ISO & API Gap Analysis
The purpose of the Gap Analysis or Gap Assessment is to find the gaps between an organization’s management system and the ISO or API criteria they are aiming to conform with or certify to. The results of the Gap Analysis should outline, clause by clause, what requirements of defined criteria are not being met or cannot be verified as being fulfilled; and what needs to be completed in order to meet those requirements.
A Gap Analysis is an exhaustive exercise, in which every clause of the ISO or API standard is checked for compliance. While a thorough Gap Analysis includes verification of implementation, it is highly focused on reviewing required documentation and records– usually performed from a desk or meeting room. This is why Gap Analyses are also called “Desktop Audits”.
Contact Mireaux and let our expert Auditors gauge your progress and efforts toward certification. Call us at 713-589-4680.
Mireaux’s Consulting services involve full turnkey assistance in the development and implementation of management systems that conform to the desired ISO, or API standards.
Web QMS Software
Cloud-based, secure and powerful, our Web QMS software helps you achieve, maintain, and improve your ISO and API certifications, allowing your employees full access and visibility to your management system – anytime, anywhere.
- Approved Supplier List -> Supplier Corrective Actions
- Asset Register
- Behavioral Base Safety (BBS)
- Business Continuity Plan (BCP)
- Calibration -> Out-of-Tolerance Conditions
- Communication Plan
- Conformity Matrix
- Contingency Planning
- Corrective Action
- Critical Processes
- Critical Services and SRP
- Customer Complaints
- Customer Property
- Customer Satisfaction
- Emergency Contacts
- Emergency Preparedness
- Employee Certifications
- Employee Handbook
- Equipment Maintenance
- External Audits -> External Audit Findings
- External Documents
- HSE Manual
- HSE Policy
- Information Security Incidents
- Internal Audits -> Internal Audit Findings
- Inventory Control
- ISMS Manual
- ISMS Policy
- Job Descriptions
- Job Safety Analysis (JSA)
- Lessons Learned
- List of Legal Requirements
- Main Process Map
- Management of Change (MOC)
- Management Reviews -> Management Review Action Items
- Monitoring and Measuring
- Nonconformance Report (NCR)
- Organizational Charts
- Preventive Action
- Procedures, Work Instructions & Forms
- Product Quality Plans
- Quality Manual
- Quality Policy
- Records Retention
- Risk Assessment -> Significant Risks
- Safety Incidents
- Service Quality Plan
- Short Service Employee (SSE)
- Special Interest Groups
- Statement of Applicability
- Training Events
- Training Plan
Frequently Asked Questions
Yes, starting on April 1, 2020 Mireaux began providing Remote Auditing, which applies to Gap Analyses. When conducting a Gap Analysis remotely, Mireaux will allocate a similar amount of time for the auditing portion however there will be additional planning and setup to ensure that all needed information is available during the audit.
A Gap Analysis is beneficial when an organization has implemented some elements of the ISO or API standard desired. In this case, a thorough Gap Analysis will provide a clear indication of how close or how far the organization’s management system is in relationship to the ISO or API standard being sought.
However, if the organization does not have any elements of a management system in place, and has not worked much towards meeting any of the requirements of the ISO or API standard desired; then a Gap Analysis is not recommended. In fact, having a Gap Analysis in this situation, is likely to yield a huge gap –as you are lacking just about everything – which may already be evident to your team. If this is your case, save your money and put it towards resources for implementation.
A Gap Analysis may be conducted once or twice while the organization prepares for their certification audit – to get reassurance that their implementation efforts are moving them closer to meeting all requirements of the ISO or API standards being sought.
Having a Gap Analysis at the onset of the certification journey is worthwhile. It should provide clear guidance on the direction to take and provide assurance that you are (or are not) in the right track.
If time and budget allows, a second Gap Analysis could also be helpful before the External Audit or Certification Audit. At this point, the results of the Gap Analysis should provide confirmation that the organization is indeed ready for certification. A type of audit called Pre-Assessment – often conducted by the Registrar or Certification Body themselves – can be equated to this Gap Analysis.
Mireaux can help your organization tremendously towards achieving your desired ISO or API goals, by conducting a thorough Gap Analysis that can provide a clear roadmap to certification. Having Mireaux conduct your Gap Analysis also provides a chance for your team to discuss face to face with an expert, areas that may need attention in order to close the gaps.
Additionally upon completion of the Gap Analysis, Mireaux issues a comprehensive Gap Analysis Report that contains a detailed clause-by-clause analysis of the ISO or API standards being sought, providing for each clause:
- Details of the Gap
- Recommended actions to close the Gap
- Evaluation compliance on a scale of 1 to 5
Mireaux’s Gap Analysis Report also provides an overall percent of compliance, to give the organization a good idea of their “grade” and the road ahead.