Request for Quotation: Organizations who desire a quote for registration should make a via the Supplier Information Form (SIF) and submit it to the Quality Manager (QM) either by fax, mail, or email. The QM will review the information form to ensure the scope of the supplier is within OTSQR’s scope of accreditation and that no conflict of interest exists.
Determining the supplier’s scope: The supplier must state their intended scope of registration on the SIF. The supplier should list the Standard Industrial Classification (SIC) Code that most accurately reflects the firm’s products, services, or activities. However, if SIC codes are unknown, assistance can be given.
Site-specific & Multi-Site registration: Typically, OTSQR will only issue registration on an individual site basis, however this will be determined by OTSQR and the supplier before the quote is provided. For organizations that do similar work at multiple sites and have a head office, OTSQR may elect to issue the entire group one (1) certificate. Depending on the number of sites, this program is usually accomplished on a sampling basis during the initial registration audit and subsequent surveillance audits.
Preparation of a quotation: A quote is prepared by the QM. The quote lists the lead auditor’s daily rate, the estimate for the initial surveillance visit, and the estimate for the annual costs for registration and surveillance (following a positive decision). The terms and conditions for the quote are also specified. When the quote is mailed to the supplier, it will include an application form specifying the terms of the application for registration, a sample registration agreement so that the supplier can become familiar with the terms of registration, and a confidentiality agreement
Application for registration: If the supplier accepts the quote and desires to enter an application for registration with OTSQR, then the application form shall be signed and returned by the supplier to OTSQR.
Selection of the assessment team: The QM will select the assessment team and schedule the tentative site assessment date. The supplier may object, with cause, to any of the named auditors.
Submission of documents for review: At least four (4) weeks prior to the scheduled site assessment, the supplier should submit documentation describing their quality system to the lead auditor for review. The documentation shall include the quality manual, procedures and organizational chart.
Document review: The lead auditor shall perform the document review to determine whether or not the documented system complies with the applicable ISO 9000 Series/QS9000 Standard. The results of the document review will be provided to the supplier. Any non-conformances related to the documentation will be documented on a Supplier Improvement Request (SIR) and must be adequately addressed by the supplier before the site assessment can be conducted.
Classification of nonconformances: The assessment team will classify nonconformances as either severe or minor. Severe nonconformances are defined as a type of nonconformance that causes doubt as to whether or not the supplier is capable of supplying products or services that meet customer requirements; or total lapse of a documented system; or a series of minor nonconformances in a given element; or lack of documentation of an entire or partial quality system element. This classification is used, in among other areas, for determining whether or not to verify implementation of a supplier’s corrective action and/or increase the surveillance frequency, and to give the supplier feedback regarding the most significant non-conformances observed.
Site assessment: OTSQR shall perform a site audit of the supplier’s facilities to assess the supplier’s approach, deployment, and results of their quality system. Opening and closing meetings will be held during the assessment to review any nonconformances written and to review the overall results of the assessment. One complete cycle of internal audits and one management review must be conducted before the registration can be granted.
Preparation of the audit report: After the audit is completed, the lead auditor will prepare the report and submit it and his/her recommendation to the QM. Based on positive results and a minimal number of minor nonconformances found, the lead auditor may make a positive recommendation to the QM.
Supplier’s response to the nonconformance: The supplier shall be allowed six (6) weeks from the date of the closing meeting to respond to the non-conformances with corrective action. The QM and the lead auditor will review the supplier’s response and if adequate, the QM will determine whether or not a follow-up visit is required to verify implementation. The supplier shall be allowed up to six (6) months to implement corrective action from the date the supplier’s responses were approved by OTSQR. If a follow up visit is required, this will be scheduled at the supplier’s convenience. If the supplier’s response is not adequate, they must correct their response. The Supplier Improvement Request (SIR) cannot be closed until the supplier’s response and follow-up visit (major/severe nonconformances), if required, has been concluded positively; ; only two follow-up audits can be conducted per initial registration audit or surveillance audit.
Registration decision: The QM shall determine whether or not the supplier shall be eligible for registration. One of the following decisions shall be made: (1) eligible for registration, (2) suspended registration, or (3) deny registration.
Positive registration decision: If a positive decision is granted, the supplier shall receive the final report within two (2) weeks from the registration decision and shall sign a registration agreement with OTSQR agreeing to comply with the ISO 9000 Series/QS9000 Standards during the three (3) year duration of the agreement. However, verbal notification will take place soon after the registration decision is made.
Surveillance: Surveillance visits shall be performed at 6-6-9-9 frequency for ISO 9001/2. This frequency may be reduced or increased based on performance. During each surveillance only a sample will be taken of the respective elements of the Standard. Three elements will be audit at every event, e.g., 4.1 Management Reponsibility, 4.5 Document Control (changes to the system), 4.14 Corrective Action, 4.17 Internal Audits.
Complaints against a registered supplier: Complaints by a third party against a registered supplier may be filed with OTSQR and an investigation will be performed.
Negative registration decision: If a negative registration decision is made, before a re-audit, the supplier must meet the conditions specified by OTSQR and shall wait a sufficient amount of time to assure the major/ severe nonconformances have been corrected.
Appeals: The supplier may, in accordance with the OTSQR appeals procedure SOP 25.0 (a copy of which may be obtained upon request), file an Appeal against a decision made by OTSQR.
Use of the OTSQR and accreditation body’s registration mark: Registered suppliers are authorized to use the OTSQR registration mark along with the accreditation body’s mark to designate that their quality system is in conformance to the ISO 9001/2 Standard. SOP 13.0 details the use and restriction of the marks.
1. Process for extending or reducing scope of certification:
An extension or reductions of scope of certification of a certified company is initiated normally by the client, e.g., adding new sites, product line or service or reducing: down grading processes/product lines or poor performance. All requests for extension of scope must documented indicting the nature of the anticipated change. This document shall be submitted to OTSQR for review. The GM/Quality Manager (QM) will review the request and notify the assigned lead auditor of the requested change. The requested change will be evaluated on-site during the next scheduled audit or upon special request, an audit conducted immediately. After successful completion of the audit, the QM will review the audit report and any documentation submitted relative to the scope change. After which all required registration documentation will be modified accordingly. The resultant change will be documented on a Client Change Form, Form No. 0091and submitted to the QM for review & approval.
Reductions of scope of certification can be initiated by the client, findings during an OTSQR audit or based on a customer complaint (following an investigation that may include an on-site review).
2. Multi-site Registration/certification:
For organizations that do similar work at multiple sites and follows a common documented quality system with the system being centrally managed. OTSQR can issue the entire group one (1) certificate based on successful completion of all audited sites. Depending on the number of sites, this program is accomplished on a sampling basis during the initial registration audit and surveillance audits. The sample size is based on the total number of facilities/sites, excluding the head office. Complete details can be found in OTSQR SOP 22.0.
3. Limitations on follow-up audits:
In order to reduce the chances of consultation during multiple follow-up audits, the number is limited to two times. After the second follow-up audit and satisfactory corrective action is not achieved, the company should consider soliciting an outside quality management systems professional.
4. Explanation of the Continuous Registration option:
The Continuous Registration option is based conducting an initial audit per standard procedures and surveillance audits every six months until the expiration of the three- year period. The reassessment associated with this option is required however based on a lesser amount of time spent on-site; contingent upon your company’s performance during the previous three years.