Steps for certification
Steps for Certification:
- QMS Documented Information.
- QMS Implementation.
- QMS Internal Audit.
- QMS Continuous Improvement and Management Review.
- Registrar Certification
Step 1: QMS Documented Information (Plan):
Your current system, regardless if you have a formal quality management system or not, is assessed, reviewed and updated to meet the requirements of the quality standard. This includes creating additional documented information needed for the QMS. The documented information needed to demonstrate effective planning is the quality manual, procedures, and forms. This could be in any media. The manual is not required for most quality standards, but it is best practice for defining our system. The organization must address PDCA (Plan-Do-Check-Act) methodology, process approach and risk-based thinking.
The QARMA Group helps the organization gather the information, write and review with the organization. This, also, includes guidelines and examples. Documented information review involves the organization and QARMA Group to review and finalize the draft documents, getting them ready for release (Step 2). The process owners/management and QARMA Group make final changes.
This usually takes 6-8 weeks depending on the size of the organization and how much documented information the organization uses within their system and/or additional documented information the organization requires to achieve planned results.
Step 2: QMS implementation (Do).
The QMS (documented information) is ready for release. There may be some minor changes, but QARMA Group helps the organization release all the documents and prepare the documented information to be released throughout the organization. This includes training and initiating data, such as, but not limited to: QMS Orientation training, Risks, Corrective Actions, Risk Mitigation, Improvement Projects, Management Review, etc.
This can be within 1-3 weeks after Step 1. However, it will take approximate 6-8 weeks before Step 3 because the organization must collect data (after implementation) for the audit to demonstrate if processes achieved plan results.
Step 3: QMS Internal Audit (Check).
QARMA Group assists the organization by completing an internal audit on the organization’s QMS. The organization will receive an internal audit plan (scope of the audit), objective evidence record (evidence of where processes conform, need improvement or did not meet planned results), audit report (summary of the process nonconformity and opportunities for improvement), and auditor credentials.
This takes 2.5 days for QMS internal audit depending on the size of the organization and the scope of the audit. Internal Audits are to check whether the organization is meeting the standard requirements, meeting their requirements, and if the QMS is effectively maintained.
QARMA Group, also, assists the organization with addressing findings from the audit and another management review (Step 4). Step 4 can be with 1-2 weeks from completion of Step 3.
Step 4 Continuous Improvement (Act) and Management Review (Check and Act).
QARMA Group assists the organization with addressing findings from the internal audit with corrective actions (to address process nonconformity), risk mitigation (observations that could lead to a potential risk/problem), and improvement projects (opportunities for improvement). QARMA Group, also, assists the organization with another management review.
The organization is ready for the certification process in Step 5, depending on how much time is needed to implement all the actions (corrective, risk mitigation, improvement project) based on the audit findings.
The actions need to be implemented and closed prior to the Registrar Audit.
If you are going for certification for the first time, then there are two stages: Stage 1, and Stage 2. Stage 1 (desk assessment) is where the registrar assesses your QMS and determines if you are ready for Stage 2 (QMS audit). QARMA Group will assist the any issues that need to be corrected from Stage 1. Stage 2 usually takes place 4 weeks or more (depending on the organization) after Stage 1 to give the organization time to address the issues from Stage 1. QARMA Group can facilitate, but cannot interfere with the audit. However, we can help the organization address findings from the Registrar Audit.
If you are doing a transition audit, then there is no Stage 1. However, the organization can request a Gap Assessment by the Registrar if the organization requirements. The same principles apply with the QARMA Group assisting the organization in addressing the findings.
The total days for Stage 1 and Stage 2 is dependent on the scope and size of the company. QARMA Group can help you find the correct registrar that best suits your needs.
When you have received your certification, your organization can celebrate and share the success, improve performance, eliminate deficiencies and increase revenue.
The same principles apply with other systems, such as EMS (Environmental Management System), and IMS (Integrated Management System). There is additional work and time involved in the project.
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