Posts in category: ISO Blogs

What is ISO 22000?

Food Safety Management System that can be applied to organization which is into food production and export. caring the label of ISO 22000 certified allows company to showcase that they have strong system to protect the food and also boost customer’s confidence in the product. This is a key requirement, since the customers push for a safe food and producers expect that the raw materials supplied by the suppliers should be safe. IT hub Brazil is attracting more and more human resource and companies to foot print in the land and do business, to satisfy the food desire they start walking into producers of safe food. ISO certification shall help the food business agents to attract more customers.

What are the ISO 22000 requirements?

ISO 22000 pushes the producers and suppliers to design and document a strong Food safety management system. The standard contains the specific requirements to the implemented, followed, monitored and continually improve.

Requirements are:

•  Having holistic food safety policy drafted by the top management for the organization.
•  Set objectives that will push human resource to stay comply with the policy.
•  Form a strong food safety management team and appoint an Leader for the same
•  Frame up a strong communication procedure for both internal and external parties.
•  Providing competent resources, infrastructure and right environment for the effective operation of the FSMS
•  Having a strong HACCP and emergency plan
•  Framing up the HACCP plan as per the HACCP principles.
•  Defining a traceability system for identification of defect product.
•  Checking out if the system is in compliance with the FSMS.
•  Performing internal audit to check out the compliance thing, take a corrective action on the non conformity of product.

Prerequisite programs – ISO 22000

Prerequisite programs (PRPs)

Prerequisite programs are general programs and practices induced into the system to have a clean to do items in producing safe food products

ISO 22000 expects that the organization must push in the  programs to control the likelihood of introducing hazards through the work environment. it also helps organization to identify the areas to be focused and trained, for example pest control programs , personnel hygiene etc.

Operational Prerequisite programs (OPRPs)

ISO 22000 expects that the organization must push in the  programs to control the likelihood of introducing hazards through the work environment. it also helps organization to identify the areas to be focused and trained.

ISO 22000 procedures for food safety management system can help to get ISO 22000 certification audit faster for Food industries.

Following is the list of mandatory ISO 22000 procedures helped in food certification.

1. Procedure For emergency preparedness and response
2. Procedure for Product Withdrawal
3. Procedure For Pre-requisite Program
4. Procedure For HACCP Plan
5. Procedure For Hazard Identification Procedure
6. Procedure For Control Of Non-Conforming Products
7. Procedure For Internal Quality And Food Safety Audit
8. Procedure For Control Of Monitoring And Measuring Devices
9. Procedure For Management Review
10. Procedure For Document And Data Control
11. Procedure For Control Of Quality Records
12. Procedure For Corrective action.

Advantages of attracting ISO 9001 in Brazil

1. Attract Tender /Contract :
The primary reason to attract ISO 22000 in any location and by  businesses is to maximize the business opportunity by attracting tenders/contracts.

2. Improvement of customer satisfaction
One of the key elements in this international standard is to improve customer satisfaction. By improving the satisfaction level customer retention is at higher side, such customers help directly or indirectly in generating more business.

3. Increase your credibility and image
By getting your business ISO certified, credibility and image of your brand runs up sharp in the international and domestic market. When a company is looking for supplier or service provider, it is often a requirement to have a clean system in order to consider.

4. Improvement of employee satisfaction
The staff is highly satisfied and pumped up once there are clean roles, responsibility and accountability, a well defined show of how the roles of the staff create a impact on quality and overall success. This international standard will help organization frame up a structure that helps staffs morale increase.

5. Increased business

Research has proven that ISO certified companies have shown improvements in the area of finance. The ISO certified image attracts more business in both domestic and international market.

6. Process Consistency
A well documented system helps in minimizing process related errors. Even a minor change in the process has to be documented and implemented in best possible pattern.

How to get ISO 22000:2018 certification in Brazil– Consultants in Brazil ?

Our masters have more than 10 plus years of global experience, with hands-on experience in the field of  ISO certification, assessment and training.

“ISO 13485 Certified” means an organization has implemented an ISO 13485 Quality Management System and has successfully met all of the requirements in ISO 13485. ISO 13485 evaluates whether your Quality Management System is appropriate and effective while emphasizing the safety and efficacy of medical devices.

ISO 13485 Certification incorporates 8-clauses, three of which give direction on the expected utilization of the standard. The staying five provisos give the system to what is required of associations committed to clinical gadget creation. In this way, this is what to expect so as to accomplish consistence.

6 steps to ISO 13485:2016 certification
Planning the quality system. S
Meeting regulatory requirements. While developing your quality plan, U.S. medical device companies must comply with FDA 21 CFR 820.
Implementing design controls.
Documents, records, and training.
Management processes.
The Certification audit.

Benefits of ISO 13485 Certification
Expansion in national and international market Access (Increase device sales by accessing more national and international markets.)
Meet and regularly monitor Regulatory Requirements
Gain a competitive edge
Reduced cost of sales
Improved performance

Integrated Services :
ISO 13485 can be integrated with ISO 9001
ISO 13485 can be integrated with ISO 14001
ISO 13485 can be integrated with ISO 45001
ISO 13485 can be integrated with ISO 27001
ISO 13485 can be integrated with CE Compliance and certification

What is ISO 27001?

ISO 27001 is a globally accepted international standard published by international standardization organization (ISO), it pushes company on how to manage information and protect it. The current version of this standard was published in 2013 with 10 clauses and 114 controls. The previous version of the standard was published in 2005, it was developed by modeling BS 7799-2.ISMS can be implemented in any kind and size of the organization.

Why iso 27001 for your company?

There are several business benefits that a company can attract by implementing ISO 27001, key benefits are explained below:

Legal requirements – when running an organization , that should comply with multiple legal and regulatory requirements associated to information security, ISO 27001 will act as a tool for the for resolving the requirements, this standard gives a holistic methodology to comply with.

Marketing advantage – By getting your business processes certified even before your competitors, you may have a strong advantage over them and shall attract more customers.

Control costs – by implementing the controls an organization can prevent security incidents from occurring. By preventing them, the company can save a lot.

Disciplined organization – to match with the current trend, organization keep running fast to stay ahead in the market, result of this leads to less focus on the system and employees, by implementing ISO 27001, an organization can have a very good system, and keep employees happy.

What is the exact structure of ISO 27001

ISO 27001 own in total 10 clauses, plus Annexure A. clauses 1-3 are just the introduction and non mandatory, while clauses 4 to 10 are mandatory – which only means that all the requirements must be implemented in an organization to stay in compliance with the standards requirements. Statement of applicability has to be pushed in to implement the controls.

Clause 1: Scope – Narrates to all organization this standard can be implemented.

Clause 2: Normative references – this refers to ISO 27000 where elements are given to implement ISO 27001

Clause 3: Terms and definitions – refers to ISO 27000

Clause 4: context of the organization – this clause falls under plan window in Deming cycle (PDCA) and defines requirements for understanding external and internal issues, interested parties and their requirements, and defining the ISMS scope.

Clause 5: Leadership – this clause defines top management responsibilities, setting the roles and responsibilities, and developing information security policy, falls under plan window in Deming cycle.

Clause 6: Planning – helps organization to perform risk assessment, treatment, in developing statement of applicability and setting the information security objectives.

Clause 7: Support – defines the requirements for availability of resources, competences, communication and control of documents and records.

Clause 8: Operation – pushes organization to implement the items defined under clause 6 , so that the information security objectives are meet.

Clause 9: Performance evaluation – this clause helps organization to perform internal audit and management review meetings.

Clause 10: Improvement – defines the requirements for nonconformities, corrections and continual improvement.

ISO 27001 implementation Items are:

1. Define the ISMS scope
2. Write the top level information security policy
3. Define risk assessment methodology
4. Perform risk assessment and treatment
5. Frame up statement of applicability
6. Perform awareness programs
7. Perform internal audit
8. Perform MRM

​ISO 45001 certification – Implementation steps

1. Kick off Meeting
Kick off is the first and key meeting with the process owners and Top Management. This meeting introduces the process owners of the team and drives to discuss on the ISO project plan, roles and responsibilities of the ISO consultant and process owners.

2. Awareness program
Awareness program is an interactive program designed to provide all the team members with the basic elements on what is ISO, standard and implementation items.

3. Gap Analysis
Gap analysis is a tool used to analyze the current performance and performance expected. The gap items are then escalated to the process owners and top management. Consultant will put forward a report on what steps should be taken to meet the performance expected.

4. Documentation Training
Documentation training is an interactive program designed to provide the process owners/document controller on how to frame a standard operating procedure (SOP) and records (Evidence).

The same will be explained using the standard template designed by the ISO consultant specifically for the organization and opted standard.

5. Documentation Review
Document review is a formal assessment performed to check how well the team has framed the standard operating procedure and records. If any gap is noticed during the review, consultant shall feed in the change items to process owners.

6. Internal Audit Training
Internal audit is a simple and effective tool available in the ISO to check on how strong the system/process is constructed .The consultant will deliver an interactive program on how to perform and who all will be performing the internal audit.

7. Internal Audit
A simple and effective tool available in ISO, performed to check on how strong the system / process is constructed. This activity is performed by the process owners with the help of ISO consultant. If any to be changed/improved items are picked during the audit, the items are pushed to Management for the corrective action.

8. Management Review Meeting
Internal Audit gap and to be improved items are discussed with top management and process owners to take effective action on the same.

9. Shade Audit
Consultant will perform a pre-assessment to check on if the system is in compliance with the Standard, Customer, legal and organization requirements. This is performed before the External Audit.

10. External Audit
Final assessment on the system is performed by a certified Auditor. ISO consultant will assist the team during the audit.

How to get ISO 27001:2013 certification in Brazil – Consultants in Brazil ?

Our masters have more than 10 plus years of global experience, with hands-on experience in the field of  ISO certification, assessment and training.