We shall try to define and understand some of the terms used in quality management system. The standard ISO 9000:2005 is the basis on which the terms are defined. Here we define some of the Terms relating to Documentation in QMS
7) Terms relating to Documentation in QMS
Terms relating to Documentation in QMS as per ISO 9000:2005 can be defined as:
ISO 9000 definition:
Information is that which informs, i.e. that from which data can be derived. Information is conveyed either as the content of a message or through direct or indirect observation of some thing. That which is perceived can be construed as a message in its own right, and in that sense, information is always conveyed as the content of a message. Information can be encoded into various forms for transmission and interpretation. For example, information may be encoded into signs, and transmitted via signals.Information resolves uncertainty. The uncertainty of an event is measured by its probability of occurrence and is inversely proportional to that. The more uncertain an event, the more information is required to resolve uncertainty of that event. Information is dependent upon, but generally unrelated to, the medium or media used to store or express it. For example, a mathematical formula or the epic of Gilgamesh can be encoded in a baked clay tablet2, printed in a book, stored in a semiconductor memory chip, or retained in a human mind. The definition of information makes no assumption about either its accuracy or any direct communication between the pattern and the object or system perceiving or using it.
ISO 9000 definition:
“Information and its supporting medium.”
EXAMPLE Record, specification, procedure document, drawing, report, standard.
NOTE 1 The medium can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or a combination thereof.
NOTE 2 A set of documents, for example specifications and records, is frequently called “documentation”.
NOTE 3 Some requirements (e.g. the requirement to be readable) relate to all types of documents, however there can be different requirements for specifications (e.g. the requirement to be revision controlled) and records (e.g. the requirement to be retrievable).
Documents are written policies, process descriptions, and procedures used to communicate information. They provide written instructions for HOW TO do a specific task. Blank forms are also considered documents. Forms are used to capture data or information from performing a procedure.Documentation is any communicable material that is used to describe, explain or instruct regarding some attributes of an object, system or procedure, such as its parts, assembly, installation, maintenance and use. A document provides guidance and/or direction for performing work, making decisions, or rendering judgments which affect the quality of the products or services that customers receive. A document should be construed to mean any physical guide or direction whether written, video tape, physical sample, sample drawing, computer program or otherwise.
The ISO 9001 Standard specifies that a quality system must be documented, but it doesn’t say how. Here’s the documentation it says you must have:
- A quality policy
- Quality objectives you can measure (ie, things you want to achieve, and how you measure that)
- A quality manual
- The documents you decide are necessary to run your business (procedures, policies, forms, checklists, etc)
- Mandatory procedures for 6 areas: nonconformity, corrective & preventive action, document control, records management, internal audit.
ISO 9000 definition:
“Document stating requirements.”
NOTE A specification can be related to activities (e.g. procedure document, process specification and test specification), or products (e.g. product specification, performance specification and drawing).
Exact statement of the particular needs to be satisfied, or essential characteristics that a customer requires (in a good, material, method, process, service, system, or work) and which a vendor must deliver. Specifications are written usually in a manner that enables both parties (and/or an independent certifier) to measure the degree of conformance. They are, however, not the same as control limits (which allow fluctuations within a range), and conformance to them does not necessarily mean quality (which is a predictable degree of dependability and uniformity). Specifications are divided generally into two main categories:
(1) Performance specifications: conform to known customer requirements such as keeping a room’s temperature within a specified range.
(2) Technical specifications: express the level of performance of the individual units, and are subdivided into
(a) individual unit specifications which state boundaries (parameters) of the unit’s performance consisting of a nominal (desired or mandated) value and tolerance (allowable departure from the nominal value,
(b) acceptable quality level which states limits that are to be satisfied by most of the units, but a certain percentage of the units is allowed to exceed those limits, and
(c) distribution specifications which define an acceptable statistical distribution (in terms of mean deviation and standard Deviation) for each unit, and are used by a producer to monitor its production processes.
7.4) Quality manual
ISO 9000 definition:
“Document specifying the quality management system of an organization.”
NOTE Quality manuals can vary in detail and format to suit the size and complexity of an individual organization.
It can be defined as official document produced by a business that details how its quality management system operates. A typical quality manual will include the company’s quality policy and goals, as well as a detailed description of its quality control system that might include staff roles and relationships, procedures, systems and any other resources that relate to producing high quality goods or services. The “quality manual” describes a quality management system of the organization and says how it should work. It is a document stating the quality policy, quality system, and quality practices of an organization.
A quality manual documents an organization’s quality management system (QMS). It can be a paper manual or an electronic manual. According to ISO 9001 section 4.2.2, your quality manual should:
- Define the scope of your QMS.
- Explain reductions in the scope of your QMS.
- Justify all exclusions (reductions in scope).
- Describe how your QMS processes interact.
- Document your quality procedures or refer to them.
Notice that an ISO 9001 quality manual does not regurgitate the ISO 9001 standard. While this is a common practice, it not only fails to comply with the standard it also fails to serve any useful function.
7.5) Quality plan
ISO 9000 definition:
“Document specifying which procedures and associated resources shall be applied by whom and when to a specific project, product, process or contract.”
NOTE 1 These procedures generally include those referring to quality management processes and to product realization processes.
NOTE 2 A quality plan often makes reference to parts of the quality manual or to procedure documents.
NOTE 3 A quality plan is generally one of the results of quality planning.
A quality plan is a detailed document that sets forth practices and sequence of activities aimed at translating an organization’s quality policy into operational results, or conformance to a standard such as ISO 9000 within a specified time-frame. A document that is used to specify the procedures and resources that will be needed to carry out a project, perform a process, realize a product, or manage a contract. Quality plans also specify who will do what and when. A Quality Management Plan is a document that describes a quality system in terms of the organizational structure, policy and procedures, functional responsibilities of management and staff, lines of authority, and required interfaces for those planning, implementing, documenting, and assessing all activities conducted. A Quality Assurance Project Plan is a document that describes the necessary quality assurance, quality control, and other technical activities that must be implemented to ensure that the results of the work performed will satisfy the stated performance criteria. A Quality Management Plan documents the overall organization/program whereas a Quality Assurance Project Plan documents project-specific information. Usually you document your quality system once (and update it on a regular basis) but need to document the quality assurance activities for each project.Quality planning involves setting quality objectives and then specifying the operational processes and resources that will be needed to achieve those objectives.
ISO 9000 definition:
“Document stating results achieved or providing evidence of activities performed.”
NOTE 1 Records can be used, for example, to document traceability and to provide evidence of verification, preventive action and corrective action.
NOTE 2 Generally records need not be under revision control.
A record is a type of document. Records provide evidence that activities have been performed or results have been achieved. They always document the past. Records are generated when written instructions are followed. In other words, after data, information, or results are recorded onto a form, label, etc, then it becomes a record. Records can, for example, be used to show that traceability requirements are being met, that verification is being performed, and that preventive and corrective actions are being carried out. A Record proves that some type of required quality system action took place. Sometimes documents become records. For instance, Management Review Minutes become the record that a Management Review has taken place. Records must be kept permanent, secure, and traceable because they will be used for reporting and monitoring purposes. Typically a form gets filled in and becomes a record. The form is a document and after it is filled in it, becomes a record. Records normally get filled in and provide evidence that conformance has occurred in the Quality System. Documents offer direction and guidance on particular tasks.
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