Getting certified with the world's leading food safety management standard.
Getting certified with the global standard used by healthcare industry.
Getting certified with a globally accepted indication of security effectiveness.
Establish a complete and effective medical device regulatory strategy.
Increase product and service quality with Stendard's ISO consulting.
Our consultants are highly qualified and experienced in various ISO standards and have serviced multiple clients from different industries. Together with the use of our propriety software Stendard Solution™, we pride ourselves as a one-stop service for all your regulatory needs.
With our myriad of expertise, Stendard’s ISO consultancy can help your organisation by providing specific consulting and training services for various ISO management system.
We can guide you through your ISO consultancy journey, which includes the certification or compliance to various ISO standards by assisting in the establishment, implementation, improvement and simplification of your business processes as well as the training of your organisation.
Our experienced consultants can set up a new, existing or integrated management system for your organisation as part of your ISO consultancy journey. Some examples of an integrated management system include the establishment of:
This will ensure your organisation’s resources are maximised, preventing the management of two separate management systems.
Our ISO consultants will also assist in the certification audit follow-up actions, ensuring that your organisation obtains the ISO certificate.
Rest assured, as our ISO consultants will see through the whole ISO consultancy process to meet your needs!
Our consultants can assess if your existing system complies with the current requirements of the ISO standard as part of your ISO consultancy journey. With the gap analysis report provided, your organisation will be able to gauge the percentage of compliance to the desired ISO standard.
Our consultants can conduct first, second, and third-party audits per the ISO 19011 Guidelines for auditing management systems standards for your organisation ISO standards’ requirements on various management systems as part of your ISO consultancy journey. This can be done by checking if proper processes and implementation are practised for your team and outsourced suppliers.
Through these audits, we can identify gaps from the audits and guide you and your suppliers through the rectification process before the actual certification audit commences. This would include the follow-up actions if any findings were detected.
In addition, our consultants will also identify areas of improvement such that your organisation adopts the best practice during the implementation of various ISO standards.
Our consultants can also provide ISO training to further expand your organisation’s knowledge as part of your ISO consultancy journey. Stendard has a wide range of online courses that suit your organisation’s training needs.
We also offer face to face training sessions for our clients who prefers learning in person.
Suppose human resources might be an issue for implementing your organisation’s desired ISO standards. In that case, our consultants can also act as your outsourced QARA / MR, leading and guiding your respective teams within your organisation during your ISO consultancy journey.
We are committed to working with you towards attaining the ISO certificate successfully.
As part of implementing various ISO standards, technical standards are often involved to complement the different management system standards. One example would be ISO 13485 – Medical Devices – Quality Management Systems, where the standard requires your organisation to adopt and comply with technical standards depending on the nature of your medical devices.
If your product has an electrical component, compliance to IEC 60601-1 Medical electrical equipment –Part 1: General requirements for basic safety and essential performance is required. Likewise, if your medical device contains software, compliance to IEC 62304 Medical device software — Software life-cycle processes would be necessary as well.
Our consultants can also provide consulting services for these specific areas as part of your ISO consultancy journey or as a standalone project as well.
Our usual consultancy services start from:
Stendard can provide you with a one-stop consultancy service. At Stendard, we believe that quality is everyone’s business because it takes a team to consistently deliver and uphold excellent standards that build confidence with customers, partners and the community.
We are a regulatory consultancy and technology company that helps businesses implement international standards, streamline business processes across the organisation, and accelerate global growth.
With our vast range of consulting services, feel free to contact us, and we at Stendard will be glad to assist.
The International Standard provides guidance and help organisations to apply a common approach or concept of Plan-Do-Check-Act (PDCA) and risk-based thinking to achieve compliance and continuous improvement. The PDCA model is an iterative process that enables organsations to establish policy or objectives, implement processes to deliver results, monitor and measure performance, report and evaluate results and also take corrective actions to achieve continuous improvement.
The International Standard contains the scope, context and requirements for any types of management system standards. Organisations that wish to show commitment and demonstrate compliance can use the requirements to assess conformity. They can seek further confirmation of its conformance by pursuing certification of the management system by an external certification body.
ISO certification allows organisations to show prove of conformance to the requirements of any management system standards. It can help to demonstrate compliance to current and future statutory, industry and regulatory requirements, thereby gaining themselves recognition and competitive advantage through improving their branding/reputation and the confidence of the stakeholders, customers and business partners.
Our team ensures the competency of your team regarding ISO 13485 standards and requirements
We include a combination of online training courses and in-person training to make sure everyone within your team understands the requirements of the medical devices’ regulations and ISO 13485 standards, as well as the application of your QMS processes and documents.
You may select your ISO consultant based on their Curriculum vitae, experience, or success rate of obtaining the ISO certificate for clients.
There is an abundance of ISO consultants within the industry for your ISO consultancy needs. Thus it is vital to find one that can accommodate your unique organisational requirements.
Depending on the type of ISO certification, the expected lead time to achieve certification ranges from six to twelve months. Most certification bodies will require a sufficient amount of implementation records to demonstrate the effectiveness of the ISO standard that is being complied with.
In line with our ISO consultancy services, our typical ISO consultancy journey takes about six to nine months before getting ready for certification
Stendard can provide consultancy services for the following:
ISO 13485 – Medical Devices (including IEC 62304 and ISO 14971)
ISO 9001 – Quality Management Systems
Regulatory Requirements (Medical Devices)
ISO 22000 – Food Safety Management Systems
ISO 27001 – Information Security Management Systems
ISO 45001 – Occupational Health and Safety Management Systems
SS 620 – Good distribution practice for medical device
SS 444 – Hazard analysis and critical control point (HACCP) system for food industry
These are just some of the standards that we provide consultancy service on. To know more, feel free to reach out to us!
Is it possible to have more than one ISO certification?
Yes, there is no problem with that!
Depending on your organisation’s processes, we are able to recommend the appropriate QMS scope and processes best suited for you. We have helped clients integrate various ISO certifications, such as the ISO 13485 and ISO 27001 in cases where they handle Software as a Medical Device and want to ensure information security.
To get certified, your organisation’s QMS must meet ISO requirements as outlined in the standard. We can help ensure that you meet these requirements!
Our in-house consultants have been technically trained to advise on the appropriate rigor of testings and checks to be performed as part of a robust QMS. This includes distributor/supplier/contract manufacturer audits, software validation, IQ/OQ/PQ tests, as well as clinical evaluation and sterility tests – all major components that make or break a QMS.
Furthermore, we can perform gap analysis and mock audits to support your team with identifying any issues and rectify any non-compliance, in preparation for your official ISO certification audits.
Yes, we have plenty of experience in supporting medical device product registrations in various markets throughout the world. Our consultants focused on regulatory compliance would be able to advise on the relevant submission process and documentation requirements.
Online courses and close guidance on implementing the respective ISO standards will allow your staff to be familiar with the ISO standard. Routine practices on the required processes should also be done. It is also essential to find an approved training organisation to send your staff for ISO training courses.
Stendard also offers training that can be part of your ISO consultancy journey!
Any accredited certification bodies can provide the official ISO certification for your organisation after passing the audit conducted by them.
Stendard is incorporated under the name of YNL 360 Pte Ltd.
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