Management system guidance
ISO 9001:2008 versus ISO 9001:2015 comparison
ISO Navigator Pro™ is a free tool that provides practical, expert guidance for businesses wishing to interpret and better implement the requirements of ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018.
Our range of templates cover the requirements of ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018, and offer an easy way to implement your next management system.
How do ISO 9001:2008 and ISO 9001:2015 correlate?
Comparing quality management system requirements
Many of the requirements from ISO 9001:2008 are present with in ISO 9001:2015. The matrix below correlates the requirements of ISO 9001:2008 to the new requirements of ISO 9001:2015 and should be used to determine where the new and amended clauses are located.
The degree of change necessary will be dependent upon the maturity and effectiveness of your current management system, organizational structure and operational practices.
Therefore, a gap analysis of the new requirements is strongly recommended in order to identify realistic resource and time implications. We recommend that you:
- Train internal auditors and other key personnel on new standard;
- Using this document, undertake a gap analysis of the new requirements against the current management system;
- Develop an implementation plan to fill the gaps that you identified;
- Align your documentation and processes with ISO 9001:2015 requirements;
- Update your quality policy, quality objectives, targets and KPIs;
- Carry out minimal updates to the manual and procedures to include new terminology and key phrases;
- Ensure that any new competence needs are met and records retained;
- Create awareness for all parties that have an impact on the effectiveness of the quality management system;
- Verify the effectiveness of the changes to the management system through internal auditing, observation and inspection;
- As necessary, liaise with your Certification Body during the transition.
ISO 9001:2008 and ISO 9001:2015 comparison matrix
Existing ISO 9001:2008 documents
In ISO 9001:2008, the quality manual helped to establish and document the framework of your organization's quality management system while articulating those aspects of the QMS to any interested parties.
While there is no requirement for a quality manual or documented procedures in ISO 9001:2015, it is suggested that if they add value, then they should not simply be binned. You will be expected to maintain the integrity of the QMS during the transition process.
You do not need to renumber your existing documentation to correspond to the new clauses. It is down to each organization to determine whether the benefits gained from renumbering will exceed the effort involved.
Neither do you need to restructure your management system to follow the sequence of and titles of the requirements. Providing all of the requirements contained in ISO 9001:2015 are met, your organization’s quality management system will be compliant.
- If your quality manual fits your business and your customers require it, keep it!
- If your procedures are effective and define how your key processes operate, keep them!
- If the quality policy and related objectives align with business strategy, and they are communicated and adding value, keep those too!
The type and extent of documented information that your organization should retain and maintain, in order to be compliant with ISO 9001:2015, clearly depends on the nature of your organization’s products and processes.
The following criteria can be used to assess the different types of ISO 9001:2008 documents and information that your organization should retain and maintain as documented information by determining whether the information:
- Communicates a message internally or externally;
- Provides evidence of process and product conformity;
- Provides evidence that planned outputs were achieved;
- Provides knowledge sharing.
If any of the above criteria apply to any type of document or information within your organization's domain, then it should be retained and maintained as a form of 'documented information' as per Clause 7.5 of ISO 9001:2015.
More information on PDCA
How to apply the latest quality management principles
The latest and current quality management principles (QMPs), stated in ISO 9000:2015, are intended to provide the foundation by which any organization can continually improve its performance.
You can learn to apply the latest quality management principles in the context of your business's own particular operations by reviewing and documenting its activities in the context of each quality management principle.
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