Q:  How many companies are certified to ISO 9001 standard?
A:  Per International Organization for Standardization (ISO), by the end of 2004 there were some 650,000 registered companies to this standard worldwide.

Q:  What are the benefits of ISO certification?
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.

Q:  My company is planning to start implementation of an ISO 9001 compliant system. Where can I find basic information to start educating our staff?
A:  There are literally countless resources on the Internet on ISO and its standards. Searching for "ISO", you most likely will end up with 100,000 plus results. You may start from the ISO Website If you need a summary of benefits and do not have much time for research, visit our Download page and check our The Perfect Manual book.

Q:  What size of companies are your manuals and procedures designed for?
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 type and size. Feel free to check as an example our ISO 9001: 2000 Documentation List.

Q:  How do I know if your quality and environmental manuals and procedures will be suitable for my industry?
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).

Q:  Does your company provide technical support for your ISO 9001, ISO 13485 and ISO 14001 products that I purchased?
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.

Q:  Can I call you, if I have a question about use of your manuals and documentation sets or management systems in general?
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.

Q:  My company has been registered to ISO 9001 for a few years and now we plan to register to ISO 14001 standard. Do we need to establish separate ISO 14001 manual and documentation for the new standard?
A:  In our strong 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. Feel free to check our Download page for a preview version of ISO 9001 / ISO 14001 Integrated Manual

Q:  We are a medical device manufacturing company. ISO 13485:2003 excluded a number of requirements of ISO 9001, such a customer satisfaction. We feel that this is an important element of building a loyal customer base. How can we get around these differences and still comply with the standard?
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 its needs the best. Feel free to check our Download page for a preview version of ISO 13485 / ISO 9001 Integrated Manual

Q:  Our company has a manufacturing facility in Mexico. Many QMS documents were translated and now we have two sets of manual and many procedures. When Spanish version is changed, the English version often is forgotten. What can we do to link bi-lingual documents to avoid this problem?
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.

Q:  Can you guarantee our certification if we purchase and use your manual and procedures?
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!

Q:  How long does it take to develop an ISO 9001 quality management system to be ready for a certification audit?
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 pages and contact us to discuss ways of optimizing your pre-certification process.

Q:  We are a small company. As a Quality Manager I developed the entire system and am responsible for it. How can we audit our quality system and comply with the requirements of the standard?
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 contract auditors. Feel free to check our Auditing pages - we offer auditing and pre-certification audit assistance to companies like yours.

Q:  How do I know that your company is a reputable business which I can trust?
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.

Q:  How do you deliver you documents, when I order them?
A:  All purchased materials are e-mailed to clients after we receive purchase confirmation from PayPal. Depending on our travel schedule, you may receive your order within 30 minutes to 2-3 business days.

Call us today to discuss your specific ISO management system needs!