ISO 9001:2015 QUALITY MANAGEMENT SYSTEM
What is ISO 9001:2015 QMS?
ISO 9001 specifies the requirements for a Quality Management System where an organization needs to demonstrate its ability to consistently provide a product that meets customer and applicable regulatory requirements and aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.
It is now the only standard in the ISO 9001 family against whose requirements your quality system can be certified by an external agency. The ISO 9001 certification signifies a global benchmark in customer satisfaction products quality and leads to a significant reduction in defect levels.
The standard recognizes that the word “product” applies to services, processed material, hardware, and software intended for or required by your customer.
Benefits of ISO 9001 Certification
Customer Satisfaction
Deliver products that consistently meet customer requirements and a service that is dependable and can be relied on.
Reduced Operating Costs
Continual improvement of processes and resulting operational efficiencies mean money saved.
Improved Stakeholder Relationship
Improve the perception of your organization with staff, customers, and suppliers.
Legal Compliance
Understand how statutory and regulatory requirements impact your organization and its customers.
Improved Risk Management
Greater consistency and traceability of products and services means problems are easier to avoid and rectify.
Proven Business Credentials
Independent verification against a globally recognized industry standard speaks volumes.
Who can be certified ISO 9001:QMS?
ISO 9001: 2015 applies to any organization regardless of size or industry. More than a million organizations from more than 160 countries have implemented the ISO 9001 standard requirements on their quality management systems.
Manufacturing Companies
Service Sector
Hospitals
NGO'S
Educational
Government Organizations
Research Foundation
Fitness Sector
Shipping Industry
Aerospace
Food
Automotive
Telecom
Textile and Apparels
Medical and Test Lab
Software Development
Document required for ISO 9001:QMS
- System Manual
- System Procedure
- Policy
- Objectives
- Mission & Vision
- Standard Operating Procedure (SOP)
- Checklist
- Forms
- Formats
- Records
The extent of Documented Information differs as per:
- Organization’s size
- Activities performed by the organization
- Processes undertaken by the Organization
- Products and services offered by the organization
- The complexity of processes undertaken
- Competence of persons involved
Role of Shamkris and Process of ISO 9001:QMS Certification
Shamkris adopts a results-oriented approach to effective system implementation in the organization. A simple and practical method of system implementation helps organizations increase business efficiency and sustainability. Shamkris supports 100% documentation to obtain a certificate of success in addition to enhanced performance.
The implementation process is described below:
Time Frame
Task
Process
Day 1
GAP Analysis
Certification Body
Selection
Cost Estimates
- Finding the GAP between existing system related to ISO requirements
- Selecting the appropriate certification body
- Based on the scope of your business & certification body you choose
Week 1
Developing Documents
- Management System Manual, Management System Procedures, Policy, Objectives, Forms etc.
- Review of Standard Operating Procedures (SOP)
Week 4
Implementing Management System
- ISO Awareness training for the top management and staff
- Implementing a well-documented management system throughout the organization
Week 8
Internal Audit
MRM
CAPA
- Internal audits identifying nonconformities related to ISO requirements
- Management Review Meetings
- Corrective and Preventive Action plan for nonconformities
Week 10
Certification Body
Audit
N-C Closing
- Shamkris acts on your behalf and assists you in the third-party audit
- Closing of any nonconformities identified by the certification body
Week 12
Certificate Issued
- ISO certificates issued for 3 years
- Surveillance Audits yearly
Year on Year
Yearly Compliance
- Support of Yearly documentation for audit
FAQ
ISO 9001 is defined as the international standard that specifies requirements for a Quality Management System (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements.
The short answer is no, one person can not become certified in ISO 9001. Rather, a company or organization is what is eligible for the certification. However, a person can become certified as a lead auditor through a training course that is provided.
ISO 9001:2015 is an international standard dedicated to Quality Management Systems (QMS). The QMS is the aggregate of all the processes, resources, assets, and cultural values that support the goal of customer satisfaction and organizational efficiency.
The purpose of a quality management system is to ensure every time a process is performed, the same information, methods, skills, and controls are used and applied in a consistent manner. If there are process issues or opportunities, this is then fed into the quality management system to ensure continuous improvement.