ISO 9001:2015 Quality Management System Documented Information (Maintained/ Retained)- Knowledge

 ISO 9001:2015 QMS - QAQC Docs E-Stores

The latest edition of ISO 9001 - quality management systems standard, has been published (Sep 2015).  

ISO 9001:2015 standard requirements are generic and applicable to any organization wants to implement the QMS regardless of its type or size, or the products and services it provides.

Primary Step: Documentation Design
To establish the ISO 9001 QMS the primary step is to design the documentation as per the ISO Standard requirements.  We provide the necessary documentation templates to establish the quality management system. We also customize the QMS documentation according to the Client Organization business process/ certification scope and other requirements. 

ISO 9001:2015 allows an organization flexibility in the way it chooses to document its quality management system (QMS). This enables the organizations to determine the necessary amount of documented information needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS. 

"Documented information" - The term Documented information was introduced as part of the common High Level Structure (HLS) and common terms for Management System Standards (MSS). 

Documented information- Main Objectives:
Communication Medium ( Both Internal & External)
Knowledge Sharing
Evidence for fulfilling the requirements
Preserve the Organization's Business experience, Process techniques etc..

Definition: "Information requirred to be controlled and maintained by an Organization and the medium on which it is contained"; Documented information can be in any format and media and from any source (Example: Paper, Magnetic, Electronic or CD, Photograph)

In ISO 9001:2015, 
For Documents: the term "Maintain Documented information" and 
For Records: the term "Retain Documented information"  is used. 

What the ISO 9001:2015 says,
Documented Information is provided under the following Main Clause,
7. Support / 7.5. Documented Information

QMS Documentation shall includes,
1) Documented information required by this International standard;
2) Documented information determined by the organization as being necessary for the
effectiveness of the quality management system.

The extent of the QMS documented information can differ from one organization to another due to the:
* Organization Size and its type of activities, products and services, Processes, complexity of  processes and their interactions and competence of persons.

The other sub clauses illustrates Creating and Updating of Documented information, & Control of Documented Information. 

Documented Information to be Maintained
1.Documented information (high level transversal documents) needed to be maintained by the organization for the purposes of establishing a QMS. Please see our another post, 
List of Documented Information to be Maintained (Mandatory Requirement) - ISO 9001:2015

2.Documented information (low level, specific documents) maintained by the organization to communicate the necessary information for its Operation. (Clause 4.4)   Although ISO 9001:2015 have no specific requirements for these documents, they may add value to the QMS. The Organization to determine the extent of adding such documents according to its specific needs. Please see our another post, 
List of Documented Information to be Maintained (Non-mandatory Requirement) - ISO 9001:2015

Documented Information to be Retained
Documented information needed to be retained by the organization for the purpose of providing evidence of result achieved (records).  Please see our another post, 
List of Documents to be Retained (Mandatory Requirement)- ISO 9001:2015

Organizations can freely develop other needed records to demonstrate conformity of their processes, products and services and QMS. 

All existing documented information of the Organization  maintained and retained (Mandatory/ Non- Mandatory) documents/ records are subject to the requirements of clause 7.5. Documented Information. 

Based on the ISO 9001:2015 QMS standard requirements, we are providing documentation design services and providing the required mandatory documents. We customize the documentation according to the Client/ Organization business line.  Please contact us for your QMS documentation needs.

You may also interested to read other relevant topics:

QMS Introduction

Quality Manual (Depends on Organization requirement)

Quality Assurance Procedures

QMS Documentation Pyramid

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