ISO 9001 Standard is widely recognized standard to specify requirements for Quality
Management
System in all industries. ISO 9001 Standard provides effective Risk Assurance based Quality
Management System focusing QMS principles enhancement in Customer Satisfaction,
Leadership,
Engagement of People, Process Approach, Improvement, Evidence based Decision Making and
Relationship Management. ISO 9001:2015 enables Risk based thinking while implementing QMS,
this means to identify Risks and Opportunities in processes to establish an effective ISO 9001:2015
Quality Management system with a strong customer focus, the motivation and implication of Top
Management, the process approach and continual improvement.
ISO 9001 Standard enables Business improvements by assessing Risks and
Opportunities,
strengthen process approach to implement quality management system which ensure products and
services consistently meet customer requirements along with consistent improvement in quality.
QMS auditing to ISO 9001 certification verifies Quality is extent of suitability for compliance and
fulfillment of requirements stated by customer, inherent characteristics and regulatory requirements
of product and service as per Quality Management System requirements.
ISO 9001 Quality Management System certification by QMC indicates
organization's adherence to
QMS - Quality Management System requirements and practices and QMC as a truly QMS Auditing
Firm to ISO 9001 Certification, offers Value Auditing Services in QMS Auditing because, no matter
the type of organization, the Auditing Services of QMC are designed to meet Global Standards that
deliver Credibility in QMS ISO 9001 Certification. To achieve QMS objective, professionally trained
auditors are deputed to identify 'Opportunities for Improvements' in QMS ISO 9001 Certification.
ISO 9001 QMS Standard is widely adopted standard specify requirements for Quality management
system in all industries, no matter the types of organizations such as QMS in Hospitals, Health
Care,
Trading, Manufacturing, QMS in Service Companies, Software, Construction and also QMS in
Medical Devices in India. QMC offer ISO 9001 Certification in all cities in India.
ISO 9001:2015 standard is released on 15 September 2015. As per IAF guidance, ISO
9001:2015
Standard shall have three years transition period starting from published date of ISO
9001:2015
Standard. For latest information, keep in viewing QMC website for updates on ISO 9001
standard
2015.
Know more on ISO 9001:2015 HIGHLIGHTS OF ISO 9001:2015 STANDARD INCLUDE Quality
Management System requirement documentation as per ISO 9001:2015 Standard means activity or
process to document that contains sufficient information for effective implementation of processes
and be retained to provide evidence that activities were performed.
The new ISO 9001:2015 standard includes three basic core concepts :
a.) process approach
b.) plan-do-check act methodology, and
c.) which is new in the 2015 version is risk based thinking
New structure of ISO 9001:2015 standard has aligned with the common 10-clause to ensure greater
harmonization among its many different management system standards. The new revision to ISO
14001:2015 will also adopt this same structure, which is built around the Plan-Do-Check-Act
sequence. This will help organizations to integrate the requirements of more than one ISO
Management System Standard.
ISO 9001:2015 version further require that organization 'determines' processes needed for quality
management system and identify all the processes that include Actions to Address Risks and
Opportunities.
Risk Based Thinking is a new and welcome addition to ISO 9001:2015 standard
requirement
How will the organisation prevent, or reduce, undesired effects? How will the organisation ensure
that it can achieve its intended outcomes and continual improvement? One big plus is that
preventive action does not now appear. The assumption is that the risk management process has
features which creates inherent preventive actions via the improvement cycle.
A structured approach to risk assessment for a quality management system requirement can
describe a process, an actual or potential threats and decision on whether to accept, mitigate,
eliminate or transfer the risk, and identify the controls needed to ensure the effectiveness of the
processes. By including 'potential' threats, organization can put in place preventive actions.
Quality objective as per ISO 9001:2015 Certification are seen as those that have a direct impact on
customer requirements, have a direct impact of the efficiency of the client's business, which means
an improvement in the quality system processes. ISO 9001:2015 standard requires quality
objectives to be measurable which means that targets have to be set. The requirements around the
ISO 9001:2015 objectives have also been made more detailed. They are to be consistent with the
ISO 9001:2015 quality policy, measurable (if practicable), monitored, communicated, and updated
as appropriate. They have to be established at relevant functions and levels. Now planning how to
achieve its quality objectives is introduced in the new version of ISO 9001:2015 standard.
The main differences in content between the old and new version of ISO 9001 standard?
The adoption of the high level structure as set out in Annex SL of ISO Directives Part 1•
An explicit requirement for risk-based thinking to support and improve the understanding and
application of the process approach
Fewer prescriptive requirements
More flexibility regarding documentation
Improved applicability for services
A requirement to define the boundaries of the QMS
Increased emphasis on organizational context
Increased leadership requirements
Greater emphasis on achieving desired process results to improve customer satisfaction
Transition means extra paperwork? No! New ISO 9001:2015 standard requires an
organization to
document a number of things but, these are relatively less as compare to previous version of
standard, new standard gives you flexibility to document system (Except mandatory requirement)
without unnecessary paperwork.
Some of the benefits to your organisation:
* Provides senior management with an efficient management process
* Marketing opportunities
* Sets out areas of responsibility across the organisation
* Mandatory if you want to tender for some public sector work
* Communicates a positive message to staff and customers
* Identifies and encourages more efficient and time saving processes
* Highlights deficiencies
* Reduce your costs
* Provides continuous assessment and improvement
Some of the benefits to your customers:
*Setting organization-wide direction
*Fewer returned products and complaints