What Exactly is ISO Certified? And Why Does it Matter?

What is ISO 9001?

ISO 9001 is the international standard that specifies requirements and best practices for a QMS. Being ISO 9001 certified means an organisation is able to demonstrate the ability to consistently deliver products and services that meet and exceed customer and regulatory expectations. The latest version of the standard is known as ISO 9001:2015 and is used by over a million organisations worldwide across all industries and sizes.

ISO 9001:2015 specifies requirements for a quality management system where an organization

• needs to demonstrate its ability to consistently provide a product that meets customer and applicable statutory and regulatory requirements, and
• aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

What is a Quality Management System (QMS)?

A QMS is a documented system that outlines the processes and responsibilities for achieving an organisation’s quality and continuous improvement objectives. A QMS should be internally developed and tailored to the organisation and its customer’s needs.

ISO recommends that an effective QMS should be designed to achieve the following 7 quality management principles:

1. Customer focus: meet and exceed customer needs
2. Leadership: unified direction and purpose across management and employees
3. Engagement of people: ensure competent and engaged staff. Employees should have sufficient training and support to do the job right
4. Process approach: well understood internal processes to improve efficiency
5. Improvement: proactive approach to driving improvement and adapting to changing conditions
6. Evidence-based decision making: quality metrics are established, measured and acted upon to drive continuous improvement and ROI
7. Relationship management: identify and effectively manage key stakeholder and supplier relationships

A documented QMS does not have to be aligned or certified with ISO 9001 to achieve a company’s quality and improvement objectives. Each business should weigh the benefits and burden of going through an ISO 9001 certification process.

Pre- Requisite to ISO Certification

Choosing the type of ISO Certification

First of all, you need to choose the type of ISO certification required for your business. There are various types of ISO certification available such as :

• ISO 9001 2015 — Quality Management
• ISO 14001 — Environmental Management
• ISO 27001 — Information security Management
• ISO 22008 — Food Safety Management and so on.

Choosing an ISO Certification Body

It must be noted that ISO itself does not provide certification to the companies. Certification is done by the external bodies. It is very important that you choose a recognised and credible certification body.

While choosing the ISO registrar, you should keep the following in mind:

• Evaluate several ISO Certification service providers.
• Check if they are following the CASCO standards. CASCO is the ISO committee that works on issues relating to conformity assessment.
• Check whether it is accredited or not. Accreditation is not compulsory but they must meet the requirements of ISO Accreditation bodies.

Steps involved for ISO Certification

1. Create an application /contract

The applicant and the registrar should agree on a contract. This contract usually defines rights and obligations of both parties and includes liability issues, confidentiality, and access rights.

2. Quality Documents Review

The ISO auditor will view all your quality manuals & documents related to various policies & procedures being followed in the organisation . Review of existing work will help the ISO auditor to identify the possible gaps against the requirements stipulated in the ISO standards.

3. Make an Action Plan

After the ISO auditor communicates the existing gaps in your organization, you should prepare an action plan to eliminate these gaps. Prepare the list of the required tasks to be performed to bring the desired changes in your organization. You may be required to give training to your employees to work efficiently while adapting to new procedures. Make all the employees aware of the ISO standards in terms of work efficiency and quality standards.

4. Initial Certification Audit

The initial certification audit is divided into two categories- Stage 1 & Stage 2.

Stage 1: The ISO auditor will audit the changes made by you in the organisation . They will then try to identify the possible non-conformities in your systems and procedures to the desired quality management system. They will divide these non-conformities into minor and major non-conformities. The applicant must carefully assess all these non-conformities and get it aligned as per the desired quality standards through modification in the techniques and processes used by the organisation.

Stage 2: After all the required changes are done in the organisation, the ISO auditor does the final auditing. The auditor will check whether all the non-conformities have been eliminated or not as per ISO quality standards. If the ISO auditor is satisfied, they will prepare the final ISO audit report and forward it to the registrar.

5. Completing the ISO Certification

After all non-conformities are addressed and all the findings are put in the ISO audit report, the registrar will grant you the ISO certification.

6. Surveillance Audits

Surveillance audit is basically conducted to ensure that ISO quality standards are being maintained by the organisation . It is conducted from time to time.

Cost involved in the ISO Certification Process

Cost for getting ISO certification is not fixed and varies from organisation to organisation . The ISO certification agency calculates the cost of ISO certification separately for each organisation after considering them on different parameters such as :

• Number of employees
• Number of Processes
• Level of risk associated with the scope of services of the organisation
• Complexity of the management system
• The number of working shifts etc.

Time taken for ISO Certification Process

Time taken in completing the whole process of ISO certification also varies from organisation to organisation . The fair idea can be given by the ISO certification agency after assessing the size of the company.

Generally, the time required to complete the process of ISO certification is approximate :

• Small organisations: 6–8 months
• Medium organisations: 8–12 months
• Large organisation: 12–15 months

What are the benefits of ISO 9001 quality management system

The advantages of ISO 9001 are not overstated. Companies large and small have gained great benefits from using this standard by discovering cost and efficiency savings. Here are the explanations of six main benefits of an ISO 9001 quality management system and why they are important:

• Improvement of your credibility and image
• Improve the Quality of Products and Services
• Meet the Requirements of Potential Business Partners
• Better process integration
• Drive Customer Satisfaction
• Leadership Engagement
• Improve your evidence for decision making
• Improve Company Culture

References

https://www.iso.org/certification.html

https://www.iso-9001-checklist.co.uk/iso-checklists-eur.htm

https://safetyculture.com/

https://www.process.st/