Control of Documented Information QnA

•       Why the 'Control of documented information QSP' does not contain any forms?

The 'Control of Documented information’ Procedure (that you have purchased) regulates the Documented Information Management activities in full compliance with ISO 9001: 2015.

Here is the additional information regarding the Documented Information Format.

1) ISO 9001:2015 does not contain any requirements as for the Documented information format

2) ISO 10013 recommends that the format of the documented information is the Organization’s own decision.

3) It is a good practice to use 5 W method when developing the document (the document is considered self-sufficient if it answers the following 5 questions:

- WHAT to do?

- HOW to do it?

- WHO does it? (distribution of responsibility and authority)

- WHERE to do it?

- WHEN to do it?)

As defined in ISO 10013, it is a decision of the Organization to define the amount and the structure of the documented information (document titles, their number, detailed descriptions, etc.).

•       What are the required records for cl. 7.5.1.a and cl. 7.5.1.b of ISO 9001:2015?

ISO 9001:2015 7.1.5  General: ‘The organization’s quality management system shall include: a) documented information required by this International Standard; b) documented information determined by the organization as being necessary for the effectiveness of the quality management system. NOTE The extent of documented information for a quality management system can differ from one organization to another due to: — the size of organization and its type of activities, processes, products and services; — the complexity of processes and their interactions; — the competence of persons.’

In ISO 9001:2015 7.5.1.а the documented procedures (traditionally called Level 2), execution of which implements the requirements of the Standard are discussed. A good practice, that started with the version of ISO 9001:2000,  shows that to meet all the requirements about 17 Documented Procedures are necessary. They are listed in the Program of QMS Development, Implementation, and ISO 9001:2015 Certification Preparation (the Program is available for free download from our site).

ISO 9001:2015 7.5.1.b talks about a lower level Documented information (it is traditionally called Level 3), including that provide the details for the Procedures mentioned above, and other documents, that are used by the Organization. A good practice is to link the different levels of documentation via references:

- In Quality Manual (Level 1) to Documented Procedures (Level 2);

- In the Documented Procedures (Level 2) to the Level 3 documents.

This makes it possible to interconnect all the QMS Documented information.

Building a Quality Management System

Building a Quality Management System (QMS) can be divided into 3 phases.

QMS Development Phase includes the following activities:

- Initial audit of the organization
- Evaluation of existing management system ‘As-is’
- Definition of QMS Processes and their Owners.
- Forming of the QMS development team.
- Executive’s order for QMS development.
- ISO 9001:2015 QMS Development team training.
- Development of the Organization’s

• Mission 
• Strategy 
• Quality Policy 
• Quality Objectives 

- QMS Processes development
- Development of the first edition of the backbone of the Organization’s standards.

QMS Implementation Phase includes the following activities:

- Employees training
- Validation and approval of system QSP
- Checking the third level QMS normative documentation.
- ‘Quality Manual’ Development

The following activities should be conducted when preparing the QMS for the ISO 9001:2015 Certification:
- QMS Internal auditors training
- Conducting of internal preliminary audit
- Corrective actions based on the internal audit results.
- Signing a contract with the Certification body.
- Conducting of Certification audit and nonconformities elimination.

We created the PROGRAM of QMS Development, Implementation and Preparation for ISO 9001:2015 Certification to facilitate completing the steps. The PROGRAM contains practical tips and recommendations and can be downloaded for free from our site.

A collection of our ISO 9001:2015 Documents and Templates

ISO 9001:2015 Audit Checklist

We've added a new document to our ISO 9001:2015 Documents and Templates collection.

 
ISO 9001:2015 Audit Checklist



The Checklist contains explanations and recommendations that:

• Facilitates the audit;
• May serve as a guide in the transition to the new version of ISO 9001: 2015 using 'fill the gap' methodology;
• Allows for QMS self-assessment for compliance with ISO 9001: 2015;
• Facilitates learning and understanding of the new version of ISO 9001:2015 requirements
• User-friendly format and professional layout - reviewed and approved by experienced ISO 9001 quality auditors.
• 72 pages
• $109.00

 

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Environmental management guidance standard now published

Following the revision of ISO 14001, the newly revised ISO 14004:2016 Environmental management systems -- General guidelines on implementation has been published.


Dr Anne-Marie Warris, Chair of ISO/TC 207/SC 1, the technical committee that developed the standard and undertook the revision, said:
“The new version of ISO 14004 provides organizations with further details and information in relation to the new ISO 14001:2015. Some of the changes include a focus on protecting the environment, environmental performance, life-cycle perspective, leadership and strategic environmental management.”

The standard is available on the ISO website.