The ISO 9001:2015 revision will include some dramatic changes to ISO 9001. In our three-part "ISO 9001:2015 Explained" series, we discuss the major changes revealed so far in the development of the standard. Here, Part 1 focuses on the new clause, 'Context of the organisation'.
Why context is so important
Implementing a quality management system (QMS) is a strategic decision influenced by the context of the organisation. "Context of the organisation" is a new clause of ISO 9001, requiring organisations to consider both the internal and external issues that can impact on their strategic objectives and how they plan their QMS.
Your organisation should focus particularly on factors and conditions that can affect your products, services, investments and interested parties. Context becomes an important consideration and helps to ensure that your QMS is designed and adapted for your organisation rather than taking a 'one size fits all' approach.
Determining the context (step by step)
While there is no prescribed method of determining the context of your organisation in relation to ISO/DIS 9001, you should take this simple and pragmatic four-step approach:
- Identify the internal issues that can affect your organisation's products, services, investments and interested parties.
- Identify the external issues that can affect your organisation's products, services, investments and interested parties.
- Identify who are the interested parties and what are their requirements.
- Regularly review and monitor those internal issues, external issues and interested parties you have identified.
1. Identifying internal issues
Your organisation's internal context is the environment in which you aim to achieve your objectives. Internal context can include your approach to governance, your contractual relationships with customers, and your interested parties.
Internal issues can include your:
- regulatory requirements
- strategies to conform to your policies and achieve your objectives
- relationship with your staff and stakeholders, including partners and suppliers
- resources and knowledge (e.g. capital, people, processes and technologies)
- risk appetite
- product or service
- standards, guidelines and models adopted by the organisation
- information systems
2. Identifying external issues
To understand your external context, consider issues that arise from your social, technological, environmental, ethical, political, legal and economic environment.
External issues may include:
- government regulations and changes in the law
- economic shifts in your market
- your competition
- events that may affect your corporate image
- changes in technology
3. Identifying interested parties
Your interested parties include customers, partners, employees and suppliers. When developing your QMS, you only need to consider interested parties that can affect your:
- ability to consistently provide a product or service that meets your customers' needs and any statutory requirements and regulations
- continual improvement process
- ability to enhance customer satisfaction through effectively applying your system
- your process for ensuring you conform to your customers' requirements and any statutes or regulations that apply
4. Regular reviews and monitoring
You must regularly review and monitor those internal or external issues you have identified. Once you understand your internal context, management can carry out a 'PEST' (political, economic, social and technological) analysis, for example. By doing this, you can determine which factors will affect how you operate.
While you have no control over external issues, you can adapt to them. PEST factors can be classified as 'risks' and 'opportunities' in a SWOT (strengths, weaknesses, opportunities, threats) analysis or other alternative methods.
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