Quality Management, ISO 9001, Quality Management System, SHEQ, SHEQ Software

ISO 9001 Managing Documented Information

Managing Documented Information

INTRODUCTION TO ISO 9001 Managing Documented Information – Winning the paper warfare

QUALITY MANAGEMENT SYSTEM ISO 9001:2015 CLAUSE 7.5

One of the most talked-about clauses since ISO 9001 first became a standard in 1987 is the amount and sort of documents. Document and record control is now contained under Clause 7.5 Documented Information.

Many have made the mistake of “too much is never enough”.  People think that this is the basis for including everything and anything in their system, which is unnecessary.  Consultants take advantage of inexperienced clients by designing and implementing too many documents, such as policies, procedures, checklists, etc.  They do this as they are interested in the bottom line and how much money they can charge.  Furthermore, they get a second chance to invoice again when they frequently audit the same documents.  They will then insist on implementing additional documents to comply with another section of the standard if they find a non-conformance.  And, so it goes on and on until eventually, you are drowning in documents.

CRITICISM OF ISO 9001

There has been a lot of debate regarding the number of documents required to achieve certification.  Some feel the need to design and implement millions of records with the excuse that it is an ISO 9001 requirement.  However, others argue that the standard must be taken into account but not cast in stone.

“I firmly believe that the madness around documentation is the reason why ISO 9001 hasn’t become more popular.”

ISO claims that over a million companies have received certification; on the contrary, this number is small compared to the possible amount that could be certified.  Companies maintain that achieving certification is not worth the pain and suffering of creating numerous documents.

CERTIFICATION BODIES

Some state that a company must create documents so that they pass the audit.  I heard a rumour that a business had to revise its quality manual to meet the standard’s clauses.  Is this going to add value?  Undoubtedly not.  It is a money-making exercise!  If you get an incompetent auditor who can’t link the manual to the standard for documentation, then why must the company incur extra costs?

HOW MANY DOCUMENTS DO YOU NEED

It is for the business to decide how many documents are required, “necessary for the effectiveness of the quality management system”.  The successful management of the QMS is the Quality Manager’s responsibility.

Firstly, what documents don’t you need:

  • Quality Manual
  • Forms Register
  • Records Register
  • Document Register
  • Document Change Register

Secondly, what documents do you need:

  • Document identification and description
  • Suitable layout – language, software version, graphics, paper, electronic
  • Review and approval
  • Available for use
  • Protected – from loss of confidentiality, improper use, loss of integrity
  • Controlled – distribution access, retrieval and use, storage and preservation, presentation of legibility, changes, retention and disposition

QUALITY MANUAL

We decided after extensive investigation and meetings that having a Quality Manual would add value to our system.  Additionally, the Quality Manual is excellent for:

  • Communicating the QMS to employees
  • Training new personnel about the QMS
  • Assisting suppliers to understand our QMS requirements
  • Giving access to our QMS to clients who want to view or audit it

Consequently, we use Mango to control our documentation.  For instance, the Quality Manual, policies, procedures and checklists that we use to show that we comply with the ISO 9001 standard, legal and regulatory requirements. Our employees use Mango so as not to create millions of unnecessary documents.  It is an orderly, concise, and easy to operate software system.

IN SUMMARY

1.     Decide what a streamlined and efficient QMS looks like

  1. You only require documents for the efficient execution of the QMS
  2. Then, decide how extensive your QMS will be
  3. A Quality Manual is not a have to have, but rather a good to have
  4. Then, remember that your documentation must be managed and controlled.

USE SHEQ SOFTWARE

At SRM, we use Mango to design and implement our ISO 9001:2015 Quality Management System documentation.  In addition, Mango makes it so simple as opposed to using a hard copy system.  Not only does SRM use Mango Compliance Software, but many of our clients as well – www.mangolive.com  Mango makes it easier to get ISO 9001:2015 certification.

SRM is ISO 9001:2015, ISO 14001:2015 and ISO 45001:2018 certified. Contact our consultants today. Let us know if we can help you with the development and implementation of your Quality Management System.

Associated Blogs

https://srmc.co.za/iso-9001/

https://srmc.co.za/iso-90012015-is-all-about-managing-relationships/

 

Links to our services:

https://srmc.co.za/services/consulting/

https://srmc.co.za/iso-certifications/