ISO 9001 is an internationally recognized standard, specifying the Quality Management Systems (QMS) requirements. Organizations follow this standard to depict their ability to provide services or products that effectively and consistently meet the stated customer and regulatory requirements. ISO 9001 was most recently updated in the year 2015, and it is now known as ISO 9001:2015. Organizations of any size or industry deploy this standard to create a system that can help them continuously improve on their services and ensure customer satisfaction.
The ISO 9000 family of standards includes several documents, but organizations can only certify ISO 9001 in the 9000 series. According to the requirements for ISO 9001 certification:
- The size of your organization does not matter.
- It does not matter what industry you are in (service or manufacturing).
- ISO 9001 is not a standard for products. It is a process-based standard to control your processes so that the end product meets the desired results.
- An individual cannot get certified to ISO 9001. However, they can become ISO 9001 Certified Lead Auditor after a five-day training course. On completing it, they receive the pass to audit other companies.
- “ISO Certification” or “ISO 9000 Certification” does not exist; there is only ISO 9001 certification.
- ISO 9001 is not a membership group. Organizations cannot “join” ISO 9001 but can get certified. To obtain certification, organizations need to follow the necessary steps to implement an ISO 9001 QMS. Then a Certification Body will audit your organization’s performance against the ISO 9001 Requirements. On passing the audit, they will issue an ISO 9001 Certificate that will demonstrate that your organization has a registration with ISO 9001. The validity of this certification is three years. Your organization needs to get re-certified every three years to maintain the ISO 9001 certification status.
ISO 9001 Mandatory Requirements
- Monitoring and measuring equipment calibration records
- Product or service requirements review records
- Records of training, skills, experience and qualifications
- Design and development outputs review the record
- Design and development inputs record
- Design and development controls record
- Design and development outputs record
- Design and development changes records
- Characteristics of service to be provided and product to be produced
- Customer property record
- Production or service provision change control records
- Conformity of product or service with acceptance criteria record
- Nonconforming outputs record
- Monitoring measurement results
- Internal auditprogram
- Internal audits result
- Management review results
- Corrective actions results
Non-Mandatory Requirements (But Often Included)
- Procedure to determine the organization and interested parties’ context
- Procedure for competence, training and awareness
- Procedure to address risks and opportunities
- Procedure for document and record control
- Procedure for design and development
- The procedure of equipment maintenance and measuring equipment
- Sales procedure
- Warehousing procedure
- Procedure for production and service provision
- Procedure for management corrective actions and nonconformities
- Procedure for internal audit
- Procedure for monitoring customer satisfaction
- Procedure for management review
What is the ISO 9001 Structure?
- Clauses 0 to 3: Introduction, Scope, References, Terms and Definitions
- Clause 4: Context of the organization
- Clause 5: Leadership and commitment
- Clause 6: Planning for the QMS
- Clause 7: Support & resource management
- Clause 8: Operational planning and control
- Clause 9: Performance evaluation
- Clause 10: Improvement actions
To Conclude:
These are a few essential pointers you need to keep track of to understand ISO 9001 certification better. It will help you set up and operate a quality management system to bring consistent, good-quality products and services to your customers and open up avenues for business growth.
