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ISO 9001 Policies Procedures Manual
Procedures Manual Sections:
- Introduction to ISO 9000
- Quality Manual Preparation
- QMS Quality Manual
- ISO 9001 Quality Procedures
- Quality Reports and Forms
Based on ISO 9001:2008
ISO Certification, Registration and Accreditation
Increasingly, European customers expect U.S. companies to have their quality systems certified (audited) or registered to one of the standards of the series. This involves having an accredited independent third party registrar conduct an on-site audit of the company’s operations against the requirements of the appropriate ISO standard.
The terms certified, audited or registered are often times used interchangeably. For ISO purposes, certification is the same as registration. Once a company has passed an audit, the company is certified by that auditor and entered into an ISO directory or registered for a specific ISO standard.
Therefore, accredited registrars certify organizations through an audit process for registration in an official directory of companies that have passed ISO standards.
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ISO Accreditation Bodies
ISO Member countries have organizations that are chartered to accredit Registrars. In the US, it’s the Registrar Accreditation Board (RAB); in Canada, the Standards Council of Canada (SCC), and in the Netherlands, the Raad Voor Accreditatie (RvA).
The American Society for Quality (ASQ) established the Registrar Accreditation Board (RAB) in 1989. In 1991, ANSI and RAB joined forces to establish the American National Accreditation Program (NAP) for Registrars of Quality Systems.
On January 1, 2005, RAB and the ANSI-RAB NAP was replaced by the ANSI-ASQ National Accreditation Board (ANAB). ANAB accredits certification bodies for ISO 9001 quality management systems (QMS), ISO 14001 environmental management systems (EMS) and other industry-specific requirements.
These Accreditation Bodies publish the requirements that they set forth for Registrars to become accredited. These requirements generally follow other ISO documents. The Accreditation bodies regularly audit registrars’ procedures, systems and audit practices to ensure they meet and maintain systems to the ISO requirements.
ISO Registrars
Their place in the system is to certify or register companies that meet the requirements of ISO 9001:2000. Registrars must meet the requirements of the ISO Accreditation Bodies. These requirements include things such as independence; Registrars cannot consult for instance. This system ensures uniformity in the registration process.
Finding ISO Registrars
Accreditation Bodies maintain directories of the Registrar organizations that they accredit. These directories are available on their websites. You can normally find these websites by doing a search on the Accreditation Body’s name or initials.
A directory of registrars in the U.S. can also be found at the ANSI-ASQ National Accreditation Board website which offers access to a searchable database of accredited registrars in the United States.
In Canada, contact the Standards Council of Canada for a list of registrars. All other countries should consult the accreditation authority or member body for their country. Consult the ISO website for a complete list of ISO Member bodies.
Industry publications such as Quality Systems Update also list Registrars. Their website has a listing of Registrar’s available in North America with website or addresse and phone numbers.
The Quality Digest Magazine conducts annual surveys of Registrar’s clients and reports the customer satisfaction ratings in their July issue. This can be a valuable resource in selecting a Registrar suited to your needs.
Selecting ISO Registrars
Registrar qualifications are a key consideration. As you research Registrars you will notice that some appear to be very limited in scope just based on their names. Registrars must be accredited in a particular industrial sector in order for them to be able to certify a company in that sector. Some Registrars are accredited in several if not all sectors; others specialize in certain sectors. The best approach to evaluating a Registrar’s qualifications for your industrial sector is to contact the Registrar.
After qualifications, price is always a concern. Be sure to evaluate the total cost including expenses, fees and the cost of surveillances.
Probably as important as price, within limits of course, is the overall experience a client gets with a registrar. Important areas to consider are the interpersonal skills of the auditors; the office support and ability to get questions answered; are the audits a value-added experience, will the Registrar work with you, how flexible are they in adjusting dates – how many weeks notice.
And make sure to talk to some of the Registrar’s clients and review the Quality Digest articles on Registrars.
ISO Auditors
Auditors work for or contract to Registrars to perform registration assessments and surveillances. They are the “front line” in the process. The Registrars are responsible for ensuring Auditors meet qualification requirements. Their requirements include training in auditing, ISO 9001 training, and at least one member of the audit team must have experience in the industrial sector of the company being audited.
Verify credentials. If a person claims to be certified as an ISO 9000 lead auditor, ask to see proof of his or her certification. Make sure the certification is current by checking the expiration date. Facts about ASQ’s certification are available via the ASQ website.
Auditors collect the objective evidence demonstrating the effectiveness (or lack thereof) of the company’s quality management system and make registration recommendations to the Registrar. The Registrar has the ultimate decision, however.
Considerations Before ISO Registration
Ensure that your system is fully implemented, procedures are being followed and records are maintained. Conduct both an internal audit and a management review noting any exceptions before the registration process begins.
- Internal Audits Use internal audits to ensure your system is in place. Make sure your records show all elements have been audited at least once.
- Management Review Conduct at least one Management Review and ensure records (meeting minutes for example) are maintained showing all required items were discussed and appropriate action items assigned.
- Exceptions If you have any exceptions, make sure they are noted with appropriate rationale in your Quality Manual.
