ISO 9001:2015 Quality Management Systems

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What is ISO 9001?

ISO 9001 is the international standard that sets out the criteria for a quality management system (QMS). The Standard will help you monitor and manage quality, measure performance, and benchmark your organisation's service using seven quality management principles.

ISO 9001 is globally recognised as the top standard for ensuring quality products and services, with over one million certifications worldwide.

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What is the main objective of ISO 9001?

The main objective of ISO 9001 is to provide a set of requirements for a quality management system that can be used by any organisation, regardless of its size or industry, to consistently meet customer requirements and enhance customer satisfaction.

What are the 7 principles of ISO 9001?

1. Customer focus

ISO 9001 requires organisations to satisfy customer needs and expectations by providing quality products and services. Organisations must also monitor customer feedback and use it to continuously improve their products, services, and processes.

2. Leadership

Top management should lead quality management and set a clear vision for the business. They should demonstrate commitment to the QMS and ensure that all employees understand its importance in achieving customer satisfaction.

Top management should also create a culture of continual improvement, set quality objectives and communicate them throughout the organisation.

3. Engagement of people

ISO 9001 states that organisations should involve their employees in the development and implementation of their quality management system. This includes providing training and support to ensure that employees understand and use the QMS.

Organisations should also ensure that the roles, responsibilities and authorities of personnel are clearly defined and communicated.

4. Process approach

The process approach is based on managing an organisation’s processes as a system to achieve consistent results. It involves identifying, analysing and managing processes and their interactions to improve overall performance.

5. Improvement

ISO 9001 states that organisations should regularly review their processes and systems to identify areas of improvement and make changes accordingly. It also encourages organisations to seek feedback from customers and stakeholders on the effectiveness of their processes and services.

This principle is key to ensuring quality standards are maintained and continually improved upon.

6. Evidence-based decision making

ISO 9001 emphasises evidence-based decision making, which uses data and objective evidence.

This principle requires that decisions are based on facts, not opinion or intuition. This means that decision makers should use accurate, reliable and verifiable data to inform their decisions. This approach leads to better decision-making and fairness.

7. Relationship management

ISO 9001 requires organisations to manage relationships with customers and other stakeholders in a systematic and effective way.

The standard outlines principles of relationship management such as understanding customer needs, building trust, managing complaints, responding to feedback and providing consistent service.

Organisations must have a plan for managing customer relationships, which should involve monitoring customer satisfaction, building customer loyalty and prioritising customer-centred activities.

ISO 9001:2015

ISO 9001 was updated in 2015 to remain relevant and allow more flexibility when implementing a QMS. The revised Standard places greater focus on risk-based thinking to ensure that the QMS is cost-effective regardless of the size or nature of the organisation, and also changes some of the terminology to allow a QMS to address service quality as well as product quality.

Why should you implement an ISO 9001 QMS?

ISO 9001 provides organisations with a way to show they consistently provide quality products and services. An ISO 9001 QMS will help you to:

  • Demonstrate your organisation’s ability to consistently provide quality products and services;
  • Meet your customers’ needs and statutory and regulatory requirements;
  • Win and retain more clients with better customer service;
  • Improve operational performance by cutting errors and increasing profits;
  • Become a more consistent competitor in your marketplace; and
  • Widen business opportunities by demonstrating compliance.

What are ISO 9001’s requirements?

The requirements include:

Establishing a Quality Management System (QMS): Organisations must develop and implement a QMS that meets the requirements of ISO 9001 and is suitable for their needs.

Documentation: Organisations must document their QMS and the processes, procedures and documents necessary to ensure consistent performance.

Management responsibility: Senior management must demonstrate their commitment to the QMS by establishing quality objectives, providing resources and conducting management reviews.

Resource management: Organisations must identify and provide the necessary resources for the effective implementation and maintenance of the QMS.

Product realisation: Organisations must ensure that their products and services meet customer requirements and applicable regulations.

Measurement, analysis, and improvement: Organisations must monitor, measure, analyse and improve their QMS processes.

Get started with ISO 9001

Adopting a QMS is a strategic decision that will improve performance, customer satisfaction and operational efficiency. To help you get started with your ISO 9001 project, we suggest using the following tools:

ISO 9001:2015 Standard

This is the current version of ISO 9001. It specifies the requirements for a quality management system (QMS) and is essential for any organisation looking to implement a certified QMS.

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ISO 9001 Toolkit

Organisations must demonstrate their compliance with ISO 9001, which can include thousands of pages of documentation for more complex businesses.

Our ISO 9001:2015 QMS Documentation Toolkit provides all the direction and tools you need to streamline your implementation project.

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ISO 9001 Foundation Training Course

This one-day staff awareness training course is delivered by an experienced ISO 9001 consultant and trainer. This in-house course, delivered at your organisation, is an ideal way to ensure all staff have the same level of training. This course can be tailored to your organisation’s own policies and procedures.

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ISO 9001 quality management consultancy

IT Governance consultants use methodologies and tools that have been developed and honed over 10 years.

We offer a free initial assessment to show you where you stand with ISO 9001 and the steps necessary for success. A fixed-price proposal will be offered to help you quickly assess the value of using IT Governance to achieve ISO 9001 certification.

Nine good reasons for using the IT Governance consultancy service to assist your ISO 9001 project:

  1. You can use our free initial assessment to see where you currently stand and find out how we can help you achieve success.
  2. Our fixed price consultancy enables you to control all the costs of achieving certification.
  3. Our implementation approach and methodology are pragmatic, proven and straightforward.
  4. We help you increase internal buy-in by leveraging your resources to achieve your certification/conformance goals.
  5. We transfer knowledge and skills to you and your staff so you can meet compliance targets after implementation ends.
  6. We are a one-stop shop with comprehensive and integrated ISO 9001 resources including experienced consultants, books, documentation and tools.
  7. We customise your Quality Management System to meet your needs, stay within budget, and comply with ISO 9001.
  8. We can link your ISO 9001 QMS with your health and safety, environmental, information security or other ISO management systems.
  9. Our simple, 'no quibble' 100% guarantee of successful certification removes all worry.

Find out more about our ISO 9001 consultancy services

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