ISO 9001 Consultancy

ISO 9001 is the international standard for quality management systems. It is voluntary, and it applies to organisations of any size in any sector. With CE Danışmanı (CE Consultant) you get your ISO 9001 certificate through a single point of contact for the whole process.

What ISO 9001 covers

The standard does not regulate the product directly. It sets the minimum requirements for the management system that produces it, so that errors are identified and prevented, and those that occur are corrected with minimal harm. It states what must be done, not how, so each company builds a system that fits its own operations.

The quality management principles behind it:

• Customer focus
• Leadership
• Engagement of people
• Process and system approach
• Continual improvement
• Evidence-based decision making
• Mutually beneficial supplier relationships

What a company gains

• Defined responsibilities and authorities
• Documented, repeatable processes and staff who know them
• Records and data that are reviewed regularly and support decisions
• Fewer errors and less rework in production
• Structured evaluation and monitoring of suppliers
• Risks identified in advance
• Easier dealings with customers abroad who ask for ISO 9001

Who issues the certificate?

ISO itself does not certify. ISO 9001 certificates are issued by certification bodies accredited by a national accreditation body that is a signatory to the IAF multilateral recognition arrangement. In Turkey that body is TÜRKAK. Certified companies use the certification mark of that body under its rules, not the ISO logo.

The process

1. Gap analysis. Comparing current practice with the requirements of the standard.
2. System design and documentation. Quality policy and objectives, process descriptions, procedures, instructions and records.
3. Implementation and training.
4. Internal audit and management review.
5. Certification audit by the accredited certification body.

How long this takes depends on the size of the company and on how much of the system already exists.

Validity

ISO 9001 certificates are valid for three years. During that period the certification body carries out a surveillance audit each year.

Typical documentation

• Quality policy and quality objectives
• Scope of the quality management system and process descriptions
• Procedures such as document control, risks and opportunities, supplier evaluation, nonconforming product, corrective action, design and development, production, sales and customer management
• Instructions, plans and records

ISO 9001 alongside product certification

Traceability, document control and inspection procedures built for ISO 9001 are the same disciplines a technical file needs. Manufacturers with a working quality system find CE marking, machinery conformity and the production audits for EAC certification easier to prepare for.

Sector-specific standards build on ISO 9001, for example ISO 13485 for medical devices and ISO/TS 22163 for the rail sector.

How CE Danışmanı helps

• Gap analysis and system design
• Preparing the documentation with your team
• Staff and internal auditor training
• Internal audit and preparation for the certification audit

Tell us about your company and we will reply with our offer as soon as possible.

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