What is the ISO 9001:2015 standard?
The ISO 9001:2015 standard is the perfect place to start for companies and organizations who are looking to improve the quality of their products. By going through the process of certification for ISO 9001:2015, your company will be able to implement a Quality Management System (QMS) that reduces customer complaints, increases the quality of your products and services, and improves your bottom line.
The standard can be implemented by organizations of any size, industry, or location. There are currently more than 1 million companies that are ISO 9001 certified across the world.
The benefits of ISO Certification include:
- Increase Customer Satisfaction
- Reduced Operating Costs
- Meeting Customer Requirements
- Reduce Waste
- Increase Efficiency
- Globally Recognized Standard
What is the process for getting ISO 9001:2015 certification?
Organizations that are looking to achieve ISO 9001:2015 certification (and most other ISO certifications) need to go through the following broad steps:
- Planning: The certification process will go significantly smoother if your organization plans beforehand. This step includes defining the certification scope, assigning responsibility for the certification process, aligning top management, and conducting a gap analysis.
- Documentation: Specific documentation requirements are defined in the ISO 9001 standard. Your organization will need to prepare these documents which include but are not limited to the following: quality policy, objectives, scope statement, procedures, work instructions, process maps, and more.
- Implementation: After outlining the procedures and processes required to achieve certification, the next step is implementing them. This includes ensuring staff follows work instructions, redesigning work processes, and keeping records on specific metrics.
- Internal Audit: After the standard has been implemented at your facility, the next step is conducting an internal audit. This audit can be conducted by training in-house auditors or hiring a third party. In order to meet the Internal Audit requirements of the ISO 9001 standard, your organization needs to conduct a full internal audit that covers your entire quality management system.
- Certification: After completing an internal audit and addressing deficiencies, your final step before certification is to conduct a Certification Audit, generally arranged for by an independent, certification body.
What is the difference between ISO 9001:2008 and ISO 9001:2015?
The ISO 9001:2015 standard is regularly revised in order to reflect new developments in quality management and modernize the standard to fit new technologies, practices, etc. If you are on a previous version of the standard, you normally have three years to be re-certified in order to achieve the new version of the standard.
The most recent iteration of the ISO 9001 standard was finalized in 2015 and is referred to as ISO 9001:2015.
Integrated Management Systems: The standard also now shares the same structure as all modernized management standards (AKA High Level Structure – HLS). This structure is shared among ISO 9001, ISO 14001, ISO 22000, and more. This update has allowed for the development of integrated management systems between these standards without significant hurdles. For example, if you were to implement ISO 14001 after achieving ISO 9001 certification, specific sections of the ISO 14001 standard would overlap with the 9001 standard – reducing redundancy and allowing for more efficient management.
PDCA Cycle: The ISO 9001:2015 standard’s now incorporates the PDCA (Plan, Do, Check, Act) cycle into its clauses. PDCA is a four step model for continuous improvement. See the breakdown of clauses below:
- Plan: Clauses 4, 5, 6, 7
- Do: Clause 8
- Check: Clause 9
- Act: Clause 10
Risk Based Thinking: Risk based thinking is now a fundamental part of ISO 9001:2015 as companies are encouraged to use risk analysis processes to identify challenges and opportunities through risk analysis techniques such as FEMA, FMECA, HACCP, FTA, HAZOP, PHA, and more.