Quality systems policy document

Planned arrangements is another unusual term, especially when throughout the standard the terms documented quality system and documented procedures have been used. However, so that audits are not restricted to documented procedures and policies, the term planned arrangement has been used. It encompasses contracts, specifications, plans, objectives, strategies - in fact any arrangement made by the organization to satisfy customer needs. You therefore need to define what constitutes your planned arrangements. 

Clause 4.2.2 of ISO/IEC 17025 requires that a quality policy statement be issued by the top management and that the quality system policy and objectives are defined and documented in the quality manual. 

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. 

A signed statement by management without its approval to the quality system documented policies and procedures will indicate that it is not committed to honoring the policies and procedures. Managers need to approve the documents within the quality system that prescribe activities for which they themselves are responsible. This serves to demonstrate that they agree with the manner in which the policy has been interpreted and are prepared to provide the resources needed to implement the documented practices. 

If we look at ISO 10013, which is referenced for guidance in preparing a quality manual, we will see that it shows that the quality manual is a top-level document containing the stated quality policy, the quality objectives, and a description of the quality system (see Figure 2.2). The definition in ISO 8402 supports this concept and the requirement aligns with this definition. However, ISO 8402, ISO 10013, and the above requirement from ISO 9001 provide a choice as to whether the manual contains or refers to procedures. 

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. 

It would be sensible to document your quality policies separately from your quality objectives and keep these separate from the other quality system documentation. A solution is to have ... 

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. 

These lists tell us something about the nature of quality records, especially by what is not included. Absent from the lists are policies, procedures, instructions, plans, specifications, and any other prescriptive documents. The records all have one thing in common they describe the results of some activity - the results of inspections, tests, reviews, audits, assessments, calculations, etc. However, these lists are dominated by records relating to product quality rather than to the operations of the quality system. In addition to audit records, the following records may need to be maintained to demonstrate the effectiveness of the quality system ... 

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. 

A document stating the quality policy and describing the quality system of an organization (ISO 8402). 

The qualities of the product and their tolerances must be deduced from the protocols of the development. The methods to measure the qualities must be described as documented in the development protocols. The directives (a) to (t) are not detailed here. They must be written in accordance with company policies and the Quality Systems Manual for each individual production. The tolerances are given in brackets e. g. 1 °C. ... 

Each construction organization shall be responsible for developing a QSP. The Quality System shall include a quality manual, quality policy and objective, structure of organization, documented procedures, work instructions, a quality plan, and document and data control. 

The quality management system documentation includes quality policy, a quality manual, and documented procedures required by this international standard and quality standards. 

The CD contains Quality Systems Manuals with samples of policy stotements that can be customized to fit your organization. It provides you with 20 Standard Operating Procedures that you con edit to your specifications and print when you need them. Written in a global format applicable to any process-related industry, ISO 9001 2000 Document Development Compliance Manual A Complete Guide and CD-ROM gives you everything you need to document the ISO 9001 process quickly, effortlessly, and cost-effectively. 

A quality manual has to document those procedures and policies that are carried out in the laboratory that can affect an analysis. In addition details of the organisational relationships, responsibilities and authorities of all of the more senior staff and the internal auditors are described. The manual will probably include descriptions of the resources of the laboratory, examples of records used, calibration and audit schedules, and routines such as the periodic review of the quality system. 

The quality system should be documented in a QA program manual that outlines all the quality policies and procedures for the laboratory. This manual should be considered the handbook for all employees. New employees should become familiar with the document so that they can use it to answer questions that may arise in their work. New or retrained employees should sign a form documenting that they have read and understood the manual. This form should be kept in the personnel files. 

To obtain a realistic assessment, the method and detail of the purchaser s evaluation of a new supplier must be formalised, and the results documented. The opportunity must be taken to view the supplier under normal operating conditions, with the involvement of the relevant technical staff. Systems of working routines must be made available and the operation of quality systems defined. The supplier company should explain its organisation (line/functional disposition), its personnel training policy, and its philosophy and commitment to quality. 

The Quality Manual is a documented base for this quality system. It is intended to describe the quality policy and the commitment of the supplier to quality. 

The standard requires laboratories to document their policies, systems, programs, procedures, and instructions to the extent necessary to meet the requirements of customers while ensuring the quality and traceability of measurements, meaning that the laboratory determines the degree of detail found in its documentation. The laboratory must also be able to demonstrate objective evidence that the degree of detail presented in its quality system documentation is generating the desired and required outcome. Documentation must be available in a repeatable form and will normally be in either written or electronic form. 

The Multi-Agency Radiation Survey and Site Investigation Manual (MARSSIM) describes the quality system as consisting of all efforts devoted to produce quality results that are authentic, appropriately documented, and technically defensible (EPA, 2000c, Chapter 9). The purpose of the quality manual or QAP is to describe, in a single document, all elements of the quality system. This includes all laboratory policies regarding quality and all of the QA measures implemented by the laboratory. Some records may be included in the QAP itself, while others are filed as specified in the QAP. The QAP defines every element of laboratory operation and represents the laboratory s commitment to quality. The interconnected elements of QA policy that must be included in the QAP are... 

The quality system must be described in written documents approved by management (policies, quality manual, etc). 

The policy document defines the aims of the accreditation relative to the company the rest of the quality management system will be based on this documentation. 

ISO 9000 is a quality assurance model that is made up of 20 generic quality system requirements or elements and a four-level integrated structure. It works on the premise that quality is achieved through a disciplined approach to documentation, traceability, and management of all company policies, procedures, work instructions, and records. This premise is actualized because ISO 9000... 

Once a laboratory has implemented a quality system in accordance with these requirements, it must make a formal application to UKAS to have its system assessed for the purpose of accreditation and at this stage submits its Quality Manual and its proposed schedule of accreditation for examination, along with any other documentation requested by UKAS. The manual describes the policies and practices through which the laboratory addresses the requirements of the standard. Provided UKAS is reasonably satisfied with the documentation received, and once the laboratory has been advised of any areas needing further attention before assessment, the arrangements for the assessment visit are made. It takes the form of a major assessment/audit... 

From the above, it may be seen that the application of quality systems to the management of health and safety at work has distinct benefits, especially when consideration is given to the tremendous overlap between the two subject areas. Overlap examples include policies systems and procedures standards documentation - records training (including record keeping) statistical analyses - causal, numerical accident/complaint investigations audits/inspections (internal and external) and the taking of remedial control action. 

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