In the life sciences industry, a quality management process is critical for both regulatory compliance and continuous product improvement. However quality management system can quickly break down when the number of people and locations involved in the process is expanded beyond a single-site and a few dozen employees. Quality Management System covers pharmaceutical, medical device, biotechnology and diagnostic companies to manage quality issues and initiatives across a large, complex and distributed organization. Quality Management System meets critical needs by giving customers a flexible, easily expandable solution that brings a consistent and compliant approach for the entire organization.
Relevant Life Sciences Industry Standards
- ISO 9001-Quality Management System
- ISO 14001-Environmental Management System
- ISO 45001-Occupational Health and Safety Management System-OH&S,
- GMP-Good Manufacturing Practice
- GDP-Good Distribution Practice
- GDSP-Good Distribution and Storage Practice
- ISO 50001-Energy Management System.
Introduction to ISO 9001:2015-Quality Management System.
Most organizations face challenges when developing a quality management system. These challenges are potentially greater due to:
- Availability of resources;
- Costs involved in setting up and maintaining a quality management system;
- Difficulty in understanding and applying a quality management system, especially concepts such as organizational context, organizational knowledge, process approach and risk-based thinking.
1.What is a quality management system?
A quality management system (QMS) is the way an organization directs and controls its activities that are related to achieving its intended results.
Broadly, it consists of organization’s structure together with the planning, processes, resources and documented information that is used to achieve quality objectives (such as for meeting customers’ and relevant interested parties’ requirements, to improve quality management system, or to improve products and services).
Every organization will already have a management structure and on that basis its quality management system is built. Organization might be fulfilling many of its requirements included in ISO 9001, but has simply not yet organized its activities into a formal quality management system.
2.Why have one?
The adoption of a QMS is a strategic decision that helps an organization to improve its overall performance and to provide a sound basis for its sustainable development initiatives.
Many organizations implement a formal quality management system after finding that their customers want assurance that the products and services they are looking to purchase or obtain will meet their requirements for quality. Those customers are looking for the confidence that can be provided by an organization offering products and services produced under an effective quality management system, such as one conforming to ISO 9001.
A quality management system, on its own, will not necessarily lead to an improvement of work processes or to improvements of products and services. It will not solve all industry problems. It is a means for organizations to take a more systematic approach to fulfilling the organization’s objectives, which in turn should achieve such improvements.
3.What is ISO 9001:2015
ISO 9001:2015 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement).
4.What benefits we can assure through the implementation:
- Ensure that customers get consistent, good quality of products and services, which can bring the business benefits;
- Assess the overall context of organization to define who is affected by its work and what they expect from you. This will enable you to clearly state your objectives and identify new business opportunities.
- Put your customers first, making sure you consistently meet their needs and enhance their satisfaction. This can lead to more repeat custom, new clients and increased business for your organization.
- Work in a more efficient way as all your processes will be aligned and understood by everyone in the business or organization. This increases productivity and efficiency, bringing internal costs down.
- Meet the necessary statutory and regulatory requirements.
- Expand into new markets, as some sectors and clients require ISO 9001 before doing business.
- Identify and address the risks associated with your organization.
5.This standard is applicable to:
Any legal dealing with sectors like, Pharma, Chemicals, Food Processing, Iron and Steel, Construction, Automotive, Aerospace, Granite, and Service organizations like Trading Houses, Banks, Hospitals, Diagnostic Centres, Insurance, Educational Institutions, Government Agencies, NGOs, etc. are eligible to implement and get certified.
1.Introduction to ISO 14001:2015-Environment Management System.
Awareness of environmental problems is growing in most countries and it is believed that current development patterns cannot be sustained in the long term. Governments are increasingly enacting legislation aimed at protecting the environment, and customers are requiring their suppliers to incorporate best practices and demonstrate compliance with environmental requirements.
2. What is ISO 14001:2015
This standard sets out the criteria for an environmental management system. It provides a framework that a company or organization can follow to set up an effective environmental management system.
It can be used by any organization regardless its activity or sector.
This standard can provide assurance to company management and employees as well as external stakeholders that environmental impact is being measured and improved.
3. Why to have ISO 14001:2015
- Meet the company’s legal requirements and environmental impact.
- Keeping the measurable objectives and targets to reduce environmental impact and be in legal compliance.
- Gaining the support for an EMS from the company’s leadership.
- Communicating and sharing the objectives, targets and results with both the internal and external stakeholders.
4. Benefits of ISO 14001:2015
Organizations and companies find that using the standard helps them to:
- Improved control and management of emissions, effluents and wastes;
- avoidance and safe handling of hazardous or potentially polluting materials;
- reduction in generated wastes;
- energy efficiency improvements and cost savings;
- conservation of natural resources, including water, land and precious minerals;
- a comprehensive approach to satisfying legal and other requirements;
- operational efficiency and cost savings;
- pursuing environmental initiatives that are aligned with business priorities.
- increased profitability, better access to markets and improved relationships with stakeholders (e.g. customers, regulators, investors, insurers, neighbours).
5. Standard applicable to
Organizations of all kinds which are concerned with achieving and demonstrating sound environmental management system, performance by controlling the impacts of their activities, products and services on the environment, which include manufacturing like Cement, Steel, Pharma, Chemical, Food Processing etc., and service industries likes Construction, ETP service providers and Software service providers.
1.Introduction to ISO 45001-Occupational Health and Safety Management System.
Health and safety in the workplace are the number one concern of most businesses, yet still deaths and injuries occur. ISO 45001 sets the minimum standard of practice to protect employees worldwide.
According to the International Labour Organization (ILO), there are currently more than 2.78 million deaths a year as a result of occupational accidents or work-related diseases, in addition to 374 million non-fatal injuries and illnesses. Aside from the enormous impact on families and communities, the cost to business and economies is significant.
2.What is ISO 45001?
ISO 45001, Occupational health and safety management systems – Requirements with guidance for use, is the world’s first International Standard for occupational health and safety (OH&S). It provides a framework to increase safety, reduce workplace risks and enhance health and well-being at work, enabling an organization to proactively improve its OH&S performance.
3.Why Implement ISO 45001?
- Makes a safe place to work.
- reduced number of incidents,
- employee absenteeism,
- employee turnover,
- reduced downtime and reductions in insurance premiums.
4.What benefits it brings to organizations?
- Key potential benefits from use of the standard include:
- Reduction of workplace incidents
- Reduced absenteeism and staff turnover, leading to increased productivity
- Reduced cost of insurance premiums
- Creation of a health and safety culture, whereby employees are encouraged to take an active role in their own OH&S
- Reinforced leadership commitment to proactively improve OH&S performance
- Ability to meet legal and regulatory requirements
- Enhanced reputation
- Improved staff morale
Manufacturing such as Pharmaceuticals, Chemicals, Hospitals, Steel, Cement, Construction, Glass, Bakery, Paper and service industry like IT, ITeS.
1.Introduction to ISO 50001:2018-Energy Management System
Energy is critical to organizations, but often represents a significant cost – both to them and the environment.
World energy consumption continues to rise, it has more than doubled in the last 40 years and is projected to increase a further 30 % by 2040.
Energy is the major contributor to climate change, making up nearly 60 % of the world’s greenhouse gas emissions. Taking action to better manage our energy consumption not only helps the planet, it saves money for organizations and society as a whole.
2.What is ISO 50001:2018
ISO 50001:2018, Energy management systems – Requirements with guidance for use, is a strategic tool that helps organizations put in place an energy management system and use their energy more efficiently and effectively.
An energy management system helps organizations better manage their energy use, thus improving productivity. It involves developing and implementing an energy policy, setting achievable targets for energy use, and designing action plans to reach them and measure progress. This might include implementing new energy-efficient technologies, reducing energy waste or improving current processes to cut energy costs.
3.What benefits will ISO 50001 bring to my business?
- Greater levels of compliance to energy legislation.
- Reduced risk of incurring energy-related fines and prosecutions, and lower insurance premiums.
- Increased ability to proactively identify and address issues ahead of legislative changes.
- Improved reputation and stakeholder trust.
- Cost savings through improved energy management.
- More ethically sound and cost-effective procurement procedures.
- Reduced waste and increased efficiency.
- Sustainable energy use in the face of rising costs.
4.Why ISO 50001:2018
- Reduction in energy consumption
- Energy cost reduction
- Emission reduction
- The reputation of organisation.
- a) is applicable to any organization regardless of its type, size, complexity, geographical location, organizational culture or the products and services it provides;
- b) is applicable to activities affecting energy performance that are managed and controlled by the organization;
- c) is applicable irrespective of the quantity, use, or types of energy consumed;
- d) requires demonstration of continual energy performance improvement, but does not define levels of energy performance improvement to be achieved;
- e) can be used independently, or be aligned or integrated with other management systems.
- Introduction to GMP- Good Manufacturing Practice
Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.
The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.
- What is GMP -Good Manufacturing Practice
GMP –Good Manufacturing Practice-is part of a quality system covering the manufacture and testing of active pharmaceutical ingredients (Pharma GMP), pharmaceutical products (Pharma GMP) Foods Products (Codex GMP), Cosmetics (Cosmetic GMP) and Herbal Products (Herbal GMP).
Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation.
GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing.
Ten Principles of Good Manufacturing Practice
1. Design and construct the facilities and equipments properly
2. Follow written procedures and Instructions
3. Document work
4. Validate work
5. Monitor facilities and equipment
6. Write step by step operating procedures and work on instructions
7. Design ,develop and demonstrate job competence
8. Protect against contamination
9. Control components and product related processes
10. Conduct planned and periodic audits
- Why GMP -Good Manufacturing Practice:
- Ensuring the safety and efficacy of drug products and medical devices.
- Is a legal regulations, based on the United States Food, Drug and Cosmetic Act.
4.Who should apply
Companies / Person(s) who import or manufacture pharma/cosmetic products, or have products imported or manufactured on their behalf are responsible for applying to the authority to have their products registered
Our GMP Consultants with Pharma, Bulk Drug and Food Industry background will help in application of GMP Principles.
- What are the benefits GMP brings to business:
- Increases the credibility and offers a competitive advantage in the marketplace for contract manufacturers
- Increases senior management confidence in the preparedness of manufacturing facilities for inspection;
- Decreases the time and cost for companies selecting contract manufacturer.
6.Our Consulting approach:
- Gap Analysis: Assessment of existing management system practices against the selected standard requirements.
- Project Plan: Prepare a implementation project plan based on the time lines looking for;
- Orientation Training: Top/Senior Management orientation on selected standard requirements and implementation action plans preparation;
- Developing different levels of documentation ( Tier 1-3/4): Identification of processes required for the products produced and services provided; External and internal issues affecting the business, interested parties needs and expectations, Framing draft quality policy, organizational objectives, role, responsibility and authority, various risks affecting and opportunities arises, functional and system procedures, different implementation formats and checklists;
- System Implementation: Implementation of the selected management system as per the developed documentation;
- Company-wide Training: Training on detailed clause wise requirements and relating them to their departments, 5-S implementation, and Internal audit.
- Internal Audits: Periodic assessment of system implementation and corrective actions.
- Pre assessment: Initial audit by Certifying agency, and, implementation of corrective actions.
- Final Assessment: Certification audit by the Certifying agency and recommendation for certification
Professional Trainings for individuals:
Internal Auditor-1) ISO 9001-Quality Management System-QMS, 2) ISO 14001-Environmental Management System-EMS, 3) OHSAS 18001-Occupational Health and Safety Assessment Services & 4) WHO-GMP (Good Manufacturing Practice)
Lead Auditor-1) ISO 9001-Quality Management System-QMS, 2) ISO 14001-Environmental Management System -EMS, 3) OHSAS 18001-Occupational Health and Safety Assessment Series & 4) ISo27001-Information Security Management System-ISMS.
- Lean Champion, 2. Value Stream Mapping, 3. Quick Changeover (SMED), 4. Standard Work,5. Lean Culture, 6. Kanban, 7. Lean Metrics & 8.A3 – Problem solving
- TPM Champion, 2.Individual Improvement,3. Planned Maintenance,4. Quality Maintenance6. Office TPM & 7. Losses & Overall Equipment Efficiency