Conforms to specified requirements

Are the means used to ensure that product conforms to specified requirements documented in the form of a quality manual and quality system procedures ... 

Do the inspections and tests verify that incoming products, semi-finished products, and finished products conform to specified requirements before use, processing, or dispatch ... 

Are quality records maintained which demonstrate conformance to specified requirements and the effectiveness of the quality system ... 

The standard requires suppliers to establish and document a quality system as a means of ensuring that product conforms to specified requirements. 

This requirement clearly defines the purpose of a quality system, that of ensuring that products conform to specified requirements. One of the principal differences between ISO 9000 and ISO/TS 16949 is the emphasis placed on internal efficiency and effectiveness. Implementing the requirements of ISO/TS 16949 will cause the waste, errors, and internal costs to be minimized. Unlike ISO 9001, ISO/TS 16949 requires the system to enable the organization to implement its quality policy and achieve its quality objectives, which after all is its purpose. This fundamental shift in concept is also behind the changes being made to ISO 9000 in the year 2000 edition. 

A system is an ordered set of ideas, principles, and theories or a chain of operations that produces specific results to be a chain of operations, the operations need to work together in a regular relationship. A quality system is not a random collection of procedures (which many quality systems are) and therefore quality systems, like air conditioning systems, need to be designed. All the components need to fit together, the inputs and outputs need to be connected, sensors need to feed information to processes which cause changes in performance and all parts need to work together to achieve a common purpose i.e. to ensure that products conform to specified requirements. You may in fact already have a kind of quality system in place. You may have rules and methods which your staff follow in order to ensure product conforms to customer requirements, but they may not be documented. Even if some are documented, unless they reflect a chain of operations that produces consistent results, they cannot be considered to be a system. 

You could be forgiven for restricting your quality system to the products or services you supply because all the requirements in the standard except clause 4.3 focus on an end product or service conforming to specified requirements. Contract or order requirements will go beyond end product or service requirements. They will address delivery, quantity, warranty, payment, and other legal obligations. With every product one provides a service for instance one may provide delivery to destination, invoices for payment. 

The standard requires the supplier to establish and maintain documented procedures to ensure that purchased product conforms to specified requirements. 

The standard requires that where specified in the contract the supplier s customer or his/her representative shall be afforded the right to verify at the subcontractor premises and the supplier s premises that subcontracted product conforms to specified requirements. 

The standard requires that the supplier ensures that incoming product is not used or processed (except in the circumstances described in 4.10.1.2) until it has been inspected or otherwise verified as conforming to specified requirements and requires that verification be in accordance with the quality plan or documented procedures. 

The standard requires that where required bp the contract, the proposed use or repair of product which does not conform to specified requirements shall be reported for concession to the customer or customer s representative. The supplementary requirement requires customers to be informed promptly in the event that nonconforming product is shipped. 

How do you ensure that product which does not conform to specified requirements is prevented from inadvertent use or installation ... 

How do you seek permission for the purchaser to use or repair product that does not conform to specified requirements ... 

Records can take various forms reports containing narrative, computer data, forms containing data in boxes, graphs, tables, lists, and many others. Where forms are used to collect data, they should carry a form number and name as their identification. When completed they should carry a serial number to give each a separate identity. Records should also be traceable to the product or service they represent and this can be achieved either within the reference number or separately, providing the chance of mistaken identity is eliminated. The standard does not require records to be identifiable to the product involved but unless you do make such provision you will not be able to access the pertinent records or demonstrate conformance to specified requirements. 

The standard requires that quality records be maintained to demonstrate conformance to specified requirements. 

Infrastructure includes resources such as buildings, equipment, supporting services, information and communication technology etc. The infrastracture shall be determined, provided and maintained so that the laboratory product conforms to specified requirements. 

Materials and services that are purchased by the laboratoiy should conform to specified requirements and satisfy the defined needs. The laboratory shall define the purchasing requirements and ensure that such requirements are met by the pmchased product. The laboratoiy supphers should be evaluated for their quality and reliability and should always be monitored regularly. The evaluation of... 

Certification is the procedure by which a third party gives written assurance that a product, process or service conforms to specified requirements. 

Certification refers to assurance of conformity to specified requirements... 

The act of reviewing, inspecting, testing, checking, auditing, or otherwise verifying and documenting whether items, processes, services or documents conform to specified requirements is known as verification. 

Quality planning is performed by the quality assurance department to fully meet specified requirements. Procedures and instructions for quality are kept current to conform to specified requirements. 

Consideration is given to the control exercised at the source and documented evidence of quality conformance provided. All incoming materials are inspected or otherwise verified as to conforming to specified requirements before being released for use to production. This verification is in accordance with the quality plan or documented procedures. All incoming materials released for urgent production purposes are positively identified and recorded in order to permit immediate recall in the event of nonconformance. 

Establishing product conformance to specified requirements by use of process monitoring and control methods... 

Packing system] establishes the processes of packing, preserving, and marking, to the extent necessary, to ensure conformance to specified requirements and identifies, preserves, and segregates all product from the time of receipt until the plant s responsibility ceases. 

The packing, preservation, and marking processes (including materials used) are controlled to the extent necessary to ensure that conformance to specified requirements is identified, preserved, and segregated for all products from the time of receipt until the responsibility ceases. 

ISO/DIS 13485 The supplier shall establish, document, and maintain a quality system as a means of ensuring that product conforms to specified requirement. The supplier shall prepare a quality manual covering the requirements of ISO 9001. The quality manual shall include or make reference to the quality system procedures and outline the structure of the documentation used in the quality system. 

Each manufacturer shall establish and maintain procedures for acceptance of incoming product. Incoming product shall be inspected, tested, or otherwise verified as conforming to specified requirements. Acceptance or rejection shall be documented. 

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