2653 S. Iris St.
Lakewood, CO
80227 USA

303-985-7942

Frequently Asked Questions

ISO 9001 - Quality Management System -  Environmental Management System
Questions and Answers

A.  Per International Organization for Standardization (ISO), by the end of 2004 there were some 650,000 registered companies to this standard worldwide.

A.  The benefits are numerous. Internally, your company will use a management system that allows consistent quality of products and services. Having an ISO certificate helps your company to market its products and services to your prospects as ISO certifications become a good credential indicating that your company focuses on quality, customer satisfaction and continual improvement. For more details on benefits of ISO certification visit our Download page and check our The Perfect Manual book.

A.  Our materials are designed to address requirements of particular standards; therefore our manuals and documentation sets can be used by a company of virtually any size. Feel free to check as an example our ISO 9001: 2000 Documentation List.

A.  Our ISO 9001, ISO 13485 and ISO 14001 manuals and procedures were designed to address requirements of particular standards not industries. As defined in element 1.2 Application of the ISO 9001:2000 Standard: "All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided" (ISO 9001).

A.  Our products do not require any technical support. In fact, since the beginning of our operation in 1998 we did not receive a single inquiry for support. Our templates are in Microsoft® Word and Excel formats and if you are basically familiar with these programs, you are ready to go. Please check samples of our documents on our Download Page.

A.  Yes, you are welcome to call us if you have such questions. We will be glad to assist you. If you need help beyond a short conversation with your quality or environmental management systems, we offer various consulting programs.

A.  In our opinion, no! Our approach to documentation of quality and environmental management systems is optimization. If your company already have a Records Procedure or Documentation Management Procedure, we can not justify duplication of documentation - the processes are the same. Of course you will need to develop and implement ISO 14001 specific procedures, such as Environmental Aspects, Programs, Emergency Preparedness, etc. This is the reason why we developed an Integrated ISO 9001 / ISO 14001 Manual.

A.  A number of companies that we worked with in the medical device industry have a similar opinion. We agree, while compliance with regulatory requirements is the key element for a company in a regulated environment, it may assist business to know how satisfied their customers are. Based on our experience in this area, we developed an Integrated ISO 9001 / ISO 13485 Quality Manual to allow a company to choose what set of requirements fits their needs the best.

A.  This is a typical problem with multi-lingual documentation. The best solution we found through years of working in this environment is to create a single bi-lingual document formatted in two columns. With this approach, it is easy to ensure that text in both languages will be modified when needed.

A.  The simple and straight-forward answer is no. This is simply because registrars are not looking just at your manuals and procedures. They are looking at the effectiveness of your quality or environmental management system. Our manuals and procedures designed to save you time and money on developing an effective quality or environmental management system. Commitment of you management team to and active involvement of all employees in your management system will guarantee your certification!

A.  Like anything else, it depends on the effort, time and resource commitment of the company. We have worked with companies that received certificates in just 3-4 months, and we witnessed other companies dragging the process for years. As a rule, most registrars expect to see at least 2-3 months worth of records demonstrating evidence of effectiveness of the system, so if your management is totally committed and you have all the resources you need, you may count on 3-4 months. Realistically, average time would be around 6-9 months. Feel free to visit our Consulting page and contact us to discuss ways of optimizing your pre-certification process.

A.  There are two ways you can audit your system in this situation. You may train an employee, who is independent of activities audited or you may consider external resources, such as consultants or contract auditors. Feel free to check our Consulting page - we offer auditing and certification audit assistance to companies like yours.

A.  Quality Works has been in business since 1998. We served hundreds if not thousands of customers around the World. We are a member of a local Better Business Bureau chapter and BBB On-line Reliability Program. Just click on the BBB On-line logo to check our BBB record. Also, feel free to visit About us and fill our the order page. Shipping costs are not applicable to our delivery method. All purchased materials are e-mailed to clients after we process their credit card payment. Depending on our travel schedule, you may receive your order between 15 minutes to 2-3 business days.

A.  It is easy to order from Quality Works. Simply click the "Add to cart" button and follow secure Pay Pal process. As a rule, we will send you your .zip file within two business days, depending on our travel schedule. Our products are delivered vis e-mail, so we do not have shipping costs.

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