QualityMgmtSOW 2022-Rev1.pdf

US Coast Guard Yard 31 May 2022 ISO 9001:2015 Certification Rev-1

Statement of Work: AUDIT OF THE U.S. COAST GUARD YARD QUALITY

MANAGEMENT SYSTEM FOR CONFORMANCE TO ISO 9001:2015

1.0 SCOPE

1.1 This specification outlines auditing the U.S. Coast Guard (CG) Yard’s Quality Management System for conformance to the International Organization for Standardization (ISO) 9001:2015 standard.

2.0 APPLICABLE DOCUMENTS

2.1 The following documents form a part of this specification to the extent specified herein.

Unless stated otherwise, the documents shall be the version listed by the number and date from the referenced organization.

2.1.1 ISO 9001:2015 Quality Management Systems- requirements with guidance for use.

3.0 REQUIREMENTS

3.1 Accreditations

3.1.1 The Offeror shall be a Certification Body (CB) accredited to ISO 17021 with a scope of accreditation which includes ISO 9001:2015 and International Accreditation Forum (IAF) Code 20 for Shipbuilding. In addition, the Accreditation Body (AB) which accredited the CB must be a member of the IAF with a scope of membership that includes management system certification.

A copy of the Offeror’s Certificate of Accreditation must be provided with the submitted proposal.

3.2 Experience

3.2.1 The Contractor shall have a published directory of companies that have achieved registration and/or certification to ISO 9001:2015 in conjunction with the Contractor's evaluating audits.

3.2.2 The Lead Auditor shall have experience with at least one U.S. Government facility (other than the CG Yard), have a familiarity with the Federal Acquisition Regulations, and have a working knowledge of the shipbuilding/repair industry. Documentation outlining the Lead Auditor’s experience shall be provided as part of the submittal. Contractor shall provide a list of Lead Auditors with resumes that are qualified.

3.2.3 The Lead Auditor shall be certified by Exemplar Global, International Registry of Certified Auditors (IRCA), or the equivalent. The Lead Auditor shall be certified for ISO 9001:2015. All members of the Audit Team shall have participated in at least three (3) audits of facilities for compliance with ISO 9001:2015. The Offeror shall provide resumés for the secondary auditors and documentation that they have participated in the minimum number of audits.

3.3 Availability

3.3.1 The auditing schedule shall fall within the time constraints specified in the Contract.

3.4 Assessment Process

3.4.1 Re-Certification Audit

3.4.1.1 The Contractor shall perform a re-certification audit for conformance to ISO 9001:2015.

a. The Audit Team shall interview all levels of CG Yard personnel to determine the extent to which the Quality Management System as documented in the CG Yard’s Quality Management System Manual has been implemented.

b. The Contractor will work with the CG Yard’s Quality Assurance (QA) Team Leader to develop the audit schedules. The Contractor will approve the audit schedule at least 30 days prior to the start of the re-certification audit.

c. At the conclusion of the audit, the Lead Auditor shall conduct a closing meeting for the CG Yard’s Top Management to summarize results, note difficulties, and provide a draft report with recommendations.

d. A re-certification audit report shall be prepared and provided no less than 30 days after the completion of the audit. The report shall detail the results of the audit, itemize non-conformances, requests corrective actions and set a time limit for the CG Yard’s corrective action responses. At no time shall the CG Yard be provided with less than 90 calendar days to respond. This time frame shall be determined by the time and date of the certified mail receipt or the electronic delivery date of the audit report.

3.4.1.2 Registration

a. The degree of registration to be granted shall be subject to the Contractor's determination of the degree to which the CG Yard’s Quality Management System is in conformance with ISO 9001:2015.

b. The Contractor shall identify the deficiencies found in the CG Yard’s Quality Management System and shall specify a time limit for corrective actions to be implemented. The degree of reassessment required to achieve full registration shall also be determined by the Contractor.

c. The registration shall include Delivery of Certificates of Compliance to ISO 9001:2015 and presentation of camera ready artwork of the Contractor's Quality Management System mark and those of the Contractor's accrediting agencies for use on CG Yard publications and stationery.

d. The certificate of registration shall be valid for a period of three (3) years from the date of issuance and may be withdrawn subject only to a CG Yard request for withdrawal, or Lead Auditor's determination that the CG Yard is not fully compliant with ISO 9001:2015 during a scheduled subsequent surveillance audit.

3.4.2 Surveillance Audits

3.4.3.1 The Contractor shall conduct surveillance audits approximately every 12 months (in agreement with the CG Yard QA Branch) to certify that the CG Yard continues to comply with the CG Yard’s Quality Management System and ISO 9001:2015.

a. The Audit Team shall interview all levels of CG Yard personnel to determine the extent to which the Quality Management System as documented in the CG Yard’s Quality Management System Manual has been implemented.

b. The Contractor will work with the CG Yard’s Quality Assurance Team Leader to develop the audit schedules. The Contractor will approve the audit schedule at least 30 days prior to the start of the re-certification audit

c. Upon completion of the audit, the Lead Auditor shall conduct a closing meeting for the CG Yard’s Top Management to summarize results, note difficulties, and give a draft report with recommendations.

d. A surveillance audit report shall be prepared and provided for each audit no less than 30 days after the completion of the audit. The report shall detail the results of the audit, itemizes non-conformances, requests corrective actions and sets a time limit for the CG Yard’s corrective action responses. At no time shall the CG Yard be provided with less than 60 calendar days to respond.

3.5 Future ISO 9001 Standards

3.5.1 The intent of this Statement of Work is specifically for certification to ISO 9001:2015. A transition plan to ISO 9001:2022 will be addressed with the Contractor.

3.6 Expenses

3.6.1 Travel expenses shall be in accordance with Federal Travel Regulations.

www.gsa.gov/ftr

4.0 QUALITY ASSURANCE

4.1 The Contractor shall have a multi-layered appeals system through which the CG Yard may appeal any ruling, determination or action of the Contractor relating to the auditing and registration processes.

5.0 PREPARATION FOR DELIVERY

5.1 All written reports and Registration Certificates shall be delivered to the Contracting Officer and the Quality Assurance Management, QA Branch.

6.0 NOTES

6.1 ISO documents may be obtained from:

American Society for Quality 611 E. Wisconsin Ave.

P.O. Box 3005 Milwaukee, WI 53201-3005 Phone: 888-722-2440

6.2 USCG Yard-Registrar Services/ISO 9001:2015

Scope of ISO 9001 Certification - Design, construction, and repair of ships, ship systems, ship components, ordnance, electronics, industrial products, and related services.

6.3 Number of Personnel is approximately 680.

6.4 This request is for 1 Facility, U.S. Coast Guard Yard, M.S. 1 2401 Hawkins Point Road Baltimore, MD 21226-1797