ATTM 0004_ISO90012015 Contract Provisions.docx

ISO9001:2015 Contract Provisions ISO9001:2015 contract provisions, continued If the Contractor is registered to ISO9001:2008 and becomes registered to ISO9001:2015 or is already registered to ISO9001:2015 at the start or during the life of this contract, then the requirements of ISO9001:2008 shall remain in effect. The systems and or processes in place under ISO9001:2008 shall not be dismantled or changed. The specific requirements of this contract with respect to the 2015 revision are listed below.

ISO9001:2015 Revision. If the Contractor and or Subcontractor(s) register to this revision, contract provisions a - l (below) shall be exercised to ensure continued QMS effectiveness. These requirements consist of:

a. The Contractor’s and or Subcontractors’ QMSs shall consist of a process for corrective action that addresses identification, development, and implementation of preventive actions. The corrective action* process shall not be ignored due to the emphasis and requirements in the ISO9001:2015 revision for risk based thinking.

b. Work instructions shall be written for all operations that directly and indirectly affect manufacturing. Such operations consist of engineering, quality, inspection, purchasing, outside services, retrofit, repair*, re-work*, shipping, service, warranty and related processes.

c. Procedures and documents in place during and after the implementation of the ISO9001:2008 revision shall remain in effect when the ISO9001:2015 revision takes effect.

d. Formal and documented training for all complex jobs relating to manufacturing (as explained in “b” above) shall continue to take place.

e. The Contractor’s written quality objectives shall be shared with the Government upon request.

f. The written output of the Contractor’s risk based thinking analysis shall be shared with the Government upon request. When risk analyses are done in areas of the company other than engineering, design and manufacturing, a quantitative scale shall be used for risk rating and ranking. Risk analyses for engineering, design, and manufacturing are covered under FMEAs.

g. All linkages between procedures and processes that are required by ISO9001:2015 shall be documented and shared with the Government upon request.

h. All the requirements in this contract shall be flowed down to the Subcontractors of production parts and services. All requirements of this contract, ATPD2131, “Army Technical Purchase Description System Specification Family of Medium Tactical Vehicles (FMTV) - A1/A1P2”; “ATPD2352, Army Technical Purchase Description Transparent Armor;” all work directives, and Technical Data Package (TDP) shall be part of the Contractor’s and Subcontractors’ requirements and shall be part of the context* of the organization. PdM MTV shall be included in the category of interested parties*, so that the Contractors and Subcontractors shall meet PdM MTV needs and expectations*.

i. The Contractor and Subcontractors shall not exclude departments, functions, sectors, and business units within the boundary of the scope* of their certification. The products and services affecting the integrity and quality of FMTV trucks, trailers, kits, and services shall be included in the scope of the registration* (reference ISO9001:2015, paragraph 4.3, “Determining the Scope of the QMS”)

j. All material purchased or manufactured by the Contractor that is classified by the Contractor, the Subcontractors, or the Government as non-conforming shall be marked, tagged, and segregated from conforming material. Traceability of the nonconforming items shall be maintained through the application of the disposition at the Contractor and Subcontractors. Government approval is required for the rework, repair, and use of material previously classified as non-conforming. All non-conforming material shall be subject to evaluation through the Contractor’s or Subcontractor’s corrective and preventive action process. Root cause or causes shall be determined, and subsequently eliminated or mitigated. The Government will hold authority for approval of all corrective action reports.

k. All material purchased or manufactured by the Contractor that is classified by the Contractor, the Subcontractors, or the Government as non-conforming shall be marked, tagged, and segregated from conforming material. Traceability of the non-conforming items shall be maintained through the application of the disposition at the Contractor and Subcontractors. Government approval is required for the rework, repair, and use of material previously classified as non-conforming. All non-conforming material shall be subject to evaluation through the Contractor’s or Subcontractor’s corrective and preventive action process. Root cause or causes shall be determined, and subsequently eliminated or mitigated. The Government will hold authority for approval of all corrective action reports.

l. No exclusions shall be allowed to the requirements in the 2015 revision.

* Definitions of ISO9001:2015 terms used above:

Context of the Organization – Business environment combination of internal and external factors and conditions that can have an effect on an organization’s approach to its products, services, and investments and interested parties.

Interested Party – Person or organization that can affect or be affected by, or perceive themselves to be affected by a decision or activity of the organization.

Scope, Boundary of – (See ISO9001:2015 paragraph 4.3) The Organization determines the boundaries and applicability of the QMS to establish its scope. The organization shall consider external and internal issues, requirements of relevant interested parties, and the products and services of the organization.

Needs and expectations of interested parties – are those issues having an impact or potential impact on the organization’s ability to consistently provide products and services that meet the customer and applicable statutory and regulatory requirements. The organization shall determine if the requirements of these interested parties are relevant to the QMS.

Organization – In this contract is synonymous with the Contractor and Subcontractors.

Risk – The effect of uncertainty on an expected result. The effect can be positive or negative. Risk is often characterized by a reference to potential events and consequences or a combination of these.

* Definitions of PdM MTV specific terms used above:

Corrective Actions – Are a set of actions taken to eliminate root causes and prevent recurrence. PdM MTV requires containment and a preliminary root causes analysis within 30 days of the discovery or report of the problem. If PdM MTV rejects the corrective action report from the Contractor re-submissions with updates and corrections shall be made within 7 days of the Government’s disapproval. The cycle of re-submissions shall not continue for more than 90 days.

Rework - A procedure applied to a product to eliminate a nonconformance to the drawings, specifications, or contract requirements that will completely eliminate the nonconformance and result in a characteristic that conforms completely.

Repair - A procedure which reduces, but does not completely eliminate, a nonconformance. Repair is distinguished from rework in that the characteristic after repair still does not completely conform to the applicable drawings, specifications, or contract requirements.

Technical Data Package (TDP) - Identifies specifications and installations at a component level. The TDP does not identify the performance requirements of the final assemblage of these components at the system level.

Army Technical Purchase Description (ATPD) – The physical characteristics and performance requirements are identified by these specifications. Therefore, these specifications will form the basis for establishing and evaluating the vehicle’s physical characteristics and performance.

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