Free Whitepaper: How can ISO 9001 Help Your Business Grow?
When you operate a business, you may encounter other businesses that boast about their ISO 9001 certification, or you may encounter customers who want to know if you are ISO 9001 certified. The ISO 9001 system can help you to improve your business through quality management, so this white paper helps you understand what ISO […]
Recognition of EN ISO 14971 as a harmonized standard in support of the European Medical Device Regulations
Back in June, it was reported by TC 210, the committee responsible for medical device standards such as ISO 14971 and ISO 13485, that the European standard EN ISO 14971:2019 with its amendment A11:2021 had finally been cited in the Official Journal of the European Union (OJEU) as a harmonized standard in support of the […]
IATF Updates FAQ 29 to Give New Guidance on Contingency Plans
On May 26th, 2022, the IATF posted that they had approved Stakeholder Communique SC-2022-008 Release of Sanctioned Interpretations (SIs) and Frequently Asked Questions (FAQs) related to IATF 16949:2016 and an SI for Rules 5th Edition, with the changes being effective in June. Of note, FAQ 29 was updated with guidance for developing effective contingency plans:
ISO 9001 Auditing Practices Group Updates Auditing Competence Guidelines
The ISO 9001 Auditing Practices Group is constituted as an informal group of quality management system (QMS) experts, auditors and practitioners, drawn from the ISO Technical Committee 176 Quality Management and Quality Assurance (ISO/TC 176) and the International Accreditation Forum (IAF). On June 1, 2022, the group revised its guidance for auditing competence and published the revised document on […]
After a Global Pandemic, Are Fully Remote QMS Audits Truly Effective?
Although ISO 19011—“Guidelines for auditing management systems” has included language about remote QMS audits since the 2018 revision, this became a reality for many of us in March 2020 with the onset of Covid-19 and the mass lockdowns that ensued. Many of us have been exclusively auditing quality management systems remotely for a year and […]
TC 176 Orders Design Specification for ISO 9001 Early Revision – But is it Needed?
ISO standards, by ISO’s procedures, go through a review every five years for the purpose of ensuring that all content is still relevant, and that technology has not caused the standard to become obsolete. This is very critical for technical standards, but less so for management standards, which are typically codifying management best practices that […]
TC 176 Approves New Interpretation of ISO 9001:2015 Clause 8.2.3.1
ISO/TC 176, the Technical Committee responsible for the flagship quality management standard ISO 9001, among several others, has recently approved a request for interpretation regarding ISO 9001:2015, clause 8.2.3.1.
IATF Updates Rules 5th Edition FAQ in Response to Ongoing Semiconductor Shortage
On April 7th, 2022, IATF reported that the organization had approved Stakeholder Communique SC-2022-006 Rules 5th Edition FAQ and Sanctioned Interpretations. Of special note is the update to FAQ 8, which poses the question as to whether additional audit time should be added if poor OEM scorecard performance is caused by the ongoing semiconductor shortage […]
IATF Approves Communique SC-2022-007 in Response to Ongoing Conflict in Ukraine
On 4/8/2022, the IATF approved Stakeholder Communique SC-2022-007 IATF certification activities in Ukraine. The purpose of this Communiqué is to advise all IATF Stakeholders regarding global waivers and measures of the IATF (International Automotive Task Force) in response to the situation in Ukraine. First and foremost, the thoughts of the IATF are with the Ukrainian […]