ISO 9001:2015

ISO 9001:2015 is an update of ISO 9001:2008 and is part of a series of quality management system standards, sometimes referred to as ISO 9000. These currently comprise of the following standards and guidelines:

• ISO 9000:2015 – Fundamentals and Vocabulary, this standard describes the fundamental concepts and principles of quality management.
  
• ISO 9001:2015 – Requirements, which specifies the criteria for certification
  
• ISO/TS 9002:2016 – Guidelines for the application of ISO 9001:2015
  
• ISO 9001:2015 for Small Enterprises – What to do?

ISO 9001 benefits for your organisation include:

• Increase in your organisation’s performance and productivity – certification improves efficiency through reduction of waste and systematic measurement of performance. Having a robust system in place gives more time to invest in performance & productivity
  
• Enhanced customer satisfaction – Customers know what to expect from a quality certified company. ISO 9001 systematically tracks errors and prevents them thus reducing the number of customer complaints
  
• Global recognition – ISO 9001 is a globally recognised quality standard that can open new market opportunities or help to maintain current market share. Certification also attracts investment > Employee engagement – An ISO 9001 Quality management system encourages communication and increases morale among the employees
  
• Competitive advantage – certification provides an advantage over competitors or the opportunity to compete on the same basis as larger organisations (e.g. ability to tender or submit price quotations)
  
• Focus on objectives and customer expectations – greater emphasis on meeting customer requirements and implied needs through continuous incremental improvement
  
• Ease of integration with other management systems

Risk-based thinking enables an organisation to determine the factors that could cause its processes and its quality management system to deviate from the planned results, to put in place preventive controls to minimise negative effects, and to make maximum use of opportunities as they arise.

It is most likely that an organisation already has a quality management system but it is probably informal and not well documented. ISO 9001 provides a more systematic approach to achieving organisation’s objectives.

It should not result in excessive bureaucracy, paperwork or lack of flexibility nor should it be a financial burden. Quality management systems should be considered an investment as the return on investment will be in terms of the previously mentioned benefits and improvements.
A documented quality manual is optional. However, an organisation must provide documented
information as required by the standard (ISO 9001:2015) The organisation is required to set out clear plans as to how they will achieve the quality objectives. The purpose of this planning process is to insure you meet your objectives and targets including customer requirements and prevent non-conformities from occurring – for both products and services. You determine the risks and opportunities that confront your organisation in delivering its products or services and plan actions to address them.
The organisation is required to set out clear plans as to how they will achieve the quality objectives. The purpose of this planning process is to insure you meet your objectives and targets including customer requirements and prevent non-conformities from occurring – for both products and services. You determine the risks and opportunities that confront your organisation in delivering its products or services and plan actions to address them.

An organisation may utilise various types of documented information to capture their planned actions such as

• Quality Policy, mission, vision, goals, and purpose statements
  
• Strategy, business plans and operations plan
  
• Operating procedures, work instructions, flow charts including KPI’s
  
• Software programmes and schedules, drawings, registers and checklists
  
• Internal audits, non-conformance analysis, the customer feedback loop.