Specified requirements

Temperatures given are for information purposes and are not specified requirements for the alloys. 

Most ISO 9000 registered organizations claim to provide quality products and services, so why should there be so many dissatisfied customers when there are over 270,000 organizations in the world certified to ISO 9001, 9002, or 9003 One of the principal requirements in the standard is for the supplier to establish a quality system as a means of ensuring that product or service meet specified requirements. If an organization s products or services do not meet specified requirements then clearly the system has failed, but the failure is no fault of the standard - it is a fault of the way the standard has been applied and interpreted both by the organizations themselves and by the auditors who determine conformity. If the specified requirements are less than those of the customers, it is inevitable that products will bring dissatisfaction. This realization has, in the case of the automotive industry, led to two distinct needs ... 

These are the characteristics which need to be specified and their achievement controlled, assured, improved, managed, and demonstrated. These are the characteristics which form the subject matter of the specified requirements referred to in ISO 9000. When the value of these characteristics is quantified or qualified they are termed quality requirements or requirements for quality. ISO 8402 1994 defines requirements for quality as an expression of the needs or their translation into a set of quantitatively or qualitatively stated requirements for the characteristics of an entity to enable its realization and examination. While rather verbose, this definition removes the confusion over quality requirements and technical requirements. (An additional definition is provided in Appendix A.) Technical requirements for a product or service are quality requirements. The requirements of ISO 9000 are quality system 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 records maintained to provide evidence that product has been inspected and tested and meets the specified requirements ... 

Are the devices used to demonstrate conformance of product with specified requirements controlled, calibrated, and maintained in accordance with documented procedures ... 

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

The requirement does not cross refer to clause 4.16 on Quality records, clearly indicating that there is no requirement in this clause for problems to be recorded, as other clauses such as 4.10, 4.13, and 4.14 cover this. However, these clauses only relate to problems in not meeting the specified requirements and therefore may exclude types of problems not governed by specified requirements. So having identified the responsibilities of these personnel there may be no compulsion to provide a means for such problems to be documented, resolved, and prevented from recurrence. 

The standard requires management with responsibility and authority for corrective action to be promptly informed of products or processes which become noncompliant with specified requirements. 

This requirement is similar to that in clause 4.14.3 under Preventive action since the data collected for preventive action serves a similar purpose. In one case an analysis of company-level data serves to identify overall trends and predict potential failures that will affect achievement of the goals. In the preventive action case, the data serves to identify local and overall trends and predict potential failures that will affect achievement of specified requirements for the product, process, and quality system. It would be sensible to develop a data collection and analysis system that serves all levels in the organization, with criteria at each level for reporting data upwards as necessary. You should not treat this requirement separately from that for preventive action since the same data should be used. However, the explanation given in clause 4.1.5 of Operational performance does include some factors that may not be addressed in your preventive action procedures. 

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. 

Generically there are two types of requirements defining requirements and verification requirements. Defining requirements specify the features and characteristics required of a product, process, or service. (Within the standard these are termed specified requirements.) These may be wholly specified by the customer or by the supplier or a mixture of the two. Verification requirements specify the requirements for verifying that the defining requirements have been achieved and again may be wholly specified by the customer or by the supplier or a mixture of the two. With verification requirements, how-... 

In order to verify that the products or services meet the specified requirements you will need to carry out tests, inspections, assessments, etc. and these need to be performed against unambiguous standards of acceptability. You need to establish for each requirement that there are adequate criteria forjudging compliance. You need to establish how reliable is reliable , how safe is safe , how clean is clean , how good is good quality . Specifications often contain subjective statements such as good commercial quality, smooth finish, etc., and require further clarification in order that an acceptable standard can be attained. The secret is to read the statement then ask yourself if you can verify it. If not, select a standard that is attainable, unambiguous, and acceptable to both customer and supplier. 

How do you identify whether any quality control, inspection and testing techniques, and instrumentation requires updating to meet specified requirements ... 

Although ISO 8402 defines quality as the totality of characteristics of an entity that bears on its ability to satisfy a stated or implied need, ISO 9001 does not require the required characteristics to be specified. Note 2 of clause 4.3.4 defines a contract and accepted order as agreed requirements but not specified requirements as used elsewhere in the standard. It would have made for less ambiguity if the term customer requirements had been used throughout and then there would be no doubt as to what requirements and to whose requirements these clauses refer. 

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 control the design of the product in order to ensure that the specified requirements are met. 

Product specifications should specify requirements for the manufacture, assembly, and installation of the product in a manner that provides acceptance criteria for inspection and test. They may be written specifications, engineering drawings, diagrams, inspection and test specifications, and schematics. With complex products you may need a hierarchy of documents from system drawings showing the system installation to component drawings for piece-part manufacture. Where there are several documents that make up the product specification there should be an overall listing that relates documents to one another. 

Ensure that your documented policies and practices specify all the documents that need to be produced and are used to produce products and service that meet the specified requirements. Any document not referred to in your published policies and procedures is therefore, by definition, not essential to the achievement of quality and not required to be under control. 

The standard does not define what the specified requirements are in this case. Elsewhere in the standard the term seems to relate to customer requirements but when purchasing you may well not be passing on customer requirements to your supplier. In cases other than when truly subcontracting work, you will in all probability be deriving your own requirements. 

The standard requires the supplier to review and approve purchasing documents for adequacy of specified requirements prior to release. 

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. 

In many cases these requirements will not apply but in some contractual situations the customer may provide products or services for use by the supplier in connection with the contract. This clause of the standard specifies requirements that apply in such situations. The product being supplied may have been produced by a competitor, by the customer, or even by your own firm under a different contract. These requirements apply to any product supplied to you by your customer and not only to what is to be incorporated into supplies. The customer may in fact supply facilities, equipment, software, or documentation for use in conjunction with the contract, which may be provided on loan, to be returned on completion of the contract or to be retained. Customer-owned tooling and returnable packaging also constitutes customer supplied product. If you use the customer s facilities, such use should be governed by the regulations imposed in the contract rather than these requirements. If the customer supplies documentation, unless it is required to be returned, you should assume it is yours to keep. Such documentation is not governed by these requirements although, if the customer requires the documents to be returned, you should assume that these requirements do apply, but apply them with discretion. 

The standard requires that where, and to the extent that taceability is a specified requirement, the supplier is to establish and maintain documented procedures for unique identification of individual product or batches and goes on to require this identification to be recorded. 

How do you ensure that the results of these processes comply with specified requirements ... 

The standard requires suppliers to establish and maintain documented procedures for inspection and testing activities in order to verify that the specified requirements for product are met. 

The way the requirement is worded implies that the purpose of the procedures is to verify that specified requirements are met rather than this be the purpose of carrying out the inspection and test. Whether the procedures verify that specified requirements have been met or whether the inspections and tests achieve this purpose is immaterial, as you need to verify that you have met the specified requirement and have records which demonstrate this. 

The requirement only relates to the specified requirements (i.e. the requirements specified by the customer) but clearly you will need to verify that the product meets the requirements which you have prescribed in the product or process specification. 

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 key phrase in this clause is or otherwise verified as it allows you to receive product into your company and straight onto the production line if you have verified that it conforms to the specified requirements before it arrives. An example of this is where you have performed acceptance tests or witnessed tests on the supplier s premises. You may also have obtained sufficient confidence in your supplier that you can operate a Just-in-time arrangement but you must be able to show that you have a continuous monitoring program which informs you of the supplier s performance. 

The standard requires that where incoming product is released for urgent production purposes, prior to verification, it shall be positively identified and recorded in order to permit immediate recall and replacement in the event of nonconformity to specified requirements. 

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