Are Specifications Documents Required for ISO 9001 Certification?

The requirements for ISO 9001 certification are divided into various documents that are critical for maintaining a quality management system. These documents not only ensure compliance with the standard but also facilitate consistent performance and customer satisfaction. One of the key questions is whether specifications documents are mandatory for achieving ISO 9001 certification. This article delves into the requirements under both ISO 9001-2008 and ISO 9001-2015 standards to provide a comprehensive understanding.

Documents Required for ISO 9001 Certification

ISO 9001 is a widely recognized international standard for quality management systems. The certification process requires the submission of several documents to demonstrate that the organization has a robust quality management system in place. These documents are:

Quality Manual Quality Policy Quality Objectives Quality Records Six Procedures: Control of Documents, Control of Records, Internal Audit, Control of Nonconforming Product, Corrective Action, Preventive Action

ISO 9001-2008: The Old Standard

ISO 9001-2008, while now superseded by the 2015 version, still has co-existence with the newer standard until September 15, 2018. Here are the key requirements under this standard:

Clause 4.2.1

According to ISO 9001-2008, clause 4.2.1 requires:

A documented statement of quality policy and quality objectives A quality manual Documents and records required by the international standard Documents including records necessary to ensure effective planning, operation, and control of processes

The standard mandates the use of documented procedures, particularly control of documents (4.2.3) and control of records (4.2.4). Additionally, procedures for internal audits, control of nonconforming products, corrective action, and preventive action are also required (8.5.2 and 8.5.3).

ISO 9001-2015: The New Standard

ISO 9001-2015, introduced to replace the 2008 version, integrates documents and records under clause 7.5, titled 'Documented Information.' This clause includes the following sub-clauses:

7.5.1 General 7.5.2 Creating and Updating 7.5.3 Control of Documented Information

Clause 7.5.1 states that an organization's quality management system should include:

Documents required by the international standard Documents determined by the organization as necessary for the effectiveness of the quality management system

The new standard also emphasizes the control of documented information to ensure its integrity and traceability. This integration simplifies the management of documents and records, promoting a more streamlined and efficient system.

Design and Development Specifications

The question also pertains to specifications, particularly in the context of design and development. ISO 9001-2008 requires the following documentation for design and development:

Design Development Input records Design Development Review records Design Development Verification records Design Development Validation records Records of reviews of design changes and actions

Under ISO 9001-2015, the following documentation is required for design and development of products and services:

Design and Development Planning Design and Development Inputs Design and Development Controls Design and Development Outputs Design and Development changes and its reviews

Conclusion

In summary, specifications documents are indeed required for ISO 9001 certification, although the specific requirements may vary slightly between the 2008 and 2015 versions. Regardless of the standard in use, maintaining clear and detailed documentation is essential for quality management and achieving certification. Organizations must comply with the relevant clauses and maintain documented procedures and records to ensure their quality management system is effective and compliant.

Related Keywords

ISO 9001 Quality Manual Documentation Requirements