ISO 9001:2015 8.5.6 and 7.5.3 Document Control Questions

Devin A

Involved In Discussions
#21
Thankfully since I took over, customer issues have dropped drastically! I think that's in part because I came from being an operator so when I see an issue, rather than just saying there's an issue, I can sit with the operator and show them exactly what's going wrong and how to fix it. Quite a useful tool in my toolbox!
As for managing risks.. I'll have to think on that one haha. VP and I are going to sit down about the COTO report today and figure out what's there and what we need to do.
The customer issues we have had have been very very minor and they didn't require corrective actions or anything. We just talked about what was going wrong and I assured them I'd get it sorted out and get good product to them!
We've addressed all of our nonconforming issues from our last audit so hopefully we can skate by with only a few minors with this one. Given the whole quality department upheaval and an inexperienced person taking over the department there's no hope of a perfect audit, but if we pass we pass! By the next one I'll be ready for it!
 
Elsmar Forum Sponsor

Devin A

Involved In Discussions
#22
So a quick question about 9.2 as a whole. In our internal audit procedure it states that the audits need to be done by a certified auditor, though I see no such requirement in the ISO clause itself. Could we scrap that line? Our only certified auditors are.. Well.. Not the most detail oriented and have almost no understanding of ISO. At least I've looked in the book a little! :ROFLMAO:
 

KimGr

Involved In Discussions
#23
Do you know who trained them? They do not need to be certified but they do need to be competent. Do they have a training record? I would base my SOP on what they currently have then fix that after the audit even if you skate by. Outside training is a good thing to have.
 
#24
It's common to see such things in a procedure - as if it actually means anything. Trainers often issue a certificate, but it doesn't attest to anything but the fact the client paid the bill! Unless it's an accredited course, certificates are meaningless.

What's more important is that an internal auditor is competent. It's not too difficult to come up with some criteria which shows how an internal auditor is competent to do an audit.
 

Devin A

Involved In Discussions
#25
Thank you very much! We had one of our "certified" guys do our internal audit recently and I just looked through them and just.. Wow. He wrote maybe 30 words total, half of which were "N/A" :lmao:. I'll ask VP to change the procedure so I can go through and do some. We may also alter our procedure to state they're done annually at the end of the year to kind of sidestep that one for the audit.. Buuut I think I'd do a few if I have time beforehand anyways.
 

KimGr

Involved In Discussions
#26
See 9.2.2 a - make sure that you are covering importance, changes, and results of previous audits in your schedule. You are not required to audit annually so if you just write that you are open to a N/C. Basically, audit where you need to based on risk. There is another good thread out there and AndyN above mentioned something about having a book he wrote on the subject.
 
#27
Thank you very much! We had one of our "certified" guys do our internal audit recently and I just looked through them and just.. Wow. He wrote maybe 30 words total, half of which were "N/A" :lmao:. I'll ask VP to change the procedure so I can go through and do some. We may also alter our procedure to state they're done annually at the end of the year to kind of sidestep that one for the audit.. Buuut I think I'd do a few if I have time beforehand anyways.
Internal audits shouldn't take much time. I usually get them done in 2 - 3 hours. Don't forget, you're not auditing the whole QMS each time. You have the freedom to define the scope and criteria for the audit as suits your needs. Doing one a year isn't going to be much use and ISO 9001:2015 doe a better job of pointing audit process owners towards what might be considered. Suffice it to say, if you're doing an internal audit and it looks like the CB does, except the auditor is a member of your staff, you're doing it wrong!
 

Devin A

Involved In Discussions
#28
So if I'm understanding that right, we could just write something along the lines of internal audits will be done as deemed needed based on process risk? 9.2.1 states that they must be done at "planned intervals" which makes me feel like I'm understanding what you said wrong haha.
 

KimGr

Involved In Discussions
#29
That's too vague. You are right! You do have to have planned intervals, meaning that you have a schedule (see a1 & a2). The timing of the schedule itself should be based on importance, performance (status) and risk (look back at how you did/look ahead at plans like new tech or business). If you have a process that's not doing well - audit them first. You then have to have an allowance in there for the schedule to change, again based on poor performance and risk (changes in the business or processes), like having a new person in charge of quality in Q3 ;) [although that one sounds like an opportunity style risk vs negative]. Hope I didn't confuse you further.
 
Thread starter Similar threads Forum Replies Date
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
R AS9100D internal audit checklist or ISO 9001 2015 to AS9100 D AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J Opportunity in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 27
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
K Integrating ISO 9001:2015 with ISO 17025:2017 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Sequence of ISO 9001:2015 Implementation Steps ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Brizilla Employee Data Privacy Policy - ISO 9001:2015 requirement(s)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S ISO 9001:2015 Internal Auditing Internal Auditing 8
Q Process: Knowledge Section 7.1.6 of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
A What must be recorded? (ISO 9001:2015, subclause 10.2) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S ISO 9001:2015 vs 21 CFR Part 211 matrix Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
M Does the ISO 9001:2015 standard require a disaster recovery plan or emergency response plan ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
M ISO 9001:2015 and AS6081:2012 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Implementation ISO 9001: 2015 ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
J Audit Checklist for Integrated Management System for ISO 9001:2015, ISO 14001 & OHSAS18001 (IMS) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
lanley liao How to understand the clause 6 Planning of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
T ISO 9001:2015 - Small Shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M ISO 9001:2015 case study sample ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Sample of Nonconformity report for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Case study help as per ISO 9001: 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
M Case study solution help required as per ISO 9001 : 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
F Logistics and IT clauses in ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
V Quality Objectives - ISO 9001 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
Gun46 ISO 9001 : 2015 Lead Auditor Exam General Auditing Discussions 16
Q ISO 9001:2015 man days for surveillance audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D ISO 9001:2015 4.3 Determining the Scope of the QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
I ISO 9001:2015 Section 9.3.2 C1 "customer satisfaction and feedback from relevant interested parties" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
I ISO-9001:2015 and "Relevant Parties" Management Review Meetings and related Processes 2
I Master Document Access - ISO 9001:2015 clause 7.5.3 Document Control Systems, Procedures, Forms and Templates 5
qualprod Why new clause (7.1.6) in ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
I Where can I beg, steal (just kidding of course) or borrow good training material on the ISO 9001:2015 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Robert Stanley Which Registrar Should I Choose for ISO 9001:2015 registration? Registrars and Notified Bodies 10
M ISO 9001:2015 8.2.1 Contingency Plan required for small Business? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Help with Drawing Review - ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
V ISO 9001:2015 7.2 Competence ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 35
B ISO 9001:2015 Transition: Much Easier Than You Think! Misc. Quality Assurance and Business Systems Related Topics 0
A Process Documentation for ISO 9001:2015 Internal Auditing 2
C Migrate ISO 9001:2015 Certificate Registrars and Notified Bodies 4
J ISO 9001:2015 Small Operation Management Review General Auditing Discussions 6
E Three basic questions about ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C ISO 9001:2015 Monitoring and measuring resources. Application a service industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
W ISO 9001:2015 Management Review Input Template wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
G Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing? Quality Management System (QMS) Manuals 14
N ISO 9001:2015 Customer Complaints Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
O Performance Measurement ISO 9001: 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Does ISO 9001-2015 have a requirement for manufacturing equipment to be numbered? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
V ISO 9001: 2015 Production drawing Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
KCalaba21 ISO 9001:2015 6.2.2 E - "e) how the results will be evaluated." ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3

Similar threads

Top Bottom