Quality system procedures

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

A procedure is a sequence of steps to execute a routine task. ISO 8402 defines a procedure as a specified way to perform an activity. It prescribes how one should proceed in certain circumstances in order to produce a desired result. Sometimes the word can imply formality and a document of several pages but this is not necessarily so. A procedure can be five lines, where each line represents a step to execute a task. 

Quality system procedures are a certain type of procedure. They implement the operational policies and regulate processes that produce an output, the quality of which is essential to the business. Procedures do not in fact achieve quality - it is people who do that. Procedures do not take decisions, it is people who do that. So you could have the best procedures in the world and still not achieve quality. It has to be a combination of both for you to achieve the desired quality. 

The standard only refers to procedures as the category of quality system documentation. If we use the term documented practices we have a wider choice as to the types of documents we put into the quality system. Many documents are not procedures. They do not tell us how to proceed or specify a way to perform an activity. They specify criteria we must meet or provide guidance in conducting a task. They may, however, give examples or define rules to follow. 

The relationship between these documents and the policies described in Part 2 

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Are the means used to ensure that product conforms to specified requirements documented in the form of a quality manual and quality system 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 requires the supplier to prepare a quality manual covering the requirements of the standard and also requires the quality manual to include or make reference to the quality system procedures and outline the structure of the documentation used in the system. 

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. 

In what document are the quality system procedures either contained or referenced ... 

How do you ensure your quality system procedures are consistent with the requirements of ISO/TS 16949 and your quality policy ... 

Ensure your quality system procedures identify all the types of document requiring control including external documents. 

Don t work to instructions unless provided in the quality system procedures, product specification, production plan or in approved change notices or remedial action instructions or by the nonconformity review board. 

Introducing a quality system, thus requiring awareness of ISO 9000, the quality policies and objectives, and training in the implementation of quality system procedures, standards, guides, etc. 

The audit plan should be consistent with written quality auditing procedures included in the quality manual or other quality system documentation. The plan should include or refer to the objective criteria to be used to evaluate conformance to requirements. The plan should include or refer to other documents that will be used during the audit, including previous audit reports. If the audit is to include the review of batch or production records, such review should be conducted in accordance with a specified sampling plan or other appropriate statistical rationale as specified in a firm s quality system procedures. 

Documented quality system procedures and instructions are prepared to meet the requirements of all pertinent standards. 

All quality system procedures and instruction changes are properly documented. 

All quality system procedures and instructions are implemented to ensure effectiveness of the quality management system. To ensure continual improvement, facilities, equipment, and documents are reviewed and approved for implementation. The compatibility of the process with the production facilities and infrastructure is ensured to achieve product realization in compliance with the customer requirements. The implementation is achieved through ... 

The preparation of documented quality system procedures and instructions in accordance with the requirements of this standard... 

A quality audit has been defined as A systematic, independent examination of a manufacturer s quality system that is performed at defined intervals and sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives 21 CFR 820.2 (t). Another definition is Quality Audit A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives (International Organization for Standardization/American Society for Quality Control). 

Establish Quality System procedures Conduct quality audits ... 

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