API SPEC Q2:2011 pdf free download.Specification for Quality Management System Requirements for Service Supply Organizations for the Petroleum and Natural Gas Industries
5.1.2 Determination of Requirements
The organization shall determine:
a) requirements specified by the customer, including the requirements for service planning, execution, and evaluation;
b) legal and other applicable requirements; and
c) requirements not stated by the customer but considered necessary by the organization for the execution of service and provision of service-related product.
Where the customer provides no documented statement of the requirements, the customer requirements shall be confirmed by the organization and records maintained (see 4.5).
5.1.3 Review of Requirements
The organization shall review the requirements related to execution of the service or provision of service-related products. This review shall be conducted prior to the organization’s commitment to provide a service to the customer and shall ensure that:
a) requirements are defined,
b) requirements differing from those previously identified are resolved, and
c) the organization has the capability to meet the defined requirements.
Where contract requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.
Records of the results of the review, including resulting actions, shall be maintained (see 4.5).
5.2 Planning
The organization shall identify and plan the processes and documents needed for service and service-related product realization.
In planning, the organization shall address the following:
a) customer-specified requirements, including critical success factors (see 5.1);
b) key performance indicators;
c) legal and other applicable requirements;
d) initial risk assessment (see 5.3);
e) required resources and work environment management (see 4.3);
f) service and/or service-related product design (see 5.4);
g) contingency planning (see 5.5);
h) management of change (see 5.11); and
i) records needed to provide evidence that the realization processes meet requirements (see 4.5).
5.3 Risk Assessment and Management
The organization shall maintain a documented procedure to control risk throughout the execution of a service.
The procedure shall:
a) identify risks (potential or real) associated with services and service-related products;
b) identify and use risk management tools and techniques;
c) select, communicate and implement the mitigation or preventive control measures to reduce or avoid exposure to loss; and
d) notify the customer of remaining risks that may impact the service.
Records of risk assessment and actions taken shall be maintained (see 4.5).
5.4 Design and Development
5.4.1 Design and Development Planning
The organization shall maintain a documented procedure to plan and control the design and development of the service, including the use of service-related products.
The procedure shall identify:
a) the design and development stages;
b) the activities required for completion, review, and verification of each stage;
c) the interfaces between different groups involved in design and development; and
d) the responsibilities and authorities for the design and development activities.
When design and development are outsourced, the organization shall ensure the supplier meets the requirements of 5.4 and provide objective evidence that the supplier has met these requirements.
5.4.2 Design and Development Inputs
Inputs relating to design of the service shall be determined and records maintained (see 4.5). These inputs shall include:
a) customer-specified requirements (see 5.1);
b) legal requirements; and
c) other applicable requirements including:
1) requirements provided from an external source,
2) requirements for service-related products, including its functional and technical requirements,
3) environmental and operational conditions,
4) results from risk assessments (see 5.3), and
5) historical performance and other information derived from previous similar service designs.
5.4.3 Design and Development Outputs
The outputs of design and development shall be documented to allow verification against the design and development input requirements.
Design and development outputs shall:
a) meet the input requirements for design and development;
b) provide information for purchasing of any required service-related product;
c) provide controls for the execution of the service, including allowable variations in the service execution parameters;
d) include or reference acceptance criteria for the completion of the service; and
e) identify critical service-related product.API SPEC Q2 pdf download.API SPEC Q2:2011 pdf free download
