The ISO 9001 Quality Management Systems standard has recently been updated. The committee for the review and revisions was comprised of 153 experts from 81 countries.
The reason for the update, according to acting ISO Secretary-General Kevin McKinley? “The world has changed, and this revision was needed to reflect this.” McKinley goes on to highlight three major areas that motivated the revisions:
- Globalization, including a reduction in trade barriers and tariffs
- Service-based economies demand support from manufacturing companies
- Complex supply chains
Highlights of the changes include:
- Greater focus on the customer
- Focus on achieving conformity of products and services to meet customer needs and expectations
- Risk-based thinking enhances the process: Plan, Do, Check, Act governs but with the realization that not all processes have the same impact on the ability to deliver on #2
- No specific prescribed documented procedures: organizations can determine their own needs for documentation based on customer and regulatory requirements
ISO 9001:2008-certified organizations have a three-year window to transition to ISO 9001:2015. Therefore, as of September 2018 the ISO 9001:2008 certification will no longer be valid.
According to Douglas Nguyen, ACDi’s Quality Manager, one other significant change is in clause 4 that has a new requirement—context of the organization. Doug commented, “ISO 9001:2015 further emphasizes and defines the roles of management and leadership teams, relative to an organization’s quality management system improvements and changes. To that end, top management needs to identify and document internal and external influences (influences that are related to the sustainability and success of the company) such as customers, culture, markets and suppliers.” Identifying, documenting and realizing what impact these influences have on the business aligns well with the objectives of risk-based thinking.
ACDi, as a premier electronics manufacturing services provider, continues to embrace our commitment to quality. Our goal is to obtain AS9100 certification by the end of 2016, our 13485 certification by Q2 2017 and transition to the new 2015 standards within the three-year window.
If you have any questions or comments about ACDi’s QMS, feel free to email firstname.lastname@example.org.