1. Why should I use a consultant?
Many organizations or companies find that they do not have the time to undertake creation or upgrade of an ISO 9001 system. Also, it is typically not cost effective to hire someone into the company to be responsible for the program, because once the system is created it is not a full-time position to maintain; and because companies are more successful if they involve as many different people in the company as possible, which ensures effective implementation and buy-in.
2. What is ISO?
ISO stands for International Organization for Standardization, located in Geneva, Switzerland. This organization is responsible for maintaining and publishing the ISO standards and guidelines. It also is the greek word for ï¿¿equalï¿¿.
3. What is ISO 9001?
ISO 9001 is the standard defining quality management system requirements. This standard provides the requirements for an organization to establish, implement and maintain a quality management system that will ensure its overall effectiveness in satisfying the defined requirements.
4. What is registration?
Registration is the process of having your quality management system reviewed and approved by a registrar with regard to the ISO 9001standard (or other industry standard).
5. What is a registrar?
A registrar is an organization that performs registration audits. Registrars are approved by accreditation bodies to perform this service.
6. How do I find a registrar?
You can find registrars by searching the National Accreditation Board (ANAB) website at www.anab.org.
7. What are the costs associated with registration?
Registration costs vary depending on the number of employees, number of facilities, the quality management system standard, and the processes in place at a company. Costs typically include: documentation review, initial registration audit, report preparation, and surveillance audits.
8. What are the benefits of implementing ISO and getting registered?
Some of the benefits of ISO 9001 include: improved customer satisfaction, improved communication, reduced variation, increased predictability, increased market share, improved employee awareness, and reduced scrap and nonconformances.
9. How do I handle registering multiple locations?
A company may opt for multiple locations under one registration certificate or to register each location separately. This decision depends on the differences between size, scope, and complexity of activities at each location and the organization structures.
10. What training is required?
Typically training is required for personnel to understand the requirements of ISO 9001. Additionally, companies may need to train their people on any new processes that have been defined during the course of implementation. Many choose to provide some formal training for their internal auditors.
11. Do my internal auditors have to be certified?
There are certified internal auditor courses available; however, there is no requirement that internal auditors be trained in one of these certified courses. Auditors simply must be qualified and competent to do internal audits.
12. What is AS9100?
AS9100 is the international aerospace industryï¿¿s quality management system standard. It adds aerospace unique requirements to ISO 9001. Authored by SAE, AS9100 and related standards are available through www.sae.org.
13. What is TL 9000?
The QuEST Forum publishes the TL 9000 as the telecommunication industryï¿¿s quality management system standard, based on ISO 9001. TL9000 is structured in two handbooks for the requirements and measurements. Both are available through www.asq.org and www.questforum.org .
14. What is ISO/TS 16949?
ISO/TS 16949 is the international automotive industryï¿¿s version of ISO 9001. It includes all the requirements of ISO 9001 plus additional automotive requirements.
15. What is QS 9000?
QS-9000 is the U.S. automotive industryï¿¿s version of ISO 9001. It includes all the requirements of ISO 9001 plus additional automotive requirements determined by the major automotive and trucking OEMs. Available through www.asq.org and www.aiag.org .
16. What is the difference between QS and TS?
QS is published by the Automotive Industry Action Group (AIAG) in the U.S. TS is an international standard that is subject to periodic review and modification by an international committee.
17. What is ISO/IEC 17025?
ISO 17025 is a global standard for the technical competence of calibration and testing laboratories. Nearly all national standards bodies and accreditation agencies around the world have adopted it. A growing number of companies require it and some industries have even incorporated it into sector-specific standards (for example, the automobile manufacturers' QS9000). Available through www.asq.org or www.iso.org.
18. How long will ISO 9001 stay around?
Since its initial publication in 1987, ISO has been adopted and accepted by most countries around the world, by most industries (automotive, telecommunication, aerospace, financial, education, healthcare, etc.) as either a required or voluntary standard for quality management systems, and by some government agencies (Department of Defense, FAA, FDA, etc.) as a flow-down to their suppliers. Since its initial issue, adoption and registration to this standard has seen exponential growth over the years. It has become the way that organizations and companies do business.
19. How long does it take to implement ISO 9001?
Typical implementation takes anywhere from 6 to 18 months, to be ready for registration. The variation depends on the amount of time key employees can dedicate to the process.
20. What are the steps for implementation?
The general steps for implementation include: gap analysis of current system, steering committee and management training, definition of company processes, development of quality manual, definition or documentation of processes (procedures and any related work instructions), quality management system implementation and related training, internal auditor training, conducting internal audits of entire system, conducting a full management review, and quality management system maintenance and improvement.
21. How much of my time will it take to implement and maintain ISO 9001?
For ISO steering committee members, it will typically take about 2 to 8 hours per week of their time over the implementation period. For the main ISO coordinator this time may be more.
22. How do I define my ï¿¿productï¿¿?
According to ISO 9000:2000, product (3.4.2) is defined as ï¿¿result of a process (3.4.1)ï¿¿; process is defined as ï¿¿set of interrelated or interacting activities which transforms inputs into outputsï¿¿.
23. What are ï¿¿permissible exclusionsï¿¿?
According to ISO 9001-2000 section 1.2 Application, ï¿¿All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion. Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.ï¿¿
24. Which standards do I need to purchase?
You need a copy of the applicable standard (i.e. ISO 9001, TL 9000, AS9100, ISO/TS 16949, etc.) and a copy of ISO 9000. ISO 9000 (Fundamentals and Vocabulary) is a normative reference, which means that it is required. This provides employees with a consistent understanding of terminology.