TECHNOCRAT CONSULTANTS is pioneer consultant in this region to cater our client for following sector specific standards.
ISO 27001:2013 is released
The new standard puts more emphasis on measuring and evaluating how well an organisation's ISMS is performing, and there is a new section on outsourcing, which reflects the fact that many organisations rely on third parties to provide some aspects of IT.It does not emphasise the Plan-Do-Check-Act cycle that 27001:2005 did. More attention is paid to the organisational context of information security, and risk assessment has changed. Overall, 27001:2013 is designed to fit better alongside other management standards such as ISO 9000 and ISO 20000, and it has more in common with them.
A.6.1.5 Information security in project management
A.12.6.2 Restrictions on software installation
A.14.2.1 Secure development policy
A.14.2.5 Secure system engineering principles
A.14.2.6 Secure development environment
A.14.2.8 System security testing
A.15.1.1 Information security policy for supplier relationships
A.15.1.3 Information and communication technology supply chain
A.16.1.4 Assessment of and decision on information security events
A.16.1.5 Response to information security incidents
A.17.2.1 Availability of information processing facilities
The revised standard has been written using the new high level structure, which is common to all new management systems standards. This will allow easy integration when implementing more than one management system
Terminology changes have been made and some definitions have been removed or relocated
Risk assessment requirements have been aligned with BS ISO 31000
Management commitment requirements have a focus on “leadership”
Preventive action has been replaced with “actions to address, risks and opportunities”
SOA requirements are similar, with more clarity on the need to determine controls by the risk treatment process
Controls in Annex A have been modified to reflect changing threats, remove duplication and have a more logical grouping. Specific controls have also been added around cryptography and security in supplier relationships.
Greater emphasis is on setting objectives, monitoring performance and metrics
ISO 22716 – Cosmetics Good Manufacturing Practices
Cosmetics Good Manufacturing Practices (GMP) is one of the pillars of the New European Regulation for Cosmetics.
This regulation sets very high requirements to ensure consumers’ safety. Amongst these new legal requirements, all cosmetics products circulating onto the European Market will have to be produced according to the Cosmetics Good Manufacturing Practices described by the ISO 22716 standard.
All participants in the cosmetics products chain, European and non-European, are concerned. Ingredients producers, products final assembler, distributors and importers/exporters, all actors are involved and new responsibilities have been defined.
Cosmetics Good Manufacturing Practices are a set of hands-on advice, operational rules and organizational guidelines especially focused on human, technical and administrative factors affecting product quality.
The objective of the GMP is to define the activities which lead to the final product corresponding to the expected specifications, and therefore product safety.
ISO 22716 is the standard describing the Cosmetics Good Manufacturing Practices. It has been written in collaboration with cosmetics industry professionals and promotes best-in-class methods. The scope of ISO 22716 is not only limited to production activities but also includes control, storage and expedition.
The BRC Global Standard for Consumer Products Issue 3
The Standard sets out the requirements for the production and supply of safe and legal consumer products of consistent quality. The products may be retailer-branded (private label) or branded, or be unbranded products.
The scope of Consumer Products, Issue 3 covers a wide range of non-food products in the global marketplace; including formulated products such as shampoos, paints and cosmetics, fabricated items like televisions and toys, electrical goods, furniture and textiles.
A how to get started section that covers everything you need to know to achieve BRC certification
Improved categorisation of products into three risk groups
A new grading system for certificated sites
Revised frequency of audits
Inclusion of 'Fundamentals' for the most important issues
Enhancement of the section on product conformity measures
Information to help with gaining certification
Improved layout - product groups shaded differently for clarity
In partnership with RILA (Retail Industry Leaders Association) Washington USA
ISO 15378:2011 - MANUFACTURERS OF PRIMARY PACKAGING MATERIAL FOR MEDICINAL PRODUCT
ISO 15378:2011 – GMP Certification is applicable for Healthcare - Primary Packaging Material Manufacturers. It incorporates the requirements of ISO 9001 with additional GMP requirements specific to packaging materials. In this global era, quality norms for healthcare industry have become very stringent. To ensure risk free business, most of the healthcare product manufacturers demand some sort of assurance from their suppliers of Packaging material either through supplier audit or third-party certification. ISO 15378:2011 – GMP Certification covers entire manufacturing process and is designed specifically for industries manufacturing Healthcare Packaging Material.
PS 9000 - MANUFACTURERS OF PACKAGING MATERIAL FOR MEDICINAL PRODUCT
PS 9000 was developed by the Pharmaceutical Quality Group (PQG) for manufacturers of packaging material for medicinal product and now orally inhaled medicine, with reference to Good Manufacturing Practice (GMP).
Its primary objective is to facilitate risk management and implementation of a controlled system to eliminate these risks to ensure production of safe products to correct requirements.
The standard is aligned to ISO 15378 (Primary packaging materials for medicinal products) and based on these principles as well as ISO 9001. Fully recognised and supported by the MHRA, it incorporates many quality management principles in line with GMP and regulatory requirements.
The 2011 revision has added focus on electronic origination and controls and the interface with production throughout all process steps, as well as ensuring the importance of controls in terms of traceability and verification of materials throughout the process chain.
It is an interactive standard that can be applied to Global, Primary, Secondary and Complex manufacturers, each with specific requirements. How can PS 9000 benefit my organisation?
PS 9000 is a standard relevant to all parts of the pharmaceutical industry supply chain, allowing shared knowledge, practices and implementation to manage risks and safeguard the wellbeing of people and business
Whether a contractual need or simply looking to reduce overall risk to your organisation and products, there are a number of key benefits to implementing a certificated PS 9000 system.