Share this ...

QMS – ISO9001:2015 Documentation Matrix

As the 2015 standard used the terms documented information, the clarification was address in the annex of the standard and extracts of the clarification as followed:

ISO9001:2015 - A.6 Documented information

As part of the alignment with other management system standards, a common clause on “documented information” has been adopted without significant change or addition (see 7.5). Where appropriate, text elsewhere in this International Standard has been aligned with its requirements. Consequently, “documented information” is used for all document requirements.

Where ISO 9001:2008 used specific terminology such as “document” or “documented  procedures”, quality manual” or “quality plan”, this edition of this International Standard defines requirements to“maintain documented information”. Where ISO 9001:2008 used the term “records” to denote documents needed to provide evidence of conformity with requirements, this is now expressed as a requirement to “retain documented information”. The organization is responsible for determining what documented information needs to be retained, the period of time for which it is to be retained and the media to be used for its retention. A requirement to “maintain” documented information does not exclude the possibility that the organization might also need to “retain” that same documented information for a particular purpose, e.g. to retain previous versions of it.

 

Where this International Standard refers to “information” rather than “documented information” (e.g. in 4.1: “The organization shall monitor and review the information about these external and internal issues”), there is no requirement that this information is to be documented. In such situations, the organization can decide whether or not it is necessary or appropriate to maintain documented information.

 End section A6

 

To provide the guide for organization, we develop the matrix that use the word “Recommend”, and “Mandatory”. Recommend mean that the documented information is not compulsory but highly recommended to organization as the best practice and to address the requirements. While the word mandatory is list in remark to indicate that ISO9001;2015, required the documented information to be maintain or retain.

 

Clause #
ISO9001:2015
Maintained (Documents)
Retained (Record)
Remark
  Context of the Organization       
4.1 Understanding the organization and its context Recom4mend to have list of issues-link with risk & opportunities Management Review - Including result of monitoring  
4.2 Understanding the needs and expectations of interested party Recommend to have legal register Management Review - Including result of monitoring  
4.3 Determining the scope of QMS Recommend to maintained Quality Manual   Mandatory to maintain
4.4 QMS and its processes Recommend to maintain in process ID   Mandatory to maintain
5 Leadership         
5.1 Leadership and Commitment      
5.1.1  General      
5.1.2  Customer focus      
5.2 Quality Policy      
5.2.1 Establishing the quality policy      
5.2.2  Communicating the quality policy Quality Policy   Mandatory to maintain
5.3 Organizational Roles, Responsibilities and Authorities Recommend to maintain organization chart and job decription    
6 Planning      
6.1 Action to address risks and opportunities  Recommend to have list of issues-link with risk & opportunities    
6.2 Quality objectives and planning to achieve them Quality Objectives   Mandatory to maintain
6.3 Planning of changes  Recommend to maintain management of change procedure (MOC)    
7 Support      
7.1 Resources      
7.1.1 General      
7.1.2 People Recommend to maintain Recruitment procedure    
7.1.3 Infrastructure Recommend to maintain Asset management & Maintenance (Corrective/ Preventive) Procedure    
7.1.4     Environment for the operation process    Recommend to maintain Asset management/ work environment procedure    
7.1.5  Monitoring & Measuring resources      
7.1.5.1  General Recommend to maintain Calibration procedure Calibration report Mandatory to retain
7.1.5.2  Measurement Traceability Recommend to maintain Calibration procedure Calibration report Mandatory to retain
7.1.6  Organizational Knowledge Recommend to maintain knowledge management procedure Recommend to retain lesson learned  
7.2 Competence   Retained comptency record Mandatory to retain
7.3 Awareness      
7.4 Communication Recommend to maintain communication matrix    
7.5 Documented Information                    
7.5.1  General      
7.5.2  Creating and Updating Recommend to maintain control of documented information procedure    
7.5.3  Control of documented information Recommend to maintain control of record procedure    
8 Operation                    
8.1 Operation Planning and Control Recommend to maintain quality plan    
8.2 Requirements for products and services      
8.2.1  Customer Communication Recommend to maintain customer complaint/ feedback procedure    
8.2.2  Determining the requirements for product and services Recommend to maintain sales/ marketing procedure    
8.2.3  Review of the requirements for products and services Recommend to maintain contract/ order review procedure Retain contract/ order review record Mandatory to retain
8.2.4  Changes to the requirement for products and services Recommend to maintain management of change procedure (MOC)    
8.3 Design and development of product and services      
8.3.1 General Recommend to maintain design and development procedure    
8.3.2 Design and development Planning Recommend to maintain project plan    
8.3.3 Design and development inputs   Design input i.e. specs Mandatory to retain
8.3.4 Design and development controls   Review, verification, validation records Mandatory to retain
8.3.5 Design and development outputs   Design output i.e spec, drawing etc Mandatory to retain
8.3.6 Design and development changes   The changes and result of reviews Mandatory to retain
8.4 Control of externally provided processes, product and services Recommend to maintain purchasing procedure    
8.4.1  General   Evaluation, selection, monitoring performance and reevaluation Mandatory to retain
8.4.2  Type and Extent of Control Recommend to maintain supplier quality manual    
8.4.3  Information for external providers   PO, contract   
8.5 Production and Service Provision      
8.5.1  Control of production and service provision Recommend to maintain quality plan, Work Instruction, schedule Record required from quality plan  
8.5.2   Identification and Traceability   Traceability record Mandatory to retain
8.5.3 Property belonging to customers or external provider   Customer property record Mandatory to retain
8.5.4  Preservation Recommend to maintain handling, storage procedure    
8.5.5  Post Delivery activities Recommend to maintain post delevries procdure i.e. warranty, servicing etc    
8.5.6  Control of changes   Change record Mandatory to retain
8.6 Release of products and services Recommend to maintain quality plan and outgoing procedure Record required from quality plan Mandatory to retain
8.7 Control of Non conforming output Recommend to maintain control of NC procedure Non conformance record Mandatory to retain
9 Performance evaluation      
9.1 Monitoring, measurement, analysis and evaluation      
9.1.1  General   Monitoring, measurement, analysis, evaluation record Mandatory to retain
9.1.2  Customer satisfaction   Customer satisfaction record  
9.1.3  Analysis and evaluation.   Analysis and evaluation record  
9.2 Internal audit   Audit program and result Mandatory to retain
9.3 Management review   Management review record Mandatory to retain
9.3.1  General      
9.3.2  Management review inputs      
9.3.3  Management review outputs   Management review record Mandatory to retain
10 Improvement      
10.1 General      
10.2 Nonconformity and corrective action Recommend to maintain corrective action procedure NC and corrective action record Mandatory to retain
10.3 Continual improvement   Management review record  

Search EFR Certified Client

Company Name:

Registration No:

For inquiries

EFR Certification - EFRC

ASCB (E) Ltd
6, Ferris Place, Bournemount, Dorset,
BH8 AUO. UK

Malaysia Office:

2909-B (Level 2), Jalan Merbau 3,
Bandar Putra,
81000 Kulaijaya, Johor, Malaysia.

India Office:

EFR Certification Services
Chennai, Tamil Nadu, India.

Iran Office:

EFR Certification Iran
3 rd Floor, No.1 , Keivan Alley, 4 th St., FatemiAve, Tehran, Iran.