Quality management system course- Communication & documented information (ISO 9001:2015)
- Communication
ISO standard requires from organization to define the needs
for internal and external communication relevant for the quality management and
should define what and when will be communicated, by and with whom will be
communicated. etc.
- What is importance for communication clause in ISO 9001:2015.
This clause is important because communication information
is the basic of the understanding and understanding of the quality management
system is the key for its effectiveness.
Determining the communication process that is mean assign
one person to be in charge of communicating with the customer but have clearly defined
rules for what type of information should be communicated inside or outside of
the company, who is allowed or responsible to communicate the corresponding
information and to whom will significantly contribute to better quality
management system in the company.
Standard not required
communication rules to be documented. Depending on the type of the company the rules
can be more or less formal, fully documented or stated in a few sentences within
other policies, procedures and plan.
For example,
information about customer satisfaction are crucial for effective management
review. So, this information must be distributed where they are needed.
- Documented information.
This clause of section
7 in ISO 9001 define the requirements about how documented information should
be created, updated, and controlled.
- Documented information types.
Generally, there are
two types of documented information
- Information that guide you how the processes are conducted. For example, procedures.
- Information as an evidence of the results achieved or activities performed. For example, the records.
- Examples for documents.
Procedures, polices,
plans, records, emails, paper forms, record in database, logs in measuring devices,
etc.
- Steps should be followed by company when creating or updating documented information.
- Appropriate identification and description such as title, date, etc.
- Proper media and format used for documenting. For example, the media can be electronic, or paper and format can refer to using the write language, proper software, or version of software, etc.
- Documented information review and approve that are appropriate.
- Controlling documented information.
The company should
control the documented information to ensure it is available for use when
needed and protect from the loss of confidentiality, integrity, or improper
use, etc.
To be able to control
the documented information the company should taken consideration the following
activities:
- How to distribute, access, retrieve and use the information.
These activities refer
to the aspects such as, sending documented information by email, distributed
the via USB memory stick, printing them, password protecting them, limiting the
access to them, etc.
- How to store and preserve the information.
For example, storing
electronic information in shared folder on company’s file server or in the
folder in the cloud, storing papers in the archive or in locked cabinets, etc.
- How to control the changes.
These activities refer
to the versions control such as the market version on front page and in the
file name.
- How to dispose the documented information.
The company should
determine how long the different types of information will be kept and when and
how will be destroyed or deleted.
For example, the
company should first identify the information that are regulated by law and
control them in compliance with the law. Then the company should decide how to
control the rest of the documented information. For example, a company may
decide that old versions of procedures will be kept only 3 months after the
electronic version will be deleted and all hard copies will be shredded.
Additionally, the company
should control documented information from external origin that are relevant
for the quality management system of the company.
Example for
information external origin, customer emails, the ISO 9001 standard,
instruction manuals for equipment, laws, etc.
The standard does not
require these rules to be documented. However, it is good practice to document
the procedure that includes all required elements.
For example, procedure
for control of documents and records.
- what is importance for documented information clause
This clause is important because it set structured and
unified approach for how the company should control its documented information.
Having these rules especially, if there written in a procedure, will give you
all employees clear directions how to create, use, and control the information.