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Frequently Asked Questions |
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General Registration Questions
Questions Regarding Registrars
Questions Regarding our Auditors
Questions Regarding the Registration Process
Questions Regarding NQA
Questions Regarding Aerospace Standards
Glossary
What is the difference between registration and certification? What certifications or accreditation should I select? Internationally, the two terms are used interchangeably. ANAB uses the term registration to reduce confusion by consistently associating registration with the qualification of management systems and associating certification with the qualification of either products or individuals as in “product certification” or “Auditor certification.” If you do business only in the United States, the ANAB is probably sufficient. If you deal in foreign markets, choose the UKAS (British) certification, or both. International Memorandums of Understanding make it unnecessary to hold more than one accreditation in most cases. Industry specific standards may have different accreditation bodies, please refer to those standards pages within with site for more detailed information. What is accreditation? Accreditation is the means that an authoritative body (such as ANAB, short for ANSI–ASQ National Accreditation Board) uses to give formal recognition that an organization (such as a Registrar) is competent to carry out specific tasks. Accreditation, which is voluntary and strictly enforced by the accreditation body, provides assurance to a Registrar's customers that the Registrar operates according to internationally accepted criteria. What are the principles of the ISO 9001:2000 standard? The quality management principles of ISO 9001:2000 are aligned with the philosophy and objectives of most quality award programs. These principles are:
How long is my registration valid? All quality management system registrations are issued for three year cycles, as required by the governing bodies. Your certificate will be issued with a “valid until” date three years beyond its issue. NQA will schedule your audits such that your new certificate will be issued prior to the expiration of the original certificate. What is the difference between an “Assessment” and an “Audit”? Internationally, the two terms are used interchangeably, as are the terms “Assessor” and “Auditor”. How will ISO 9001:2000 help us improve customer satisfaction? “Customer satisfaction” is recognized as one of the driving criteria for any organization. In order to evaluate if the product meets customer needs and expectations, it is necessary to monitor the extent of customer satisfaction. Improvements can be made by taking action to address any identified issues and concerns. ISO 9001:2000 is based on quality management principles that include the “process approach” and “customer focus”. The adoption of these principles should provide customers with a higher level of confidence that products will meet their needs and increases their satisfaction. How will the implementation of ISO 9001:2000 help my organization to improve its efficiency? ISO 9001:2000 aims at improving the effectiveness of the organization. For improved organizational efficiency, the best results can be obtained by using ISO 9004:2000 in conjunction with ISO 9001:2000. The guiding quality management principles are intended to assist an organization in continual improvement, which should lead to efficiency throughout the organization. What is meant by “continual improvement”? “Continual improvement” requires an organization to focus on continually increasing the effectiveness and/or efficiency of its processes, to fulfill its policies and objectives. Continual improvement (where “continual” highlights that an improvement process requires progressive consolidation steps) responds to the growing needs and expectations of customers and ensures a dynamic evolution of the quality management system. Does ISO 9001:2000 address financial issues? While financial information may be used to demonstrate the effectiveness of certain aspects of a firm's quality management system, it is not addressed by the ISO 9001:2000 standard. Although the ISO 9004:2000 guidance standard emphasizes the financial resources needed for the implementation and improvement of a quality management system, ISO Registrars do not require or audit financial information. Additionally, any such information that may be disclosed in the course of an ISO audit is protected by strict confidentiality agreements signed by the Registrar and its Auditors. How does ISO 9001:2000 relate to the needs of specific business sectors? The text of ISO 9001:2000 is more generic than the 1994 version in order to be applicable to different types of product and to organizations of different sizes. Due to this generic nature it may be that some industrial or commercial sectors will identify additional requirements to attend to their specific needs. To assure consistency between the ISO 9001 requirements and sector requirements, a pilot study was conducted using the development of an automotive industry document as the test vehicle. The pilot project successfully achieved the publication of an ISO technical specification (ISO/TS 16949). How can a small organization adapt to the requirements of ISO 9001:2000? What flexibility is allowed? The requirements of ISO 9001:2000 are applicable to small, medium, and large organizations alike. ISO 9001:2000 provides some flexibility, through clause 1.2 “Application”, on the exclusion of certain requirements for specific processes (e.g. those covered by clause 7, such as design activities) that may not be performed by the organization. However, the individual organization still needs to demonstrate its capability to meet customer and applicable statutory or regulatory requirements for its products, and to consider this when determining the complexity of its quality management system. My organization provides services. How is the ISO 9001:2000 standard applicable to us? ISO 9001:2000 was designed to take a “generic” approach applicable to all types of organizations. As such, it is equally appropriate to all sectors, including service providers. The definition of the term ‘product’ in ISO 9000 also includes services, and ISO 9001:2000 was written to reflect this definition. AIR has Auditors with experience in most manufacturing and service industries. One of the first things we do is make sure that you are matched with an Auditor familiar with your type of business. Also, every AIR customer has the opportunity to get acquainted with the Auditor selected for their account before a firm audit assignment is made. Can we use our registered status to promote our company? It's no secret that registration under the international ISO 9001:2000 standard is a powerful marketing advantage that sets a company apart from its competitors and can help get new customers while retaining existing ones. What some firms don't realize is that there are specific rules that apply to the use of ISO as a marketing tool. One common mistake is to claim that one's product is “ISO–registered”. Registration under ISO 9001:2000 applies only to your quality management system, not to your products or services. For this reason, marketing materials must never use ISO or Registrar logos or artwork in a way that could be misinterpreted to mean that products or services are ISO–certified or registered, and in fact the Registrar will withdraw a firm's registered status if it engages in such practices. It should also be noted that the International Organization for Standardization (ISO) forbids firms from using its copyrighted ISO logo. For specific guidance on this issue, ask your Registrar. What are the differences between the previous version and ISO 9001:2000? The main changes that were introduced are:
What new requirements were introduced into the revised ISO 9001 standard? The main new requirements include:
What does my organization need to do if it is registered to ISO 9001, ISO 9002 or ISO 9003:1994? ISO 9001:2000 superseded ISO 9001, 2 and 3 as of December 15th, 2003, and registrations to the 1994 versions of ISO 9001, ISO 9002, and ISO 9003 are no longer valid. You will need to evaluate which specific requirements of ISO 9001:2000 are applicable to the nature of your business and the extent to which your present quality management system (QMS) meets those requirements. Provisions have been made to exclude non–applicable requirements within Section 7 of the standard through clause 1.2 “Application”. If, for example, the nature of your products does not require you to perform design activities or if your product is provided on the basis of established design, you will need to discuss and justify the exclusion of these requirements with your certification/registration body. (See also the ISO/TC 176/SC2 Introduction and Support Package: Guidance on ISO 9001:2000 Clause 1.2 Application.) Will I be able to certify/register my organization to ISO 9004:2000? No. As ISO 9004:2000 is a guidance standard, it is not intended to be used for third party certification purposes. A key element in the new ISO 9004 is the ability to perform self–evaluation. Third party QMS certifications/registrations are performed to ISO 9001:2000, which has consolidated the previous ISO 9001, 9002, and 9003 standards. How will interested parties benefit by the organization adopting ISO 9004? If the system is appropriately implemented utilizing the eight Quality Management Principles, all interested parties will benefit from ISO 9004. Customers and users will benefit by receiving products and services that are:
People in the organization will benefit by:
Owners and investors will benefit by: Suppliers and partners will benefit by: Society will benefit by:
What is a Registrar? A Registrar (also known as a Certification/Registration Body or CRB) is a third–party company that is contracted to perform an impartial evaluation of an organization’s quality, environmental, or other management system's conformance to the requirements of the appropriate ISO standard, and to issue a registration certificate once conformance is verified. How does the accreditation body determine whether a Registrar meets the ANAB accreditation criteria? ANAB Auditors evaluate a prospective Registrar's written policies and procedures, including the credentials of its staff and Auditors. If they are acceptable, the NAP audit team performs a rigorous on–site examination of the Registrar’s internal operations and then witnesses the Registrar conducting a complete customer audit. How often are accredited Registrars re–examined? Accreditations are valid for four years. Surveillance audits are routinely conducted by ANAB six months after accreditation has been granted, and then on the first, second, and third anniversaries of the accreditation. A complete reassessment is required every four years. Additional audits may be performed if the Registrar wishes to extend the scope of accreditation to cover additional industry sectors or to participate in certain specialty fields. What should I do if I believe that an ANAB–accredited Registrar has not done an adequate job? Each Registrar is required to have a system for handling complaints. ANAB evaluates the operation of the complaint system during its Surveillance Audits. Every Registrar also has an appeals system through which customers can appeal adverse decisions. The Registrar's appeals system is also evaluated by ANAB during Surveillance Audits. How are NQA’s auditors certified? NQA's auditors are either RAB/QSA or IRCA certified, or both. In addition, most of our over 100 auditors carry certifications for multiple standards such as the Aerospace, Automotive, or Environmental industry standards and are able to integrate the audits. Do associate/contract auditors receive training on NQA procedures? All NQA’ auditors receive an initial training which includes the observation of audit activities by management (Our Audit the Auditor Program) as well as attending NQA’s semiŠannual training conferences. In addition, our Assessor Manager holds monthly meetings with the audit staff in order to disseminate new information and discuss and new interpretations, questions or situations they might have encountered that month. From where will my auditor be traveling? NQA's audit staff of over 100 is located throughout the country in order to provide more local service to you. Your Client Support Representative will utilize the most qualified auditor in the closest proximity to your facility. Will the auditor have experience in our industry? Yes, NQA, USA and the Accreditation Bodies, require that the auditor be experienced in your Industry Sector. What is the average length of experience of an NQA auditor? On average, NQA auditors have over 12 years of experience in the auditing/quality industry, in addition to work experience gained prior becoming an auditor. What is the registration process? Registration is performed by a Registrar organization (also known as a Certification/Registration Body, or CRB). It is accomplished through a series of document reviews and facility visits and audits. The Registrar's Auditors look at an organization's procedures, processes, and operations to determine their conformance to the requirements (elements) of the applicable quality system standard, and verify that the organization's operations conform to its’ internal documentation and procedures. The Registrar looks at a variety of issues including but not limited to the applicant organizations administrative, design, and production processes; quality system documentation; personnel training records; management reviews; and internal audit processes. Preparation for registration can take anywhere from several weeks to more than a year, depending on the readiness of the organization applying for registration. The actual process of registration depends on factors such as the size of the organization, the scope of its activities, and the number of facilities being registered and their location. The document review typically takes one or two days, and the on–site Initial Assessment can take anywhere from two to as much as ten or more days, depending on the factors noted above. Step 1: Complete the Questionaire and submit. A Quotation will be returned to you in less than 48 hours. If you would prefer to have the questionnaire mailed or emailed to you, please email us at iso@nqaŠusa.com. Step 2: Sign and return the Quotation and Registration Agreement with a purchaser order or check for the initial activity (the document review in most cases). You will then be assigned to a Customer Support Representative who will contact you to discuss the scheduling of your activities, including the Optional PreŠAssessment, as well as the auditor choices available to you. Step 3: Quality Manual Review Š The first step in the audit process will be a review of the Quality Manual and Level I and II Policies and Procedures. The Quality Manual and Procedures encompass or reference all of the documented quality system policies, procedures and work instructions that form the foundation for the overall planning and administration of activities affecting quality. This activity can be conducted at your facility, or the manuals can be forwarded to us for an off site review. Step 4: Pre assessment Audit (Optional) Š The preŠassessment is an optional service which can be tailored to meet the individual needs of the organization. Reports issued during the pre assessment will detail corrective action requests to be completed by the registration assessment. The pre assessment is not a guarantee of a pass or fail at the main registration assessment; however, it can be used as an indicator of the strength or weakness of the areas of the system sampled. Step 5: Registration Assessment Š The assessment is aimed establishing compliance of the company's DQS with the applicable standard (supported by Briefing notes and guidance notes as appropriate) and establishing, by seeking objective evidence that the company is working in accordance with their DQS. The assessment includes an opening meeting between the Audit Team and the organizations representatives, the assessment itself, and a closing meeting at which the findings (if any) are given to the company in a report along with a recommendation for registration. Step 6: ReŠAssessment Š Upon receipt of your registration, you will begin the ReŠAssessment Cycle. The purpose of continued surveillance visits is to ensure continuing compliance with the standard. The program will ensure that over the three year period, all elements of the quality management system are assessed. The triennial cycle ends with a Re assessment audit, which may or may not increase the on site time required. The following topics will be covered in all surveillance visits: clearance of previous nonŠcompliances, internal audits, management review, customer complaints, quality objectives, customer satisfaction, continual improvement, changes to the DQS, changes to the scope, use of the registration/certification mark, number of employees, and a sample of other components of the system. What is a Pre–Assessment? Is a preliminary assessment required? A Pre–Assessment is an option that helps a company determines its readiness for the Registration Audit. Other terms for Pre–Assessment are Pre–Audit and Trial Audit. Pre–Assessments offer the opportunity to experience a third–party audit with no risk of failure. During a Pre–Assessment, the audit team evaluates a firm's quality system for compliance with the relevant standard, with the firm's internal quality system documentation, and looks for evidence of proper implementation. Audit findings are discussed with the client and are described in a written Pre–Assessment report; formal Non–Conformance Reports (also known as NCR's) may or may not be issued. Because accredited Registrars are prohibited from offering registration and consulting services together, the Registrar may not offer its clients specific advice on how to resolve non–conformances. The pre–assessment report provides a clear description of any problems that are found, however. In most cases, a pre–assessment by your Registrar is preferable to one performed by your consultant, because although the consulting firm can recommend specific solutions, the fact remains that they are auditing their own work and may be biased and/or miss problems. The number and frequency of Pre–Assessments are limited by ANAB guidance. NQA offers pre–assessments as an optional service. Many companies utilize a consultant in the development of their quality management system, and he or she may have included a preŠassessment as part of their package. NQA recommends to our clients that they opt for a pre–assessment which is 50% of the required audit days for registration assessment. During the preŠassessment, NQA can perform a truncated assessment, or can tailor the activity dependent upon input from the client. An example would be to have the auditor focus on an area the client feels weak in, such as design or document control Š the two biggest problem areas for most companies. Will our quality system documentation be reviewed on site? NQA’s methodology is to check that the declared Documented System (including Level I and II Policies and Procedures) is adequate and complete to each element of the applicable standard. The documented system can be reviewed at your site, as a stand alone activity or part of a preŠassessment, or you can forward your documentation to us for review. NQA will accept the manual in electronic or paper format. Who does a Registrar interview during the course of the registration process? A Registrar's audit team can interview anyone from the chief executive officer to line workers and operators. This interview process is typically done on a sampling basis and covers a wide range of personnel from diverse divisions and departments. What happens if a Registrar finds nonconformance’s at my facility during the registration audit? It is important to note that there are several degrees of nonconformances. Typically, these are minor and major nonconformances, and possibly also observations. An observation is just that: an observation. It is not considered to be a violation of the criteria. It is typically an identifier that there may be a better way to monitor a process or document a procedure. It's not a problem; just a potential for improvement – a way to avoid future problems. A minor nonconformance by itself doesn’t indicate a systemic problem with the quality management system. It is typically an isolated or random incident. An example is if the most current version of a document is not available at an operator's station; the updated version exists but a copy of it is not available for the operator's use and the operator is using an outdated procedure. Other examples are a form without a document control number on it or an internal audit with an overdue corrective action request pending. A major nonconformance occurs when one of the criteria of the standard is not addressed or has not been addressed adequately. Typically, major nonconformances occur when an organization has not addressed all of the requirements of a specific element or criterion. They also occur when an organization has put a process or procedure in place but has not implemented it or cannot yet demonstrate effective implementation. One of the most common major nonconformances is the failure of an organization to complete a full internal audit and/or management review prior to the Initial Assessment. A major nonconformance can also occur if a significant number of minor nonconformances in a given activity or against a given element point to a systemic failure. For example, a minor nonconformance in document control may not in itself constitute a significant problem. But if several problems (the audit team leader judges what constitutes a significant number) are found with document control, then this points to a larger systemic document control problem and would constitute a major nonconformance. In most cases, the Registrar will require corrective action for minor nonconformance’s to be implemented no later than the next scheduled Surveillance Audit. Major nonconformances are typically required to be corrected as quickly as the Auditor feels is possible. Most Registrars will not issue a Registration Certificate until any major nonconformances have been acceptably corrected. In some cases, if a nonconformance can only be cleared by on–site inspection, the Auditor may require a special follow–up visit. How helpful may a Registrar be to the success of an organization's registration effort? A Registrar accredited by the ANAB (ANSI–ASQ National Accreditation Board) may not engage in advice giving or consulting with the organization it is registering, although a body related to the Registrar may do so under certain conditions. One of the conditions of accreditation is that registration and consulting may not be marketed together, nor may anything be said or implied that registration may be easier as a result of utilizing the services of a particular consultant. Persons engaged in both registration assessment and consulting must separate these activities for the same supplier, by at least two years of time. ANAB considers private or tailored training to be consulting if it is offered by a Registrar (or related body) to an organization being registered. What is a Surveillance Audit? Surveillance Audits, sometimes referred to as “maintenance of approval” audits, are the means by which a Registrar verifies that your quality management system remains effective and compliant with the relevant standard. The Registrar will review each element of the standard at least twice during the three–year registration period; once during the Initial Audit, and again at one of the Surveillance Audits and/or the renewal audit. The Auditor checks certain key elements of your quality system at each Surveillance visit, verifies that your Internal Audit and Management Review activities continue to be effective, and verifies your corrective action for any non–conformances that may have resulted from previous audits. The two most common schedules for surveillance are two audits annually at approximately six–month intervals, or one annual Surveillance Audit. The total number of audits days per year will be the same in both cases, and should total about one–third of the days that were required for the Initial Audit, as required by IAF–PL–01–014 “IAF Guidance on the Application of ISO/IEC Guide 62:1996”. Surveillance frequency is determined by factors such as the complexity and effectiveness of your system. For example, if the Registrar has concerns about effectiveness, it may require more frequent surveillance. The Registrar is responsible for assuring that the surveillance program is sufficient to verify continued conformance to the standard. ANAB requires the Registrar to have documented justification for any variation from the surveillance audit duration specified in the IAF Guidance. A periodic renewal/re–approval audit is also required. Normally this occurs in the third year of the registration cycle, with duration of about two–thirds the number of days that were required for the Initial Audit. What does the Registration Certificate say? The Registration Certificate states that the organization's quality management system has been assessed by the Registrar and found to conform to the applicable standard. It lists the location(s) and the scope of activities that were covered by the assessment, and gives the dates during which the certificate is valid. In this context, it is important to note that only the quality system itself may be certified, never products or services. How does the Registration Certificate identify the scope of the quality management system? It is important for the certificate to clearly define the processes, products, and services (the “scope”) that are covered by registration/certification. The merging of ISO 9001, 9002, and 9003 into a single standard (ISO 9001:2000) has made it all the more important to clearly define what is covered by certification/registration. What is a process? Any activity or operation, which receives inputs and converts them to outputs, can be considered to be a process. Almost all activities and operations involved in making a product or providing a service are processes. For organizations to function, they must define and manage numerous inter–related processes. Often the output from one process will directly form the input into the next process. The systematic identification and management of the various processes employed within an organization, and particularly the interactions between such processes, may be referred to as the Ōprocess approachÕ to management. ISO 9001:2000 is based on just such a process approach, in line with the guiding quality management principles. What is NQA’s typical lead time for scheduling my audit activity? NQA’s Client Support Representatives begin the scheduling process for a particular month eight weeks in advance in order to optimize the schedule for both the clients and the auditors involved. This lead time allows us to team your audit with other audits in your region. However, NQA does maintain an extensive staff of auditors, and can also accommodate a client’s need for a quick turn around due to customer requirements. How long has NQA been in business? National Quality Assurance (NQA) has been in business since 1988 in the United Kingdom. NQA, USA was founded in 1992 as a joint–venture subsidiary between NQA Ltd. and National Technical Systems, the U.S. largest independent testing and certification laboratory. Does NQA have experience with small manufacturers? Approximately 70% of NQA’s clients are small firms with less than 100 employees. NQA prides itself on its ability to work with small and medium sized business, including price discounts. What will my registration cost? Registration costs depend primarily on the amount of time that the process takes, which is based on factors such as the number of employees, the size of the organization, the scope and complexity of its' operations, and the number of facilities being registered. The initial cost for a Document Review and an on–site Audit for a company with ten or fewer employees typically runs $800.00–$1,600.00 (US). The cost of maintaining the registration will vary based on the cost per day and frequency of surveillance audits, and on the distance the Auditor must travel to the audit site. The amount of audit time required for the Initial Assessment is based on IAF–PL–01–014 “IAF Guidance on the Application of ISO/IEC Guide 62:1996”. When soliciting quotes for registration, a company should be sure to ask the Registrar if they have qualified local Auditors and to confirm how many employees and what other criteria will be used to determine how much audit time will be required. Complete our Questionnaire and we will return a complete Quotation for services. There are no hidden costs, no charge for travel time, and no report fees. Which aerospace standard is right for me? There are 3 aerospace standards, all of which are based upon the ISO 9001:2000 standard. The AS9100B is a globally harmonized aerospace standard for quality assurance in design, development, production, installation and service. It applies to all components of the aerospace industry from suppliers to manufacturers of aircrafts and aerospace vehicles. The AS9110 standard was developed for aerospace maintenance organizations. Lastly, the AS9120 standard is for use by organizations that procure parts, materials and assemblies and sells these products to a customer in the aerospace industry. This includes organizations that procure products and splits them into smaller quantities. It is not intended for organizations that rework or repair products. Which OEM’s are requiring AS91XX registration? OEM’s are not unilaterally requiring registration to one of the aerospace standards for all of their suppliers. That said, a number of the large OEM’s have specifically required AS91XX registration in order to be able to bid on a specific contract but as of this date, none of the large OEM’s require registration for their entire supply chain. What is OASIS? Will my audit results be posted there? OASIS standards for “Online Aerospace Supplier Information System”. The purpose of the OASIS database is to provide independent verification of the status of certification. The International Aerospace Quality Group (IAQG) issued a letter in May 2003 detailing the roll out of OASIS. AIR5259 requires Certification/Registration Bodies (CRB’s) to submit the results of aerospace audits to the OASIS database. The results of a company being audited to one of the aerospace standards will be posted in that database as required by AIR5259. |
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