BS EN 9100-2003 pdf download.Quality management systems — Requirements (based on Iso 9001:2000) and Quality systems — Model for quality assurance in design, development, production, installation and servicing (based on ISO 900 1:1994).
Multiple validations may be performed If there are different intended uses.
7.3.6.1 Documentation of design andor development verification and validation
At the completion of design and/or development, the organization shall ensure that reports, calculations, test results, etc., demonstrate that the product definition meets the specification requirements for all Identified operational conditions.
7.3.6.2 Design and/or development verification and validation testing
Where tests are necessary for verification and validation, these tests shall be planned, controlled, reviewed, and documented to ensure and prove the following:
a) test plans or specifications identify the product being tested and the resources being used, define test objectives and conditions, parameters to be recorded, and relevant acceptance criteria;
b) test procedures describe the method of operation, the performance of the test, and the recording of the results;
C) the correct configuration standard of the product is submitted for the test;
d) the requirements of the test plan and the test procedures are observed;
e) the acceptance criteria are met.
7.3.7 Control of design and development changes
Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of de&gn and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered.
The organization’s change control process shall provide for customer and/or regulatory authority approval of changes, when required by contract or regulatory requirement.
Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4).
7.4 Purchasing
7.4.1 Purchasing process
The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.
The organization shall be responsible for the quality of all products purchased from suppliers, including customer-designated sources.
The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4).
NOTE See EN 9130 for guidance.
The organization shall:
a) maintain a register of approved suppliers that includes the scope of the approval;
b) periodically review supplier performance: records of these reviews shall be used as a basis for establishing the level of controls to be Implemented;
c) define the necessary actions to take when dealing with suppliers that do not meet requirements;
d) ensure where required that both the organization and all suppliers use customer-approved special process sources;
e) ensure that the function having responsibility for approving supplier quality systems has the authority to disapprove the use of sources.
7.4.2 Purchasing information
Purchasing information shall describe the product to be purchased, including where appropriate
a) requirements for approval of product, procedures, processes and equipment,
b) requirements for qualification of personnel,
C) quality management system requirements,
d) the name or other positive Identification, and applicable issues of specifications, drawings, process requirements, inspection instructions and other relevant technical data,
e) requirements for design, test, examination, inspection and related instructions for acceptance by the organization,
f) requirements for test specimens (e.g., production method, number, storage conditions) for design approval, inspection, investigation or auditing,
g) requirements relative to
7.4.3 VerIfication of purchased product
The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.
Verification activities may Include
a) obtaining objective evidence of the quality of the product from suppliers (e.g., accompanying documentation, certificate of conformity, test reports, statistical records, process control),
b) inspection and audit at suppliers premises.
c) review of the required documentation,
d) inspection of products upon receipt, and
e) delegation of verification to the supplier, or supplier certification.
Purchased product shall not be used or processed until It has been verified as conforming to specified requirements unless it is released under positive recall procedure.
Where the organization utilizes test reports to verity purchased product, the data In those reports shall be acceptable per applicable specifications. The organization shall periodically validate test reports for raw materiaL
Where the organization delegates verification activities to the supplier, the requirements for delegation shall be defined and a register of delegations maintained.
Where the organization or its customer intends to perform verification at the supplier’s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.
Where specified in the contract, the customer or the customer’s representative shall be afforded the right to verify at the supplier’s premises and the organization’s premises that subcontracted product conforms to specified requirements.
Verification by the customer shall not be used by the organization as evidence of effective control of quality by the supplier and shall not absolve the organization of the responsibility to provide acceptable product, nor shall it preclude subsequent rejection by the customer.
7.5 Production and service provision
7.5.1 Control of production and service provision Planning shall consider, as applicable.BS EN 9100-2003 pdf download.