section policy statement (give each of the sections a policy statement).
- Gather all existing, relevant paperwork, such as, data, forms, tags (project leader arranges for this to be done prior to the group meeting).
- Flowchart the existing process, using the paperwork to help identify the steps.
- Assess the process to the company’s needs.
- Assess the process to ISO 9001 requirements.
- Complete a draft of the procedure and review / revise to create a synthesis of company needs and ISO 9001 requirements.
- Complete a smooth draft of all documentation.
- Obtain appropriate internal approval.
- Release the approved documentation (as outlined in your Documentation procedure).
- Implement (educate the people involved in the process).
- Begin Internal Auditing (utilize Corrective and Preventive Action as appropriate).
How do we ensure the goal of ISO 9001 registration?
- Say what you do (Quality System Documentation)
- Do what you say (Implementation)
- Prove it (Audit /Registration)
- Improve it (Continuous Improvement)