Last week, simpleQuE president Jim Lee offered his top notes regarding the upcoming ISO changes. With ISO 9001 FDIS due this week, and the full release of ISO 9001:2015 on September 21, here are four more notes on the pending changes.
- Every certification body will set their own rules for when they stop issuing ISO 9001:2008 certificates for companies getting certified for the first time. We are seeing 18 to 24 months after the release of ISO 9001:2015. It is not practical for anyone to issue a 2008 certificate 24 months after the release of the new standard due to costs and repetitive registration audits less than 12 months from the initial certification.
- Leadership will be more heavily involved as the management systems must be integrated with the company’s strategic direction. Leadership will have to justify and defend their compliance and approach to meeting the management systems (i.e. context of the organization as it relates to internal and external issues, the stakeholders or interested parties, then determining the risks and opportunities so that the company can set the priorities and objectives for the business). Some of this information may not be documented, so leadership will have to convince their auditor that they understand their context and stakeholders and have established the appropriate objectives for the business based on the risks and opportunities.
- The quality management system needs to be integrated with the company’s strategic plan. The company needs to tie their management system process to the business processes and determine what needs to be monitored and measured, so you know how the business processes are performing. When the process is not performing as intended or is deteriorating, management should be aware and taking action to try to turn it around.
- The quality manual is no longer mandatory and it is not as prescriptive what documented procedures are required. ISO 14001 has been that way for over 10 years, so companies, consultants and auditors will be learning from the environmental side to see how they’ve been handling that for over 10 years, and what may be acceptable for quality systems.
View our infographic, The Facts Behind ISO 9001, for information regarding the standard.