ISO 9001:2015 is an international standard for Quality Management Systems (QMS). It basically outlines a structure for improving quality and terms of understanding for any organization looking to provide an assurance that the products and services that the organization is producing is consistently meeting to the requirements and expectations of customers and other relevant interested parties in the most efficient manner possible. The QMS is the cumulative of all the business processes, resources, personnel, assets, interested parties, and cultural values that support the goal of customer and all interested parties’ satisfaction and organizational efficiency.
ISO 9001:2015 basically sets out the criteria for a quality business management system and is the only standard in the family that can be certified to. It can be used by any organization, large or small, Government, Non-Profit, SMEs etc regardless of its industry type or activity.
The ISO 9001:2015 standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. These principles are explained in more detail in ISO’s quality management principles. Using ISO 9001 helps ensure that customers get consistent, good-quality products and services, which in turn brings many business benefits.
As an ISO 9001 certified company from Euro Veritas, UK (BAR Accreditated) you will have implemented Quality Management System requirements for all areas of the business, including:
• Risks & Opportunities
• Facilities
• People
• Resources
• Documents & records
• Training
• Services
• Equipment
• Change
• Knowledge
ISO 9001 certification from Euro Veritas, UK (BAR Accreditated) is suitable for all sizes and types of organisations and is well established around the world as an invaluable Quality Management System standard. It is suitable for organisations in all possible industry sectors and will help your organisation to overall improve management processes to compete locally and/or globally.
The process of being certified to ISO 9001:2015 encompasses the entire organisation and requires senior management to be actively involved in, it is not just a function of the Quality Department. To achieve ISO 9001 certification your organisation needs to demonstrate that it can meet the regulatory and statutory requirements and apply the standard requirements and the system effectively to be of real benefit to your customers.
ISO 9001 Certification from Euro Veritas, UK (BAR Accreditated) always does provide maximum benefit to your organisation if it approaches ISO 9001 implementation in a practical way. This will ensure that the Quality Management Systems that are adopted, work to improve the business and are not just a set of procedures that your employees will find hard to manage.
By adopting an approach that starts out to implement more efficient working practices and focuses on the business objectives of the organisation, you will achieve a system that will help and support your staff, and improve your levels of customer satisfaction.
Whether you use an external assessor or allocate an internal resource to carry out the initial assessments, you will need to ensure that they have buy-in from senior management, so that all areas of the organisation are aware of the importance of the ISO 9001 Certification process.
ISO 9001 Certification is not just suitable for large organisations but also small businesses / SME’s that will benefit from adopting efficient Quality Management Systems that will save time and cost, improve efficiency and ultimately improve customer relationships.
Some of the potential benefits to your organisation:
• Conduct Risk / Opportunity Assessment and Management
• Provides senior management with an efficient management process
• Sets out areas of responsibility, authority and accountability across the organisation
• Mandatory if you want to work in a tender for some public sector work
• Communicates a positive message to staff and customers and allrelevant interested parties
• Identifies and encourages more efficient and time saving processes
• Highlights deficiencies
• Reduces your costs
• Provides continuous assessment and improvement
• Marketing opportunities
• Improves Management of Change
• Synchronize and improve:
• Document Management
• Resource Management
• Planning
• Operations & Management
• Knowledge Management
• Continual Improvement and Management
Some of the benefits to your customers:
• Improved quality and service
• Delivery on time
• Right first time attitude
• Fewer returned products and complaints and a better complaint management system
• Independent audit demonstrates commitment to quality
| ISO 9001:2015 Clauses | |
|---|---|
| Section | Description |
| 1. Scope | ISO 9001:2015 applies to organizations that want to show their ability to meet customer requirements and regulatory obligations through the development of consistent products and services. |
| 2. Normative Reference | ISO 9000:2015 Quality management systems – Fundamentals and vocabulary is the primary supporting document outlining the principles and methodology of ISO 9001:2015. |
| 3. Terms and Definitions | The controlled vocabulary of ISO 9001:2015 is contained in the document ISO 9000: 2015 Quality management systems - Fundamentals and vocabulary. |
| 4. Context of the Organization | Organizations should identify all issues, requirements, and priorities that are relevant to their objectives for their QMS, including those of any third-parties. They should also determine and document the scope of the QMS and the processes that will contribute to the creation, maintenance, and continuous improvement of the QMS. |
| 5. Leadership | Organizational leadership should demonstrate its commitment to the QMS by ensuring alignment with strategic objectives and processes, providing resources as necessary, and ensuring the achievement of the intended results of customer satisfaction. The organization must establish regular channels to communicate Quality values to all employees and delegate responsibilities for maintaining the QMS to well-trained subject matter experts. |
| 6. Planning | Organizations should consider the context and requirements of all parties to enhance desired effects, prevent undesired effects, and improve Quality processes. They can then address the risks and opportunities, integrate actions into the QMS processes, and evaluate those actions to determine their impact. They should establish realistic Quality objectives and the means for measuring their impact, and then implement any required changes to the QMS that are within the scope of the resources available. |
| 7. Support | Organizations should determine the resources (people, infrastructure, and environment) required for the implementation and maintenance of the QMS. They should ensure that all QMS professionals understand and are trained on their responsibilities and that the principles of the QMS are communicated widely. They should also create and maintain all required QMS documentation. |
| 8. Operation | Organizations should implement the QMS according to the scope that was determined in the planning stage, ensuring that it is suffciently documented and meets the requirements of customers, regulators, and stakeholders. They should also ensure that all suppliers and vendors conform to these same standards. Products and services that are not ready to meet QMS standards should not be released to the public, and all nonconformities should be documented and addressed. |
| 9. Performance Evaluation | Organizations should use internal audits to measure, analyze, and evaluate the effectiveness of the QMS to ensure that it is meeting customer requirements for consistent products and services. They must identify and take corrective action on any non-conformity and should review the QMS regularly to ensure that it aligns with the overall QMS strategy. |
| 10. Improvement | Organizations should identify opportunities for continual improvement, take immediate corrective actions for nonconformities, and retain controlled documentation of all improvement activities on a continuing basis. |
Required Documentation for ISO 9001:2015- though not the full list:
How do you become certified ISO 9001:2015?
Organizations looking to become certified in ISO 9001:2015 will likely fit into one of 3 groups:
• those who have never been certified to ISO 9001, or,
• those who are already certified to ISO 9001:2008 and need to update to ISO 9001:2015, or,
• those who are certified to a different ISO standard eg ISO 14001:2015, ISO 13485:2016 etc.
