What is ISO 9001?

13th October 2014 Keith Flight

What is it for?

ISO 9001 provides a framework for good management practices. These standards support an organization in providing the best possible product or service.

These good practices have been collected into a set of standardized requirements which applicable regardless of the size or context of the organization. ISO 9001 provides a tried and tested framework for a systematic approach to quality management meaning that certified businesses demonstrate that they have a solid set of procedures for managing their business and a carefully managed attitude towards the continual improvement of their organisation.

In the context of ISO 9001 “quality” refers to all those features of a product or service which are required by customers. “Quality management” is what the organisation does to ensure that it’s products or services satisfy the customer’s quality requirements and comply with any regulations applicable to those products or services. To meet the standard organisations commit themselves to continually improving their performance. They do this by directing attention towards organisational processes, and not products. The premise is that the efficient management of processes is the most effective method of ensuring that the product satisfies customers quality requirements.

Over a million organizations worldwide are independently certified, making ISO 9001 one of the most widely used management tools in the world today

Who is it for?

The principles laid out in the standard are good practice for any organisation, but certification is recommended for any business that wants to demonstrate to others excellence within their business and their thorough approach to quality management. What are the benefits? Within the organisation

  • Internal benefits include:
  • Improvements to organisational effectiveness and efficiency.
  • Assurance of continual improvement of your business.
  • Satisfy regulatory requirements, e.g. certification is sometimes mandatory if you want to tender for public sector work.
  • Encourages efficient, time saving processes.
  • Reduces your costs.
  • Creates better working conditions for employees
  • Increased job satisfaction
  • improved health and safety
  • Improved moral
  • Improved stability of employment
  • Enables improved flexibility of operation
  • Reduced environmental impact
  • Increased return on investment for owners and investors
  • Improved operational results
  • Increased market share
  • Increased profits

Benefits to customers

Certification can demonstrate to your customers the following:

  • You fulfill customer’s quality requirements
  • You are a well organised, capable supplier.
  • You provide consistently high levels of customer satisfaction.
  • You are dependable and reliable
  • You operate the best practices in business management.
  • You are likely to have fewer returned products and complaints.
  • That you deliver on time.

What do I have to do?

Building a ‘Quality Management System’

ISO 9001 requires you to formally document the areas of your business that relate to quality in a ‘Quality Management System’. This means that you are keeping records that demonstrate that you are operating according to the requirements of the standard.

ISO 9001 uses eight quality management principles as the basis for any quality management system:

  1. Customer focus
    • Create links between customers needs and the expectations and objectives of the organisation.
    • The communication of customer needs and expectation throughout the organisation.
    • Measurement of customer satisfaction and acting on the results
    • Systematic management of customer relationships
  2. Leadership
    • Helping people understand and be motivated towards the organisation’s goals and objectives.
    • Activities are evaluated, aligned and implemented in a unified way.
    • Effective communication within the organisation.
    • Establishing a clear vision of the organisation’s future.
  3. Involvement of people
    • People understanding the importance of their contribution and role in the organisation.
    • People identifying constraints to their performance.
    • People accepting ownership of problems and their responsibility for solving them.
    • People actively seeking opportunities to enhance their competence, knowledge and experience.
  4. Process approach
    • Systematically defining the activities necessary to obtain a desired result.
    • Establishing clear responsibility and accountability for managing key activities.
    • Focusing on the factors such as resources, methods and materials that will improve key activities.
  5. System approach to management
    • Understanding of the roles and responsibilities necessary for achieving common objectives to reduce cross-functional barriers.
    • Understanding the organisational capabilities and establishing resource constraints prior to each action.
    • Continually improving the system through measurement and evaluation.
  6. Continual improvement
    • Providing people with training in the methods and tools of continual improvement.
    • Making continual improvement of products, processes and systems an objective for every individual in the organisation.
    • Establishing goals to guide and measurements to track continual improvement.
    • Recognising and acknowledging improvements.
  7. Factual approach to decision making
    • Ensure that data and information are sufficiently accurate and reliable.
    • Make data accessible to those who need it.
    • Analyse data and information using valid methods.
    • Make decisions and take action based on factual information balanced with experience and intuition.
    • Reflecting on previous decisions with the knowledge of what was and why.
  8. Mutually beneficial supplier relations
    • Create value for both parties.
    • Ability to be flexible and have a rapid response to changing market or customer needs and expectations.
    • Optimization of resources.
    • Clear and open communication
    • Sharing information and future plans thus establishing joint venture development and improvement activities.

In order to build your initial QMS you must carry out the following:

  • Establish the organisation’s purpose or mission.
  • Identify the guiding principles, policies or values that will motivate the organisation to accomplish its mission.
  • Identify the factors critical to success.
  • From the critical success factors define the strategic objectives and measures of success.
  • Identify and define the key stages in the processes and that will achieve these objectives.
  • Identify the skills and competencies required for each process stage to be completed as planned.
  • Identify the specific outputs and how they will be measured.
  • Define the information, activities and resources required to deliver the required outputs for each process stage.
  • Identify the measuring and monitoring methods for verifying the outputs, ensuring the integrity of measurement and confirming objectives have been achieved.
  • Identify the methods for improving performance.
  • Identify the methods for validating the process objectives

How do I get certified?

Once the Quality Management System is in place and has been in operation for long enough for evidence of its effectiveness to have accumulated, it is possible to submit the system for certification. This will involve engaging the services of a third party certification body.

There are a number of certification bodies in the UK and worldwide who provide this service. In the UK theses bodies are regulated by the United Kingdom Accreditation Service (UKAS).

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