Standards procedure clause

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 requirement for procedures does not stipulate that they need to address all 30 requirements of this section of the standard. Procedures are required only for the control, calibration, and maintenance of these devices. The requirements in clause 4.11(a), for instance, requiring you to determine the measurements to be made and the accuracy required, are not requirements concerning the control, calibration, and maintenance of these devices. They are requirements concerning measurement. The procedure requirement only addresses the devices used for measurement and therefore does not apply to software other than software used for measurement. 

Starting materials should be dispensed only by authorised persons, following a standard procedure which ensures that the correct marerials are accurately weighed or measured. Scales and measues with accuracy appropriate to the various quantities to be dispensed should be available. Each dispensing operation should be checked and the check recorded (see Clause 545). 

Compliance with gas cylinder rules (with their latest amendments) and all relevant codes of design, fabrication and testing is a must. Stage inspection clause should be put in work order. Final test must be carried out in the presence of the purchaser s representative and should be as per statutory requirements. It is better to test the vessel again after installation as per standard procedures. 

Does ISO 9001 require the other types of policies to be defined and documented There is no requirement in clause 4.1.1 but in clause 4.2.2 there is a requirement to prepare a quality manual covering the requirements of the standard and this is where you should document your operational policies. While the quality manual could simply contain the quality system procedures, the guidelines given in ISO 10013 clearly indicate that whether or not this is the case, the manual should describe the organization s policies for meeting the requirements of the standard. These aspects are addressed in Part 2 Chapter 2. 

The standard does not require you to document how you maintain your quality policy but the requirements of clause 4.5.1 place the quality policy into the category of documents which need to be governed by documented control procedures and hence all changes must be reviewed and approved. 

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. 

The standard requires documented procedures to be prepared consistent with the requirements of this international standard, but what does this mean Preparing procedures consistent with the requirements of the standard means preparing those procedures where the standard requires them. Outside ISO 9001, ISO/TS 16949 does not use the same wording to require procedures. In some clauses it requires a process and in others it requires methods or a methodology or a system. Although systems are not procedures, procedures are not processes and methods are not necessarily procedures, systems, or processes. Some methods, however, will inevitable need one or more procedures. By including systems, methods, and processes, the standard now requires 43 documented procedures directly. 

This requirement acknowledges that not all the requirements of the standard can be addressed by procedures. As described previously in this chapter, quality system documentation consists of several types of documents with procedures being one type. The requirement is therefore sending out a strong message that the supplier should not produce procedures to address each element of the standard or each clause. 

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. 

This general requirement for procedures introduces uncertainty into what particular procedures are actually required. The standard does not require the design control procedures to address each requirement of this clause but were they not to, you would need to demonstrate that the absence of such procedures had no adverse affect on the quality of design. 

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... 

The standard doesn t require a procedure covering inspection and test status however, as clause 4.2 requires a documented quality system, you will need to document the methods employed to denote inspection and test status. If you use stamps you will need a register to allocate stamps to particular individuals and to indicate which stamps have been withdrawn. When a person hands in a stamp it is good practice to avoid using the same number for 12 months or so to prevent mistaken identity in any subsequent investigations. 

The standard only requires a procedure for implementing corrective and preventive action and not for determining it, although the requirements of clauses 4.14.2 and 4.14.3 do require the actions to be determined - presumably before being implemented ... 

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. 

The impact of this requirement depends upon what constitutes the specified requirements. The standard does not require you to demonstrate conformance with every requirement of ISO 9001. However, if your customer has invoked ISO 9001 in the contract, this clause requires that you maintain sufficient records to demonstrate compliance. As stated elsewhere in this book, there is no definition clarifying what specified requirements are. If specified requirements are a//the requirements that you have specified in your quality system, your plans, procedures, specifications, etc., this requirement may well be viewed as the most onerous in the standard. A pragmatic approach to take is to declare in your quality manual that the specified requirements are specified customer requirements . 

The requirements for internal audits apply to audits of the quality system, including the policies, practices, products, and services to which the quality system relates. They are not limited to audits of procedures. In order to determine whether the quality system is effective in maintaining control, you need to check that the resultant products and services meet the specified requirements and that prescribed quality objectives are being achieved. If the products and services are not meeting the specified requirements, or the prescribed objectives are not being achieved, something is clearly amiss with the quality system. The requirements do not apply to audits of suppliers or subcontractors as they are covered in clause 4.6 of the standard. 

Audits of practice against procedure or policy should be recorded as they are observed and you can either do this in note form to be written up later or directly onto observation forms especially designed for the purpose. Some auditors prefer to fill in the forms after the audit and others during the audit. The weakness with the former approach is that there may be some dispute as to the facts if presented some time later. It is therefore safer to get the auditee s endorsement to the facts at the time they are observed. In other types of audits there may not be an auditee present. Audits of procedure against policy can be carried out at a desk. You can check whether the documents of the quality system satisfy all the clauses of the standard at a desk without walking around the site, but you can t check whether the system is documented unless you examine the operations in practice. There may be many activities which make the system work that are not documented. 

The terminology used in this Standard is slightly different from the others in that it is appropriate for the particular discipline. For example, the term, referral laboratories in paragraph 4.5 of ISO 15189 is used in a slightly different sense to the comparable clause in ISO/IEC 17025. Included in this section are consultants who may provide a second opinion. If the referral laboratory is an external laboratory, to which samples are submitted for a supplementary or confirmatory examination procedure and report, it is much the same as a contract laboratory in ISO/IEC 17025. There is an extra Annex in this Standard which covers the ethics applicable to laboratory medicine. 

Section 5.4 of the ISO/IEC standard 17025 (ISO/IEC 2005) requires Testing laboratories shall have and shall apply a procedure to estimate the uncertainty of measurement, and in a test report where applicable, a statement on the estimated uncertainty of measurement information on uncertainty is needed in test reports when it is relevant to the validity or application of the test results, when a client s instruction so requires, or when the uncertainty affects compliance to specification limits (ISO/IEC 2005, section 5.10). Although the reporting clause leaves open the possibility of not including the measurement uncertainty of a result, I believe that the added value to the client of a proper measurement uncertainty statement far outweighs any temporary problems that may be caused by unfamiliarity with the measurement uncertainty concept. 

The last section of this book provides a set of 20 explicit standard operating procedures written in a global text to describe the elements of the revised standard. The contents of the procedures can be specifically tailored to an individual company s operations, and reference can be made to specific documents and associated applicable procedures. Taking into consideration the fact that thousands of companies are already registered and certified in compliance with the ISO 9001 11994) or ISO 9002 (1994) or ISO 9003 (1994) international standards, reference is made to the corresponding SOPs to indicate applicable clauses of both the second and the third revisions of the ISO 9000 series of standards. 

To describe the design control procedure in accordance with clause 4.4 of ISO 9001 and corresponding clauses of international standard ISO 9001 2000. 

No attempt will be made in this section to consider all the separate measurement clauses to be found in current test method standards. Until the ISO standard for the measurement of dimensions has become established long enough for all test methods to have been revised and reference it (if that happens), each test method will have its own procedure and there will not be universal agreement on detail. The essentials are to distinguish between a non-contact measurement and one applying a specified pressure, in the latter case to use the correct standard pressure, and to measure within the accuracy limits specified. 

Design procedures for conical sections are given in the codes and standards (BS 5500, clause 3.5.3). 

Clause 4 of ISO 9001 2000 presents some general requirements of the quahty management system. These include requirements dealing with the identification and management of the processes in the system. General documentation requirements are also discussed in this clause. These include the requirements for documented procedures, work instructions, and manuals. The actual, detailed requirements of the standard are stated in four clauses ... 

This document is not really a standard, in that it was not developed using a consensus procedure. It is a set of requirements, in addition to the ISO 9001 requirements, that have been developed by the Automotive Industry Action Group. The actual set of requirements were developed by representatives of Chrysler, Ford, and General Motors in 1994. The second edition was pnbUshed in 1995 and the third edition published in 1998. The clause structure corresponds to that of ISO 9001 1994. In fact the ISO standard is printed in italics within each clause, while the additional requirements are in roman letters. Since 1994, the document has been printed in five langnages in at least 63 countries. The original equipment manufacturers in the automotive industry have required their suppliers to be registered to this document in order to sell their product to them. 

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