A company’s quality management system is not an island and it isn’t static. It is connected with the context, or environment, of the business. By “connected’ it means that the QMS is influenced by external and internal factors such as company culture, company objectives and goals, the complexity of products and processes of the company, the size of the organization, the markets and customers served, the economy and culture in which the company operates and other things. While the ISO 9001 standard is generic, how it is applied differs from one business to another and the business environment of the business affects how the QMS is set up and improved over time to meet the needs of the business.
SUMMARY OF NEW ISO 9001:2015 REQUIREMENTS:
1. Determine the issues outside and inside the company that are relevant to the company’s purpose, direction and QMS. Set up a process to monitor information about these external and internal issues.
2. Understand the interested parties relevant to the QMS and their needs and expectations. Set up a process to monitor information about interested parties and their requirements.
3. Based on the relevant contextual issues and needs of relevant parties, along with the company’s products and services, establish the scope of the QMS and document it. If something in ISO 9001 doesn’t apply to the business, document the justification for excluding it.