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Home > Frequently Asked Questions
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General Registration Information
A: | 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.
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A: | 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. |
A: | The quality management principles of ISO 9001:2000 are aligned with the philosophy and objectives of most quality award programs.
These principles are:
Customer focus
Leadership
Involvement of people
Process approach
System approach to management
Continual improvement
Factual approach to decision making
Mutually beneficial supplier relationships
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A: | “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.
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A: | 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. |
A: | “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. |
A: | 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. |
A: | 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).
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A: | 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. |
A: | 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.
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A: | 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.
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A: | The main changes that were introduced are:
A new process–oriented structure and a more logical sequence of the contents
A continual improvement process as an important step to enhance the quality management system
Increased emphasis on the role of top management, which includes its commitment to the development and improvement of the quality management system, consideration of legal and regulatory requirements, and establishment of measurable objectives at relevant functions and levels.
The concept of “Application” of the standard has been introduced (in clause 1.2) as a way to cope with the wide spectrum of organizations and activities.
A requirement for the organization to monitor information on customer satisfaction as a measure of system performance.
Significant reduction in the amount of required documentation.
Terminology changes/improvements for easier interpretation.
Increased compatibility with the environmental management system standard ISO 14001
Specific reference to quality management principles.
Consideration of the benefits and needs of all interested parties.
Addition of the concept of organizational self–assessment as a driver for improvement (ISO 9004:2000)
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A: | The main new requirements include:
Continual improvement
Increased emphasis on the role of top management
Consideration of statutory and regulatory requirements
Establishment of measurable objectives at relevant functions and levels
Monitoring of information on customer satisfaction as a measure of system performance
Increased attention to resource availability
Determination of training effectiveness
Measurements extended to system, processes, and product
Analysis of collected data on the performance of the quality management system
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A: | 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.) |
A: | 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. |
A: | Customers and users will benefit by receiving products and services that are:
Conforming to the requirements
Dependable and reliable
Available when needed
Maintainable
People in the organization will benefit by:
Better working conditions
Increased job satisfaction
Improved health and safety
Improved morale
Improved stability of employment
Owners and investors will benefit by:
Increased return on investment
Improved operational results
Increased market share
Increased profits
Suppliers and partners will benefit by:
Stability
Growth
Partnership and mutual understanding
Society will benefit by:
Fulfillment of legal and regulatory requirements
Improved health and safety
Reduced environmental impact
Increased security
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A: | 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. |
A: | 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. |
A: | 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. |
A: | 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. |
The Registration Process
A: | 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. |
A: | Internationally, the two terms are used interchangeably, as are the terms “Assessor” and “Auditor”. |
A: | 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.
Step 2: Sign and return the Quotation and Registration Agreement with a purchaser order or check for the initial activity. You will then be assigned to a Client Support Representative who will contact you to discuss the scheduling of your activities, including the Optional PreЁssessment, as well as the auditor choices available to you.
Step 3: Stage One Activity: First step in the audit process will be a review of the Management System Manual and Level I and II Policies and Procedures. The Management System Manual and Procedures encompass or reference all of the documented system policies, procedures and work instructions that form the foundation for the overall planning and administration of activities affecting the management system. This activity will be conducted at your facility.
Step 4: Pre assessment Audit (Optional): The pre-ssessment 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 success 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: Stage Two Assessment The assessment is aimed at establishing compliance of the company's documented management system 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 documented management sysytem. 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: Surveillance: Upon receipt of your registration, you will begin the surveillance 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 nonУompliances, 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.
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A: | 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 management system for compliance with the relevant standard, with the firm's internal management 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) will be issued as part of the report.
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.
NQA offers pre–assessments as an optional service. Many companies utilize a consultant in the development of their management system, and he or she may have included a preСssessment 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 preСssessment, NQA can perform a truncated assessment, or can tailor the activity dependent upon input from the client. Oneexample would be to have the auditor focus on an area the client feels weak in, such as design or document control the two biggest problem areas for most companies.
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A: | 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 will be reviewed at your site, as a stand alone activity or part of a pre-assessment. |
A: | 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. |
A: | 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.
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A: | 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.
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A: | 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.
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A: | 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.
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A: | 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. |
A: | 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 process approach to management.
ISO 9001:2000 is based on just such a process approach, in line with the guiding quality management principles.
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Auditor Information
A: | 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. |
A: | 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 semiСnnual 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. |
A: | 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. |
A: | Yes, NQA, USA and the Accreditation Bodies, require that the auditor be experienced in your Industry Sector. |
A: | 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. |
About NQA
A: | 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. |
A: | 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. |
A: | 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. |
ISO 13485 - Medical Specific
A: | ISO 13485 certification may be obtained by finished medical device manufacturers, but by companies that are in the medical device manufacture’s supply chain such as provider of various electronics & electronic components, plastics & rubber (fittings, tubing, seals, etc.) metal fabricators, etc. Service suppliers may also obtain ISO 13485 certification, for example; platers, heat treaters, design / engineering companies, etc. |
A: | ISO 13485:2003 is a Quality Management System standard for the medical device industry and sub tier suppliers. |
A: | ISO 13485 is compatible with QMS standards (i.e. 9001, AS9100, etc) and with non- QMS standards (i.e. ISO 14001, OHSAS 18001, FDA 21CFR 820). ISO 13485 requirements may be easily incorporated into you existing system. |
A: | Absolutely! NQA is able to provide integrated audits, meaning NQA has multi-discipline auditors who are capable of auditing multiple standards. When scheduling your initial visit or subsequent surveillances, your Client Support Representative will discuss your needs and assign the appropriate auditor(s). |
A: | NQA has qualified ISO 13485 auditors in RI, NH, ME, OH, NC, IA, CO, CA, & UT, however, NQA auditors do not mind traveling, and are very conscious of expenses when making travel arrangements. |
A: | No. The ISO 13485 standard, just like other standards, has sector specific requirements. You will not need to develop separate procedures; however, you will need to upgrade your existing documentation to reflect the requirements of ISO 13485. |
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