2. Normative reference
2. Normative reference
3. Terms and definitions
3. Terms and definitions
4. Quality management system
4. Context of the organisation
5. Management responsibility
6. Resource management
7. Product realisation
8. Measurement, analysis and improvement
9. Performance evaluation
The first three clauses in ISO 9001:2015 are largely the same as those in ISO 9001:2008, but there are considerable differences between ISO 9001:2008 and ISO 9001:2015 from the fourth clause onwards. The last seven clauses are now arranged according to the PDCA cycle (Plan, Do, Check, Act).
ISO 14001 – ISO 14001 – Environmental Management Systems, the world’s first international environmental standard has been helping thousands of organizations to improve their environmental, sustainability and operational performance since it was first published as BS 7750 in 1992.
To ensure that ISO 14001 continue to serve organizations and maintain its relevance in today’s market place, the standard has been revised. The new standard addresses the change in environmental practices, and ensures that the management system is future proof.
Companies, organizations and society have a global responsibility to grow without compromising resources for future generations. ISO 14001 was originally written with the environment in mind and that remains the priority for ISO 14001:2015.
While still in the drafting stage (see enclosed time line for publication), this latest revision takes into account the vast changes in technology, business diversity and global commerce (which the ISO 9000 family and its spin-offs were created to support), including:
- The growth of service businesses and their needs for quality management
- Recognition of the need to harmonize, integrate quality management into overall business management systems, perhaps to serve as the basis of business management itself
- Making it easier for companies to adopt multiple ISO series general business management standards such as ISO 14001 (environmental) and/or vertical standards such as AS9100
- Helping to simplify the understanding of the standard, and make it easier (and more mandatory) to apply it more uniformly
The update/revision process is also supposed to keep the current focus on managing processes (as opposed to managing more specific program elements) as an effective method to gain a more repeatable pattern of success, and to remain more applicable to a wider array of enterprises. It is doing this to help make this standard revision more durable by “providing a stable core set of requirements for the next 10 years or more” even amid the increasingly changing business situations in which it must operate.
ISO/IEC 17025 was first issued in 1999 by the International Organization for Standardization (ISO) and the International Electro-technical Commission (IEC). It is the single most important standard for calibration and testing laboratories around the world, with more than 50.000 laboratories accredited, globally.
At the International Laboratory Accreditation Cooperation (ILAC) General Assembly in October 2013 the Laboratory Committee (which is composed of stakeholder representatives of accredited testing and calibration) recommended that ILAC request that ISO/CASCO establish a new work item to comprehensively revise ISO/IEC 17025:2005. CASCO is the ISO committee that works on issues relating to conformity assessment. CASCO develops policy and publishes standards related to conformity assessment; it does not perform conformity assessment activities. CASCO’s standards development activities are carried out by working groups made up of experts put forward by the ISO member bodies. The experts are individuals who possess specific knowledge relating to the activities to be undertaken by the working group.
A New Work Item Proposal (NWIP) was submitted by CASCO to ISO and approved in October 2014. An ISO/CASCO working group has since been established (WG44) and tasked with the revision of the standard titled: “Revision of ISO/IEC 17025 ISO/CASCO/WG 44.”
Some of the biggest changes between the 2003 and 2016 version include:
- Incorporation of risk-based approaches beyond product realization. Risk is considered in the context of the safety and performance of the medical device and in meeting regulatory requirements;
- Increased linkage with regulatory requirements, particularly for regulatory documentation;
- Application to organizations throughout the lifecycle and supply chain for medical devices;
- Harmonization of the requirements for software validation for different software applications (QMS software, process control software, software for monitoring and measurement) in different clauses of the standard;
- Emphasis on appropriate infrastructure, particularly for production of sterile medical devices, and addition of requirements for validation of sterile barrier properties;
- Additional requirements in design and development on consideration of usability, use of standards, verification and validation planning, design transfer and design records;
- Emphasis on complaint handling and reporting to regulatory authorities in accordance with regulatory requirements, and consideration of post-market surveillance; and
- Planning and documenting corrective action and preventive action, and implementing corrective action without undue delay.
Speaking to those changes, Hoxey said "it's important to bear in mind that ISO 13485 does deal with the whole lifecycle from design and development, through manufacture, transport … and on to the end of life."
- See more at: http://www.raps.org/Regulatory-Focus/News/2016/03/01/24443/New-ISO-13485...