Author: businesbytes

4 Simple Reasons to Have a Documented Procedure for Addressing Risks and Opportunities for ISO 9001: 2015

Posted on by businesbytes

ISO 9000 family of QMS standards helps organisations ensure that they meet customer needs for a product or service in addition to the statutory and regulatory requirements of the industry. The latest version of this standard is ISO 9001: 2015 and mandates that organisations carry out a few activities with regards to the risks and opportunities of the Quality Management System (QMS).

What are the Benefits of Having a Documented Risk and Opportunities Procedure?

While ISO 9001: 2015 standard does not require a documented procedure for this, it is recommended to have one for addressing risks and opportunities. Here are a few reasons why it is beneficial for organisations:

  • Be Consistent: If you are implementing a new process in your organisation, it can be helpful to document it so that you stay consistent. By documenting a new process to address risks and opportunities, you will be able to identify ways to improve the process in the future.
  • Integrate it with Your QMS Effectively: When you want to address risks and identify opportunities, it is easier to create a plan and integrate it with your QMS. By having a documented procedure, you can state how these risks were determined and how the new processes will be implemented.
  • Involve New Members: Even if you have been following a process to identify and deal with risks and opportunities for a long time, having a documented procedure can help you add new members to the team easily. These new members can get acquainted with the process if it is documented as compared to a process that has to be explained verbally since it can lead to confusion and misunderstandings.
  • Check Your Progress: Once you have identified the risks and opportunities, you need a documented risk and opportunity procedure to assess your progress and make changes if required. A short and simple risk and opportunities documented procedure can be a great asset for your organisation.


What is the Cost of ISO 9001 Certification?

The cost of the ISO certification is variable and depends on various factors such as:

  • Industry
  • Territory
  • Region
  • Size of the organisation
  • Certifying agency
  • The stage where the organisation is on its ISO 9001 certification journey

The identification and assessment of risks and opportunities for the QMS can help you create plans to address these issues and fit them into your regular activities. Get in touch with an accredited ISO certification company in India to get started on your ISO 9001 journey. The certification company will also help you document a robust risk and opportunities procedure.

How to Get ISO 13485 Certification in India?

Posted on by businesbytes

What is ISO 13485?

ISO 13485 is an international standard published by the International Organisation of Standardisation (ISO) that shares the requirements for a comprehensive Quality Management System (QMS) for the design and manufacture of medical devices. The products include medical devices in the categories of medical equipment, orthotics, functional aids, diagnostic agents, supplies for dental use, surgical, healing and hygiene products.

The latest version of the standard is ISO 13485: 2016 and meets the requirements of IEC 60601-2-25: 1993 + A1: 1999 safety of Electrocardiograms. It is has kept up with the changes in technology and regulatory requirements in the supply chain for medical devices and related services. ISO 13485: 2016 has replaced ISO 13488: 1996, ISO 13845: 2003, EN 46001: 1997 and EN 46002: 1997.

What is ISO 13485?

Accredited ISO 13485 : 2016 certification has various advantagesincluding:

  • Improved Credibility in the Market: ISO 13485: 2016 is an internationally recognised standard in the medical device industry and helps you gain an edge over your competitors in the market. You can use it as a marketing tool to grab more business opportunities since customers prefer to do business with ISO 13485 certified companies.
  • Happy Customers: A QMS in place for the design, production, installation and servicing of medical devices and related services ensures that the end product will be of good quality and safe for use resulting in fewer issues for customers and consequently lesser complaints.
  • Continual Improvement: One of the key things to stay ahead of competition in this fast-paced world is to seek opportunities for continual improvement. With the ISO 13485 Quality Management System, it becomes a part of the organisation’s culture and everyone is always on the lookout for ways to improve on how everything is done.

How to Get the ISO 13485 Certification?

Irrespective of where you are on your ISO 13485 journey, if you want to getISO 13485 : 2016 certification in India then here is the process for it:

  • Find a reputed ISO certification company for initial consultation to discuss your needs
  • The ISO 13485 certification company will then audit your organisation and carry out a gap analysis
  • They will find out the areas of non-conformity with the standard and give you an action plan to implement the standard
  • Once your organisation has implemented the suggestions, the certification company will audit your organisation
  • If there are no major non-conformities with the standard then the company will issue an ISO 13485 compliance certificate

It is important to note here that ISO 13485 certification is granted for a limited time period. If you want to retain your certification status after this time period, you will have to re-certified by an accredited certification company for compliance or implement the new version of the ISO standard, if applicable.

What is the Difference Between HACCP and ISO 22000 Standard?

Posted on by businesbytes

It is important for organisations in the food industry to follow certain systems so that the end products is safe for consumption for the consumers. HACCP system and ISO 22000 are two of the most popular terms used in the food industry. And yet, most people do not know what they are and how they are different from each other. Let us look at them one by one.

HACCP

HACCP, short for Hazard Analysis and Critical Control Points, is a systematic approach to food safety from chemical, physical as well as biological hazards in the production processes that make a food product unsafe for consumption.HACCP principles were first developed by scientists in the 60s to produce “zero defect” foods for NASA astronauts. It was later converted into an approach, referred to as HACCP system, to food safety and was successfully applied to the food industry. It is a prevention-based food safety system that measures and tries to minimise risks to a safe level.

You can get in touch with an HACCP certification services providertoget help in tailoring the HACCP guidelines to your organisation, auditing to ensure compliance and issuing an HACCP compliance certificate.

ISO 22000

ISO 22000 is a family of standards for Food Safety Management System to help both small and large organisations in the food chain to prepare, pack, distribute and sell food that is safe for consumption for the consumer. It helps minimise food-borne hazards so that high-quality and safe food products are delivered to the final consumer. ISO 22000 incorporates HACCP principles and regulations and weaves it into a broad network which can be used as a management system that not only reduces hazards in the food production processes but also allows constant performance improvement in food safety and manufacturing processes.

Get in touch with an ISO Certification Company in India to get help in implementing the food safety system. The company will then audit your organisation and issue an ISO 22000 compliance certificate if there are no major non-conformities.

Benefits of HACCP Certification and ISO 22000 certification

HACCP is a food safety system while ISO 22000 is a food safety management system standard. Here are the benefits of going for the HACCP and/or ISO 22000 certifications:

  • Strong Brand Image: By availing ISO and HACCP certification services in India, you present yourself as an organisation that is committed to providing high-quality food products to its customers. This helps you create a strong brand image in the market and also makes your customers trust you.
  • Fewer Losses: Any issues with the quality of food at any stage before or during distribution can not only lead to financial losses but also negative press. By following the HACCP system or Food Safety and Management System (FSMS), the organisations can ensure that the end products are safe for consumption leading to fewer recalls and resulting losses.
  • Ease of Taking Part in International Trade:HACCP, which is an internationally recognised certification, eliminates the need for location-specific certifications or registrations and expedites the process of entering new markets across the globe.

If you are an organisation in the food and agriculture industry, you need to make sure that you implement a globally recognised food safety system and convey your commitment to deliver the best products to your customer. Get in touch with a reputed organisation for an HACCP or ISO 22000 certification now.