Terms relating to Documentation in QMS
We shall try to define and understand
some of the terms used in quality management system.
7) Terms relating to Documentation in QMS
Terms relating to Documentation in QMS as per ISO 9000:2005 can be defined as:
7.1) Information
ISO 9000 definition:“Meaningful data”
Explanation:
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.
7.2) Document
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).
Explanation: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:
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).
Explanation: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.
(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.
Explanation: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:
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.
Explanation: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.
7.6) Record
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.
Explanation: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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