Management system guidance
Updating your quality management system
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.
Planning the transition
The greatest resource of any organization are its people, so strategies for managing both real and perceived change, or concerns and attitudes, should be addressed during transition planning. It is likely that during the first few months, Top management will need to regularly reinforce the benefits of the transition project to ensure that your employees maintain focus and motivation for upgrading the quality management system.
Adjusting the quality management system documents should also be expected as staff become accustomed to the requirements and begin to suggest improvements in usability. Instant business or quality improvements may be initially observed, however experience suggests that there is a lag phase before consistent improvements become the norm.
The benefits to the organization of a properly functioning quality management system are not just restricted to the knowledge that it complies with regulatory requirements, but that it has the discipline to manage customer requirements effectively.
How the transition will affect your audits
The changes in ISO 9001:2015 will likely affect your organization’s internal audits in many of the following ways:
- Greater reference to organizational strategy and issues;
- Will require more in depth interviews with Top management;
- More emphasis on the adoption of the process approach;
- Requires the identification of relevant interested parties;
- Greater focus on performance indicators;
- Requirements to consider changes affecting organization;
- Requires organizations to assess risks and opportunities;
- Encourages risk-based internal auditing;
- The need establish and maintain the internal audit programme;
- Includes the need for documented information as evidence of effective audit programme implementation;
- Approach internal audits as a risk assessment tool.
Existing ISO 9001:2008 documents
The extent of the documented information will differ from your organization to another because of to the size of organization and its activities, processes, products and services; the complexity of processes and their interactions, and the competence of personnel.
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 quality management system 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;
- Is a source of 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.
Our quality management system templates offer a reliable way of achieving process based compliance to ISO 9001:2008 and will ease the eventual transition to the new version of ISO 9001:2015. The three year transition period, ending in September 2018, is plenty of time to achieve compliance even if you are beginning from scratch!
More on ISO 9001:2015
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