Converting to ISO 9001:2015
The publication of ISO 9001:2015 in September 2015, signalled the start of a three-year transition period during which those organisations wishing to move to the new version of the standard need to make changes to their existing quality management systems.
“How to Convert from ISO 9001:2008 to 9001:2015” provides step-by-step advice to help you through the transition and realize the benefits of ISO 9001:2015. It maps out a framework which guides you through the options and alternatives, ensuring that you have the knowledge and information you require to seamlessly make the necessary transition.
This is an ideal companion for all Quality Managers and those in charge of overseeing their companies Quality Management System who are now tasked with ensuring that the QMS is converted to comply with the new requirements of ISO 9001:2015 in time for re-accreditation.
1 The structure of the 2015 edition of ISO 9001
2 The major changes caused by ISO 9001:2015
2.1 The new clauses in a little more detail
2.2 Are there any other significant changes?
3 The key differences between ISO 9001 2008 and ISO 9001 2015
3.3 The differences between ISO 9001:2008 and ISO 9001:2015- and vice versa
4 Key changes that you need to make
4.1 Quality Management Principles
4.3 Compatibility with other management system standards
4.4 Control of externally provided processes, products and services
4.5 Documented information
4.6 Organizational knowledge
4.7 Process approach
4.8 Products and services
4.9 Risk-based thinking
4.10 Understanding the needs and expectations of interested parties
5 Key changes you do NOT need to make
5.1 Remove the role of Management Representative
5.2 No longer have a Quality Manual or Documented Procedures
5.3 Renumber existing Quality Management System (QMS) documentation
5.4 Restructure the sequence of your existing QMS
5.5 Refresh the your QMS’s terms and definitions
6 Risk analysis
6.1 ISO 9001:2015’s requirements for addressing risks and opportunities
6.2 What is Risk?
6.3 What is risk based thinking?
6.4 What are the benefits?
6.5 What are the ISO 9001:2015 requirements for risk?
6.6 Actions to address risks and opportunities
PLUS - Annex A – ISO 9001:2015 Risk requirements
Although not officially referred to as a ‘requirements standard’, ISO 9001:2015 does, nevertheless, still contain 138 ‘shalls’ and 2 ‘shoulds’. Although these ‘138’ are the main ‘shall’ requirements applicable to specific clauses within the standard, as most of the clauses have a series of sub requirements within them, in reality the 138 ‘shalls ’actually become a total of 309 requirements and these – together with methods of how to address them - are described in detail in this particular Annex.
7 Gap analysis
7.1 How to conduct a Gap Analysis Audit
7.2 Typical Audit process
7.3 Assemble Gap Analysis Team
7.4 Prepare an ISO 9001:2015 Gap Analysis Checklist
7.5 Conduct an ISO 9001:2015 Gap Analysis
7.6 Complete an ISO 9001 Gap Analysis Report
8 Who has actual control over your QMS?
9 Leadership and commitments
9.1 So, how DO you ensure that Leadership is at the heart of your QMS?
10 Staff training
10.1 Why is it important that staff receive training in ISO?
10.2 Who should be trained?
10.3 What needs to be included in the training?
10.4 What if you have ISO 9001:2008 – what training is needed then?
10.5 Will your staff have to complete transition training?
10.6 What about your internal auditors, will they have to complete transitional training?
11 Gaining ISO 9001:2015 certification
11.1 Does my organization have to scrap its existing processes and procedures and start again?
11.2 Does my organization need to re-certify immediately now that ISO 9001:2015 is published?
11.3 What happens if we are still in the process of registering to ISO 9001:2008?
11.4 What happens if our organization doesn’t complete the transition on time?
11.5 Will all our staff have to complete transition training?
11.6 What about our internal auditors, will they have to complete transitional training?
11.7 What steps can we take right now?
11.8 How do I upgrade my existing ISO 9001:2008 registration to meet ISO 9001:2015’s requirements?
11.9 How can all this be achieved?
11.10 How long will it take to become certified to ISO 9001:2015?