Just when you thought you had the ISO 9001:2008 quality system down, low and behold you find out that a new standard has been issued by ISO. ISO 9001:2015 was released in September 2015, as the 5th edition of one of ISO’s most widely accepted standards.  All ISO standards are reviewed every five years to determine if they meet the needs of industries and users based on the latest trends globally.  Some of you have been busy transitioning or have already done so to meet the deadline of September 2018.

The good news is that Craftech Industries, Inc. is pleased to announce that it has completed its upgrade audit this past January to ISO 9001:2015.

If you are in the midst or need to shake a leg to get started, finding an overview of the standard differences should help point out areas in the system that will need to be addressed, whether in your quality manual, processes or procedures. Since you are here already, this brief overview of the new requirements of ISO 9001:2015 may be helpful.

1)The Quality Management System now Context of the Organization

For ISO 2015 you must determine external and internal issues/trends that influence your organization and monitor these issues. Figure out your interested parties and their requirements that are relevant to your QMS. Establish process performance indicators using monitoring and measurement. Assign authorities in addition to responsibilities in the processes.  Address risk and opportunities in the process.

2)Management Responsibility now Leadership

Top management must promote use of the process approach and risk-based thinking. They must communicate the importance of the QMS and conformance to its requirements. Support to members of management to demonstrate leadership in their area of responsibility must be given. The quality policy should support the strategic direction of the company and be available to relevant parties.

3)Resource Management now Planning

Risk-based thinking has been introduced as a replacement for Preventive Action in ISO 9001:2008. Organizations must consider and plan for risks and opportunities that could impact QMS results and improvements. Records must be retained for quality objectives and changes to the QMS must identify resources and responsibilities.

4)Product Realization now Support

Does your company have a suitable work environment? Look at other environmental factors including human, social, psychological and physical in relation to processes. Look at your capabilities and the constraints on your internal resources and what is needed from external resources. Develop a plan for making key knowledge available and maintaining it is now required.

5)Measurement, Analysis and Improvement now Operation

Make sure you implement actions from planning for risk, quality objective and changes. Ask yourself if you have change control processes in place.  Make sure you can address specific customer requirements and see that contingencies needed are put in place.   If your company does design and development, look at the internal and external resources, customer involvement, and potential consequence of failure in the process.

Purchasing requires that you monitor the performance of external providers and communicate how they are controlled. New requirements under this section also address control of production and service provision, property that belongs to suppliers, preservation, post-delivery activities and control of changes.

6)Performance Evaluation and Improvement are new for 2015.

What records are kept to validate monitoring, measurement and analysis? Monitoring customer satisfaction can now include results of meetings with them. Determine if your planning has been implemented effectively and its effectiveness towards actions taken to address risks and opportunities.

So what do you think? Are you up to the challenge? By the way, you will have to have at least one Management Review and all your audits done to the new standard with your auditors trained to that standard. But you can do it with leadership giving you the support and resources to take on the new and exciting ISO 2015.  Good Luck!

Should you need plastic fasteners or custom parts supplied by an ISO 9001 certified supplier, please consider Craftech.

 

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