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Spotlight on Standards: ISO 22301 (Business Continuity) and ISO 22716 (Cosmetics GMP)

Quality InsightsJanuary 20, 2023

Spotlight on Standards highlights two popular standards in each edition of Quality Insights. In this issue, we focus on ISO 22301 and ISO 22716.

“A scary number of standards”

One of our clients once asked: “There are a scary number of standards, can you help to clarify some of them?” With this in mind, we have launched Spotlight on Standards to highlight two popular standards in each edition of Quality Insights. The aim is to introduce, outline and remove a lot of uncertainty.

This time, we focus on:

ISO 22301 – security and resilience – business continuity management systems – requirements

What is ISO 22301?

Every organization will need to respond to an incident that disrupts daily business operations. Therefore, a successful business continuity management system (BCMS) is essential.

ISO 22301 is a globally recognized standard to ensure business continuity management (BCM) through implementing a robust system.

The standard specifies the requirements for implementing, maintaining and improving a BCMS to protect against, reduce the impact of, respond to and recover from disruptions. 

Key benefits

Certification follows successful completion of an audit and enables you to:

  • Implement organization-wide identification and understanding of critical business processes and the impact of disruptions
  • Proactively minimize impact
  • Increase resilience levels and recovery capabilities, as well as ensure that the business survives
  • Minimize downtime during incidents and improve recovery time(s)
  • Gain an advantage over less resilient competitors
  • Demonstrate resilience to customers, suppliers, media and stakeholders, especially during crisis conditions 

Homing in on critical areas

From identifying issues to prioritizing safety and updating processes, ISO 22301 has several key requirements to fulfill.

Key requirement areas:

  • Outline your organization’s strategy and engage stakeholders
  • Develop a recovery plan
  • Meet any new regulatory requirements and create awareness for all parties that impact your BCMS
  • Review and confirm leadership roles, responsibilities and accountabilities
  • Determine the systems that manage outsourced products and services
  • Review and understand the requirements for risks and opportunities
  • Ensure that documented information requirements are understood
  • Update the existing BCMS to meet the new requirements and verify its effectiveness

Cutting to the core

ISO 22301 contains several core concepts that, if implemented correctly, can help to enhance your organization.

Some core requirements:

  • The context of your organization
  • Interested stakeholders
  • Issues, risks and opportunities
  • Leaders and risk owners
  • Threats and opportunities
  • Communications
  • Documented information
  • Operational planning and control
  • Performance evaluation
  • Nonconformity and corrections

Implementing ISO 22301

It is essential that ISO 22301 is implemented correctly to reap all of the rewards. We can support you to achieve this through our various methods, including training.

Key areas:

  • Ensure senior management support and commitment
  • Engage the entire organization through internal communications
  • Compare your existing systems with the new requirements
  • Obtain worker, customer and supplier feedback on current systems
  • Create an implementation team
  • Define roles, responsibilities and schedules
  • Start with the basic principles
  • Use training and incentives to encourage employee involvement
  • Share knowledge on the standard and consider internal auditor training
  • Regularly review the system to ensure continual improvement

ISO 22716 – cosmetics – good manufacturing practices (GMP) – guidelines

What is ISO 22716?

The safety of cosmetic products is often on the minds of manufacturers, suppliers, regulators and consumers.

ISO 22716 provides guidance on GMP for cosmetic products. It also constitutes the practical development of the quality assurance concept. It does this by offering advice on managing factors that could impact product quality to organizations of all sizes and complexity, from receipt to shipment, including production and storage.

Key benefits

Certification follows successful completion of an audit and allows:

  • Your organization to identify and control the human, technical and administrative factors that can affect product quality, thus reducing risk
  • Essential quality assurance elements to be implemented and maintained, in a continuous improvement process
  • GMP elements to be integrated with other standards, such as ISO 9001
  • You to demonstrate the adoption of essential GMP relating to cosmetic activities
  • Alignment with UN Sustainable Development Goals 3 and 8

Terminology, elements and adoption status

ISO 22716 is the global reference for regulatory and supply chain compliance in the cosmetics industry. It has been incorporated into, referenced or endorsed by many cosmetics regulations across the world.

Consistent terminology

To reach and maintain consistency and encourage common terminology, ISO 22716 has 36 definitions specific to its application.

Five core elements

The guidelines essentially have five core elements:

  • The cosmetics quality management system (QMS) and organization
  • Premises and equipment
  • Product realization and materials management
  • Deviations, complaints and recalls
  • Continuous improvement

Pinpointing the pain points

Over the years, numerous regional and international standards have aimed to enhance cosmetic product quality and safety, many specifically addressing manufacturer, supplier, wholesaler and retailer requirements.

Each standard or set of guidelines have their own problems that must be overcome if you want to achieve the greatest benefits.

Here are some key pain points to consider early on:

  • Understanding the requirements
  • The independence of the quality unit from the manufacturing units
  • Clarification of responsibilities of all personnel for manufacturing and quality
  • Supplier selection, evaluation and re-evaluation of raw materials, components and packaging materials
  • Evaluation and audits of subcontractors and suppliers
  • Reprocessing of products

Using our extensive experience of the pain points organizations face on the road to certification, we deliver a range of tailor-made services to support you every step of the way.

Moving toward ISO 22716 certification

Organizations with an existing cosmetic quality program(s) can incorporate ISO 22716 elements into it through a step-by-step approach, thus achieving compliance with global cosmetic GMP principles.

Key ISO 22716 elements

An organization with an existing cosmetic quality program(s) can build upon its existing platform to seamlessly transition to ISO 22716.

The guidelines combine general quality management principles and typical elements of cosmetic product GMP with a risk management-based approach, including:

  • Personnel
  • Premises
  • Equipment
  • Raw and packaging materials
  • Production, including packaging and labeling
  • Finished products
  • Quality-control laboratory
  • Treatment of a product that is out of specification
  • Waste
  • Subcontracting
  • Deviations
  • Complaints and recalls
  • Change control
  • Internal audit
  • Documentation

Implementing ISO 22716

It is essential that ISO 22716 is implemented correctly to reap all of the rewards.

The guidelines cover all aspects of the cosmetic product supply chain, from raw materials to final product shipment.

ISO 22716 supports organizations that wish to follow advice to manage the human, technical and administrative factors that affect product quality.

GMP follows the principles of sound scientific judgment and risk assessment to produce cosmetic products that meet defined characteristics.

You must consider:

  • The quality unit to create an independent decision-making process from manufacturing/operations
  • Management support and encouragement concerning GMP compliance
  • Enabling manufacturing and quality-control laboratory staff to report irregularities to allow for swift action in case of deviations
  • The selection of raw material suppliers and supplies used for manufacturing cosmetic products, following approved quality procedures
  • Reprocessing that follows defined/established steps when regular and distinct methods do not yield the expected results
  • Following ISO 22716 needs, so a supplier or subcontractor qualification program is in place
  • Presenting an appropriate risk-based approach for a third-party qualification program

How we can help

With expertise in all major industries, we understand each sector’s pain points and have the technical skills and logistical capabilities to ensure realistic outcomes.

An audit against ISO 22301 and/or ISO 22716 from us will help your organization to stand out from the crowd by supporting you to develop and improve performance, among other things.

Additional ISO 22301 services

We offer a range of complementary services:

  • ISO 22301 BCMS Auditor Conversion Training Course (CQI and IRCA)
  • ISO 22301 BCMS Auditor/Lead Auditor Training Course (CQI and IRCA)
  • ISO 22301 BCMS Foundation Training Course (CQI and IRCA)
  • ISO 22301 BCMS Implementation Training Course (SGS)
  • ISO 22301 BCMS Introduction and Implementation Training Course (SGS)
  • ISO 22301 BCMS Introduction Training Course (SGS)

Customized ISO 22716 services

Audits against customer-specific criteria

Our audits can be customized for all industries within the global supply chain to verify an organization’s ability to meet criteria, including quality, consumer safety and occupational health and safety.

Supplier/vendor/co-packer/licensee assessments can monitor suppliers’ adherence to your requirements and/or contractual agreements.

Products can also be verified as meeting quality, consumer safety, environmental, occupational and/or social responsibility requirements, protecting your brand and values.

Auditing against your code of practice can monitor your network’s compliance with what is defined within it, ensuring brand protection and that practices remain consistent throughout the network.

Our auditors know the characteristics of cosmetic products and can apply this to all critical steps during QMS assessment, from acceptation of raw materials to product distribution.

Our laboratories offer integrated customer-specific solutions for safety compliance and can assist you in controlling product quality, including its raw materials, packaging and compliance with cosmetics industry regulations.

Discover how our services can benefit you. For more information, contact us.

For further information, please contact:

Jason Hulbert
Associate Marketing Manager
t: +44 (0)7912 426878

About SGS

We are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for quality and integrity. Our 96,000 employees operate a network of 2,700 offices and laboratories, working together to enable a better, safer and more interconnected world.

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