What is Certification? Why is it important?

Certification is the provision by an independent body of written assurance that the product, service or system in question meets specific requirements. For some industries, certification is a legal or contractual requirement. 

Benefits of being certified?

• Quality assurance

• Strong marketing tool to attract and/or increase business 

• Enhances consumer confidence

• Proof of regulatory compliance

• Risk Management

In a global marketplace, checks and balances need to be in place. Otherwise, it would be difficult to maintain consistency and quality across industries and nations. International standards help to keep a level playing field, and one such organization is ISO. 

What is ISO Certification? 

ISO certification certifies that a management system, manufacturing process, service, or documentation procedure has all the requirements for standardization and quality assurance. ISO (International Organization for Standardization) is an independent, non-governmental, international organization that develops standards to ensure the quality, safety, and efficiency of products, services, and systems.

ISO certifications exist in many areas of industry, from energy management and social responsibility to medical devices and energy management. ISO standards are in place to ensure consistency. Each certification has separate standards and criteria and is classified numerically

Types Of ISO Certification

ISO (International Organization for Standardization) has come up with more than 20000 International standards covering different types of industries like food, technology and service, healthcare and agriculture. 

Popular ISO certification standards include:

1. ISO 9001

ISO 9001 sets out the criteria for a quality management system. It ensures that customers get consistent, good-quality products and services, which in turn brings many business benefits.

2. ISO 13485 

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services

3. ISO 14001

ISO 14001 sets out the criteria for an environmental management system.

For companies and organizations of any type that require practical tools to manage their environmental responsibilities

4. ISO 17025 

ISO 17025 enables testing & calibration laboratories to demonstrate that they operate competently and generate valid results.

5. ISO 22000 

ISO 22000 sets out the criteria for a food safety management system. It provides a layer of reassurance within the global food supply chain, helping products cross borders and bringing people food that they can trust.

6. ISO 27001 

ISO 27001 sets out the criteria for an information security management system. Enables organizations to manage the security of assets such as financial information, intellectual property, employee details or information entrusted by third parties.

7. ISO 45001

ISO 45001 sets out the requirements for occupational health & safety management systems. Enables an organization to provide safe and healthy workplaces by preventing work-related injury and ill health

8. ISO 50001

ISO 50001 specifies requirements for establishing, implementing, maintaining and improving an energy management system. The intended outcome is to enable an organization to follow a systematic approach in achieving continual improvement of energy performance.

 Process involved in getting ISO Certification in South Africa

STEP 1:

KICKOFF MEETINGS

Kickoff meetings are an essential tool to communicate and plan for the execution  of the project with minimal obstruction and to complete the project within  planned time and cost.  

Agenda for the kick off meeting is:  

• Project plan discussion - This includes discussion about accountability and   responsibility of stakeholders. Milestones and deliverables in the project  
• Scope of services and scope of certification 
• Legal and regulatory requirements

STEP 2:

CREATION OF CORE TEAM  

• Appointment of ISO Leader 
• Appointment of Quality team 
• Appointment of Internal Auditors 

STEP 3:

GAP ANALYSIS 

During this phase, a gap analysis is done to check how much of your  current practices are in line with the requirements. Your current practices are verified against these four reference criteria.  

• ISO 9001 standard requirements 
• Legal, statutory, regulatory requirements 
• Client requirements 
• Internal policies and procedures  

The results of this analysis are presented in the form of a Gap Analysis  Report. This report acts as the list of action items for the reminder  of the project.  

STEP 4:

QMS AWARENESS TRAINING  

QMS awareness training will be conducted to the employees of your  organization. The training session is to help employees to gain knowledge,  understand the concepts of ISO 9001, and align processes and practice  towards achieving higher customer satisfaction, via better  

understanding of the customer requirements and customer centered services.  When the staff have been trained they can think & act and contribute towards  achieving the goals. 

STEP 5:

QUALITY RISK ASSESSMENT (QRA) 

A Risk Management procedure shall be documented and used as reference to manage the identified risks in consultation with all function heads. Usage of ISO 31000 techniques to identify, document, prioritize, quantify and identify Internal and External risks. A thorough risk assessment is required  to ensure effective risk control. This step creates a Risk Register.  Suitable mitigation plans are identified by using the hierarchy of risk control  (Risk Management) based on the risk level, severity and likelihood. Establishment  of proactive culture to improve the customer’s satisfaction.  

STEP 6:

DOCUMENTATION  

List the policies, processes, SOPs, work instructions and records that need to be defined and documented as per ISO 9001.  By discussing with each department and function heads & creating the necessary documentation. This would be followed by SOPs and  record templates being made available for the team to operate and record the information.

STEP 7:

ESTABLISH CONTROLS  

Once the policies, processes and SOPs have been documented and the list of records to be collected has been listed and personnel have been identified and trained on such activities, then the need is to operate, monitor and  review the efficiencies of such processes.  

STEP 8:

INTERNAL AUDITOR TRAINING  

ISO 9001 Internal Auditor (IA) Training will be provided to the identified personnel. This training will equip such personnel to analyze the need for IA, plan and schedule IA, prepare audit checklists, conduct an IA and to  document and report their observations to the top management. 

STEP 9:

INTERNAL AUDIT 

This internal audit will identify still existing gaps in the system and demonstrate the level of preparedness to face the certification audit.  This audit gives the organization a chance to identify and rectify all  non-conformances before proceeding to the certification audit.  

STEP 10:

ROOT CAUSE ANALYSIS (RCA) AND CORRECTIVE ACTIONS  

All non-conformances identified during the internal audit, client or third  party audits or from Risk Assessment, Customer Feedback, Complaints,  Internal and External issues, daily walk through and any other sources have to be listed and a RCA has to be performed. The optimal correction and corrective actions are  implemented and the effectiveness of such actions is documented and  reviewed via a Corrective Action Report (CAR).  

STEP 11:

MANAGEMENT REVIEW MEETING (MRM)  

The MRM is an opportunity for all stakeholders to meet on scheduled  intervals to review, discuss and plan actions on the below agenda points. 

• Risk Assessment 
• Audit findings and non-conformances from all sources. Action plan to resolve any open items.  
• Possible changes that might affect the system 
• Improvements made to the system 
• Resources, trainings required 
• Opportunities for improvement  
• External provider and supplier’s performance 
• Customer Satisfaction and Feedback from the relevant interested parties  
• Statutory regulations 
• Extent to which Quality objectives have been made  
• Changes that could affect the system i.e. regulations or legislation 

STEP 12:

CERTIFICATION AUDIT: STAGE 1  

When the levels of preparedness have reached adequate levels, the process for certification begins. An appointed auditor of the Certification Body (CB)  verifies the preparedness via a stage 1 audit. This involves the auditor  reviewing the policies, processes, SOPs, Risk Assessment, critical operational records, IA and MRM records. Any major deviations from the CB’s expectations  will be notified at this point for bringing in the necessary corrections.This reduces the chances of major non-conformances during the certification audit.

CERTIFICATION AUDIT: STAGE 2  

On successful completion of Stage 1 audit, the auditor embarks on a detailed  audit of the practices and documentation of the QMS system of the organization.  TOPCertifier would have trained your personnel on the audit requirements and  on confidently facing the audit. Our experts will be present to assist in any  means necessary for the smooth functioning of the audit. TOPCertifier will  assist your team to close any non-conformances identified during the audit.  Upon successful completion of the certification audit, TOPCertifier will liaise  with all stakeholders to draft, approve and release the final certificate.  

STEP 13:

CONTINUATION OF COMPLIANCE  

TOPCertifier will be part of your organization’s compliance journey and assist  you at regular intervals with necessary training, system support and updates, internal and external audits and regular renewal of your certification.

Benefits of ISO Certification:

• Professionalism

The key to quality and efficiency is professionalism. Following the principles and ethics of the organization is of foremost importance for any employee. Your organization can be a top competitor in your domain.

• Improved work culture amongst the Management and  Staff 

The Management and staff become more knowledgeable about the various procedures involved in smooth running of the organization and creates a more resourceful environment.

• Simplified and efficient operational procedures

The processes, procedures involved in production are simplified and responsibilities are equally distributed amongst the staff. Develops the trust and bond between the staff, reducing complaints.

• Consumer safety, trust and satisfaction 

Consumer confidence enhances when your product exactly matches the consumers’ expectations. Be it in terms of quality, safety, eco-friendliness and reliability. Better quality ensures little to no complaints from the consumers. When the quality control management of the organization is good, you get to know what your consumer needs and always strive to meet that demand which in turn enhances trust and loyalty.

• Improves Brand value 

Your organization gains professional status amongst the public and gets worldwide recognition, thereby enhancing its brand value.

• Boosts stability and consistency 

It develops a sense of trust amongst the consumers that your products/services consistently are of the required standards and there are no irregularities or compromises in the quality.

• Increased revenue and profit

If a product/service is ISO certified, then it is reliable and trustworthy, its brand value increases, therefore people consistently buy it which enhances the revenue of the organization and the organization becomes profitable. 

• Your organization gains international recognition and improves trading 

Trade barriers between the countries will be broken if your organization is ISO certified.

Import and export of various resources becomes easy if there are no trade barriers. Certain raw materials are cheaper in some countries. So importing those raw materials will be easier and the cost of your end products can be priced competitively.

What is the Cost of ISO Certification?

There is no fixed cost for getting an ISO Certification. It varies from one organization to another.

Some of the factors that affect costing are the number of employees, type of services offered, risks associated with the company, complexity of the management system and many such factors.