24 Feb 2016

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ISO 9001:2015 
specifies requirements for a quality management system.ISO 9001:2015 Plus Redline 

ISO 9000:2015 Plus Redline 
ISO 9000:2015 describes the fundamental concepts and principles of quality management.
ISO 19011:2011 Plus Redline 
http://www.qaqcdocumentstores.com/ISO 19011:2011 provides guidance on auditing management systems, including the principles of auditing, managing an audit programme and conducting management system audits.

ISO 14001:2015 Plus Redline 
ISO 14001:2015 specifies the requirements for an environmental management system that an organization can use to enhance its environmental performance.

ISO/IEC 27000:2014 Plus Redline 
ISO/IEC 27000:2014 provides the overview of information security management systems (ISMS), and terms and definitions commonly used in the ISMS family of standards.

ISO/IEC 27001:2013 Plus Redline 
ISO/IEC 27001:2013 specifies the requirements for establishing, implementing, maintaining and continually improving an information security management system within the context of the organization.

ISO/IEC 27002:2013 Plus Redline 
ISO/IEC 27002:2013 gives guidelines for organizational information security standards and information security management practices including the selection, implementation and management of controls taking into consideration the organization's information security risk environment(s).

ISO/IEC 20000-1:2011 Plus Redline 
ISO/IEC 20000-1:2011 is a service management system (SMS) standard. It specifies requirements for the service provider to plan, establish, implement, operate, monitor, review, maintain and improve an SMS.

ISO/TS 22003:2013 Plus Redline 
ISO/TS 22003:2013 defines the rules applicable for the audit and certification of a food safety management system (FSMS) complying with the requirements given in ISO 22000 (or other sets of specified FSMS requirements).

ISO 15189:2012 Plus Redline 
Medical laboratories - Requirements for quality and competence (includes Redline Version)

ISO 14644-1:2015 Plus Redline
ISO 14644-1:2015 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and clean zones.

ISO 14644-2:2015 Plus Redline
ISO 14644-2:2015 specifies minimum requirements for a monitoring plan for cleanroom or clean zone performance related to air cleanliness by particle concentration.

ISO 9022-20:2015 Plus Redline
ISO 9022-20:2014 specifies the methods relating to the environmental tests of optical instruments including additional assemblies from other fields.

ISO/IEC 11695-1:2015 Plus Redline
ISO 9022-20:2014 specifies the methods relating to the environmental tests of optical instruments including additional assemblies from other fields.

ISO 10958-2:2015 Plus Redline 
ISO 10958-2:2015 specifies requirements and test methods for snowboards as sports equipment on which bindings are attached.

ISO 11451-2:2015 Plus Redline 
ISO 11451-2:2015 specifies a method for testing the immunity of passenger cars and commercial vehicles to electrical disturbances from off-vehicle radiation sources.

ISO 11660-2:2015 Plus Redline 
ISO 11660-2:2015 establishes the particular requirements relating to access, guards and restraints for mobile cranes.

ISO 12006-2:2015 Plus Redline 
ISO 12006-2:2015 defines a framework for the development of built environment classification systems.

ISO 1215:2015 Plus Redline 
ISO 1215:2015 applies to commercially dry virgin cork, raw reproduction cork, ramassage, gleanings, burnt cork, corkwaste, boiled cork pieces, and boiled corkwaste and specifies the conditions of packaging for each type.

ISO 12647-2:2013 Plus Redline
ISO 12647-2:2013 specifies a number of process parameters and their values to be applied when producing colour separations, printing formes and print production.

ISO 16061:2015 Plus Redline 
ISO 16061:2015 specifies general requirements for instruments to be used in association with non-active surgical implants.

ISO 16124:2015 Plus Redline 
ISO 16124:2015 specifies dimensions and tolerances to the dimensions applicable to steel wire rod as defined in ISO 6929.

ISO 16071:2015 Plus Redline
ISO 16071:2015 specifies the test method, the reagents, and the procedure to be used in an accelerated atmospheric corrosion test constituting.

ISO 1683:2015 Plus Redline
ISO 1683:2015 specifies reference values used in acoustics, in order to establish a uniform basis for the expression of acoustical and vibratory levels.

ISO 1762:2015 Plus Redline
ISO/TS 1762:2015 describes the determination of the residue (ash) on ignition of paper, board and pulp. It is applicable to all types of paper, board, and pulp samples.

ISO 2028:2015 Plus Redline
ISO 2028:2015 specifies four methods for the isolation of dry polymer from synthetic polymer latices containing anionic surfactants, for the purpose of subsequent testing.

ISO 20361:2015 Plus Redline
ISO 20361:2015 specifies all the information necessary to carry out efficiently and under standardized conditions the determination, declaration, and verification of the airborne noise emission of liquid pumps or pump units.

ISO 2144:2015 Plus Redline
ISO 2144:2015 describes the determination of the residue on ignition of pulps, papers, and boards. The International Standard is applicable to all types of pulp, paper, and board.

ISO 2834-2:2015 Plus Redline
ISO 2834-2:2015 specifies a test method for preparation of test prints produced with liquid water-based or solvent-based printing inks as used in flexography and gravure printing.

ISO 34-1:2015 Plus Redline
ISO 34-1:2015 specifies three test methods for the determination of the tear strength of vulcanized or thermoplastic rubber.

ISO 3723:2015 Plus Redline
ISO 3723:2015 specifies a method for verifying the end load rating of a hydraulic fluid power filter element. It also verifies the ability of a hydraulic fluid power filter element to withstand the designated axial loading imposed by installation and use.

ISO 6742-1:2015 Plus Redline
ISO 6742-1:2015 is applicable to lighting devices used on cycles intended to be used on public roads and, especially, bicycles complying with ISO 4210 and ISO 8098.

ISO 8036:2015 Plus Redline
ISO 8036:2015 describes the characteristics of immersion liquids used in microscopy. It classifies immersion liquids according to their field of application and specifies requirements and test methods for each type.

ISO 8536-10:2015 Plus Redline
ISO 8536-10:2015 applies to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-8.

ISO 8536-11:2015 Plus Redline
ISO 8536-11:2015 applies to sterilized infusion filters for single use used up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set.

ISO 8536-8:2015 Plus Redline
ISO 8536-8:2015 gives users information on sterilized infusion sets for single use with pressure infusion apparatus up to a maximum of 200 kPa (2 bar).

ISO 8536-9:2015 Plus Redline
ISO 8536-9:2015 applies to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar).

ISO 9022-12:2015 Plus Redline
Optics and photonics - Environmental test methods - Part 12: Contamination (includes Redline Version)

ISO 9022-14:2015 Plus Redline
Optics and photonics - Environmental test methods - Part 14: Dew, hoarfrost, ice (includes Redline Version)

ISO 9022-17:2015 Plus Redline
Optics and photonics - Environmental test methods - Part 17: Combined contamination, solar radiation (includes Redline Version)

ISO 9022-2:2015 Plus Redline
ISO 9022-2:2015 specifies the methods relating to the environmental tests of optical instruments including additional assemblies from other fields.

ISO 9022-3:2015 Plus Redline
ISO 9022-3:2015 specifies the methods relating to the environmental tests of optical instruments including additional assemblies from other fields.

ISO 9022-6:2015 Plus Redline
ISO 9022-6:2015 specifies the methods relating to the environmental tests of optical instruments including additional assemblies from other fields.

ISO 9022-7:2015 Plus Redline
ISO 9022-7:2015 specifies the methods relating to the environmental tests of optical instruments including additional assemblies from other fields.

ISO 9022-8:2015 Plus Redline
ISO 9022-8:2015 specifies the methods relating to the environmental tests of optical instruments including additional assemblies from other fields.

ISO 9928-1:2015 Plus Redline
ISO 9928-1:2015 specifies general requirements for the contents of a crane operating manual.

ISO 9942-1:2015 Plus Redline
ISO 9942-1:2015 specifies the minimum requirements for labels for the identification (marking) and the operation of cranes.

ISO/IEC 11695-1:2015 Plus Redline
ISO/IEC 11695-1:2015 defines the physical characteristics of optical memory cards using the holographic recording method.




For Queries/ Orders please contact: qaqc.estores@gmail.com


18 Feb 2016

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








For Queries/ Orders please contact: qaqc.estores@gmail.com

http://www.qaqcdocumentstores.com/