Develop a Quality Management System that defines your processes and procedures for doing business, and conforms to the standard, Define organization’s purpose, Define quality policy and objectives of your organization, Identify and document processes that are needed to produce your product/service
Develop Quality Manual, Develop documented procedures required by the standard. Policy, objectives, SOP, work instruction, Implement your Quality Management System.
Communicate and provide training, Perform Internal Audit, Conduct Management Review
Have Certification Audit performed by your Certification body, Quality System should be in place 2-3 months prior to Certification Audit.
Example: The Certification process
shall consist of following key stages :
Step 1: Preparation. The first step addresses how to best prepare for the implementation of ISO 9001 at your small or midsize company - including making a decision on your certification approach.
Step 2: Documentation as per the apply of standard
Step 3: Implementation of documentation
Step4: Training plan for awareness of standard documents
Step 5: Internal Audit
Step6: Management review meeting
Step7 :Organization ready for apply of ISO Certification
Step8: Select Certification body (Example TNV certification Pvt Ltd)
Step 9: Application/enquiry process
Step 10: Review Process
Step11 : initial Certification Audit (Stage1 & Stage2 )
Purpose of Stage1 Audit : Assess client’s Documented Management System, Evaluate your Locations and any site-specific conditions, Assess your understanding of the requirements of the standard, Agree the scope of your Documented Management System, processes and location(s) and related statutory and regulatory aspects and associated risks, Plan the Stage 2 Audit and establish your planning arrangements for Internal Audits and Management Reviews.
Purpose of Stage 2 Audit : The purpose of the stage two audit is to evaluate the effective implementation of the client’s management system. As a minimum, you must audit the following and your report must show clear audit evidence against these requirements. Audit evidence is documents and records that you have seen, staff/employees that you have spoken to, part numbers or project numbers that you looked at, equipment serial numbers, activities that you observed, or any other evidence that you verify during the audit.
Step12: Closure of NC
Step13: Issue the certificate
Step14: Surveillance Audit
Step15: Re-Certification
Certification
Investment?
Below are the main costs associated with achieving ISO certification.
Internal costs associated with planning, developing, documenting and implementing the QMS including
· Gap Analysis
· Training and awareness
· Internal quality audits
· Management Review meeting
· Preparing Manual & Procedures and documentation implementation
Certification body -Registrars
costs
· Application fee, administrative and maintenance fees.
· Pre- assessment – optional
· Certification audit - cost dependent on size and complexity of organization
· Surveillance audits - cost dependent on size and complexity of organization
· Travel expenses
Optional
costs
· External training
· Consultant services
User questions & answers