What Does ISO Stand for?

The International Organization for Standardization decided not to use an acronym for their organization, because it would bedifferent in different languages. Instead, they used the word “ISO,” which is derived from the Greek word “isos” meaning “equal.”The standards act as an equalizer for companies doing business across global boundaries.
Apart from the Quality Management System standards, there are many other standards that are maintained by the InternationalOrganization for Standardization located in Geneva. Switzerland, and their 158 member countries

What is ISO 9001?

short, ISO 9001 is a voluntary Quality Management System standard that helps organizations ensure they are meetingcustomer requirements. Note that the key word in the title is “Management.” The intent of the 9001 standard is to implementsystems that Management can use to bette run the business.

What is the DIfference between ISO 9000, ISO 9001, ISO 9002, ISO 9003 and ISO 9004?

ISO 9000 indicates the overall series of the Quality Management System standards. ISO 9001 is the number of the actualstandard to which a company achieves certification. Both terms are often used synonymously to refer to the certification. The yearof the current revision of the standard appears in the title, such as ISO 9001.

What are the Benefits of Certification?

Apart from the obvious benefit of opening up market opportunities where ISO 9001 certification is a requirement, the biggestbenefits stem from having a structure to improve your processes. Because the standard is really based on best practices fororganizations, it provides management with the tools to objectively decide where things are working well. and where to best applyresources to make things run more smoothly. So – ideally. ISO 9000 helps your management team maximize the effectiveness ofyour business, thereby enhancing growth and reducing cost. From your customers’ perspective, it gives them confidence that youhave an organization that can consistently meet their needs.

My company is a very small. Can I get certified?

Absolutely. We’ve worked with companies of one or two people who decided to get certified. The processes that you’ll put in placewould have the same intent as a much larger company; it’s just that the implementation will be simpler. We work withorganizations to assist them in balancing the appropriate level of documentation with what’s necessary to meet requirements.

How much will this cost?

The answer depends on a number of factors. There are costs to implement, cost related to the Registrar and costs to maintain. Interms of costs to implement, if you choose a full do-it-yourself approach, the only real costs will be in the time for resourcesdedicated to the implementation process and in time spent writing documents and training your staff. If you have little experiencewith ISO 9000. or have limited internal resources, you might choose to get some outside professional help or a consultingcompany like us.Costs of registration are dependent on the size of your organization as well. Most registrars charge a certain rate per day to beon -site at your facilityTo maintain your certification, the Registrar must return at least annually to audit a portion of your system.Those costs will be less than the original visit, since the time spent will be shorter. Once every three years, the Registrar returnsto audit your entire system.

Does ISO apply to my Industry?

The ISO9000 standards are general enough to apply to any industry. We have clients in industries ranging from manufacturing togovernment and defense contractors; from education to call center operations to software development and they can all apply thestandard to their business model.

Do I need a Consultant?

Many companies choose to attain ISO certification on their own, so having a consultant is not a mandatory but highly advisable.We do believe that having access to a consultant’s knowledge and expertise can be very helpful as you try to sort out how toapply ISO in your business. And if you have an urgent need to attain certification and limited resources. using a consultant isoften the most practical approach. We provide several flexible options to meet most needs.

What is the Process Model?

The process model is based on the idea that an organization is a system of intedinked processes. The ISO 9001:2000 Standardis designed to manage and improve those processes. First, you identify your key processes. Second, you define quality standardsfor those processes. Third, you decide how process quality will be measured. Fourth. you document your approach to achievingthe desired quality, as determined by your measurements. Fifth, you evaluate your quality and continuously improve.

Are Process Flow Charts Required?

Flow charts are not specifically required, but more than likely expected by your registrar. The standard requires that you identifyyour processes and determine the sequence and interaction of the processes. This is most easily accomplished by preparing flowcharts of your product realization processes.

How many procedures are we required to write?

The standard specifically requires six procedures:Control of Documents Control of Records Internal Audits Control of Nonconforming Prod cut Corrective Action and PreventiveActionThat may not be enough: the standard also asks that you prepare any other documents you need to for planning, operation andcontrol of your processes. The standard also asks that you have available the work instructions you feel are necessary. Theanswer to how many procedures or work instructions are required: you must decide this

What records are required by the standard?

The standard specifically requires records for the following items:Management reviews Education, training,skills and experience Evidence that processes and product or service meetrequirements Review of customer requirements and any related actions Design and development including: inputs. reviews.verification, validation and changes Results of supplier evaluations Traceability where it is an industry requirement Notification tocustomer of damaged or lost property Calibration Internal audit Product testing results Corrective action Preventive actionRecords you need to provide evidence of following your processes.

How often should we have management review meetings?

Thereis no specific requirement for frequency of management review meetings. We recommend quarterly meetings. This allowsyou to stay on top of upcoming issues and yet collect data between meetings that is meaningful. We have found annual meetingsare not acceptable to all registrars. With annual meetings you may not be able to prevent issues or resolves issues in a timelymanner. Management Review

Are job descriptions required?

No, thereis no requirement for job descriptions. You are required to do two related tasks: define responsibility and authority anddefine competency in terms of education, experience, skills and training. Job descriptions are one way of accomplishing this.There are other ways including preparing organizational, job responsibility lists, and competency matrices.

What is the Process auditing?

Recently we have been receiving questions regarding process auditing and what it means. If you are auditing your qualitymanagement system by area or department and then auditing all the applicable ISO elements while in that department, you aredoing process auditing. If you are auditing your quality system by ISO elements throughout the organization you are not set upcurrently for process auditing. Process Auditing.

How often should we audit each area?

Thereis no specific requirement for audit frequency. The audit schedule should be based on the importance of the area and onwhat previous audits have uncovered. In a new system, you will want to audit frequently, perhaps monthly. to make sureeverything is implemented and working. In a mature, audits can be performed much less frequently. For a mature system (inplace for several years) we recommend every six months to one year. Taper down your audits over time. If you start at monthly.try quarterly for awhile and see if it is working. Do not audit less than annually.

How long will it take me to get certified?

Of course this depends upon several factors such as: how large your organization is: how complex your processes are; whatprocedures you may have in place already, etc. For a smaller company (less than 100 employees) an implementation can take 4-8 months; for a larger company (more than 100 employees) the process can take 12-18 months. The process also depends onthe time and resources your company can apply to implementation.One note about the timeframe – once you have met the requirements. there is some time needed for your systems to mature andto produce records that show evidence the systems are working. Most registrars prefer to see 2-3 months worth of records afteryou’ve implemented everything. That time needs to be figured in your overall timeline upfront, especially if you have to meet adeadline for registration.

How Many documents will I need? what are the requirements?

Many people are hesitant to begin the certification process. because they incorrectly believe that they will need mounds ofpaperwork to comply. In fact. the ISO standard only requires a quality manual and six written procedures: Control of Documents.Control of Records, Internal Auditing, Control of Nonconforming Product, Corrective Action, and Preventive Action. Beyond thoserequirements. it’s really up to you how much additional documentation you need to plan. operate and control your businesseffectively. Some companies find the need to add extra controls they didn’t have previously; some use the process to delete olderdocuments that are redundant or not worthwhile to maintain

My customers ask me to become ISO certified…or….I need to bid on projects that requires ISO certification. How can I do this quickly?

You can certainly be ISO certified in as little as 4 months. It requires focused attention on your part and often the help from anexperienced outside consulting resource. Another option to speed up your ISO project would be to utilize a template -baseddocumentation package like we provide on the 9000World website.

Do I need a full time person Dedicated to run my ISO program?

There are several factors that dictate how much time to dedicate to the Quality System. Factors such as size of the organization,complexity of the process. manual administrative systems verses automated or electronic systems (ex: Document Control) allhave a role in determining if there is a need for a full-time person. Of course, during the set-up of the Quality ManagementSystem there is more of a time commitment than after you are certified. For most small companies, it is a part time role.

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