Documentation standards quality policy

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

The chief executive should formally document the organization s quality policy. This policy should include the relative priority assigned to continuous quality improvement, the acceptable standard for quality, and the system to achieve that standard. 

It is not mandatory that you have documented procedures for forming the quality policy and the quality objectives, defining the responsibility of personnel, identifying resources, or conducting management reviews. However, section 4 of the standard is titled Quality s /stem requirements and section 4.2 requires that a quality manual be prepared covering the requirements of the standard. It follows therefore that you need to address the requirements of section 4.1 in your quality manual. You have a choice of how you address the requirements providing they are documented. 

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. 

Maintenance is concerned with retaining something in or restoring something to a state in which it can perform its required function. However, the standard does not require that the maintenance of policy is to be preventive or corrective. In other words it does not require that maintenance of the quality policy should be carried out before or after it is changed. Even so, it is advisable to maintain documented policies in line with your beliefs and to do this ... 

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 standard requires that the management with executive responsibility define and document in the business plan its goals, objectives, and measurements to deploy the quality policy. 

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 the supplier to prepare documented procedures consistent with the requirements of this international standard and the supplier s stated quality policy. 

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. 

The reason for an Exposition is so that there is a description of the system showing how it works and how it controls the achievement of quality. This is different from the policies and procedures. The policies are a guide to action and decision and as such are prescriptive. The procedures are the methods to be used to carry out certain tasks and as such are task related. They need to be relatively simple and concise. A car maintenance manual, for example, tells you how to maintain the car but not how the car works. Some requirements, such as those on traceability and identification, cannot be implemented by specific procedures although you can have specific policies covering such topics. There is no sequence of tasks you can perform to achieve traceability and identification. These requirements tend to be implemented as elements of many procedures which when taken as a whole achieve the traceability and identification requirements. In order that you can demonstrate achievement of such requirements and educate your staff, a description of the system rather than a separate procedure would be an advantage. The Exposition can be structured around the requirements of ISO/TS 16949 and other governing standards. It is a guide or reference document and not auditable. 

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. 

Appropriate documents are those which are needed to carry out work and a list of 11 such documents is provided in the standard as examples. However, it may not be appropriate to place the quality manual at all locations if it does not contain any operational policies or procedures. The work instructions should specify the documents that are required for the task so that it is then clear that any not specified are not essential. It should not be left to the individual to determine which documents are essential and which are not. 

You need to develop documented procedures that define your subcontractor evaluation and selection process and in certain cases this may result in several closely-related procedures for use when certain conditions apply. Do not try to force every purchase through the same selection process. Having purchasing policies that require three quotations for every purchase regardless of past performance of the current subcontractor is placing price before quality. Provide flexibility so that the policies and procedures complexity match the risks anticipated. Going out to tender for a few standard nuts and bolts would seem unwise. Likewise, placing an order for lm of equipment based solely on the results of a third party ISO 9000 certification would also seem unwise. 

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 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. 

Pharmacists should be involved in all steps of pain management. This includes the initial development of pain management policies and procedures development of standardized pain assessment and documentation forms development of standardized treatment orders, including recommendations to manage adverse effects education of staff on the implementation of the new pain management standards and quality assurance efforts to evaluate the policies and procedures. 

Hence, analysis of indicator snbstances representative of the entire group is common practice. Indicator substances which have to be analysed have been specified in the proposal for a Directive of the European Parliament and of the Council on enviromnen-tal quality standards in the field of water policy, amending Directive 2000/60/EC, and will be added to the final version of the guidance document on chemical monitoring as soon as the negotiations on this Directive have been completed. 

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. 

B.3. Use of documented Quality Management System (QMS), e.g., policy, manual, procedures, standards (see Section 8)... 

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... 

To a great extent, use of audits stems from quality management practices that began with ISO 9000 and related standards. The concept requires companies seeking to achieve ISO 9000 certification to thoroughly document their management systems to ensure quality defined by the standard. Then independent auditors visit the company and its operations to verify that it conforms to the standard and to internal policies and procedures. Later, international standards applied the overall process to other areas, including safety and health. 

Establishing the requirements for a company s quality management systems, the ISO 9000 series provides a set of world-wide standards. Listing the features and characteristics required in the documented policies, manuals, and procedures of an organisation, its aim is to support a process of systematic quality assurance and control. However, rather than outlining the specific methods by which to achieve control, these standards represent a codification of the principles of control, enabling alternate interpretation and application across a wide range of environments. The series encompasses five individual standards ... 

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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