Clause 2 - References

ANSI/ISA-84.00.01-2004-1 lists four parts of lEC 61508 as normative references. ANSI/ISA-84.01-1996 lists a number of informative references in ANSI/ISA-84.01-1996, Annex C, but no normative references. 

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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. 

Although the title of this clause refers to subcontractors, this term is not used in ISO 9001 in the traditional sense of organizations supplying products or service to customer specifications. It is used in ISO 9001 to refer to any organization that supplies products or services to a customer whether to their own specification or a customer specification. For consistency therefore, the term subcontractor in this section has no special meaning. 

Throughout the standard, various clauses reference the clause on quality records. To avoid repetition, the common requirements for quality records are assembled under one heading. The requirements, however, are not limited to those clauses in which this requirement is referenced as many other clauses refer to records. However, as all clauses will generate some documentary evidence it should not be assumed that all such documents are quality records. The requirements, however, apply only to original records and not to any copies other than those taken for security reasons or copies of subcontractor records. There are several types of document used in a quality system and only some are classified as quality records. As quality records are documents it might be assumed that the requirements of clause 4.5 on document and data control apply to quality records. As clause 4.16 is not cross referenced in clause 4.5 (except for clause 4.5.2.2), there is clearly no requirement for you to apply the requirements for document control to quality records. (See also Part 2 Chapter 5.) Figure 5.2 illustrates the difference between quality records and documents. 

Rule 1 A that clause (referred to as a restrictive clause in The ACS Style Guide) introduces information (about the word or phrase just before it) that is considered essential to the meaning of the sentence. If the that clause were deleted, the sentence would lose its intended meaning ... 

Without any prejudice to the provisions of Article 1, the general safeguard clause referred to in Article 37 of the Act of Accession shall apply until 31 December 2012 if energy supply is disrupted in Lithuania. 

Generally, this clause refers to an international standard, if such exists. If necessary, specific preconditions and methods of sampling or pre-treatment steps for the preservation of the samples (e.g., filtration, acidification, bottle material, storage conditions) are given. 

Target The entity/relationship to which the clause refers. For example the entity in question could he a responsibility, or a resource expected to he used. A relationship could include the allocation of aresource to a group for use in a situation. 

General Duty Clause Refers to Section 5 (a) (1) of the Occupational Safety and Health Act of 1970, which states... 

Safety function" is used throughout ANSI/ISA-84.01-1996. The following limited sampling of clause references illustrate the use "safety function" throughout ANSI/ISA-84.01-1996, such as Clauses 5.2.1, 5.4.1,6.2.1, and 6.2.2. 

Prior use is often used where devices designed in compliance with lEC 61508 are not available hence, prior use plays a significant role in the application of the grandfather clause (refer to TR84.00.04-1 Clause 3.0 and Annex A). 

General Duty Clause Refers to Section 5 (a)(1) of the Occupational Safety and Health Act of 1970 which states Each employer shall furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees, and shall comply with occupational safety and health standards promulgated under this Act. 

The first two maintains-clauses refer to the memory resp. ownership-model of VCC. The writes-clause specifies that the destination register is written by the instruction. The last line states the postcondition of mfmsr. In this way, most of the PowerPC instructions can be handled. However, for memory and branch instructions there may be access to the kernel and user address spaces, which requires additional handling. How to model these instructions is outside the scope of this paper, though. 

Where a Member State ascertains tliat a product, bearing the CE-marking and used in accordance with its intended use, is liable to endanger the safety of persons or health, it shall take all appropriate measures to withdraw such a product from the market. That Member State shall immediately Inform the Commission which is obliged to investigate whether or not the measure is justified. Where the Commission considers that the measure is justified, it shall immediately inform the Member State which took the initiative and also the other Member States. This entails that the other Member States must also take action against the product concerned. That latter disposition is referred to as the safeguard clause. 

The Claus process consists of partial combustion of the hydrogen sulfide-rich gas stream (with one-third the stoichiometric quantity of air) and then reacting the resulting sulfur dioxide and unbumed hydrogen sulfide in the presence of a bauxite catalyst to produce elemental sulfur. Refer to the process flow diagram in Figure 7. 

A note in clauses 4.10.1.1 and 4.12 explains that reference to the quality plan should be interpreted as control plan. 

In the context of ISO 9001, the quality policy referred to in clause 4.1.1 is one of the corporate policies. It is characterized by a single policy statement which declares the organization s commitment to quality and the strategy adopted to discharge this commitment. 

The supplementary requirement in clause 4.1.1.1 for goals to deploy the quality policy creates an ambiguity because it is unclear as to whether these goals are the same organizational goals referred to in clause 4.1.1 or some other goals. For clarity, goals are addressed separately under Quality objectives in this chapter. 

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. 

There are three references to the management review in other sections of the standard preventive action information (clause 4.14.3), internal audit results (clause 4.17.1), and changes to procedures (clause 4.14.1.1) are required to be submitted for management... 

The supplementary requirements provide a welcome addition to this somewhat inadequately specified clause of ISO 9001. However the reference to clause 4.1.1.2 with respect to objectives specified in the quality policy is somewhat ambiguous. Clause 4.1.1.2 does not require objectives to be included in the policy this is required in clause 4.1.1.1. As stated previously, system effectiveness is judged by how well the system enables implementation of policy and achievement of objectives. Therefore, requiring records that contain evidence of this is a logical interpretation. Such records need to identify the matters reviewed, the results, the actions, and the decisions taken, together with the names of those responsible and the date by which actions are to be completed. The records should also contain the data used to conduct the review as the basis upon which the decisions have been made and so that comparisons can be made at later... 

The 1987 version of ISO 9001 required the quality policy and the quality system procedures and instructions to be documented, clearly identifying three levels of documents in practice, organizations produced an intermediate level between the quality policy statement and the procedures which addressed the requirements of the standard and cross-referenced the associated procedures. This intermediate level together with the quality policy statement was often referred to as the quality manual. However, some manuals merely paraphrased the requirements of the standard, some described the quality system, and others confined the manual to the organization s operational policies. The guidance given in clause 5.3.1 of ISO 9004-1 suggests that the quality system documentation consists of policies and procedures. Clearly these policies are of a somewhat lower level than the corporate quality policy addressed in Part 2 Chapter 1. 

Work instructions are identified in a Note to clause 4.2.2 of ISO 9001 and in clause 4.9.2 in ISO/TS 16949 where it states that job instructions are equivalent to work instructions. In ISO 9001 it implies that work instructions define how an activity is performed but in ISO 8402 1994 a procedure is defined as a specified way to perform an activity. There isn t enough difference between these two definitions to warrant a change in the term and its inclusion may well create much confusion, especially as ISO 9004-1 does not refer to work instructions or any other type of instructions. The list of topics that should be addressed by job instructions in clause 4.9.2 of ISO/TS 16949 certainly does not by itself imply that job instructions define how an activity is performed ... 

The quality system developed to meet the requirements of ISO/TS 16949 is likely to be a generic system, not specific to any particular product, project, or contract other than the range of products and services which your organization supplies. By implementing the policies and procedures of the documented quality system, product, project, or contract specific plans, procedures, specifications, etc. are generated. ISO 9001 contains a series of quality system requirements, not product quality requirements. For a given product, project, or contract there will be specific product, project, or contract requirements and it is these requirements to which this clause of the standard refers. 

The requirements in clause 4.2.4.11 are linked with other elements of the standard, even when there is no cross reference. This relationship is illustrated in Figure 2.8. 

So what are these appropriate stages In the note which appends the requirements of clause 4.4.7 of the standard, the reference to design reviews implies that it is a design... 

The quality plan would be a logical place for such controls to be defined but clause 4.2.3 does not specifically refer to subcontractor controls. Any intention that they be defined in the quality plan is hidden in 4.2.3.1(b) where it requires you to give timely consideration to the identification and acquisition of any controls etc. Some companies produce a Quality Assurance Requirement Specification to supplement ISO 9001 and also produce a Subcontractor Surveillance Plan. In most other cases the controls may be defined on the reverse side of the purchase order as standard conditions coded and selected for individual purchases. 

The production plan referred to previously is a work instruction, as it instructs those to whom it applies to carry out certain tasks. Control procedures may include assembly procedures, plating procedures, painting procedures, maintenance procedures, etc. and differ from process specifications (see later) in that the process specification defines the results to be achieved in operating a process rather than how to run the process. In addition to the list of contents provided in ISO/TS 16949 clause 4.9.2, the documentation should define ... 

The term approval can be taken to mean certification or qualification, the difference being that certification is performed each time the equipment is repaired and qualification only when the equipment is introduced into service. The standard only refers to the term qualification in connection with special processes, but this clause does not distinguish between special and ordinary processes and equipment. However, there are two levels of approval that apply to processes and equipment initial qualification approval and periodic setting-up approval. 

In continuous production, product is inspected by taking samples from the line which are then examined while the line continues producing product. In such cases you will need a means of holding product produced between sampling points until the results of the tests and inspections are available. You will also need a means of releasing product when the results indicate that the product is acceptable. So a Product Release Procedure or Held Product Procedure may be necessary. The standard implies, however, that if you have released product under positive recall procedures you do not need to hold product while in-process inspection and tests are performed. The reference to clause 4.10.3(a) is also ambiguous because the inspections and tests carried out in accordance with the quality plan or documented procedures may not cover those necessary to verify product on receipt into the plant. It would be wise to hold any product until you have... 

Unlike the other requirements, which only referred to inspection, test, and measuring equipment, this clause adds test facilities. Facilities include the equipment and the area or room in which it is kept or used. Test facilities are any room, area, or complex in which tests are carried out. Inspection, measuring, and test facilities include functional and environmental test laboratories, test and inspection chambers, calibration rooms. 

Quality records are those records identified in Chapter 16. This is a bit of a catchall as concessions, service reports, customer complaints, and data from processes and work operations are all quality records. However, the standard does not cross refer to clause 4.16 at every mention of records or similar document and therefore the requirements of 4.16 only apply in those cases where it is referenced. Service reports, for instance, do not need to comply with the requirements of clause 4.16. 

Handling provisions serve two purposes, both related to safety protection of the product from the individual and protection of the individual handling the product. By referring back to clause 4.15.1 it would appear that element 4.15 of the standard is only concerned with safety of the product and not the individual however, the two cannot and should not be separated and handling procedures should address both aspects. 

These are the minimum number of records to be created and maintained. There are a further three records which a scan of the standard will reveal, although there is no cross reference to clause 4.16 ... 

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