THE CHANGES OF THE ISO 9001: 2015 SO WITH THE EDITION ISO 9001: 2008

THE CHANGES OF THE ISO 9001: 2015 SO WITH THE EDITION ISO 9001: 2008

Main Category: Information-knowledge
Category: ISO 9001

The new version ISO 9001: 2015 was officially issued and applied from 15/09/2015 (replacing the ISO 9001: 2008 version) with breakthrough changes, 
helping enterprises go into the management in essence. Context for global competition is growing. The new ISO 9001: 2015 version is expected to be maintained by the ISO organization for up to 25 years.

ISO 9001: 2015 is made up of requirements that pertain to aspects of a quality management system. About structure: ISO 9001: 2015 has 10 terms corresponding to the PDCA cycle. Terms 4 to 7 - Plan, Clause 8 - Do, Clause 9 - Check, Clause 10 - Act. Specific:

• Item 0-3 - Introduction and scope of the standard

• Item 4 - The context of the organization

• Item 5 - Leadership

• Item 6 - Planning

• Clause 7 - Support

• Clause 8 - Activities

• Clause 9 - Performance Evaluation

• Clause 10 - Improvement

Về thuật ngữ: có 69 thuật ngữ mới được đưa vào phiên bản ISO 9001:2015 với bố cục cụ thể hơn, dễ hiểu hơn và phạm vi sử dụng linh hoạt hơn, trong đó có các cụm từ như:

In addition to structural changes compared to the old version, ISO 9001: 2015 has variations on all clauses, typically implied in Articles 4, 5, and 6.

Terms “4. The context of the organization ”

This provision requires businesses to identify “inside” and outside contexts to evaluate how they affect their business (4.1). To define this context, businesses can use strategic planning tools such as:

– SWOT (Strenghs – Weaknesses – Opportunities – Threats): Strong Points – Weak – Opportunities – Threats, BCG (Boston Consultant Group);

– MGSC matrix (Grand Strategy Selection Matrix): Matrix overall strategy selection;
– SPACE matrix (Strategic Position and Action Evaluation): strategic location matrix and action assessment;

– McKINSEY matrix with competitive position and industry appeal;

– Quantitative Strategic Planning Matrix (QSPM);

– The Business Model Canvas: sketching the business model …

It is important that the output of this process must be strategic (possibly through evaluation to determine which strategy is chosen), implement, test, and adjust strategy throughout the business cycle. .

In order to implement the strategies, the business must plan the objectives (6.2), the QMS planning and the core processes of the business.

The new version also requires understanding of the expectations of stakeholders (4.2) such as: Employees, investors, customers; Suppliers, business partners, rivals …

Old version requires: When establishing, implementing, maintaining, improving QMS, the enterprise also identifies the necessary processes. The new version requires more, x specifies “input”, “output” requirements, measures through “indicators” and “risks” (if possible) for these processes.

Terms “5. Leader role:

Top management must demonstrate leadership and commitment to quality management systems expressed through the requirement of “self-responsibility” … to ensure the commitment of the leadership …
The new version no longer requires leadership representation (QMR in the old version) with the expectation that leaders must directly control the quality management system (QMS).

Terms “6. Planning QMS “with” risk-based thinking “:

This change is very important instead of the “preventative action” in the old version. When business prevention is more proactive, react, prevent or reduce unwanted effects. Since then, the company has been continuously improving.

Preventive action is “automatic” when a risk-based management system. “Risk management” will help businesses reduce the dangers that directly affect the quality of products / services. It directly affects the inputs (Man, Material, Machine, Method, Measurement, …), not just the output of the process.
Principles of risk control may be: technology change or method change, technology control (living with floods), administrative control, PPE protection or protection Fruit, incident response (in case of emergency), …

The risks are different and the risk varies, so the new version requires: Identify and select high risk risks for control. Control of these risks must go through “goals” and / or “procedures” to control them.
According to the guidelines of the International Accreditation Forum (IAF), organizations accredited to ISO 9001: 2008 have 3 years from the date of adoption of the new standard for conversion to ISO 9001. : 2015. This means that an ISO 9001: 2015 certificate can only be issued as of 15/09/2015. Organizations may continue to apply the old standard and all ISO 9001: 2008 Certificate will expire after September 14, 1818.

Refer to: https://www.iso.org