Quality Management System [QMS]
ISO 9001:2015 is a generic standard for Quality Management System Implementation prepared by Technical Committee ISO/TC 176. The fifth edition ISO 9001:2015 is compatible to ISO 14001:2015 and replaces ISO 9001:2008.
ISO 9000 is the most widely used international standard that provides a framework for an effective QMS. ISO 9001 is implemented by more than one million organizations in 178 countries worldwide.
ISO 9001 is set of requirements for a quality management system implementation & certification. Three pillars of ISO 9001 are Interested parties satisfaction, Leadership and continual improvements.
ISO 9001: 2015 is applicable to the processes for Design, manufacturing & supply of products and realization of services an organization supplies.
The ISO 9000 family is primarily set standards for "quality management". This means what the organization does to meet:
- The customer's quality requirements
- Applicable regulatory requirements,
- Customer satisfaction, and
- Achieve continual improvement of its performance.
- Context of the orgnisation
- Leadership
- Planning
- support
- operations
- Performance Evaluation
- Improvement
SCOPE & APPLICATION
ISO 9001:2015 is set of requirements for a quality management system where an organization
- Needs to demonstrate its ability to consistently supply product that meets customer requirements while meeting all applicable Statutory and regulatory requirements, and
- Set objectives to enhance customer satisfaction through the effective application of the system and continual improvement of the same.
- Exclusions are considered for where any requirement(s) of the Standard cannot be applied due to the nature of an organization and its product or services.
- Exclusions are limited to requirements specified in Clause 8 and not affecting customer requirements and applicable statutory and regulatory requirements.
One of the automotive industry’s most widely used international standards for quality management, IATF 16949, is evolving with the publication of a new global industry standard by the International Automotive Task Force (IATF).
IATF 16949, a technical specification for automotive sector quality management systems, was first developed in 1999 by the IATF in conjunction with ISO’s technical committee for quality management, ISO/TC 176. Since then, it has become one of the most widely used international standards in the automotive industry, harmonizing the different assessment and certification systems in the global automotive supply chain.
On October 3rd, 2016 IATF 16949:2016 was published by the IATF and supersedes and replaces the current ISO/TS 16949, defining the requirements of a quality management system for organizations in the automotive industry. It will be aligned with and refer to the most recent version of ISO’s quality management systems standard, ISO 9001:2015. IATF 16949:2016 will fully respect ISO 9001:2015 structure and requirements, and is not a stand-alone quality management standard, but is implemented as a supplement to, and in conjunction with, ISO 9001:2015.
IATF will ensure continued alignment with ISO 9001 by maintaining strong cooperation with ISO, through its participation in ISO/TC176.
New to the latest revision of IATF 16949:2016 is the inclusion of language on corporate ethics. The new standard states that certified organizations must implement basic corporate responsibility policies such as anti-bribery policy, an employee code of conduct, and an ethics escalation (whistle-blower) policy.
Based on ISO 9001:2015, it replaces ISO/TS 16949:2009. All organizations currently certified to ISO/TS16949:2009 will need to successfully transition by 14th September 2018.
What are the benefits?
- Gain your license to trade internationally and expand your business
- Improve processes to reduce waste and prevent defects
- Remove the need for multiples certificates for vehicle manufacturing
- Integrate ISO/TS 16949 with other management systems
- Demonstrate compliance to win new business and investment prospects
- Requirements for safety-related parts and processes
- Enhanced product traceability requirements to support latest regulatory changes
- Requirements for products with embedded software
- Warranty management process including addressing NTF (no trouble found) and use of automotive industry guidance
- Clarification of sub-tier supplier management and development requirements
- Addition of corporate responsibility requirements.
This standard includes ISO 9001:2015 quality management system requirements and specifies additional aviation, space, and defense industry requirements, definitions, and notes.
It is emphasized that the requirements specified in this standard are complementary (not alternative) to customer and applicable statutory and regulatory requirements.
If there is a conflict between the requirements of this standard and customer or applicable statutory or regulatory requirements, the latter shall take precedence.
This International Standard specifies requirements for a quality management system when an organization:
- Needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
- Aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
NOTE 1: In this International Standard, the terms “product” or “service” only apply to products and services intended for, or required by, a customer.
NOTE 2: Statutory and regulatory requirements can be expressed as legal requirements.
ISO 10002:2018 provides guidance on the process of complaints handling related to products within an organization, including planning, design, operation, maintenance, and improvement. The complaints-handling process described is suitable for use as one of the processes of an overall quality management system.
ISO 10002:2018 is not applicable to disputes referred for resolution outside the organization or for employment-related disputes.
It is also intended for use by organizations of all sizes and in all sectors. Annex A provides guidance specifically for small businesses.
ISO 10002:2018 addresses the following aspects of complaints handling:- Enhancing customer satisfaction by creating a customer-focused environment that is open to feedback (including complaints), resolving any complaints received, and enhancing the organization's ability to improve its product and customer service;
- Top management involvement and commitment through adequate acquisition and deployment of resources, including personnel training;
- Recognizing and addressing the needs and expectations of complainants;
- Providing complainants with an open, effective, and easy-to-use complaints process;
- Analysing and evaluating complaints in order to improve the product and customer service quality; auditing of the complaints-handling process;
- Reviewing the effectiveness and efficiency of the complaints-handling process.
ISO 15378:2017 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.
Benefits
- Evidence of adherence to legal requirements and contractual obligations
- Reduction and control of risks
- Clear statement of the organization’s competence
- Creates competitive advantages
- Improves quality capability
- Saves time and costs
ISO 29001:2020 defines the quality management system for product and service supply organizations for the petroleum, petrochemical and natural gas industries.
ISO 29001 (published in 2020) defines the quality management system requirements for the design, development, production, installation and service of products for the petroleum, petrochemical and natural gas industries. Developed as a direct result of a partnership between ISO and the international oil and gas industry (led by the American Petroleum Institute - API), ISO 29001 specifically focuses on the oil and gas supply chain. The ISO/TS 29001 standard is based on ISO 9001 and incorporates supplementary requirements emphasising defect prevention and the reduction of variation and waste from service providers. These requirements have been developed separately to ensure that they are clear and auditable. They also provide global consistency and improved assurance in the supply quality of goods and services from providers. This is particularly important when the failure of goods or services have severe ramifications for the companies and industries involved.
This standard is for all organizations working within the oil and gas industry supply chain. Certification to ISO 29001 ensures standardization and improvement within the sector.
Benefits
Customer loyalty
Repeat business and referral
Operational results such as revenue and market share
Flexible and fast responses to market opportunities
Costs and cycle times through effective and efficient use of resources.
Alignment of processes which will best achieve desired results
Competitive advantage through improved organizational capabilities
Understanding and motivation of people towards the organization's goals and objectives, as well as participation in continual improvement.
Confidence of interested parties in the objectiveness and efficiency of the organization, as demonstrated by the financial and social benefits from the organization's performance, product life cycle, and reputation
Ability to create value for both the organization and its suppliers by optimization of costs and resources as well as flexibility and speed of joint responses to changing markets.