More than one million business organizations have ISO 9001 certification from all around the world. This system ensures your clients are consistently receiving high-quality services and products and makes them aware that you

  • Understand their needs
  • Have the capacity to meet and exceed their expectations, and
  • Have the tools to detect and fix problems when they come up.
ISO 9001 certification has a variety of benefits like,

  • Uplifting your reputation. It builds trust and confidence with stakeholders by making sure that your company complies with requirements, including customer, regulatory, and risk.
  • Enhance customer experience by delivering excellent services ad product them. You can show your proof of commitment to global standard achieving ability and quality so that they can buy confidently.
  • boosting cost efficiency and reducing the cost of quality through inducing a consistent risk-based approach to business
  • Streamlining your business by having the tools to evaluate business performance and continually improving processes.

Being an internationally recognized standard, certification to ISO9001 helps you break through the language barrier and be competitive on an international scale.

ISO 9001 at a glance

The management system follows the PDCA (Plan, Do, Check, Act) lifecycle approach briefly detailed below.

PLAN

  • Business organization context
    An understanding of the scope, boundary conditions of the management system, internal and external influencing factors, and parties along with their needs and expectations.
  • Leadership
    Starting from above, Top Management need to demonstrate understanding and commitment to the management system. This means ensuring resources are made available, clear communication of responsibilities, authorities are defined.

    Establishing the policy, objectives, and strategic direction of the business are ways that Leaders of the organization ensure that goals are set and understood.

  • Planning
    With the understanding of the business context and direction, the business uses a risk-based approach to planning to meet the requirements of the management system.
  • Support
    This elements establishes resources includes infrastructure, work environments, people, documented information as well as equipment, many of which stems from the output of risk planning.
DO
  • Operation
    Though service and product realization, we make processes for understanding customer requirements, design and development, purchasing and controls, as well as post-delivery activities such as warranty obligations.
CHECK
  • Evaluation of performance
    The establishment of monitoring and measurement processes to periodically look at the business and evaluate the performance of the management system as well ass products and services. This includes internal audits and process reviews to feed into continual improvement activities.
ACT
  • Improvement
    A commitment is required by ISO 9001 for continuous improvement. It involves managing nonconformities, understanding the cause of issues, taking the right actions when necessary, and evaluating the effectiveness of these actions.

What is the ISO 9001 assessment process?

While applying for ISO 9001 certification, your company is needed to undergo an independent assessment process. This assessment process reviews operational sites, services, processes, and how your business complies with the requirements of the international standard. This demonstrates that your business has effectively implemented sections of ISO 900. A surveillance audit required annually, with a re-certification audit every 3 years.

ISO Consultants

Our work on the development and implementation of management systems is based on principles – an individual approach with a comprehensive solution to the needs of the client. Each time the project is prepared for specific tasks, depends on the current state of the management system of the customer’s company. ISO Consultants of our company carry out a project of preparation and implementation of management system, working closely with representatives of client company.

It allows to understand business processes, to react on current changes, to analyze successfully intellectual experience of company employees and successfully use obtained information for preparatory process of management system implementation and as a result to get ISO 9001 certificate.

Integrate ISO standards

The introduction of the High-level Structure (HLS) through annex SL, the integration of Quality with other management systems, such as Safety and Environmental, becomes simpler with many elements, such as risk, objectives, improvements, and management reviews becoming shared processes. There may even be benefits in certification with most bodies offering time discounts for integrated systems.
Speak to us about how we can help you integrate other management systems, including medical device, into your business.
So, whether you are going to start a new business or want improvement in current business, contact our team to get a suitable package and start achieving your goals