Sample Action Plan for Implementing ISO 9001:2015
By Lynn Clyde, BRC Quality Consultant
The ISO 9001 standard is revised every several years to ensure that it is relevant for the marketplace and that it continues to offer the best possible practices for your Quality Management System. The ISO 9001:2015 international standard was officially released in September 2015, and organizations have 3 full years from the date of release to update their QMS to the new requirements. This means that organizations will be required to have their QMS meet the new requirements by September 2018 at the latest, and ISO 9001:2008 will no longer be recognized.
When transitioning to the new version, organizations may consider the following action plan. Keep in mind that this plan is not all inclusive and every organization will be different, depending on the existing QMS that is in place. This is a guideline and the action items do not necessarily need to be conducted in this order, but it is strongly recommended that the first few items be addressed first.
1) Presentation to leadership on the new requirements of the standard. Consider the information in the IRCA white paper “ISO 9001:2015 Understanding the International Standard”. Visit the BRC Resource Library or download a copy directly.
2) Establish a steering committee for the transition to ISO 9001:2015. Hint: this should involve “leadership”. J
3) Conduct a Gap Analysis
4) Determine/clarify context of the organization (4.1).
- Identify internal/external issues.
- Consider conducting SWOT/PEST/LE analysis.
5) Determine/clarify interested parties and their needs and expectations (4.2).
6) Review/clarify the scope of the QMS (4.3).
7) Review the processes of the organization, ensuring they include the required information for the process approach (4.4). This could also be done later in the implementation.
8) Review quality policy to ensure alignment with context and strategic direction (5.2). Communicate it to the organization – again and again and again….
9) Identify risks and opportunities throughout the organization (6.1, etc.). Consider identifying them for all key processes/projects and significant changes to the QMS.
10) Review quality objectives for alignment to the policy and strategic direction, ensuring they are measured, evaluated and there is an action plan to achieve them (6.2).
11) Consider developing a communication plan for all key communications in the organization (7.4). Note: there is no requirement in the standard to maintain this as documented information.
12) Communicate the requirements of ISO 9001:2015 to the entire organization (7.3). Ensure that all employees understand:
- the quality policy;
- the quality objectives that are relevant to them;
- their contribution to the effectiveness of the QMS and benefits of improved performance; and
- implications of not conforming with the QMS requirements.
13) Ensure there is a system for addressing change management (6.3 & 8.5.6).
14) Determine/clarify the systems for capturing and maintaining organizational knowledge (7.1.6).
15) Review monitoring, measurement, analysis and evaluation, including customer satisfaction (9.0).
16) Conduct internal audits to the new version of the standard (9.2). This can begin as the new version is being implemented.
17) BRING ON THE REGISTRAR!!