When we want to implement any ISO standard as Quality Management System in an organization for certification such as ISO 45000:2018, ISO 14000:2015, ISO 17025:2017 and the most popular ISO9001:2015, it is expected to learn and understand the useful terms use in QMS from many.
Some of the terms which are / may be useful, are listed below:
- Process
- Procedure
- Work Instruction
- Records
- Documents
- Review
- Policy
The details of each term are explained below with dictionary meaning and with example / explanation with respect to ISO or QMS.
- PROCESS
The dictionary meaning is,
“A series of actions or steps taken in order to achieve a particular end”.
Explanation:
To simplify this, during writing any process just think, what is required to do with reasons why?
Example:
Complaint handling process.
2. PROCEDURE
The dictionary meaning is,
“An established or official way of doing something”
Explanation:
Here something means PROCESS from our Quality Management System point of view, so in procedure, we have to write how process is carried out.
Example:
As per ISO 17025:2017 clause 6.3.3 Environmental Condition Monitoring required procedure how same is carried out.
3. WORK INSTRUCTION
Work instruction is further detailed out of procedure in step by step manner as performed by operator.
4. RECORDS
The dictionary meaning is,
A thing constituting a piece of evidence about the past, especially an account kept in writing or some other permanent form.
Example:
To understand for QMS, we can take example of measurement of data of product which is written on a paper, which is nothing but FORM or in soft copy in digital format. This forms having dimension is a evidence in future e.g , to refer during receipt of any complaint from customer.
5. DOCUMENTS
A piece of written, printed, or electronic matter that provides information or evidence or that serves as an official record.
Example:
Document for requirement of competency of personnel.
6. REVIEW
A formal assessment of something with the intention of instituting change if necessary.
Example:
Periodic review of manual and or procedure / SOP for any changes or change in process.
7. POLICY
A course or principle of action adopted or proposed by an organization or individual.
Example:
Referring to ISO17025:2017 clause 8.2.2 states “The policies and objectives shall address the competence, impartiality and consistent operation of the laboratory”. So Quality policy states about competence and impartiality and Quality objective or KPI to be in-line with or address consistence operation.
QUALiTYViVA 