ISO 9001 Implementation

Quality Systems

Complete and certifiable ISO 9001:2015 implementation

We implement ISO 9001:2015 quality management systems from scratch. Proven methodology in 7 phases, complete documentation, training, internal audits. Until successful certification in 4-8 months.

4-8months to certification
85%+first audit approval
Proven methodology
What is it?

ISO 9001:2015 Implementation

ISO 9001 implementation is the process of designing, documenting and operating a quality management system (QMS) that meets ISO 9001:2015 requirements. It's not just documentation: it's transforming your operation so processes are controlled, measured, and continuously improving.

Difference with certification: Implementation is the internal work you do with Alternative to have the system running. Certification is the external evaluation by a certification body that verifies compliance and grants the certificate. Implementation is necessary before certification.

Alternative approach: We don't implement bureaucracy. We implement pragmatic systems that add real value: documented processes your team uses, quality controls that prevent problems, indicators that guide decisions. The system must work for your company, not your company for the system.

ISO 9001:2015 Principles

Customer focus
Leadership
People engagement
Process approach
Continuous improvement
Evidence-based decisions
Relationship management
Who Is It For

Do you need to implement ISO 9001?

Client requires certification

Your main client requires ISO 9001 to continue the business relationship.

Regulated industry

Banking, pharmaceutical, food or energy sectors with regulatory requirements.

International expansion

ISO 9001 facilitates entry to international markets with global recognition.

Growing company

You need to standardize operations to maintain quality while scaling.

Informal system

Undocumented processes create inconsistencies. You need a formal system.

Tenders

ISO 9001 certification is valued in public and private tenders.

Methodology

Our Methodology in 7 Phases

Structured and proven process that takes you from initial diagnosis to successful certification. Each phase has clear deliverables and defined success criteria.

1
PHASE 1Initial Diagnosis1-2 weeks

Current state evaluation, gaps vs ISO 9001:2015 and implementation plan.

2
PHASE 2System Design2-3 weeks

QMS architecture, processes, responsibilities and quality KPIs.

3
PHASE 3Documentation4-6 weeks

Quality manual, procedures and instructions aligned to ISO 9001:2015.

4
PHASE 4Implementation6-8 weeks

Training, quality controls and adjustments based on operational feedback.

5
PHASE 5Internal Audit1-2 weeks

Audit by certified auditors and non-conformity identification.

6
PHASE 6Corrections2-4 weeks

Corrective actions and final preparation for certification.

7
PHASE 7Certification1-2 weeks

Audit simulation and support during Stage 1 and Stage 2.

What's Included

Everything needed for successful certification

Complete Documentation

Quality manual, procedures, work instructions, forms. All aligned to ISO 9001:2015 and adapted to your company.

Training

Training for all staff on processes, quality controls, and system use. Knowledge transfer for autonomous operation.

Internal Audits

Internal audits by ISO 9001 Lead Auditor certified auditors. Non-conformity identification and corrective action plan.

Support

Support throughout implementation. Regular meetings, question resolution, adjustments as needed. Until successful certification.

Measurable benefits

4-8
months

until certification

85%+
approval

first audit

20-30%
reduction

non-conformities

100%
traceability

documented processes

50%+
reduction

customer complaints

0
risk

certification loss

ISO 9001:2015 Requirements

Standard Structure (Clauses 4-10)

ISO 9001:2015 is structured in 10 clauses. Clauses 4-10 define the quality management system requirements you must implement.

  • Identification of interested parties
  • Quality management system scope
  • Processes and their interactions
  • Quality policy
  • Roles and responsibilities
  • Top management commitment
  • Actions for risks and opportunities
  • Quality objectives
  • Change planning
  • Necessary resources
  • Personnel competence
  • Documented information
  • Operational planning
  • Supplier control
  • Control of non-conformities
  • Monitoring and measurement
  • Internal audit
  • Management review
  • Non-conformities
  • Corrective actions
  • Continuous improvement

Frequently Asked Questions

Typically 4-8 months. Small companies: 4-5 months. Medium companies: 6-8 months. Includes implementation, internal audits and certification preparation.

Implementation is the internal process to design and operate the system. Certification is the external evaluation that verifies compliance and grants the certificate. Alternative supports you in both.

No. ISO 9001 requires documented processes with continuous improvement, not perfect ones. We document what works and improve what doesn't.

With minor non-conformities, you have 30-90 days to correct. With Alternative, 85%+ pass the first audit thanks to rigorous prior internal audits.

Depends on size and complexity. Includes consulting, documentation, training and audits. Request personalized quote with free diagnosis.

Yes. Annual internal audits, management review and continuous improvement. Re-certification every 3 years. Alternative offers post-certification support.

Certifiable implementation

Do you need to certify ISO 9001?

Free 30-minute diagnosis. We evaluate your current situation, identify gaps vs ISO 9001:2015, and present a personalized implementation plan with timeline and budget.

Gap assessment vs ISO 9001:2015
Personalized implementation plan
Realistic timeline (4-8 months)
Detailed budget with no surprises