ISO 9001: Quality Management System

ISO 9001: Quality Management System

• ISO 9001 is an internationally recognized standard for quality management systems.
• It is part of the ISO 9000 family of standards, covering a range of quality assurance topics.
• ISO 9001:2015 helps companies gain recognition for their quality management and demonstrate it to their customers.
• The standard is applicable to any type of industry and organization of all sizes.
• It assists in providing consistent products and services, leading to customer satisfaction, regulatory compliance, and continual improvement.

History of ISO 9001

• The history of ISO 9001 can be traced back to the 1950s with US and UK government departments establishing standards for military procurement.
• The defence industry adopted mutual recognition of NATO AQAP, MIL-Q, and Def Stan standards.
• BS5750, the first specific 'quality management system' standard, was published in 1979.
• The ISO 9001 standard was developed by the International Standards Organisation (ISO) to extend the reach of quality management to an international audience.
• The standard was first published in 1987 and has been reviewed and updated every 5-8 years to ensure relevance to global business.

ISO 9000 Series

• The ISO 9000 series comprises of three standards:
  • ISO 9000:2015: Quality management systems – Fundamentals and vocabulary
  • ISO 9001:2015: Quality Management Systems – Requirements
  • ISO 9004:2018: Quality Management Systems – Managing for the sustained success of an organisation (continuous improvement)

Plan-Do-Check-Act (PDCA) Cycle

• The PDCA cycle is a project management framework for implementing incremental change.
• The cycle consists of four steps: plan, do, check, and act.
• It is designed to help teams make small, incremental changes and test each step's success or failure before moving onto another one.
• The PDCA cycle is a continuous improvement approach, allowing teams to achieve large-scale transformations over time.
• Any department in a business can use the PDCA cycle for any incremental change, such as changes to a company's business process, product, or team culture.

Example of PDCA Cycle

• An example of using the PDCA cycle is A/B split testing in marketing campaigns.
• In the "Plan" stage, a team identifies a challenge or opportunity and decides to change a single element of the campaign.
• The team then runs both versions simultaneously to test the change and evaluates the results.
• The PDCA cycle allows teams to make incremental changes and test their success or failure before moving onto another one.

Understanding the Organization and its Context

• Implementing a Quality Management System (QMS) is a strategic decision influenced by the context of the organization.
• The "context of the organization" is a new clause of ISO 9001, requiring organizations to consider internal and external issues that can impact strategic objectives and QMS planning.

Determining the Context

• There is no prescribed method of determining the context, but a simple four-step approach can be taken:
  • Identify internal issues that can affect products, services, investments, and interested parties.
  • Identify external issues that can affect products, services, investments, and interested parties.
  • Identify interested parties and their requirements.
  • Regularly review and monitor identified internal and external issues and interested parties.

Internal Issues

• Internal context includes the environment in which the organization aims to achieve its objectives.
• Internal issues can include:
  • Regulatory requirements
  • Strategies to conform to policies and achieve objectives
  • Relationships with staff, stakeholders, partners, and suppliers
  • Resources and knowledge (e.g., capital, people, processes, and technologies)
  • Risk appetite
  • Assets
  • Products or services
  • Standards, guidelines, and models adopted by the organization
  • Information systems

External Issues

• External context includes the social, technological, environmental, ethical, political, legal, and economic environment.
• External issues can include:
  • Government regulations and changes in the law
  • Economic shifts in the market
  • Competition
  • Events that may affect corporate image
  • Changes in technology

Regular Reviews and Monitoring

• Regular reviews and monitoring of identified internal and external issues are necessary.
• A PEST (political, economic, social, and technological) analysis can be used to determine factors that affect operations.
• PEST factors can be classified as 'risks' and 'opportunities' in a SWOT analysis.

Understanding the Needs and Expectations of Interested Parties

• Interested parties include customers, partners, employees, and suppliers.
• When developing a QMS, only interested parties that can affect:
  • Ability to consistently provide a product or service that meets customers' needs and statutory requirements
  • Continual improvement process
  • Ability to enhance customer satisfaction
  • Process for ensuring conformance to customers' requirements and regulations
• Organizations need to identify stakeholders or interested parties relevant to their operations, including customers, suppliers, employees, regulatory bodies, shareholders, and the community.