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Program Manual for the Registration of Quality Management Systems

Introduction

Program Manual for the Registration of Quality Management Systems

The Canadian General Standards Board (CGSB) is pleased to present its Registration Program for Quality Management Systems. The program offers registration to the ISO 9001:2000 standard, Quality management systems - Requirements, or to a related standard in the ISO 9000 family.

This program was developed by the CGSB to identify quality organizations to procurement groups needing assurance that deliverables would meet their intended uses. The program provides a convenient, cost-effective way for organizations to demonstrate to governments, corporate buyers, wholesalers, retailers and private consumers that their quality systems can consistently deliver superior products and services.

The benefits to organizations participating in this voluntary program include

  • demonstration through third-party evaluation that their quality system continues to meet the requirements of ISO 9001:2000 or a related ISO 9000 Quality Management Systems standard;
  • recognition as a source of consistently reliable quality products and services.

Read this manual carefully. It describes how the program works and will help you in preparing your application. 

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How the Program Works

Briefly, organizations gain admission to the program by demonstrating that

  • their documented quality management system meets the requirements of ISO 9001:2000 or a related ISO 9000 Quality Management Systems standard;
  • they comply with their own stated quality system.

The organizations and their extent of recognition are listed on a registration list, available to purchasing professionals at all levels of government, corporate and institutional users, retailers, and the general public. Through a program of scheduled assessments carried out by the CGSB, the buyer is assured that the sources of supply of products and services conform to internationally recognized standards of quality assurance.

To achieve this level of confidence, the program has four phases:

For complete information on CGSB policies governing this program, refer to the most recent edition of the CGSB Policy Manual for the Conformity Assessment Division available from CGSB

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ISO 9000

The growing world trend towards quality commitment in industry has been the driving force behind the creation of the ISO 9000 family of Quality Management Systems standards. These standards establish a forum for quality improvement against discreet criteria. They also facilitate third-party evaluation and formal recognition of organizations that can meet the requirements of the standard. This has culminated in the use of quality system evaluation as a valuable tool for procurement.

The CGSB registers quality management systems to ISO 9001:2000, Quality Management Systems - Requirements, or to any related standard in the ISO 9000 family. As a registrar, the CGSB is an independent third party, ensuring impartiality and fairness.
 
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Phase 1: Application

Organizations wishing to participate in the CGSB registration program must submit the following:

Application and Undertaking Form

This legal document, when signed by a senior officer of the organization, grants the CGSB the authority to assess the applicant's quality management system.

In signing the form, the applicant undertakes to

  • abide by the terms and conditions of the program;
  • maintain a system of quality assurance that will ensure the continuing quality of its products;
  • document its quality management system;
  • provide access to the CGSB staff, or their representatives, in conducting their on-site assessments;
  • pay all applicable fees.

If an application is rejected, the organization will be informed in writing. Organizations can appeal the CGSB'S decisions. Organizations also have the right to view their own registration records kept by the CGSB.

All documents and information submitted by an applicant are treated in strict confidence and will only be released with the applicant's consent.   

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Phase 2: Preparation for Assessment

Following completion of Phase 1, a Registration Specialist (RS) is assigned who will be the applicant's main point of contact with the CGSB. The RS reviews the application, resolves any differences or misunderstandings, and in consultation with the Senior Technical Authority (STA), selects a Lead Auditor. The Lead Auditor will be either a qualified CGSB staff member or a qualified subcontractor working under the authority of the CGSB, who is bound by all program requirements (e.g. Industry Code and language).

Document Review - The Lead Auditor reviews the organization's documentation against the requirements of ISO 9001:2000 and issues a Document Review Report. The applicant must address all areas of the report where the requirements were not satisfied.

Pre-assessment - A pre-assessment of the applicant's quality management system may be conducted if deemed necessary by the CGSB or if requested by the applicant.

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Phase 3 : Assessment

Following acceptance of the Quality Management System documentation, the CGSB will assign an assessment team. The assessment team usually includes the Lead Auditor who conducted the documentation review. It may also include, depending on the size of the facility to be registered and the expertise required, additional team members, such as technical experts. These technical experts do not make decisions about compliance.

The Lead Auditor acts as the Assessment Team Leader and conducts the assessment in accordance with ISO 19011 and CGSB procedures. The Lead Auditor is responsible for at least the following:

  • Scheduling the assessment date
  • Arranging for office space
  • Arranging for guides
  • Arranging for the applicant's management to be available
  • Planning the assessment activities
  • Assigning relevant portions of the assessment to team members.
  • The on-site assessment includes at least the following:
  • Opening Meeting
  • Verification of the Implementation of the Quality Management System
  • Closing Meeting.

At the Closing Meeting, the Assessment Team Leader informs the applicant of any non-conformities, clarifies their significance and sets out the assessment team's recommendation about registration.

The Lead Auditor then prepares an assessment report that meets program requirements. The report contains at least the following:

  • General information on the client and the assessment
  • Scope and purpose of the assessment
  • Overview including a brief description of the client, its products, and any other pertinent information
  • Summary of the most important observations, positive as well as negative, about the quality management system
  • Degree of reliance that can be placed on the assessment
  • Summary of the findings and any general comments
  • Summary of the Closing Meeting
  • Registration recommendation.

Recommendations are generally one of the following:

  • Offer of registration
  • Offer of registration after response to corrective action requests are acceptable to the CGSB (Program Management)
  • On-site verification of corrective actions requests
  • Complete re-assessment ( In this case corrective action requests are not issued; rather, a report is issued recommending a complete re-assessment at a future date.)

Next, the CGSB reviews the Lead Auditor's recommendation and pertinent technical information about the applicant's quality system. A decision is made to grant or deny the registration, or to ask that additional information be provided. If non-conformities are identified during the assessment, the applicant must take satisfactory corrective action before the CGSB recommends that the Director of the CSGB prepare a written offer of registration.

Applicants are considered registered only when they have received a signed letter of offer from the Director of the CGSB.

Quality Management Systems

Applicants who receive a registration offer are required to enter into a license agreement with the CGSB. This legal agreement provides the registered organization with a unique registration number and authorizes the organization's use of the CGSB Registration Mark - a registered quality mark recognized across North America - on business stationary and promotional material. License agreements are renewable every three years if program requirements continue to be met.

A certificate is issued to the successful applicants following the signing of the license agreement. The certificate shows the applicant's name, the address of the registered facility, and the scope of registration, including permissible exclusions for ISO 9001:2000 registrations. The certificate is valid for three years. A new certificate is issued upon satisfactory completion of re-assessment.

The ISO 9001:2000 standard permits exclusions of elements. Permissible exclusions are limited to those elements in clause 7 of the standard, must be fully documented and acceptable to the CGSB, and will be verified during assessments.

An up-to-date list of registered organizations can be viewed at www.ongc-cgsb.gc.ca

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Phase 4 : Surveillance and Re-Assessment

Quality System Changes - Organizations must promptly notify the CGSB, in writing, of any intended changes to their quality system. These include changes to policy and procedures, organization, scope of registration, location, or any other change affecting conformity to ISO 9001:2000. Before approving a change, the CGSB may require a site visit or a re-assessment.

CGSB Program Changes - The CGSB will notify organizations, within a reasonable time, of any changes it intends to make to program requirements. Registrants' views will be considered before the CGSB makes decisions on the precise form and effective date of proposed changes to the program.

Surveillance Audits - The CGSB conducts surveillance audits at least once a year, usually during the anniversary month of the initial assessment. Approximately one third of the organization's quality management system will be audited during a surveillance audit. The surveillance audit will be assigned, planned and executed in a similar manner to the initial assessment. Upon completion of the surveillance audit, a report is issued that meets the same criteria as for the report mentioned in Phase 3.

To remain in the program, the registrant continues to agree to

  • abide by the program requirements;
  • discharge to the satisfaction of the CGSB any non-conformities that arise. These include non-conformities identified during the on-site audit, and misuse of logos and trademarks, as specified in the license agreement.

Registered organizations are required to keep records of complaints from their clients and make them available to the CGSB auditors.

Re-assessments (full system audits) are conducted every third year, usually during the anniversary month of the initial assessment.

Re-assessments will be assigned, planned and executed in a similar manner to the initial assessment. At the conclusion of the re-assessment, a report is issued that meets the same criteria as the report mentioned in Phase 3.  

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De-Listing, Appeals and Re-Application

If a major non-compliance occurs, or a series of faults are identified, the registered organization is given the opportunity to provide an explanation and voluntarily take corrective action within a specified time period.

In the event of repeated quality problems, complaints from users, or other evidence that indicates a lack of quality assurance within the registered facility, the CGSB may, at its discretion, decide to

  • audit more frequently;
  • return to the facility to verify the effectiveness of the corrective action;
  • suspend or de-list the registrant.

Registered organizations that fail to demonstrate their ability or willingness to meet the program requirements within a specified time period will be suspended or de-listed.

Any decision made against the registered organization by the CGSB may be appealed. Details of the appeal process are available from the CGSB. All participating organizations have a right of final appeal of the decision to the Standards Council of Canada (SCC). Organizations that wish to re-apply to the program following de-listing must repeat the entire listing process. 

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Costing

CGSB administers Registration Programs on behalf of participating organizations on a cost-recovery basis. The costs of participating in this program are tailored to the needs of the organization and commensurate with the registration activities required.

Costs estimates are set out in the form of a quotation covering a three-year period and will be provided on request to individual organizations. The final amount of the fee could increase if major non-conformity is found at the audit and a revisit is required. 

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Preparing your Application

Step 1: Application and Undertaking Form - Form RSQ 001 is a legal document certifying your company's commitment to quality and adherence to the appropriate quality model. It must be signed by a senior company official in charge of quality assurance and by a responsible officer of the company (president, vice-president, secretary-treasurer).

Step 2: Applicant Profile Form - Completion of Form RSQ 003 ensures that the CGSB captures all necessary program information: the location\facility to be registered, the standard to be applied (e.g. ISO 9001:2000), and the proposed scope of registration.

Step 3: Submission of Quality Management System Documentation and Registration Fee

Mail to:

Client Services
Canadian General Standards Board
Gatineau, Canada
K1A 1G6

E-mail: ncr.cgsb-ongc@pwgsc.gc.ca

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Date Modified: 
Date Reviewed: 2005-07-15

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