In short, ISO 9001 is a voluntary Quality Management System standard that helps organizations ensure they are meeting customer requirements. Note that the key word in the title is "Management." The intent of the 9001 standard is to implement systems that Management can use to better run the business.

The International Organization for Standardization decided not to use an acronym for their organization, because it would be different 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 International Organization for Standardization located in Geneva, Switzerland, and their 158 member countries

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

The answer depends on a number of factors. There are costs to implement, cost related to the Registrar and costs to maintain. In terms of costs to implement, if you choose a full do-it-yourself approach, the only real costs will be in the time for resources dedicated to the implementation process and in time spent writing documents and training your staff. If you have little experience with ISO 9000, or have limited internal resources, you might choose to get some outside professional help or a consulting company like us.

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 to apply ISO in your business. And if you have an urgent need to attain certification and limited resources, using a consultant is often the most practical approach. We provide several flexible options to meet most needs

The process model is based on the idea that an organization is a system of interlinked processes. The ISO 9001:2015 Standard is designed to manage and improve those processes. First, you identify your key processes. Second, you define quality standards for those processes. Third, you decide how process quality will be measured. Fourth, you document your approach to achieving the desired quality, as determined by your measurements. Fifth, you evaluate your quality and continuously improve.

Many people are hesitant to begin the certification process, because they incorrectly believe that they will need mounds of paperwork 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 those requirements, it’s really up to you how much additional documentation you need to plan, operate and control your business effectively. Some companies find the need to add extra controls they didn’t have previously; some use the process to delete older documents that are redundant or not worthwhile to maintain

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) all have a role in determining if there is a need for a full-time person. Of course, during the set-up of the Quality Management System there is more of a time commitment than after you are certified. For most small companies, it is a part time role.

Of course this depends upon several factors such as: how large your organization is; how complex your processes are; what procedures 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 on the time and resources your company can apply to implementation.

No, there is no requirement for job descriptions. You are required to do two related tasks: define responsibility and authority and define 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.

There is no specific requirement for audit frequency. The audit schedule should be based on the importance of the area and on what previous audits have uncovered. In a new system, you will want to audit frequently, perhaps monthly, to make sure everything is implemented and working. In a mature, audits can be performed much less frequently. For a mature system (in place 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.

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

In addition to these if you are looking at answers to the other questions, get in touch with us for the answers.