ISO 9001 - Quality Management System

 

What is ISO 9001?

ISO 9001 is an international standard that enables all sizes of organisations in varying sectors to improve performance, meet customer expectations and champion their commitment to quality. As a globally recognised standard, certification can also lead to an increase in the national and international trades of goods and services.

Requirements included in this standard define how to establish, implement, maintain, and continually improve a quality management system (QMS). Furthermore, as it is recognized as the basis for what a QMS should include, many corporations require this certification from their suppliers.

Once certified, organisations can proudly promote themselves as certificate holders in any of their promotional materials and can include the URS certification logo free of charge.

 

Who requires an ISO 9001 certification?

As ISO 9001 is applicable to all sectors of all sizes, any organisation can benefit from being certified in this standard. This includes:  

 

• Manufacturing


• Healthcare


• Education


• Electronics


• Government

How can ISO 9001 benefit your business?

Becoming certified for ISO 9001 can bring a wide range of benefits to your organisation, including:

 

• Increasing sales and profit margins


• Reducing waste costs


• Ensuring customer satisfaction


• Creating a safer workplace

How can you prepare for an ISO 9001 Certification?

Although the thought of starting the certification process may seem daunting, there are a variety of steps you can take to make the process to becoming certified far more streamlined:

 

• Familiarise yourself with the ISO 9001 standard


• Prepare all required documentation indicated by the standard


• Complete a gap analysis to highlight areas of your organisation that aren’t complying to the standard


• Provide staff training to ensure all employees are compliant with the standard


• Carry out internal audits to recognise areas in need of improvement


• Conduct a management review to assess your organisations Quality Management System

What are the key requirements of ISO 9001?

When working towards becoming certified for ISO 9001, there are various areas that will be a focus during the audit. These areas include:

 

• Customer focus


• Quality Policy


• Customer Relationship Management


• Quality Planning


• Employee Competence

What clauses make up the structure of ISO 9001?

 

Clause 4 - Context of the organisation:

This clause covers internal and external factors that may have an impact on an organisations objectives and outcomes. Emphasis is also placed on exploring the needs and expectations of interested parties, and determining the organisations QMS scope and processes.



Climate Change Amendments:

The amendments have not changed the requirements of clause 4.1 and 4.2, rather they have added an assurance that climate change is considered for the management system. Due to the necessity of climate awareness, it should be considered by organisations and is therefore included as part of the standard.

Rather than a transition being required, organisations should instead consider and apply the guidance provided in the amendment. Should a company minute their considerations during their Management Review regarding CCC as well as evidence of their considerations and any actions, a discrepancy shall NOT be raised. However, should no minute exist for any considerations, then a discrepancy will be raised.

Where a minute and evidence does exist but is clearly of little relevance to CCC an Opportunity for Improvement (OFI) will be raised.

 

Clause 5 – Leadership

Clause 5 concentrates on the importance of leadership and commitment when maintaining a Quality Management System. It also touches on the approach top management should have towards customer focus, Policies, and organisational roles and responsibilities.

 

Clause 6 – Planning

The planning clause of ISO 9001 focuses on the development of a quality management system and highlights importance of planning for risks and opportunities that may arise. Alongside precautionary planning, this clause also explores how planning can be utilised to ensure your organisation achieves its quality objectives.

 

Clause 7 – Support

This clause considers the variety of resources that are needed to maintain a quality management system and deliver services and products. Each of the subclauses includes resources such as people, infrastructures, environments and the means of measuring and monitoring them. In addition, the Support clause also touches on competency, awareness, communication and documentation.

 

Clause 8 – Operation

Clause 8 outlines the operational processes involved in planning for products and services and is the only clause where parts can be excluded if they do not apply to the organisation. This section also includes requirements for design and development, control, production, release and control.

 

Clause 9 – Performance Evaluation

This clause approaches the means of using monitoring, measurement, and analysis to evaluate the performance of your Quality Management System. This section also covers internal audits, management reviews and customer satisfaction.

 

Clause 10 – Improvement

In the final section, Clause 10 outlines the methods of continual improvement that can be used to enhance your organisations QMS; including corrective actions and nonconformities.

How long will your ISO 9001 certificate be valid for?

Your ISO 9001 certificate will be valid for at least three years; dependent on the type of site that is being certified.  

 

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