Transitioning to ISO 9001:2015
What's New in ISO 9001:2015
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The most noticeable change to the standard is its new structure. ISO 9001:2015 adopts the new High-Level Structure, new terms, and definitions as other ISO management system standards.
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Another major difference is a significant increased emphasis on risk-based thinking. While this has always been part of the standard, the new version gives it increased prominence.
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Increased focus on process management, with greater emphasis on producing desired outputs.
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Puts greater emphasis on leadership engagement.
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Fewer and less explicit requirements for documented procedures. More explicit requirements on documented information.
What Do I Need to Know and Do About the ISO 9001:2015 Transition?
Step 1 - Talk to your accreditation body. While the transition period, in theory, would allow organizations to become certified or have surveillance audits according to ISO 9001:2008 until September 2018, most of the accreditation bodies announced that they will stop issuing new certificates to 9001:2008 much sooner. Talk to your accreditation body as soon as possible to understand their timeline.
Step 2 - Review and familiarize yourself with the new 9001:2015 standard. While some things have certainly changed, many remain the same. To help you easily identify if parts of the standard have moved to other sections check out this correlation matrix, available from ISO/TC 176/SC 2.
Step 3 - Develop a Transition Plan. We recommend a Gap Assessment to kick off your transition process. During the Gap Assessment, we evaluate your current Quality Management System to determine your current level of compliance with the new ISO 9001:2015 standard. The Gap Assessment will provide you with a checklist of necessary changes that need to be implemented to be fully compliant with the ISO 9001:2015 standard.
Step 4 - Provide training and awareness for all parties within the organization that have an impact on the quality management system.
Step 5 - Update your existing quality management system to meet the new requirements.
How Can Labtopia Help with My Organizations' Transition to ISO 9001:2015?
Gap Assessments
Our comprehensive assessment focuses on your current documented quality management system and will provide a clear picture of your QMS’ readiness for transition. The gap assessment results in a precise checklist of action items that need to be implemented to meet the new standard’s requirements.
Labtopia's Gap Assessments Include:
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A formal review of existing practices against requirements of the standard and your business application Identification of how you already meet specific new requirements
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Identification of areas where you might be unclear on how requirements apply or whether you meet them
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Highlights any risks and weaknesses based on the new requirements
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Deliverables include a Checklist with the GAPS
Customized Consulting
Labtopia offers ISO 9001:2015 consulting services geared to supporting existing quality systems in the laboratory or manufacturing environment. Implementing a quality system can drain a company’s resources and can be frustrating and costly if not done properly. Our experts have aided large multi-national, global companies. At the same time, we recognize that small and medium sized businesses must meet the same quality and regulatory requirements as their larger counterparts and some companies may not need full-time support.
Lead or assist your team with a gap assessment, transition planning, and effective documentation development.
Transitioning
Lead or assist your team with a gap assessment, transition planning, and effective documentation development.
Internal Audits
Conduct an on-site internal audit of your quality management system. Identify process effectiveness and any process deficiencies found.
Corrective Action Review
Assist with corrective action review and closure.
Training
Deliver internal audit, management overview and requirements training.
Pre-Certification Audit Support
Conduct on-site pre-certification audit prior to the certification body audit to boost confidence of system effectiveness and certification success.
Custom Consulting
Custom consulting services defining your specific needs and requirements.
ISO Accredited Auditors
Labtopia’s Team is comprised of ISO Accredited Auditors who are also former lab and quality directors with extensive experience in managing QA/QC systems and directing bench activities in regulated environments. What does this mean for you? It means we understand the issues and challenges faced in your unique environment and we can provide valuable insight into what lead assessors and auditors are looking for as well as provide practical real-world advice and best practices.
Labtopia offers our clients fully customizable curricula proven to both improve and empower your Team. Courses are offered at Labtopia's facility in Houston or can be can be customized and taught on-site at your facility.
Our trainers have technical and scientiļ¬c backgrounds and are accredited ISO Internal Auditors. What does this mean for you? It means we understand the issues and challenges faced in your unique environment and we can provide valuable insight into what lead assessors and auditors are looking for as well as provide practical real-world advice, best practices, and tips.
Training
Current ISO 9001:2015 course offerings include:
ISO 9001:2015 Internal Auditor Training
Introduction to ISO 9001:2015 Training