ISO 9001 was revised to meet the needs of the changing business environment and to ensure that the standard is relevant to the current needs of the marketplace. Here are the 5 major differences between the old ISO 9001:2008 and the new ISO 9001:2015 standards.
High Level Structure
The most prominent change to the new standard is a new structure known as High-Level structure. This structure is common across multiple standards and increases the ease of implementing several ISO standards within an organization, due to the commonality of the structure being followed.
Risk Based Thinking
There is increased focus on risk-based thinking in ISO 2001:2015. The standard requires organizations to address risks and opportunities in a structured manner. To address this requirement, organization may need to use techniques of risk analysis like FMEA to identify and mitigate risks.
Context of the Organization
ISO 9001:2015 gives lot of emphasis on capturing the context of the organization. Context of the organization means business environment driven by external factors such as legal, regulatory, financial, social and cultural while still considering the internal environment. Internal factors may include; organizational structures, resource capabilities. Context of the Organization is also dependent on the needs and requirements of the interested parties. The context that is relevant to strategic direction of the organization should be used to define your Quality Management System. This is an additional requirement which needs to be handled within an existing Quality Management System.
Requirements of Interested Parties
Suppliers, shareholders, employees, Legal or regulatory bodies, are now included as interested parties, in addition to customers who were predominately the only interested party in ISO 9001:2008. To address this requirement, organizations need to identify all relevant stakeholders and capture their requirements relevant to the quality management system.
ISO 9001:2015 puts lot more emphasis on leadership engagement and management commitment. The standard requires greater involvement of top management in controlling the quality management system.
New requirements on understanding context, capturing risks and opportunities and involving all interested parties to understand strategic direction of the organization requires that the Quality Management System operates in conjunction with business processes and strategies. Involvement of top management becomes important to achieve this and improve the effectiveness of Quality Management System.
In previous version of ISO 9001, there was a concept of appointing Management Representative (MR). This has been removed in the 2015 version. The duties of the management representative are still required however, some of these duties now need to be managed by upper management. This change ensures management is directly involved in establishing and implementing the Quality Management System, therefore integrating it into all elements of the business.
ISO 9001:2015 does not mandates certain documented procedures or a Quality Manual. The Quality Manual has been replaced by the concept of Documented Information. The information can be any format and can come from various sources.
To the novice quality manager, ISO jargon can be extremely overwhelming. What is an NCR? What do you mean by OFI? Are we certified or accredited? But before you go and pull out your hair, let’s take a moment to go over some of the most frequently used terms and their definitions with regards to ISO and Management System Certification.