ISO 13485 e ISO 22716 quality control p.s.. and medical devices – Burotec

ISO 13485: PS QUALITY CONTROL, PSDIV AND MEDICAL DEVICES:

The international standard ISO 13485 specific requirements of a quality management system where an organization needs to demonstrate its ability to provide medical products and related services that consistently meet customer requirements and regulatory requirements for sanitary products and related services.

The main objective of this international standard is to facilitate harmonized regulatory requirements of sanitary products for quality management systems.

All requirements of this standard are specific to organizations providing medical devices, regardless of the type or size of the Organization.

BUROTEC features of a team technical of professional specialized in this complex sector to perform your project. Our consultants will accompany you step by step in the process, ensuring efficiency and speed in the execution of the work.

You offer a integral service to get its system of management of quality of product health:

• Data collection and issuance of initial assessment report
• Design of manual of quality and procedures specific
• Definition of a planning of dates with objectives of certification
• Implementation of procedures; Conference training and information
• Internal audit
• Support in it audit of certification to auditors of entity chosen
• Annual maintenance of the implanted system
• Permanent online consulting.

Ask for information about the advantages of ISO 13485 and requirements to be met in its case by sending an e-mail to [email protected] or by calling to the +34 913768950.

ISO 22716: QUALITY CONTROL COSMETIC PRODUCTS:

The ISO standard 22716 establishes the guide to good practices in manufacturing cosmetic products. This guide, sets out the regulatory guidelines and requirements that have been emerging in recent years to meet the regulatory needs of the Cosmetic Manufacturing sector, in order to improve quality and thus support both manufacturers, Wholesalers, suppliers and retailers.

The vocation of the ISO standard 22716 is to provide a specific tool for quality management in:

• Manufacturing
• Packaging
• Tests
• Storage
• Transport

This approach to quality based on common ISO standards and schemes, guarantees us the perfect integration with other quality systems such as ISO 9001 or even other schemes dedicated to consumer products such as BRC (British Retail Consortium)

ISO 22716 being a specific standard of the cosmetics sector, is aimed at all kinds of industries related to it, whether they’re cosmetics labs, Pharmaceutical, etc.

In short, all those companies that in their manufacturing process develop cosmetic products

Certification in ISO 22716 promotes the systematic application and assimilation of good manufacturing practices in the cosmetics sector.

In addition, a certificate according to ISO 22716 is the harmonised way of demonstrating compliance with good manufacturing practices requested by the EC Regulation 1223/2009 as we see in the key points of the norm:

• Process control
• Staff training
• Places unfavourable to product contamination
• Management of raw materials and packaging materials
• Documentary system
• Chain of responsibility.

Request information about the advantages of the standard ISO 22716 and requirements to be met in its case by sending an e-mail to [email protected] or by calling to the +34 913768950.