Policy manual

Is there a Quality Assurance Policy Procedure Manual Date issue / / ... 

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. 

You will note that the heading of this section of the standard is Quality policy, and not Quality policies, as if there should be only one policy. Many companies do have a single quality policy statement at the front of their quality manual, but this is more of a quality philosophy rather than a policy of a form that will guide conduct (see also Commitment). 

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. 

Define, agree, and publish operational policies for meeting each of the requirements of the standard and publish them in a policy manual. 

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. 

For a quality manual to be a manual it should contain the procedures and instructions, as does a computer manual or a car maintenance manual, so whether one volume of the manual contains or refers to other documents does not prevent the collection of documents being referred to as the quality manual. Manuals tend to include operating instructions, hence the word manual. The quality manual should therefore contain all the policies and practices but not necessarily in one volume. 

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. 

There is no requirement for you to state the policies to meet each clause of the standard but many organizations in fact do just this. ISO 9001 requires the manual to cover the requirements of the standard and ISO 10013 gives an example of how this may be done. ISO 10013, however, points you in the direction of producing a quality manual which is structured in the sequence of the key elements of the standard rather than the operations of your business. This is fine for third party auditors but not for your staff, who will probably want to know your policy on some aspect of your operations in order to make a certain decision. This is where you need operational quality policies organized around the operations of the business - such an approach is deemed acceptable in ISO 10013. 

A Policy Manual containing the corporate and operational quality policies... 

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. 

It is often difficult to separate quality policies from other policies such as finance, personnel, and marketing. To avoid duplication, overlap, and possible conflict (as well as simplify maintenance) a single policy manual would be preferable. 

The limitations with this method are that you can only add new sections to the end of the quality manual, otherwise the procedure numbers would need to change. Also you cannot relate a procedure to a specific policy unless the section contains only one policy. 

No deviations from the policies stated in the policy manual will be permitted without written authorization of the Managing Director... 

Determine the operational policies needed to implement the corporate quality policy and place these in a policy manual with the corporate quality policy. 

Create a system manual that describes your quality system and how it works and references all the procedures, standards, etc. that implement your quality policies. 

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. 

Before committing the company or department to a system of planned maintenance, it is essential that there is a complete overview of the total demand on plant, equipment and resources and the benefits from the implementation of such a system, manual or computerized. Varying systems and/or part systems exist in almost every engineering maintenance department, which are due to company policy, changes in departmental staff or workforce, commitment of persons responsible, or, as is the situation in a number of instances, a previous breakdown, which the... 

A more detailed document in the form of a health and safety manual. This manual would include the company s policy statement, company rules, safe working procedures, etc., and would normally be located in a nominated office. It is necessary in using this method that all staff are made aware of its contents and its location. 

The use of contractors to carry out work that may in the past have been done by direct labor or during a normal sub-contract does not relieve the company from the responsibility of ensuring that all those working on their premises do carry out their work in a safe manner. The following contractor s conditions and safe working practices should form a part of the company s health and safety policy manual. 

Table 64.2 provides examples of hazardous chemicals that require investigation when a catastrophic release occurs or when one could have happened. These OSHA guidelines should be used in conjunction with site-specific procedures. For a complete listing of the reportable chemical used in your plant, refer to the site Hazardous Materials Policy and Procedure Manual. 

These laboratory values may not concur with the normal range ot values in all hospitals and laboratories. The hospital policy manual or laboratory values sheet should be consulted tor the normal ranges ot all laboratory tests. 

Documentation requirements - Create quality policy, quality manual, procedures, and document control and distribution function. Retain records for the expected lifetime of the device or a minimum of 2 years... 

NIOSH. 1989a. NIOSH Manual of Analytical Methods. Occupational air method no. 7905. NIOSH recommendations for occupational safety and health compendium of policy documents and statements. Cincinnati, OH U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, National Institute for Occupational Safety and Health. 

Manual of Policies and Procedures (MaPP6010.2). Review management. Procedures for tracking and reviewing phase 4 commitments, URL http //www.fda.-gov/cder/mapp/6010-2.pdf, accessed 3-10-2001. 

Mitchell, G., Griggs, R.H., Benson, V., and Williams, J., The EPIC Model, Environmental Policy Integrated Climate formerly Erosion Productivity Impact Calculator, Manual, Texas Agricultural Experimental Station and U.S. Department of Agricultural, Agricultural Research Service, Temple, TX, 1998. 

The manual sets out the policy in each area, not the detailed instructions as to how procedures are carried out. 

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. ... 

National Standards Institute, 1986. Construction Policy Design Manual, U.S. Department Of... 

Biosafety Level 2 (BSL-2) Similar to Biosafety Level 1 and is suitable for work involving agents of moderate potential hazard to personnel and the environment. Required practices are BSL-1 practices plus limited access, biohazard warning signs, sharps precautions, and a biosafety manual defining any needed waste decontamination or medical surveillance policies. 

Therefore, we have two options. We can write a test harness that performs the requisite sequences and checks the postconditions by comparing states before and after, or we can perform the equivalent checks manually by following a written test procedure. This is a matter of policy in your project. Each approach will be appropriate in different circumstances. Either way, you are systematically defining test sequences based on refinement of abstract actions. And, either way, the documented action conformance should be used to guide the creation of the tests, and the retrievals (whether only documented or actually coded as we saw earlier) provide the mapping between the different levels of the model. 

Manual code system, in searching patent literature, 18 223-225 Manual of Classification, 18 209 Manuals of Policies and Procedures (MAPPs), 13 688 Manufactured carbon, 4 735 Manufactured fibers, 11 165, 174-175 24 613-614, 616-618. See also Regenerated fibers Synthetic fibers olefin, 11 231-242 regenerated cellulose, 11 247 Manufactured graphite, 4 735 Manufactured products, nanotechnology and, 17 44-45 Manufactured water, 26 96 Manufacturing... 

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