18 October 2014

Beda ISO 9001:2008 vs ISO 9001:2015 (ISO9001 yang terbaru)

Perbedaan ISO 9001:2008 dengan ISO 9001:2015 (draft) dapat di lihat pada tabel di bawah ini.

Buat yang lagi belajar memahami standar manajemen mutu yang terbaru ISO 9001:2015, tabel ini pasti bermanfaat.

Perubahan mendasar antara standar ISO 9001 yang baru dengan yang lama adalah pada standar yang baru terdapat persyaratan risk management. Sementara elemen-elemen lainnya tetap hampir sama.

Pelajari tabel berikut di bawah ini. Kalau ingin bertanya, ajukan pertanyaan Anda ke email zulkifli@sintegral.com


Beda ISO 9001:2008 vs ISO 9001:2015



ISO 9001:2008
ISO/DIS 9001
4        Quality management system
4         Quality management system
4.1     General requirements
4.4     Quality management system and its processes
4.2     Documentation requirements  
7.5     Documented information
4.2.1  General
7.5.1  General
4.2.2  Quality manual
4.3     Determining the scope of the quality management system
7.5.1  General
4.4     Quality management system and its Processes
4.2.3  Control of documents
7.5.2  Creating and updating
7.5.3  Control of documented Information
4.2.4  Control of records
7.5.2  Creating and updating
7.5.3  Control of documented Information
5         Management responsibility
5        Leadership
5.1      Management commitment
5.1     Leadership and commitment
5.1.1  Leadership and commitment for the    quality management system
5.2      Customer focus
5.1.2  Customer focus
5.3      Quality policy
5.2     Quality policy
5.4      Planning
6        Planning for the quality management system
5.4.1  Quality objectives
6.2     Quality objectives and planning to achieve them
5.4.2  Quality management system planning
6 Planning for the quality management system
6.1 Actions to address risks and opportunities
6.3  Planning of changes
5.5      Responsibility, authority and communication
5        Leadership
5.5.1   Responsibility and authority
5.3     Organizational roles, responsibilities and  authorities
5.5.2   Management representative
          Title removed
5.3     Organizational roles, responsibilities and  authorities
5.5.3   Internal communication
7.4     Communication
5.6      Management review
9.3     Management review
5.6.1   General
9.3.1  Management review
5.6.2   Review input
9.3.1  Management review
5.6.3   Review output
9.3.2  Management review
6         Resource management
7.1     Resources
6.1      Provision of resources
7.1.1  General
7.1.2  People
6.2      Human resources
          Title removed
7.2     Competence  
6.2.1   General
7.2     Competence  
6.2.2  Competence, training and awareness
7.2      Competence  
7.3      Awareness
6.3      Infrastructure
7.1.3  Infrastructure
6.4      Work environment
7.1.4  Environment for the operation of processes
7         Product realization
8         Operation
7.1      Planning of product realization
8.1      Operational planning and control
7.2      Customer-related processes
8.2      Determination of requirements for products and services
7.2.1  Determination of requirements related to the product
8.2.2  Determination of requirements related to products and services
7.2.2  Review of requirements related to the product
8.2.3  Review of requirements related to the products and services
7.2.3  Customer communication
8.2.1  Customer communication
7.3      Design and development
8.5      Production and service provision
7.3.1  Design and development planning
8.3      Design and development of products and services
8.3.1  General
8.3.2  Design and development planning
7.3.2  Design and development inputs
8.3.3  Design and development Inputs
7.3.3  Design and development outputs
8.3.5  Design and development outputs
7.3.4  Design and development review
8.3.4  Design and development controls
7.3.5  Design and development verification
8.3.4  Design and development controls
7.3.6  Design and development validation
8.3.4  Design and development controls
7.3.7  Control of design and development changes
8.3.6  Design and development changes
7.4      Purchasing
8.4      Control of externally provided products and services
7.4.1  Purchasing process
8.4.1  General
8.4.2  Type and extent of control of external provision
7.4.2  Purchasing information
8.4.3  Information for external providers
7.4.3  Verification of purchased product
8.6      Release of products and services
7.5      Production and service provision
8.5      Production and service provision
7.5.1  Control of production and service provision
8.5.1  Control of production and service provision
8.5.5  Post-delivery activities
7.5.2  Validation of processes for production and service provision
8.5.1  Control of production and service provision
7.5.3  Identification and traceability
8.5.2  Identification and traceability
7.5.4  Customer property
8.5.3  Property belonging to customers or external providers
7.5.5  Preservation of product
8.5.4  Preservation
7.6      Control of monitoring and measuring equipment
7.1.5  Monitoring and measuring resources
8.0      Measurement, analysis and improvement
9.1      Monitoring, measurement, analysis and evaluation
8.1      General
9.1.1  General
8.2      Monitoring and measurement
9.1      Monitoring, measurement, analysis and evaluation
8.2.1  Customer satisfaction
9.1.2  Customer satisfaction
8.2.2  Internal audit
9.2      Internal audit
8.2.3  Monitoring and measurement of processes
9.1.1  General
8.2.4  Monitoring and measurement of product
8.6      Release of products and services
8.3      Control of nonconforming product
8.7      Control of nonconforming process outputs, products and services
8.4      Analysis of data
9.1.3  Analysis and evaluation
8.5      Improvement
10       Improvement
8.5.1  Continual improvement
10.1   General
10.3   Continual Improvement
8.5.2  Corrective action
10.2   Nonconformity and corrective action
8.5.3  Preventive action
           Clause removed
6.1       Actions to address risks and opportunities (see 6.1.1, 6.1.2)

Tabel lengkap lihat download: Perbandingan bab ISO 9001:2015 dan ISO 9001:2008 (matriks korelasi) 

Sumber: ISO/TC 176/SC 2, Document N1224, July 2014

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