Consultancy for ISO 9001 Certification
SHAPYPRO provides consultancy for implementing, maintaining and improving quality management systems and preparing organisations for ISO 9001 certification.
The service is adapted to companies, laboratories and organisations in different sectors and includes initial diagnosis, GAP analysis, process definition, documentation, indicators, internal auditing, management review and support before the external audit.
- ISO 9001
- GAP analysis
- Internal audit
- Continual improvement
ISO 9001 Consultancy for Quality Management Systems
ISO 9001 provides a framework for managing an organisation’s processes consistently, with customer focus and evidence-based decision-making.
Consultancy should not be limited to producing documents for an audit. The objective is to integrate the requirements into real working practices, define responsibilities, control risks and generate useful information for decisions.
SHAPYPRO supports the organisation from initial diagnosis through certification preparation, adapting the system to its size, activities, resources and existing level of maturity.
When It Can Help
First Implementation
Organisations wishing to create a quality management system and prepare for initial certification.
Existing System Requiring Review
Companies that need to update processes, records, indicators, responsibilities or documented information.
Audit Preparation
Advance review before a certification, surveillance or recertification audit.
Change of Scope or Activity
Adaptation of the system to new sites, services, products, markets, processes or organisational changes.
Transition to a New Edition
Planning the changes required after publication of a revised ISO 9001 edition and its transition arrangements.
What ISO 9001 Is and What Certification Covers
ISO 9001 is the International Standard containing requirements for quality management systems. It can be applied by organisations of any size or sector.
The standard helps control how processes affecting the consistent provision of conforming products and services are planned, performed, monitored and improved.
Certification applies to the management system and the scope defined by the organisation. It does not certify an individual product or person and does not guarantee that errors will never occur.
Certification is voluntary and is performed by an independent certification body. An organisation may use ISO 9001 to improve its management without seeking certification.
Process Approach
Identification of inputs, activities, responsibilities, resources, controls, outputs and interactions between processes.
Customer Focus
Understanding requirements, controlling commitments, monitoring satisfaction and handling complaints.
Leadership and Responsibilities
Management involvement, clear roles and alignment of quality objectives with organisational strategy.
Risks and Opportunities
Assessment of factors that may affect intended results and planning proportionate actions.
Evidence-Based Decisions
Use of indicators, records, audits, complaints and other data to evaluate performance.
Continual Improvement
Treatment of issues, trend analysis and systematic review of improvement opportunities.
Current Edition and Upcoming ISO 9001 Revision
The current reference is ISO 9001:2015 together with Amendment 1:2024 on climate action changes.
The amendment requires the organisation to determine whether climate change is a relevant issue within its context and notes that interested parties may have climate-related requirements.
As of June 2026, ISO/FDIS 9001 is at the final approval stage and the new edition is expected to replace ISO 9001:2015 in September 2026.
Organisations implementing or maintaining the system should continue to use the current edition, while keeping the structure flexible and planning for transition once the final requirements and applicable arrangements have been published.
Context Review
Document whether climate change is relevant to strategy, processes, products, suppliers or interested-party expectations.
Monitoring the Revision
Follow publication of the new edition without treating draft requirements as final.
Transition Planning
Compare the system with the revised standard once published, identify changes and define an adaptation plan.
Certification Body Coordination
Confirm deadlines, audit arrangements and transition rules with the body issuing or maintaining the certificate.
The system must comply with the current edition. A future revision can be anticipated through planning, but a draft should not be treated as a published standard.
ISO 9001 Consultancy Services
The service may cover full implementation, a focused review or ongoing support to maintain and improve the system.
The scope is defined after understanding the organisation’s activities, processes, resources, risks and certification objectives.
Initial Diagnosis and GAP Analysis
Comparison of the current system with applicable requirements to identify gaps, risks and priorities.
Scope Definition
Definition of activities, sites, products, services and processes included in the management system.
Process Mapping and Characterisation
Identification of strategic, operational and support processes, including owners, interactions, controls and indicators.
Document Development
Preparation or review of policy, objectives, procedures, records, process sheets and other necessary documented information.
Risk and Opportunity Management
Definition of criteria, risk assessment and monitoring of planned actions.
Indicators and Performance Evaluation
Selection of useful measures for processes, objectives, customer satisfaction and system effectiveness.
Internal Audit
Independent assessment of conformity, implementation and effectiveness before the external audit.
Nonconformities and Corrective Action
Support with cause analysis, action planning and effectiveness verification.
Management Review
Preparation of inputs, outputs and decisions for management-level evaluation of the system.
Certification Preparation
Final review of documentation, evidence, processes and critical points before the certification-body audit.
Maintenance and Transition
Periodic support and planning for regulatory, organisational, scope or standard changes.
Initial Diagnosis and GAP Analysis
GAP analysis identifies the distance between the current situation and the system the organisation intends to implement or certify.
The review should assess both documentation and real practice. A well-written procedure has little value if the team does not follow it or records do not demonstrate its operation.
Compliance Matrix
Relationship between requirements, existing evidence, gaps and observations.
Risk-Based Prioritisation
Actions ordered by impact, urgency, dependencies and implementation effort.
Work Plan
Roadmap defining tasks, owners, deliverables and indicative deadlines.
Maturity Assessment
Evaluation of actual implementation and the system’s ability to be maintained.
Quality Management System Implementation
Implementation means incorporating the requirements into normal operations. A parallel system that exists only for the audit should be avoided.
SHAPYPRO helps establish proportionate controls, clear responsibilities and tools that can be used and maintained with the available resources.
1
Scope and Process Map
Definition of system boundaries and relationships between processes.
2
Policy, Objectives and Indicators
Establishment of commitments, measurable targets, owners and monitoring arrangements.
3
Customer Requirements
Control of quotations, contracts, changes, communication and the ability to meet commitments.
4
Design and Development
Planning, inputs, reviews, verification, validation and change control where design is included in the scope.
5
Purchasing and External Providers
Selection, evaluation, monitoring and control of externally provided products, processes or services.
6
Service Provision or Production
Instructions, identification, traceability, preservation, release and control of nonconforming outputs.
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Resources and Competence
Definition of personnel, training, infrastructure, equipment and organisational knowledge needs.
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Communication and Change Management
Coordination of responsibilities, internal communication and assessment of changes before implementation.
Documented Information and System Evidence
ISO 9001 does not require unnecessary documentation or impose a quality manual with a fixed structure. The organisation should retain the information needed to operate its processes and demonstrate that the system works.
Documents should be understandable, current and representative of real practice. Approval, distribution, access, modification, retention and withdrawal should also be controlled.
Typical Documentation
Quality Policy and Objectives
Commitments and targets that guide the system and enable progress to be evaluated.
Process Map and Process Sheets
Information on owners, sequence, resources, risks, controls and indicators.
Procedures and Instructions
Documents required to perform activities consistently where control is needed.
Records and Evidence
Results of controls, training, monitoring, audits, reviews, incidents and decisions.
Document Control
Criteria for identification, approval, distribution, updating, archiving and withdrawal.
Data and Indicators
Information used to evaluate objectives, processes, satisfaction, suppliers, incidents and improvement.
Change Control
Recording and assessment of changes that may affect the system or conformity of products and services.
Performance Evaluation and Improvement
The system should generate information showing whether processes work, objectives are achieved and actions are effective.
Improvement is not limited to reacting to nonconformities. It also involves anticipating risks, analysing trends, using opportunities and periodically reviewing system suitability.
Monitoring and Indicators
Collection and analysis of data relevant to process and objective performance.
Customer Satisfaction
Methods for obtaining and evaluating information on customer and user perception.
Internal Audit
Audit programme based on process importance, changes and previous results.
Management Review
Periodic evaluation of system results, resources, risks and improvement needs.
Nonconformities
Control of problems, immediate correction, impact assessment and decisions on further action.
Cause Analysis and Corrective Action
Investigation of causes to prevent recurrence and subsequent effectiveness verification.
Trends and Continual Improvement
Use of accumulated data to detect recurrence, deterioration and optimisation opportunities.
Benefits of Implementing ISO 9001
Benefits depend on how the system is implemented. Certification alone does not correct weak processes, but a well-integrated system can improve control, coordination and organisational learning.
Clearer Processes
Defined responsibilities, controls and relationships between activities.
Improved Traceability
Records and evidence that explain decisions and results.
Fewer Errors and Repetitions
Structured treatment of incidents, causes and corrective actions.
Data-Based Decisions
Use of indicators and trends instead of relying only on perceptions.
Improved Supplier Management
Criteria for selecting, evaluating and controlling external providers.
Customer and Market Confidence
Independent certification may support supplier approval, tenders or commercial relationships.
Foundation for Other Systems
A structure compatible with other management systems and regulatory requirements.
Certification Audit Preparation
The external audit should be approached with an implemented system and sufficient evidence that processes are routinely controlled.
Preparation should not involve creating retrospective records. Documented arrangements should match practice, process owners should understand their roles and issues should be managed transparently.
Scope and Document Review
Verification that scope, processes and documented information represent actual activities.
Evidence Verification
Review of records, indicators, suppliers, training, controls, complaints and actions.
Complete Internal Audit
Advance evaluation with sufficient independence and coverage of the system.
Management Review
Confirmation that management has evaluated results, resources, risks and improvement needs.
Action Plan
Treatment of findings, owners, dates and effectiveness verification.
Team Preparation
Explanation of responsibilities and how to present evidence without scripted answers or improvised documentation.
Certification Body Selection
Comparison of bodies, scope, accreditation, sector experience, schedule and contractual conditions.
ISO develops the standard but does not certify organisations. Certification is performed by an external certification body.
Working Methodology
Each project is organised around the starting point, scope, available resources and organisational objectives.
The methodology aims to implement a proportionate and maintainable system with clear deliverables and participation from the internal team.
Initial Review
Collection of information on activities, structure, processes, documentation, customers, suppliers and objectives.
GAP Analysis
Comparison with applicable requirements and definition of priorities.
Implementation Plan
Organisation of tasks, owners, resources, deadlines and deliverables.
Development and Implementation
Design or review of the system, training and support during application.
Internal Evaluation
Monitoring of indicators, internal audit and management review.
Certification Preparation
Final evidence review and support with closing identified gaps.
Maintenance and Transition
Ongoing support for surveillance audits, organisational changes and future editions of the standard.
Independence and Scope of the Service
SHAPYPRO provides consultancy and technical support but does not act as a certification body.
Engaging the service does not guarantee certification or a particular audit outcome. The decision remains with the independent certification body.
SHAPYPRO’s role is to help the organisation understand requirements, implement controls, prepare evidence and improve the effectiveness of its management system.
ISO 9001 Consultancy Adapted to Each Organisation
Each organisation has different processes, risks, resources and documentary needs. The scope may therefore range from a diagnosis or internal audit to full implementation and maintenance.
SHAPYPRO designs the support around the company’s real activities, avoiding generic systems that create administrative work without improving control or performance.
