ISO 9001 Requirements
Are you considering obtaining ISO 9001 certification? Are you looking for the most recent ISO 9001 requirements? Everything you need to know about the most recent regulations — monitoring, papers, and records — may be found in this blog
What is ISO 9001?
The ISO 9001:2015 international standard specifies a set of requirements for a system that establishes whether or not a company is capable of continuously providing international-quality products and services. Creating, implementing, and maintaining a Quality Management System (QMS) is a necessity for any business. It formalizes the methods and rules that help a company produce high-quality products and services. Following the ISO 9001 requirements and obtaining ISO 9001:2015 certification is one approach to accomplish this.
What is the Purpose of ISO 9001 Requirements?
ISO 9001 requirements are set out in a document that covers all aspects of an organization’s procedures and processes. The ISO 9001 requirements are to demonstrate that you have these procedures and processes implemented throughout your business, thus ensuring quality management.
By implementing the ISO 9001 requirements, your organization can increase customer experience and satisfaction. Successfully meeting ISO 9001 requirements strengthens a company’s internal structure so that it can provide high-quality services and products while fostering a culture of growth and continual improvement.
When certified organizations follow ISO 9001 quality management standards, clients may be assured that the company has implemented a proper Quality Management System.
Simply said, adhering to ISO 9001 requirements establish your company’s credibility.
ISO 9001 Requirements at a Glance
ISO 9001 requirements specify how you must monitor and measure products, services, processes, systems, and management activities so that managers and staff can:
- Identify and prevent issues that could impact the company.
- See how well you’re doing and take action if needed.
- Satisfy clients and boost customer satisfaction.
To meet ISO 9001 requirements, you must keep documented evidence of all procedures, processes, and services. ISO 9001 requirements emphasize the importance of reviewing QMS activities to determine what’s working well and where improvements can be made. This is part of how your company grows and develops new capabilities that benefit the company in its role within the supply chain. ISO 9001 requirements state that collating, organizing, and managing the many quality records you generate is incredibly important because these papers are crucial for supporting your company’s credibility.
What are the ISO 9001 Requirements?
The following are the mandatory documents and procedures for ISO 9001 Requirements:
- Calibration records for monitoring and measuring equipment
- Training, skills, experience, and qualifications records
- Records of product/service needs
- Records of design review and development outputs
- Records of design and development inputs
- Design and development control records
- Database of design and development outputs
- Records of any alteration of design and development
- Characteristics of the product to be manufactured and the service to be supplied
- Customer property records
- Change control records for production/service provision
- Record of product/service adherence to approval criterion
- Change control records for production/service provision
- Results of the measurement
- Program of internal auditing
- Internal audit findings
- The management review’s findings
- The outcome of corrective actions
Certification Process After Meeting ISO 9001 Requirements
Once your organization has properly documented all ISO 9001 requirements, it’s time to hire a certification body to obtain ISO 9001 certification. The certification body will evaluate your documents and conduct external audits to verify that your organization meets all ISO 9001 requirements. The audit consists of 2 stages:
Stage 1: Preliminary Audit
As per ISO 9001 Requirements, the certification body will conduct an initial audit to determine the following:
- A review of your ISO 9001 Quality Management System’s documentation, including the system’s scope, objectives, and any policies or documents that support the system’s operation.
- A tour of the site to assist with Stage 2 planning.
- To learn about all of the company’s locations from which it operates.
- To learn about important processes, procedures, and any equipment that is employed.
- Determine if all necessary people are ready for the Stage 2 Audit by confirming that all statutory and regulatory requirements pertaining to the organization are documented.
- To find out if internal audits and management reviews have been conducted as per ISO 9001 requirements.
Stage 2: Implementation Audit
After your organization completes the first external audit as per ISO 9001 requirements, the certification body will conduct another audit to verify that all non-conformities have been resolved. The following ISO 9001 requirements will be evaluated during the Stage 2 audit:
- Review of actions done in response to the Stage 1 ISO 9001 Audit to ensure that all progress requests have been completed.
- To inspect documents for confirmation of conformance to the ISO 9001 requirements.
- The overall effectiveness of your management system as per ISO 9001 requirements, as well as whether it is supporting you in achieving the objectives of your company.
- Audit your activities and processes to verify if you have operational control and are adhering to your policies and procedures.
- Internal audits and management evaluations are analyzed.
- Effectiveness of preventative and corrective actions
Once the auditor verifies that your organization has met all ISO 9001 requirements, you will be awarded ISO 9001 certification.
Validity Period of ISO 9001 Certification
If your company successfully meets all ISO 9001 requirements, then the certification body will typically issue ISO 9001 certification for a validity period of 3 years.
Surveillance Audits
In the interim between certification and recertification audits, these audits will be undertaken on a regular basis and will focus on making sure your organization adheres to ISO 9001 requirements. Within the 3-year validity term of certification, typically two surveillance audits at the end of every 12 months.
Re-Certification Audits
Prior to the conclusion of the certification period, a re-certification audit will be performed. Re-certification audits are more extensive than surveillance audits and are similar to the ISO 9001 Stage 2 Audit.
Benefits of Meeting ISO 9001 Requirements
The ISO 9001 certification process is a long journey that your organization must undertake in order to achieve this recognition. If successful, however, you will benefit from many of the following:
- Increased revenue by attracting new customers and better leveraging existing ones
- Gaining a competitive advantage through improved business processes, which results in higher efficiency and customer satisfaction
- Attracting, retaining, and promoting employees who are committed to achieving ISO 9001 requirements
- By creating a quality management system that is more effective than others, your organization can achieve cost savings while also maintaining increased productivity
- Recognition as a company that is dedicated to continually improving its operations by adhering to ISO 9001 requirements
For further information on ISO 9001 requirements, please contact us at info@iasiso.com.
