ISO Required Documents. New

ATLANTIC LIFESCIENCES LTD.
Plot No.:16/01, Larkpleku, Tema-Aflao Road, Greater-Accra, Ghana.
QUALITY MANAGEMENT SYSTEM REQUIREMENTS

1.0 Organizational Context Document & Logbook for distribution
Internal and external issues affecting organization’s ability to achieve intended purpose.
External Factors;
Legal Issues: Positive factors,
 Regulatory Compliance
 Intellectual property protection
 Government Support and Incentives
 Market access
 Ligation protection
 Collaboration opportunities
 Risk management.
Negative factors;
 Regulatory uncertainty
 Compliance cost
 Product liability risks
 Market access barriers
Technological Issues: Positive factors

 Automation and robotics
 Data analytics
 Supply chain management solutions
 Regulatory compliance software
Negative factors
 Skill gap training needs
 Cybersecurity risks
 Data privacy concerns
 Dependency on third party vendors

 Regulatory compliance
 Ethical & societal implications
Cultural Issues: Positive factors;

 Ethical values and integrity
 Engagement & empowerment
 Continuous improvement mindset
 Collaboration & partnership with academia, research institution, government
agencies & industry partners
Negative factors
 Resistance to change
 Cultural misalignment in mergers/ acquisition
 Ethical lapses & misconduct
Competitive Issues: Positive factors;

 Brand reputation and trust
 Operational excellence
 Adaptive market strategies
 Talent acquisition & retention
 Market differentiation
Negative factors;
 Pricing pressures
 Regulatory hurdles
 Intellectual property disputes
 Market saturation
Socio economic environmental issues:

Positive factors;
 Creating opportunities for market growth
 Increasing demand for healthcare products
 Fostering supportive regulatory frameworks
 Promoting public awareness and acceptance of new treatments
Negative factors
 Economic downturns affecting purchasing power
 Disparities in healthcare access impacting market reach
 Changing regulatory landscapes introducing uncertainty
 Public skepticism towards pharma products hindering acceptance and
uptake
2.0 Organizational scope Record; Content

2.1 Stakeholder requirements matrix for QMS. The first step is to identify who are your
stakeholders in relation to your quality management system. Stakeholders can be anyone
who is affected by, or can affect, your quality performance, such as customers, suppliers,
employees, managers, regulators, competitors, or partners. You can use a simple matrix to
plot your stakeholders on two axes: high or low interest, and high or low influence. This
will help you to group your stakeholders into four categories: key players, keep satisfied,
keep informed, and minimal effort. The stakeholders of any company are interested in the
well-being of that company and can include employees, board members, stockholders,
suppliers, distributors, customers, and the community. Define the specific roles and
responsibilities of different stakeholders, from leadership to employees, suppliers, and
customers, emphasizing how each contributes to the success of the ISO 9001 quality
management system.
2.2 Stakeholder requirements monitoring report. Feedback and input should be used to
identify the strengths and weaknesses of the QMS, the opportunities and threats for
improvement, and the satisfaction and expectations of the interested parties. By soliciting
feedback and input, you can help top management and stakeholders stay involved and
committed to the QMS, and ensure its relevance, effectiveness, and efficiency.
3.0 Quality Manual
3.1 All the Documents & Tools you need to achieve certification
3.2 Proven to Work by industry leaders since 2002
3.3 Not just a Quality Manual - includes: Quality Policy & Quality Objectives, Context of our
organization, Leadership & Worker Participation, Planning, Support, Product & Service
Development, Performance Evaluation, Improvement
3.4 Document Templates
3.5 Project Plan & 18-Step Implementation Checklist
3.6 Gap Analysis Checklist, Action Plan
3.7 Procedures
3.8 Process Maps, Turtle Diagrams, Matrices
3.9 Reports & Forms
3.10 Internal Audit Checklist & Automated Charts
3.11 Non-Conforming & Corrective Action Tracker
3.12 Designed for all users, from the novices to experts, we explain everything, step-by-
step, clause-by-clause
4.0 Quality Policy document
 Purpose and general context of the organization, framework for setting quality
objectives, responsibilities and its assigned persons. The organization will need to
understand and identify all the influences that affect its business and ensure that the
strategy and direction takes this into consideration. Your organization will need to
review its current quality policy as necessary to ensure that any changes in context,
interested parties or their requirements is reflected in the policy, and to determine
whether your organization’s objectives are affected.
4.1 Quality policy distribution logbook.
A quality policy distribution logbook is a record-keeping document used to track the

dissemination of a company’s quality policy throughout the organization. It typically
includes details such as the date of distribution, the recipients, method of distribution,
and any acknowledgments or signatures confirming receipt. This logbook helps ensure
that all employees are aware of and understand the organization’s quality objectives and
commitments.
4.2 Quality management System performance report.
It provides an overview of how effectively the QMS is functioning within an

organization. It typically includes metrics such as:
Compliance with quality standards and regulations.
Customer satisfaction ratings and feedback.
Internal and external audit results.
Number of non-conformities identified and corrective actions taken.
Efficiency of processes and workflows.
Training and competency levels of employees.
Quality improvement initiatives implemented.
5.0 Risk Assessment document
 Organizational context risks along with stakeholder requirement risks and all
manufacturing and facility risks
6.0 Risk Evaluation document.
 This evaluates the effectiveness of actions taken toward identified risks.
 Options to address can include; taking the risk to evaluate how the risk is controlled,
eliminating the risk source, changing the likelihood, sharing the risk and retaining the
risk by informed decisions.
7.0 Quality Objective document
 Processes done in each department, what resources will be required, who is responsible for
tasks performed, duration with which it should be complete.
7.1 Task evaluation Report

8.0 Support
8.1 Change Control Document for QMS.
 Purpose of the changes and their potential consequences, integrity of the QMS,
availability of resources and allocation or reallocation of responsibilities and
authorities.
8.2 Resource Management plan
 Outlines how resources necessary for operation of processes are identified,

acquired, allocated and managed. It includes; infrastructure, work environment,
equipment and materials, transportation resource and ICT.
8.3 Requisition Logbook
 To formally request for items needed to continue processes or required for

personnel use.
8.4 Equipment Calibration and Maintenance Records
8.5 Inventory and Asset Register
8.6 Supplier Evaluation and Selection Records
9.0 People
9.1 Job description
 Outlining role, responsibilities and authorities for personnel involved in the

operation of processes.
9.2 Training records
 Documentation of training needs, plans, activities and records of personnel

training to ensure competency in assigned tasks.
9.3 Competency Assessment Records
 Competency assessments conducted to verify that personnel have the necessary

skills and knowledge to perform their roles effectively.
10.0 Environment
10.1 Environmental Aspect and Impact Register
 Documents that identify environmental aspects associated with process operations

and their potential impacts on the environment. (Socially, psychological and
physical)
10.2 Environmental Monitoring Report
 Records of environmental monitoring both internally and externally.
 Internally; temperatures in controlled spaces monitoring, humidity monitoring, light,

airflow and hygiene.
 Externally; Emission monitoring, waste management, energy consumption.
10.3 Environmental Management Procedures
 Outlining of organizational plans, implementation and control activities to prevent

or mitigate environmental impacts.
11.0 Monitoring and Measuring Resources
11.1 Monitoring and Measuring Plan
 Outlines how to measure and verify the conformity of products or services. It

specifies what parameters to monitor, how measurements will be taken, who is
responsible for performing these activities
11.2 Calibration Procedures

 Details how monitoring and Measuring equipment’s are calibrated, frequency of

calibration, method used and criteria for acceptability.
12.0 Measurement Traceability
12.1 Measurement Traceability document
 Describes how equipment is calibrated and how the calibration is traceable to

national or international standards along with verification.
12.2 Calibration Certificates
 Documents provided by equipment calibration service providers certifying that

the equipment has been calibrated and meets specified accuracy requirements.
13.0 Organization Knowledge
13.1 Knowledge Management Document
 Outlines how organizational knowledge is identified, captured, shared and

maintained by internal or external sources.
 Internal sources include; intellectual property, knowledge from experience, lessons

learned from failures or successes, capturing and sharing undocumented knowledge
and experience, results from improvements in products, processes and services.
 External sources include; standards, academia, conferences, knowledge from

customers or external providers and lesson learned reports.
14.0 Competence
14.1 Training Plans
 Detailed information on training Content, dates, attendees and results.
14.2 Competency Assessment
15.0 Communication
15.1 Meeting Minutes

 Records of meeting where quality related matters are discussed, including

decisions made, actions assigned and follow-up activities.
15.2 Non-conformance Reports
15.3 Customer Communication Records Content: Communication with customers

regarding quality related matters such as complaints, feedbacks and inquiries
16.0 Creation and Updates of Documented Information
16.1 Documented Information Documents
 A procedure that Outlines the process for creating, reviewing, approving and
updating documented information with the organization’s QMS
16.2 Documented Information Reviews and Approval Records.
 Dates, personnel involved and revisions made.
16.3 Documented Information Templates
 Includes templates or formats for creating various types of Documented

Information such as procedures, work instructions, forms and records.
16.4 Documented Information Register or Index
 A centralized register or index that identifies and provides access to all

documented information within the organization’s QMS including documents,
records, forms and manual.
16.5 Documented Information Distribution Records
 Includes distribution lists, dates of distribution and recipients.
16.6 Documented Information Revision History
 Records to track changes made to documented information overtime, including

revision numbers, dates of revision and descriptions of changes.
17.0 Operational Planning
17.1 Operational planning document

 Outlines Identification of process requirements, allocation of resources,

establishment of objectives and development of action plans.
17.2 Operational Objectives
 Established to achieve desired outcomes in the organization’s operations,

including quality, efficiency and customer satisfaction goals.
17.3 Operation Plans
 Plans detailing how Operational Objectives will be achieved including timeliness,

responsibilities resources required and performance indicators
17.4 Risk Management Plan
18.0 Operational Control Document
 Includes monitoring of processes, verification of conformity and implementation of

corrective actions when necessary.
18.1 Nonconformance Reports
 Records includes non-conformance, root cause analysis, corrective action taken

and follow up actions.
19.0 Products and Services
19.1 Products and Services Requirements Documents.
 It Outlines how the organization identifies, reviews and manage the requirements
for its products and services. Includes customer requirements, regulatory
requirements and internal requirements.
19.2 Customer Requirements Documents.
 Specifications, drawings, contracts, purchase orders and any other relevant

information provided by the customer.
19.3 Product Specifications.
 Must outline characteristics, features and performance criteria for products and
services to ensure they meet customers’ needs and expectations.
19.4 Service Level Agreements (SLA’s).
 Agreements that define the agreed upon level of service to be provided to

customers, including response times, resolution times and service quality metrics.
19.5 Purchasing Orders:
 Documentation of orders placed with suppliers for the procurement of products

and services, including specifications, quantities, prices and delivery dates.
19.6 Suppliers Evaluation and Approval Records.
 Suppliers performance metrics, audit and approvals.
20.0 Design Development Plan.
 Outlines the activities, resources, responsibilities and timeliness for the design and
development of products or services. It includes milestones, deliverables and
verification or validation activities
20.1 Design Inputs Documentation.
 This specifies the requirements, criteria, and constraints for the design and
development process. This includes customer requirements, applicable
regulations, standards and internal requirements.
20.2 Design Outputs Documents.
 Results of the design and development process. It includes specifications,

drawings, models, prototypes and any other outputs that define the characteristics
of the product or service.
20.3 Design Review Records.
 To evaluate the adequacy, completeness and suitability of the design outputs. This
includes meeting minutes, action items and decisions made during the review
meetings.
20.4 Design Verification Records.
 Includes test reports, inspection records and other evidence of verification.

20.5 Design Validation Records.
 Includes Validation test results, customer feedback and field trial reports.
20.6 Design Change Procedure.
 Identifying, evaluation, approving and implementing changes to the design and

development output. Ensures changes are controlled and managed properly.
20.7 Design Change Records.
 Includes reasons for the change, the impact assessment and authorization for
implementation. Provides traceability and ensures that design changes are
documented and communicated.
21.0 Control of Externally Provided Processes, Products and Services.
21.1 Supplier Evaluation Document.
 Outlines the criteria and process for selecting and evaluating suppliers of products
and services. It includes quality performance, delivery performance, financial
stability and compliance with regulatory requirements.
21.2 Approved Supplier List (ASL).
 It includes information such as supplier names, contact details, approval dates and
scope of approval.
21.3 Supplier Evaluation Records.
 Includes evaluation criteria and results, corrective actions taken and decisions
regarding supplier approval or disapproval.
21.4 Purchase Order Document.
 It includes requirements such as specifications, quantities, prices, delivery dates

and quality requirements.
21.5 Purchase Order Document.
 It includes requirements such as specifications, quantities, prices, delivery dates

and quality requirements.
21.6 Supplier Contracts.
 Terms and Conditions of the relationship including requirements, delivery

schedules, payment terms and responsibilities of both parties.
21.7 Purchase Orders & Contracts.
 Records of Purchase orders and contracts issued to suppliers, including copies of

the documents, revisions and any amendments made during the procurement
process.
21.8 Supplier Performed Records.
 Records of suppliers’ performance evaluations, including performance metrics,

trends, analysis results and any corrective actions taken to address performance
issues.
21.9 Incoming Inspection Document.
 Documents procedure that outlines the process for verifying the conformity of
externally provided products and services. It includes Inspection criteria,
sampling plans and acceptance criteria.
21.10 Inspection Records.
 Includes inspection results, non-conformance identified and disposition

decisions.
22.0 Production and Service Provision
22.1 Production and Service Provision Document.
 It includes process steps, resources required, quality control measures and

timelines.
22.2 Product Release Records.
 Includes verification of conformity to specified requirements and authorization

for release.
22.3 Service Delivery Records.

 Records of service delivery activities including confirmation of service

completion and customer acceptance.
23.0 Property belonging to customers or external Providers
23.1 Property Identification and Control Procedure.
 It includes requirements for labeling, storage, handling and disposition of such

property.
23.2 Property Register or Inventory.
 Includes customer supplied materials, tools, equipment, intellectual property and

confidential information.
23.3 Storage and Handling Records.
 Records of storage conditions, handling procedures and access controls.
23.4 Usage or Application Records.
 Usage dates, quantity used any processing transformation performed.
23.5 Security and Confidentiality Agreement.
 Includes agreements regarding data protection, intellectual property rights and

confidentiality obligations.
24.0 Internal Audit
24.1 Internal Audit Document.
 Outlines the process for planning, conducting and reporting Internal audits of the
QMS processes to assess conformity with ISO 9001 requirements, effectiveness
of the QMS and Identification of opportunities for improvement.
24.2 Internal Audit Schedule
24.3 Internal Audit Reports
25.0 Management Review Minutes.

 Documents discussions, decisions, action items and responsibilities assigned

during the meeting.
26.0 Improvement
26.1 Corrective Action Procedure Documents
26.2 Preventive Action Procedure Documents
26.3 Non-Conformity Records

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ATLANTIC LIFESCIENCES LTD.

Plot No.:16/01, Larkpleku, Tema-Aflao Road, Greater-Accra, Ghana.

QUALITY MANAGEMENT SYSTEM REQUIREMENTS

Technological Issues: Positive factors

 Dependency on third party vendors

Cultural Issues: Positive factors;

Competitive Issues: Positive factors;

Socio economic environmental issues:

2.0 Organizational scope Record; Content

A quality policy distribution logbook is a record-keeping document used to track the

4.2 Quality management System performance report.

It provides an overview of how effectively the QMS is functioning within an

Compliance with quality standards and regulations.

Customer satisfaction ratings and feedback.

Internal and external audit results.

Number of non-conformities identified and corrective actions taken.

Efficiency of processes and workflows.

Training and competency levels of employees.

Quality improvement initiatives implemented.

5.0 Risk Assessment document

6.0 Risk Evaluation document.

 This evaluates the effectiveness of actions taken toward identified risks.

7.0 Quality Objective document

7.1 Task evaluation Report

8.1 Change Control Document for QMS.

8.2 Resource Management plan

 Outlines how resources necessary for operation of processes are identified,

8.3 Requisition Logbook

 To formally request for items needed to continue processes or required for

8.4 Equipment Calibration and Maintenance Records

8.5 Inventory and Asset Register

8.6 Supplier Evaluation and Selection Records

9.1 Job description

 Outlining role, responsibilities and authorities for personnel involved in the

9.2 Training records

 Documentation of training needs, plans, activities and records of personnel

9.3 Competency Assessment Records

 Competency assessments conducted to verify that personnel have the necessary

10.1 Environmental Aspect and Impact Register

 Documents that identify environmental aspects associated with process operations

10.2 Environmental Monitoring Report

 Records of environmental monitoring both internally and externally.

 Internally; temperatures in controlled spaces monitoring, humidity monitoring, light,

 Externally; Emission monitoring, waste management, energy consumption.

10.3 Environmental Management Procedures

 Outlining of organizational plans, implementation and control activities to prevent

11.0 Monitoring and Measuring Resources

11.1 Monitoring and Measuring Plan

 Outlines how to measure and verify the conformity of products or services. It

11.2 Calibration Procedures

 Details how monitoring and Measuring equipment’s are calibrated, frequency of

12.0 Measurement Traceability

12.1 Measurement Traceability document

 Describes how equipment is calibrated and how the calibration is traceable to

12.2 Calibration Certificates

 Documents provided by equipment calibration service providers certifying that

13.0 Organization Knowledge

13.1 Knowledge Management Document

 Outlines how organizational knowledge is identified, captured, shared and

 Internal sources include; intellectual property, knowledge from experience, lessons

 External sources include; standards, academia, conferences, knowledge from

14.1 Training Plans

 Detailed information on training Content, dates, attendees and results.

14.2 Competency Assessment