Quality Service for Laboratories and Regulated Companies
SHAPYPRO provides external quality support to laboratories, manufacturers and companies that need to implement, review or maintain management systems, procedures and document controls.
The service is adapted to organisations in the cosmetics, biocides, chemicals and laboratory sectors, and includes support with Good Manufacturing Practices, audits, SOPs, deviations, CAPA, change control, training and continual improvement.
- ISO 22716 and GMP
- Audits
- SOPs and records
- CAPA and continual improvement
External Quality Support for Regulated Organisations
A quality system should help control processes, demonstrate what has been done and identify problems before they become recurring issues.
In regulated organisations, quality connects responsibilities, procedures, records, training, equipment, suppliers, deviations, complaints and improvement decisions. Where these elements are not consistent, the risk of errors, non-compliance and loss of traceability increases.
SHAPYPRO provides an independent and practical perspective to organise the system, identify gaps and adapt documentation to the organisation’s real activities.
When It Can Help
Implementation of a New System
Support in defining the document structure, responsibilities, processes and controls required from an organised starting point.
Outsourced Quality Maintenance
Periodic support to review documentation, incidents, changes, audits and improvement actions without building a complete internal quality department.
Audit Preparation
System review before customer audits, inspections, certification audits or accreditation assessments.
Outdated Documentation
Update of procedures and records where daily practice no longer matches the documented system.
Growth or Change of Activity
Adaptation of the system to new facilities, equipment, products, markets, suppliers or regulatory responsibilities.
SHAPYPRO Quality Services
Services may be commissioned as individual assignments or as ongoing support, depending on system maturity, sector and organisational objectives.
The scope is defined after an initial review to avoid unnecessary documentation and focus the work on the processes and risks that genuinely require control.
Diagnosis and GAP Analysis
Assessment of the existing system against applicable requirements, internal practice and project objectives to identify priorities and gaps.
Cosmetic Good Manufacturing Practices
Implementation, review and maintenance of processes and documentation related to ISO 22716 and controlled cosmetic manufacturing.
AEMPS Responsible Declaration
Support in reviewing requirements and preparing documentation for cosmetic manufacturing or import activities in Spain.
Internal and Follow-Up Audits
Independent evaluation of how the system actually operates and definition of actions for findings, risks or deviations.
SOPs, Instructions and Records
Development and review of procedures, technical instructions, templates, checklists and records adapted to real operations.
Deviation and CAPA Management
Support to document incidents, analyse causes, define corrective actions and verify effectiveness.
Change Control and Risk Management
Structured assessment of changes to processes, documents, equipment, suppliers, facilities, products or methods.
Training and Ongoing Support
Team-focused sessions to support the practical application of procedures, responsibilities and quality criteria.
Cosmetic Good Manufacturing Practices and ISO 22716
Cosmetic products placed on the European Union market must be manufactured in accordance with Good Manufacturing Practices.
The harmonised EN ISO 22716 standard provides guidelines for organising the quality aspects of production, control, storage and shipment of cosmetic products.
SHAPYPRO helps translate these requirements into applicable procedures and controls, rather than leaving the organisation with documents that are opened only when an auditor appears.
Personnel and Responsibilities
Definition of functions, qualifications, training, substitution arrangements and responsibilities within the quality system.
Premises and Equipment
Review of conditions, cleaning, maintenance, calibration, identification and control of premises and equipment.
Raw Materials and Packaging Materials
Criteria for receipt, identification, quarantine, release, storage, traceability and supplier control.
Production and Quality Control
Manufacturing procedures, in-process controls, batch management, release and record retention.
Storage and Shipment
Storage conditions, identification, stock rotation, finished-product control and traceability during initial distribution.
Deviations, Complaints and Recalls
Systems to investigate incidents, manage complaints, implement corrective actions and act on potential product recalls.
Subcontracted Activities
Definition of responsibilities, agreements, supplier evaluation and monitoring of outsourced activities.
Documentation and Archiving
Control of procedures, records, versions, signatures, retention periods and access to information.
AEMPS Responsible Declaration for Manufacturing and Import
In Spain, companies that materially manufacture, condition, package or label cosmetic products, as well as companies importing cosmetics from third countries, should assess the requirement to submit a responsible declaration to the AEMPS before starting the activity.
The requirement does not depend solely on owning the brand or acting as the Responsible Person. The scope should be reviewed according to the activities performed directly and those outsourced.
SHAPYPRO supports companies in organising the information and preparing the documentation required for the initial declaration or later amendments.
Activity Scope Review
Analysis of the operations carried out to identify whether the company acts as a material manufacturer, conditioner, packager, labeller or importer.
Review of Prior Requirements
Assessment of personnel, premises, equipment, storage, control, documentation and quality-system aspects.
Document Preparation
Organisation of the information required to describe activities, premises, responsible staff and processes included in the declaration.
COSMET2_DR Support
Guidance during preparation and electronic filing through the application provided by the AEMPS.
Amendments and Cessation
Review of later changes that may need to be communicated, including expansion, premises or activity changes and cessation.
Preparation for Verification
Document review to support checks, verification or inspection activities carried out by the competent authority.
Quality Audits and System Review
Audits make it possible to verify whether the system is implemented, procedures are followed and records provide sufficient evidence.
A useful audit should not merely list non-compliances. It should assess risk, identify causes, prioritise actions and help the organisation correct problems sustainably.
Initial or Diagnostic Audit
Overall assessment to understand the status of the system and establish an implementation or improvement plan.
Internal Audit
Planned review of processes, departments or specific requirements against defined criteria.
Follow-Up Audit
Periodic verification that the system continues to operate and implemented actions remain effective.
Preparation for External Audit
Advance review of documentation, records, facilities and critical points before a customer, certification or accreditation assessment.
Supplier Audit
Documentary or technical evaluation of suppliers and outsourced activities based on their impact on quality and risk.
Report and Action Plan
Delivery of classified findings, evidence, priorities and recommendations to support effective treatment.
Procedures, Records and Document Control
Documentation should describe the organisation’s real activities, define responsibilities and demonstrate that processes have been performed under controlled conditions.
An over-documented system can be as ineffective as an incomplete one. The objective is to create clear, proportionate documents that are easy to maintain.
System Documentation
Standard Operating Procedures · SOPs
Description of critical processes, responsibilities, activity sequence, controls and associated records.
Technical Instructions
Detailed instructions for specific tasks, equipment, methods, cleaning, verification or control activities.
Records and Forms
Evidence that an activity has been performed, reviewed and approved against defined criteria.
Version Control
Systems for approval, distribution, review, withdrawal and archiving to prevent the use of obsolete documents.
Change Control
Assessment and authorisation of modifications before implementation, including impact, responsibilities, training and later verification.
Archiving and Traceability
Definition of retention periods, access, protection, retrieval and relationships between documents and records.
Documented Training
Planning and evidence of the training required to apply procedures correctly.
Deviations, CAPA, Changes and Risk Management
Incidents should not be closed merely by correcting the immediate effect. Where recurrence is possible, the cause should be analysed, proportionate actions defined and effectiveness verified.
SHAPYPRO helps structure these processes so that the information generated supports decisions and system improvement.
Deviations and Non-Conformities
Recording, impact assessment, investigation and resolution of failures against procedures, specifications or requirements.
Root-Cause Analysis
Use of appropriate tools to distinguish the real cause from the visible symptoms of an incident.
Corrective Actions and CAPA
Definition of actions, owners, deadlines, evidence and criteria for effectiveness verification.
Complaints and Returns
Receipt, classification, investigation and follow-up of incidents reported by customers or distributors.
Change Control
Preventive evaluation of the impact of a change before approval and implementation.
Risk Management
Prioritisation of controls and resources according to the likelihood, severity and detectability of potential failures.
Indicators and Trends
Monitoring of data to identify recurrence, deterioration or areas requiring preventive attention.
Support for ISO 9001 and ISO/IEC 17025
The general quality service can be complemented by specific implementation or improvement projects related to ISO 9001 and ISO/IEC 17025.
The Quality Service page acts as the entry point for cross-functional needs. Full certification or accreditation projects are covered by dedicated services to keep objectives, requirements and scopes clearly separated.
ISO 9001 · Quality Management Systems
Support with diagnosis, implementation, documentation, internal auditing and preparation for certification of quality management systems.
ISO/IEC 17025 · Laboratory Competence
Consultancy for testing and calibration laboratories seeking to strengthen technical competence, impartiality, validity of results and consistent operation.
Integrated Systems
Coordination of common requirements to avoid duplication between quality systems, regulatory duties and internal procedures.
Working Methodology
Each project is adapted to the starting point, risks, available resources and organisational objectives.
Work is planned in phases to prioritise real needs and help the organisation maintain the system after the consultancy project ends.
Initial Review
Analysis of activities, organisation, documentation, processes, applicable requirements and identified problems.
Scope Definition
Definition of priorities, deliverables, responsibilities, timetable and the level of support required.
GAP Analysis and Work Plan
Comparison between the current situation and the intended objective, with actions ordered by risk and impact.
Development and Implementation
Preparation or review of documents, establishment of controls, training and support during application.
Verification
Review of records, interviews, audits or checks to assess actual implementation.
Follow-Up and Improvement
Adjustment of the system, closure of actions and definition of mechanisms to maintain continual improvement.
Independence and Scope of the Service
SHAPYPRO provides consultancy and technical support but does not act as a certification body or accreditation body.
Engaging the service does not guarantee certification, accreditation or a favourable inspection outcome. Decisions remain the responsibility of the competent body or authority.
This independence allows the work to focus on improving the system, preparing evidence and helping the organisation understand and apply the requirements relevant to its activities.
Quality Service Adapted to Each Organisation
Each laboratory or company has different processes, risks and documentary needs. The scope may therefore range from a specific review to ongoing outsourced support.
SHAPYPRO provides technical support, practical documentation and an independent perspective to strengthen process control, traceability and quality-system improvement.
