Documented Information – Part 2

The annex to ISO 9001 (A.6) says that “Where ISO 9001:2008 would have referred to documented procedures … this is now expressed as a requirement to maintain documented information”, and “Where ISO 9001:2008 would have referred to records this is now expressed as a requirement to retain documented information”.  Note: Just a little history lesson. […]

Documented Information – Part 1

According to ISO themselves, two of the most important objectives in the revision of the ISO 9001:2015 are: a) to develop a simplified set of standards that will be equally applicable to small as well as medium and large organizations, and b) for the amount and detail of documentation required to be more relevant to […]

Competence

Last century, there was one clause called training.  This has been replaced by four.  And this month we focus on 7.2.  The standard, clause 7 Support; 7.2 Competence describes; The company has: determined the necessary competence of person(s) doing work under its control that affects the performance and effectiveness of the Quality Management System; ensured […]

Management Review

The company’s top management reviews the company’s Quality Management System at planned intervals to ensure its continuing suitability, adequacy, effectiveness and alignment with the strategic direction of the company. The management reviews are planned and carried out taking into consideration: the status of actions from previous management reviews; changes in external and internal issues that […]

Awareness​

Another 2016 clause without a requirement for documented information. Neither maintained or retained (we remember the difference?). You know; maintained are procedures, videos, flowcharts, etc with retained being, well let’s just say it… records. The standard is quite explicit; The company ensures that persons doing work under the company’s control are aware of: the Quality […]

Communication​

The ‘relatively new’ clause 7. Support in 9001 covers; resources, competence, awareness, communication and documented information. But for now, let’s focus on communication. No required retained or maintained documented information. No prescription. But the certifiers are, perhaps, giving it a little too much attention. As always, the easiest way to get over that hurdle is […]