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The prior required ISO procedures were: Clause 4 Documents (2 procedures) 1) 4.2.3 Document Control 2) 4.2.4 Record Control. Clause 8 CAPA (4 procedures) 3) 8.2.2 Internal Audit 4) 8.3 Nonconforming Product Control 5) 8.5.2 Corrective Action 6) 8.5.3 Preventive Action. Procedures and a Quality Manual are no longer required by the new ISO 9001:2015, but your company can use them if you decide you want to keep them. A survey by Advisera asked what companies think about ISO 9001 and the role of the standard within organisations. They've explained it in an infographic here. SHP Online is part of the Informa Markets Division of Informa PLC.
Sponsored ContentRisk is not a straightforward concept. Definitions of risk vary, even within documents published by the International Organizations for Standardization (ISO). One ISO definition indicates that risk is the “effect of uncertainty on an expected result.” Risk is now addressed by ISO 9001:2015, “Quality management systems—Requirements,” the international standard for quality management systems (QMS), scheduled for publication next month. In it, organizations are asked to “address risks and opportunities.”. Quality Digest does not charge readers for its content.
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They never get in your way. They are there for you to read, or not.So please consider turning off your ad blocker for our site.Thanks,Quality Digest. Is the CTO and founder of, an international consulting and training organization headquartered in the United States. He is also president of Omnex Systems, a software provider of ISO 9001, ISO 14001, and ISO 27001 management systems. He developed and teaches auditor training for ISO 9001, IATF 16949, ISO 14001, and ISO 45001, as well as an Integrated Management Systems Lead Auditor training course where all three standards are combined in a single audit.Kymal is also on the ISO/TC 176, ISO/TC 207, and PC283 committees for ISO 9001:2015 (quality), ISO (environmental), and ISO 45001 (health and safety) management system development.
Dan Reid is director of standards and consulting. Reid, an ASQ Fellow and ASQ-Certified Quality Engineer is first delegation leader of the International Automotive Task Force; a member of U.S. Technical Advisory Groups for quality, environmental, and OH&S management systems; a trainer for ISO 9000, ISO 14000, OHSAS 18000, AS9100, ISO 13485, ISO 17025, and VDA 6.3; and serves on the American Association for Laboratory Accreditation (A2LA) board of directors.
Reid led the supplier development administration at GM, and served on the Chrysler, Ford, and GM Supplier Quality Requirements Task Force, which was responsible for QS-9000 and ISO/TS 16949.
One of the most obvious difference between the 9001:2008 and the 9001:2015 standard is the clause structure. ISO 9001:2008 has eight clauses (Clauses 4-8 are requirements) whereas, ISO 9001:2015 has ten (Clauses 4-10 are requirements).has many tools to help you integrate ISO Standards in their existing format, which will be simplified with Annex SL.The main reason is to help organizations that use more than one standard and make it easier to maintain.The core concepts of the new clause structure include management, customer, requirements, policy, procedure, planning, performance, objective, control, monitoring, measurement, auditing, decision making, corrective action, and nonconformity. Many of the requirements around these concepts have not changed.