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ISO 9001:2008

ISO 9001:2008 specifies quality system requirements to be used where an organization requires the ability to consistently provide conforming products, either material or services to meet a customer's expectations. The requirements are aimed at achieving customer satisfaction by preventing nonconformances.

Note: The ISO 9001 standard is currently under revision. All the latest on ISO 9001:2015 can be found on our blog.

The ISO 9001:2008 standard provides a model on which an organization may build an effective quality management system.

It does not matter if the organization is:

  • Large or small
  • Is a manufacturer, service provider or agriculture concern
  • Involved in the hardware or software industries
  • Operating in the public, private, or government sectors

The ISO 9001:2008 standard will meet your needs.

 

ISO 9001 Audit Team

The Benefits of ISO Registration

Regardless of your reasons for seeking ISO 9000 certification, these registrations should benefit your company. To gain the maximum benefits from the ISO process, it is essential that you receive cost-effective, professional services that add value to your operation. Some of the potential benefits are:

  • Increased efficiency of your operations
  • Cost savings from reduced rejected product and fewer warranty claims
  • Continual improvement of the quality of your products and services
  • Increased traceability and accountability throughout your organization
  • Enhanced ability to examine how employees work and interact between functions
  • Enhanced communication among employees
  • Improved customer satisfaction
  • Fewer customer audits and surveys
  • Improved competitive positioning within your industry
  • Increased marketability of your company and its products
  • Perceived higher quality
  • Recognition by your customers and suppliers that you have a first-class quality management system
  • Improved return on assets

NQA's emphasis is on conducting comprehensive yet fair audits of your management system, so that you and your staff understand and benefit from our input. We are dedicated to making sure that ISO 9001:2008 works for our customers.

We work closely with our clients, freely sharing all relevant information. You must be satisfied with the NQA ISO Auditor assigned to your account, and we carefully discuss your other rights. Our goal is successful registration and ongoing improvement for your company. We do our best to adapt the registration process to fit your needs and schedule.

The Steps to ISO 9001:2008 Registration

 

  • Learn What is Required by the ISO 9001 Standard
  • Select a Registrar
  • Create ISO 9001:2008-Compliant Policy and Procedures Manuals
  • Educate Your Employees
  • Implement Your Quality System Policy and Procedures
  • Conduct a Full Internal Audit
  • Conduct a Management Review Meeting
  • If the Internal Audit found Non-Conformances; Plan and Implement Corrective and Preventive Actions
  • Submit Your Policy and Procedures Manuals to The Registrar for the Document Review
  • Have The Registrar Perform an On-Site Pre-Assessment (optional)
  • Have The Registrar Perform the On-Site Registration Audit
  • If The Registration Audit finds Non-Conformances; Plan and Implement Corrective and Preventive Actions
  • Registration Certificate is Issued: 3-Year Registration Cycle Begins

The Registration Process

The process of implementing and being registered to the international ISO 9001:2008 Quality System Standard begins with a company's conscious decision to comply with the standard. Thus, before a Registration Audit can take place, an organization must go through many stages of preparation. NQA works closely with its clients from the outset, to make all relevant information available. We know that good communication makes the registration process easier and more beneficial for our clients. We want to make sure you achieve registration, and that everyone in your organization understands their role and how your ISO 9000 quality system will benefit the company.

Before Selecting A Registrar
The first step toward registration is for top management to make a commitment to the process. Without management commitment, the chance of achieving registration will be remote. Top management will be a primary focus of the Registration Audit. They must participate in the creation of a system that conforms to the ISO 9001:2008 standard.

Another responsibility for management is to educate every employee on what ISO 9000 is and how they will be expected to participate. This is also a good time to communicate a company-wide policy on quality. Buy a copy of the standard and read it. Determine how much of your existing procedures meet the standard's requirements.

Before the Registration Audit can take place, your company will need to put a system of ISO 9000-compliant policies and procedures into effect, and conduct a complete Internal Audit and Management Review to verify that those policies and procedures are being followed. The Internal Audit normally uncovers some problem areas, and the Management Review enables you to develop an action plan for solving those problems and bringing the quality system into full ISO 9000 compliance.

Selection and Use of the Registrar
A Registrar must meet your needs and just as important, help you meet the demands of your customers. You will work closely with the Registrar, so it is important to choose one that you feel comfortable with and who understands your goals.

Quoting Process: The first step is to fill out a questionnaire about your company's size and scope of activities. In turn, you will receive an initial quote for the services you need. An NQA representative will contact you to clarify your needs, and upon your approval of the quote he or she will send you additional information and a registration agreement that details exactly what we will do and what will be required from your company.

Registration Activities
After signing of the registration agreement, NQA will request your Level I (Policy) Manual and Level II (Procedures) Manual for the Document Review. The resulting report will demonstrate how well your quality system documents conform to the standard, and if non-conformities are found, it will explain them and give you references to the specific requirements that we feel may need further attention.

An optional step at this point is to have NQA perform a Pre-Assessment. This is a preliminary audit to detect any obvious non-conformances. The charge for this service is typically about one half the cost of a full Registration Assessment. The resulting report can be very beneficial and is often a good idea for firms who lack an in-house Quality Manager, because it can turn up system weaknesses and misconceptions before they become problems that might affect your chances of achieving registration.

Next, the Registration Audit (also known as the On-Site or Initial Assessment) is scheduled. This is the assessment to verify your quality system's conformance to the standard you have selected. The number of days required for the audit is determined by ISO guidelines, and typically lasts from one to five days depending on the size of your company and the nature of what it does. The Registration Audit begins with an Opening Meeting, where your company meets the Auditors. The meeting is typically brief and covers the audit schedule, how the audit will be conducted, and what will be assessed. During the audit the Auditors collect evidence of conformance by interviewing people, looking at documents, and watching your processes in action. NQA Auditors want you to have a successful assessment. We are not on a hunt for obscure problems. The Registration Audit will be comprehensive and fair.

At the end of the audit, there will be a Closing Meeting. Here, the Lead Assessor will present his or her findings and summarize whether your operation is in conformance or not. If not fully in conformance, he or she will work with your management to develop a time line of corrective actions. Following the audit, the Lead Assessor will leave your written report of findings with you, prior to his or her departure.

If you have minor, or no non-conformities, you will be submitted for registration. An audit report goes to the office of the Registrar for approval and final authorization. If you have significant non-conformances (typically referred to as "majors"), your recommendation for registration will be deferred pending additional assessment or until you submit proof of acceptable corrective action. When your corrective actions are completed and accepted, you will be submitted for registration.

Once approved, NQA issues the Certificate of Registration and the three-year surveillance cycle begins. This involves regular surveillance visits by your NQA Auditor to verify that the system remains effective and compliant to the ISO standard.

In addition to surveillance, the standard requires you to perform internal quality audits on a regular basis. Continual improvement is required by ISO 9001:2008, and so the continuing effectiveness of your system is a key issue.

At the end of the three year cycle, NQA will perform a Re-Assessment (also called a Triennial or Renewal Audit) to confirm your continued compliance, and a new 3-year registration cycle will begin.

Criteria for Granting Registration

Certain activities must be completed before a Registrar can certify a company under ISO standards. The Registrar may grant registration and authorize issuance of the "Registration Document" when the customer meets the following criteria:

  • The customer has submitted a Registration Application and Agreement that has been accepted by the Registrar.
  • The customer has a documented Quality System that is applicable to its scope of registration, and the Registrar has confirmed that the documents conform to the requirements of the applicable Quality System Standards (e.g. ISO 9000, AS 9100, etc.) as supplemented, when necessary, by any relevant supplement(s).
  • The customer's Quality System is effectively implemented and all activities meet the relevant requirements for the Quality System. The documents and forms described in the Quality System Manuals are the ones in actual use.
  • The customer has completed one full Internal Audit cycle of all applicable processes, systems and subsystems within the Quality Management System.
  • The customer has completed one Management Review of the completed audit cycle.
  • The customer demonstrates that it is keeping records of all complaints and remedial actions relative to the Quality System.
  • The certification audit reveals no, or only minor, nonconformities that will not cause a breakdown of the Quality System. Where nonconformities exist, a corrective action plan has been submitted and accepted.
  • The audit(s), follow-up audits, or surveillance(s), as applicable, are satisfactory and without critical nonconformities.
  • Where critical nonconformity exists, the customer shows that corrective action has been taken to meet all relevant requirements within the specified time limit, and the Registrar has confirmed that corrective action is satisfactory.
  • The customer has met its financial obligations to the Registrar.

 

 

To order a copy of the ISO 9001 certification standard click here.

Download a PDF file of our ISO 9001:2008 Registration Services details.

Request a quotation today to find out how NQA can help you achieve your certification goals. Click here to get started.

Page content updated on 12/07/2013