ISO 9000 FAQs

ISO 9000 is a set of standards internationally accepted by businesses and consumers. It allows organizations to establish and monitor quality management systems. ISO 9000 standards are considered to be generic standards since they can apply to any business, product or service irrespective of the industry. They have been developed and are maintained by the International Organization for Standardization (ISO).

1. What is the ISO 9000 family?

The ISO 9000 family consists of three quality assurance and quality management standards, namely, ISO 9000: 2000, ISO 9001:2000, and ISO 9004:2000. The ISO 9000:2000 and ISO 9004:2000 present guidelines for performance improvement, while the ISO 9001:2000 presents requirements. These standards are implemented by individual businesses, corporations, and government organizations.

2. What are the benefits of ISO 9000?

Major benefits include increased marketability, reduced operational expenses, better management control, improved internal communication, reduction of product-liability risks, and improved customer service.

3. What are the main phases involved in obtaining ISO 9000 certification?

There are two major phases - documentation and certification. Documentation process is done in-house or by the help of an ISO 9000 consultant. Most businesses seek the services of an experienced consultant to create the quality system. An agency accredited in this regard does the certification. The certification process includes documentation review and compliance audit. Documentation review is done with or without visits to the organization. Compliance audit is generally conducted on the site.

4. Is a consultant must for implementing ISO 9000?

The manuals of standards and certification are written in such a way that most of us can hardly understand what they are saying. Only an experienced consultant can help you understand and effectively administer new and existing quality systems.

5. How much does it cost to become ISO 9000 certified?

Unfortunately, there is no simple answer to this question. The cost depends on a lot of factors such as complexity of operations, number of locations of plants, willingness of owners, and type of standards to be implemented.

6. How long does it take to attain ISO 9000 certification?

Depending upon the commitment of the owner and/or managers, the time taken could be 3 months to a whole year. ISO certification is granted initially for a period of three years.

ISO 9000 provides detailed information on ISO 9000, ISO 9000 Standards, ISO 9000 Software, ISO 9000 Consulting and more. ISO 9000 is affiliated with Home Inspections.

Digital Photography and ISO Ratings - What You Should Know!

p>Before Digital Cameras ever came to be, most of you probably owned a standard 35mm camera with an attachable flash, like my old Nikon F1, which I foolishly sold on Ebay. If you did own one of those, and you were very adept in photography, you'll recall thatlittle nob at the bottom of the camera with a series of numbers from B1...to 4000 ASA/ISO.Simply put, when you bought film which was rated 400 ASA, as an example, you would adjust the nob to reflect an ASA reading of 400 in the small window pane aligned with a small, usually, red arrow.

The point of all this is the following; when you bring your knew digital camera to any large event, it is totally pointless to be using the built-in flash, although you see it all the time by the 100s of flickering lights. The built-in flash is much to small to have any effect when you're 100s of feet from your subject.

Since cameras list the effectiveness of a flash measured in distance or range (3' - 9' etc.), you really have to be very close to the subject for the flash to be fullyeffective.

The ISO designation you should know, is a measure used for light sensitivity. For example, a film with a rating of ISO1000 (considered fast film) is much more sensitive to light than a film with a rating of ISO100, and therefore is better able to capture images in dark surrounding areas. Actually, if you were really good in the old days, we used this to our advantage in combination with the aperture opening of the lens for some really awesome effects. But we won't go there and stick with digital.

So to be understood, digital camera technology uses the same ISO system, but since no film is used, the variable light sensitivity is accomplished by amplifying the signal.Sound confusing! In electronics, as you amplify a signal, you amplify noise levels, such as in a radio which has a weak signal. So you turn it up only to hear more static in the background.

So it was, when you selected a digital camera with a high ISO rating,because the quality of the image was less than desirable. In the early days of digital cameras, this constituted a real problem.

Today, however, this so called noise has been so controlled, that you can buy a digital camera with a high ISO rating reducing the need for a flash...in other words the capability of taking pics from far distances without a flash. In addition, when you set your camera to 'auto', the camera will automatically set the ISO, the aperture opening of the lens, and shutter speed to create the best picture possible.

For more information on understanding how ISO works, make sure you read your manual or check with the manufacturer of your camera. If you don't yet own a digital camera, here's a tip; make sure you buy the highest megapixel possible. It cost much more but well worth the investment. You won't regret it!

Jon G. Michel is a successful webmaster and publisher of digitalkool.com. Are you looking for new information on digital photography? Need a new digital camera... get all the latest information

 Jon G. Michel This article can be used as long as the article remains unchanged and the author's bio is included.

 

How Can ISO 9001:2000 be Applied to Healthcare?

Definition of ISO:

 

• ISO means “all sides being equal”. To date, more than ½ a million organizations in 149 countries have implemented the ISO Standards.
• ISO 9001:2000 is a fundamental quality management system standard that requires an organization to identify, define, document, implement (follow), monitor/measure, and continually improve the effectiveness of its processes. It is a self-directed system that requires the organization to identify and address all imposed requirements; as well as improve its organizational performance by modifying systemic issues (e.g. those traditionally associated with the “hand-offs”).

 

Application of ISO in Healthcare:

Using the ISO Family of Standards, the organization can establish a comprehensive Quality / Business Management System which:

• Provides a solid basis for compliance with all imposed requirements (e.g., JCAHO, AABB, Federal & State regulations). Makes all other certification & accreditation processes easier and less costly.
• Facilitates improved understanding of roles & responsibilities among employees; and enhanced communication/coordination between departments.
• Requires the establishment of measurable improvement objectives and accountability to those objectives through monitoring/measuring and reporting.
• Results in improved systems, processes, and outcomes.

 

Structure of the ISO 9001:2000 Standard:

The ISO:9001 2000 Standard is comprised of 8 Clauses. The 1st 3 are introductory in nature. The subsequent 5 clauses include the requirements the organization must address. They are:

 

• Clause 4 – Quality Management System
  Process Management, Documentation Requirements, Records Control
• Clause 5 – Management Responsibility
  Customer/Patient Focus, Policy, Objectives, Planning, Responsibility & Authority
• Clause 6 – Resource Management
  Human Resources, Infrastructure, Work Environment
• Clause 7 – Product / Service Realization
  Planning of New Products & Services, Customer Interface/ Communication, Design, Purchasing/Supplier Management, Production/ Service Operations, Calibration
• Clause 8 – Measurement, Analysis, and Improvement

   

  Internal Audits, Customer/Patient Satisfaction, Monitoring/Measurement of Products/Services and Processes, Handling Nonconformances, Corrective & Preventive Action, Continual Improvement

 

Process / Methodology

While the standard does not prescribe the approach or methodology to be utilized by an organization, the following is recommended.

 

Obtain Management commitment to support, understanding, involvement, provision of resources
Educate Management & Staff about the ISO 9001:2000 Standard, Scope of Work, Organizational impact
Define Key Improvement Objectives
Identify and Map Organizational Processes, key as well as support. Address all imposed requirements.
Develop the organization’s Quality Policy and Quality Manual
Establish approach to document control and access.
Develop, review/revise, and incorporate all required support documentation (e.g. Department Policies/Procedures, forms).
Educate Staff on QMS documentation
Establish and implement monitoring/measurement for each process
Train internal auditors. Implement an Internal Audit Process.
Conduct a Management Review of the QMS.
Undergo a Pre-Assessment or “Mock Survey” to assess system implementation, readiness
Make required corrections
Submit Document Review to Registrar (Quality Manual, Processes)
Undergo the Certification Audit

 

Sample Key Improvement Objectives

 

• Improve Patient Satisfaction
  Goal: Improve to 70th Percentile
  Department Goal: Reduce Wait time for Outpatient Registration to < 4 minutes
• Improve Patient Safety
  Goal: Reduce Medication Error Rate to < .3%
  Goal: Reduce fall rate to < 2.6 per 1,000 patient days

 

Sample Process Interaction Diagram
See =>http://www.iqsconsulting.net/applications-of-iso9001-to-healthcare.html

Sample Quality Policy

We will strive to be the leading provider of healthcare services in Southern Ohio. We will accomplish this through

 

• Consistent compliance with all imposed requirements;
• Our focus on Patient Safety and Satisfaction; and
• Continual improvement of our products, services, and processes.

  Innovative Quality Solutions Company is a full service training and consulting firm focused on total customer satisfaction, performance improvement and achievement of organizational objectives. Innovative Quality Solutions provides all aspects of support to organizations seeking certification and compliance to the ISO 9001, ISO 14001, AS 9100 and ISO/TS 16949 (TS 16949) Standards. Since 1995, the firm has lead more than 250 organizations to successful first time certification/registration.

  Innovative Quality Solutions is located in Akron, Youngstown, Cleveland and Columbus. Renee Mallett, Vice President, Healthcare Division, may be contacted at 614-855-0008 or email: reneem@iqsconsulting.net

The ISO Network Management Model

The rumor on how Disney uses Network Management. When the temperature rises on the park grounds at Disneyland all the prices of the beverage vending machines automatically goes up by 10% to fully capitalize on consumer demand. I believe that is an old Information Technology rumor to explain how network management works... at least I hope it is a rumor.

Why Network Management is important.
More and more organizations depend on their networks. Business’ the depend heavily on the status of their networks must have network management tools as they grow. If a network dependent business such as ebay, Google, Yahoo and many others go down for even a few minutes, they can loose literally hundreds of thousands of dollars in sales and even a small piece of their customer’s confidence which could in turn affect the value of their stock. When every second of network time counts the system must be monitored continuously. The most cost effective way to do this is to use an automated network management tool.

Network Management Standards
The International Organization for Standards (ISO) addresses the five major functional area of the Network Management Model as performance management, accounting management, configuration management, fault management and security management.

Performance Management
Performance management is monitoring, assessing, and adjusting the available bandwidth and network resource usage in order make a network run more efficiently. Performance management is a very important part of the network management model particularly to the business and/or organization that wants to streamline their network's performance. SolarWinds is a great tool for performance management.

Accounting Management
Accounting management monitors and assesses the usage of data and/or resources for the purpose of billing. This aspect of the network management is by Internet Service Providers to bill customers for the resources they use.

Configuration Management
The configuration side of network management is for tracking the hardware and software versions on the network to identify their effects on the network's operation. An example of this is Microsoft’s System Management Server (SMS) which has the capability to monitor, manage and track every piece of software and hardware on a given network.

Fault Management
Fault Management is what most people think of when they think of network management. The purpose of this area of network management is to detect, log and alert the system administrators of problems that might effect the systems operations.

Security Management
Security Management deals with controlling access to resources and even alerting the proper authorities when certain resources are accessed. In the same way that a network manager can be paged or emailed when a resource goes down, network management systems can be used to send messages when certain files, servers or routers is accesses. Intrusion detection systems such as Symantec’s Intruder Alert have this security management capability.

There are many products that support some or even all of these areas of network management. What most network management systems have in common is their use of protocols such as Simple Network Management Protocols (SNMP), SNMPv3, and Common Management Information Protocol (CMIP). There are a variety of Network Management tools ranging from Intuit's Network Management Software to IBM's Tivoli, Fidelia's Helix to AdventNet. Maybe your network management solution does not include a system that increases vending machine prices as the heat rises, but you can definitely find what you need among these and other excellent tools on the market.

References:

Cisco. Network Management Basics. Cisco.com. Feb 2002
http://www.cisco.com/

RFC 1157. Simple Network Management Protocol.
http://www.faqs.org/rfcs/rfc1157.html

Wikipedia. Network Management. Wikipedia.org.
http://en.wikipedia.org/wiki/Network_management

ITPRC. Network Management. Itprc.com
http://www.itprc.com/nms.htm

Robert Elam is a System Security Engineer who works for the U.S. government.

You can find a more detailed version of this and other articles at his blog, http://elamb.org.

How to Meet Quality Standards with ISO 9001

In today’s hectic business environment, it is vital that we are all on the same page, right? But how do we know if we meet those standards? Business owners and executives can avoid the uncertainty, and that’s where ISO 9001 certification comes in.

Standardizing Quality Systems

The ISO, or International Organization for Standardization, was established in 1947 to develop international standards for everything from electronics to management systems. Having over 13,000 standards currently in place, ISO has created the auditing and certification process known as ISO 9001. This began the drive toward quality standards.

Improving Customer Satisfaction

Companies choose to implement ISO 9001 and get certified because many customers and industries require it. By keeping customers happy, they can increase sales and profitability for their business. And if an area of the company’s program appears to be too bureaucratic and non-value-adding, then it might also be an area for continuous improvement efforts.

Enhancing Company Policy and Performance

Both customers and industries alike use ISO certification as a way to evaluate and audit their suppliers and products. Through an independent verification process, customers can gain assurance of their suppliers’ products. And as a supplier becomes certified, the testing requirement is waved, which saves the company both time and money.

Developing a Best Practices Process

Employed as a “Best Practices” model, ISO 9001 utilizes the philosophy of the “Plan-Do-Check-Act” continuous improvement cycle to achieve requirements. This process approach centers around eight quality management principles used by management as a guide toward improving performance and identifying the main elements needed in a good quality system:

1. Customer Focus

2. Leadership

3. Involvement of People

4. Process Approach

5. Systems Approach to Management

6. Continuous improvement

7. Factual Approach to Decision-Making

8. Mutually Beneficial Supplier Relationship

Building Stable Processes

ISO 9001 policies, procedures and forms can provide employers, managers and employees with a systematic and consistent approach to implementing policies, plans, procedures and work routines. Instead of building their own policies and procedures from scratch, some companies prefer to hire professional writers that have already prepared a set of written policies and procedures to help on the way to certification.

Auditing a Company System

In the certification process, an independent registrar will perform an on-site audit of a company’s operations to verify that it complies with the ISO standard. If the business complies, then that company will be registered as ISO 9001 compliant.

Effective Policies and Procedures

On the way to certification, a business can meet its ISO needs by:

• Using well-defined processes and procedures to build stable processes

• Training in the audit and certification process

• Continuously improving with ISO 9001 standards

Quality Management System

With complete procedures manuals for ISO 9001 Quality Management System, required HR procedures, and an ISO training class, a template like an ISO 9001 Quality Manager Procedures Manual Series can help a business on its way to ISO 9001 certification. Sometimes the effort can be very great, but companies typically notice a remarkable difference in efficiency and effectiveness after the first year.

Chris Anderson is currently the managing director of Bizmanualz, Inc. and co-author of policies and procedures manuals, producing the layout, process design and implementation to increase performance. To learn how to increase your business performance, visit: Bizmanualz, Inc.