PWS_16-6H3_2016_ISO_9001_Certification_Maintenance_20160613.pdf

PERFORMANCE WORK STATEMENT (PWS)

DMEA 16-6H3

13 Jun 2016 Project Engineer:

Contract Officer Representative:

1.0 SCOPE: The contractor (Registrar) will perform all audit-related actions required to maintain ISO 9001:2008 certification and perform audit-related actions required to certify the DMEA ARMS Facilities to ISO 9001:2015.

Specific tasks and associated costs noted in Paragraph 3.0 (below) will be accomplished.

1.1 TITLE: ARMS ISO 9001Certification Maintenance

1.2 APPLICABILITY: DMEA ARMS Quality Program

1.3 BACKGROUND: The DMEA ARMS Facilities are required to be a Trusted Supplier under DoDI 5200.44.

The DMEA Trusted Supplier Accreditation Program establishes the criteria for accrediting Trusted Suppliers. One component of the criteria requires all manufacturing, assembly, and test houses to be certified to ISO 9001.

The DMEA ARMS Quality Program was certified to ISO 9001 in 2003 and has maintained certification to date without a break. This PWS is a natural progression to keep the DMEA ARMS Quality program in compliance.

1.4 PURPOSE: The objective of this PWS is to maintain ISO 9001 certification of the DMEA ARMS Quality Program through effective auditing by an Accredited Certification Body (Registrar).

2.0 REFERENCE GOVERNMENT PROVIDED RESOURCES

2.1 OTHER DOCUMENTS:

Document No. Date Title ISO 9001:2008 (E) 11/15/2008 Quality Management Systems – Requirements ISO 9001:2015 (E) 09/15/2015 Quality Management Systems – Requirements ISO 17021:2011 01/02/2011 Conformity assessment -- Requirements for bodies providing audit and certification of management systems

2.2 GOVERNMENT FURNISHED INFORMATION:

Nomenclature Date Date Available Access to all documents and records under the purview of the DMEA ARMS Quality Program

2016-2020 During on-site visit only

2.3 GOVERNMENT FURNISHED FACILITIES/ACCESS:

Facility/Access Date Escorted Access to DMEA Bldg 1 and Bldg 2 during normal hours of operation 2016-2020

3.0 REQUIREMENTS:

3.1 GENERAL REQUIREMENTS:

3.1.1 Travel: The contractor is required to travel to accomplish this requirement. Negotiated travel is considered acceptable upon delivery order award. Additional/changed travel requiring an increase in delivery order funding shall be forwarded to the PCO for processing a delivery order modification prior to travel. If an increase in delivery order funding is not required, the contractor shall notify the DMEA Project Engineer/customer, in writing, of additional/changed travel.

3.1.2 MINIMUM CERTIFICATION BODY REQUIREMENTS

3.1.2.1 A certification body shall be accredited to ISO/IEC 17021 with a scope of ISO 9001 by the ANSI-ASQ Accreditation Board (ANAB) or an equivalent. To demonstrate compliance with ISO/IEC 17021, a certification body shall include in its proposal a valid certificate of accreditation from its accreditation body.

3.1.2.2 A certification body shall have an accreditation body that is a signatory to the International Accreditation Forum (IAF). To demonstrate signatory compliance, a certification body shall include in its proposal, at a minimum, its permission to use the IAF mark.

3.1.2.3 A certification body shall have experience auditing and certifying organizations in the field of semiconductor manufacturing. To demonstrate compliance, a certification body shall include in its proposal proof that it has certified other semiconductor manufacturing organizations.

3.1.3 MINIMUM AUDITOR REQUIREMENTS

3.1.3.1 All audit personnel performing on this task must be US citizens. Audit personnel must present proof of citizenship before entry onto DMEA property. Proof of citizenship can be established by one of the following means: U.S. passport, either the original or notarized copy of your birth certificate, or certificate of naturalization for DMEA security approval.

3.1.3.2 All audit personnel must hold current audit credentials from either Exemplar Global (formerly RABQSA) or International Register of Certificated Auditors (IRCA) in the appropriate schemes and grades to accomplish the intended audits. To demonstrate compliance with these requirements, a certification body shall include in its proposal a valid certificate of the intended audit personnel.

3.1.3.3 All audit personnel must have experience auditing or working within the semiconductor manufacturing sector. To demonstrate compliance, a certification body shall include in its proposal auditor background or experience of this nature for the personnel intending to perform on this task.

3.2 TASK REQUIREMENTS: The contractor shall provide services required for periodic, scope extension, and re-certification audits of the ARMS Quality Program to maintain certification to ISO 9001 Quality Management Systems – Requirements Standards.

3.2.1 ANNUAL PERIODIC AUDITS:

3.2.1.1 CY2016 9001:2008 PERIODIC AUDIT: The contractor shall provide a schedule for and perform annual on-site periodic audits of the ARMS Quality Program to the ISO 9001:2008(E) Standard during CY2016. This annual periodic audit was scheduled by DNV (Det Norske Veritas) GL Business Assurance USA, Inc. (the current DMEA certifying body) during the last certification cycle for the week of 22 Aug 2016. This audit and the re-dress of all items from previous DNV certification by DMEA must be completed by 1 Nov 2016 in order that DMEA’s current certification not be suspended. The contractor shall provide a report of findings. (A001)

3.2.1.2 CY2017 9001:2008 PERIODIC AUDIT: The contractor shall provide a schedule for and perform annual on-site periodic audits of the ARMS Quality Program to the ISO 9001:2008(E) Standard during CY2017. The contractor shall provide a report of findings. (A001)

3.2.1.3 9001:2015 PERIODIC AUDITS: The contractor shall provide a schedule for and perform annual on-site periodic audits of the ARMS Quality Program to the ISO 9001:2015(E) Standard during the two years following certification of the ARMS Quality Program to that Standard. The contractor shall provide a report of findings.

(A001)

3.2.2 SCOPE EXTENSION AUDITS:

3.2.2.1 PRE-ASSESSMENT AUDIT: The contractor shall provide a schedule for and perform an on-site Pre- Assessment audit to the ISO 9001:2008(E) Standard for section 7.3 Design and Development during CY2016. This requirement was levied during the last annual periodic audit and was scheduled by DNV (Det Norske Veritas) GL Business Assurance USA, Inc. to be conducted in conjunction with the CY2016 periodic audit (see 3.2.1.1) in order to maintain certification. This audit must be completed by 1 Nov 2016 in order that DMEA’s current certification not be suspended. The contractor shall provide a report of findings. (A001)

3.2.2.2 SCOPE EXTENSION AUDIT: The contractor shall provide a schedule for and perform an on-site Scope Extension audit to the ISO 9001:2008(E) Standard for section 7.3 Design and Development. The contractor shall provide a report of findings. Upon successful re-dress of any findings by DMEA, the contractor shall provide a Management System Certificate. (A002)

3.2.3 RE-CERTIFICATION AUDITS:

3.2.3.1 PRE-ASSESSMENT AUDIT: The contractor shall provide a schedule for and perform an on-site Pre- Assessment audit of the ARMS Quality Program to the ISO 9001:2015(E) Standard. The contractor shall provide a report of findings. (A001)

3.2.3.2 RE-CERTIFICATION AUDIT: The contractor shall provide a schedule for and perform an on-site Re- Certification audit of the ARMS Quality Program to the ISO 9001:2015(E) Standard. The contractor shall provide a report of findings. Upon successful re-dress of any findings by DMEA, the contractor shall provide a Management System Certificate. (A002)

4.0 POINTS OF CONTACT:

DMEA/ MEB Quality Lead:

Address: 4234 54th Street McClellan, CA 95652-2100 Voice:

E-Mail:

DMEA/MEBB COR

Address: 4234 54th Street McClellan, CA 95652-2100 Voice:

E-Mail: